All Recommendations
Date of current publication: August X, 2026
Lead author: Kelly S. Ramsey, MD, MPH, MA, FACP, DFASAM
Writing group: Susan D. Whitley, MD; Timothy J. Wiegand, MD, FACMT, FAACT, DFASAM; Leah L. Habersham, MD, MBA, MSCR, MSLIS, FACOG, FASAM; Sharon L. Stancliff, MD, DFASAM; Brianna L. Norton, DO, MPH; Narelle Ellendon, RN; Christopher J. Hoffmann, MD, MPH, MSc, FACP; Charles J. Gonzalez, MD
Committee: Substance Use Guidelines Committee
Date of original publication: July 16, 2021
| ALL RECOMMENDATIONS: TREATMENT OF SUBSTANCE USE (INCLUDING ALCOHOL AND TOBACCO) DURING PREGNANCY |
Potential Adverse Effects of Opioid Use
Buprenorphine or Methadone
Initiating Buprenorphine
Postpartum: NOWS and Breast/Chestfeeding
Potential Adverse Effects of Alcohol Use
Alcohol Withdrawal
AUD Treatment Options
Treatment of Tobacco Use
Cannabis Use
Treatment of Methamphetamine and Cocaine Use Disorder
|
Abbreviations: AUD, alcohol use disorder; BUP, buprenorphine; CIWA-Ar, Clinical Institute Withdrawal Assessment for Alcohol scale, revised; ER, extended release; NOWS, neonatal opioid withdrawal syndrome; NRT, nicotine replacement therapy; OB/GYN, obstetrician/gynecologist; OUD, opioid use disorder; PAWSS, Prediction of Alcohol Withdrawal Severity Scale. |
Purpose of This Guideline
Goals: This guideline on the treatment of substance use disorder (SUD) in pregnant adults (aged ≥18 years) was developed by the New York State Department of Health AIDS Institute (NYSDOH AI) to establish a standard of care in New York State. The goals of this guideline are to:
- Educate clinicians about and promote a harm reduction approach to SUD treatment in pregnant individuals
- Increase clinician awareness of the risks, to the birth parent and the fetus, associated with perinatal substance use
- Provide evidence-based recommendations on pharmacologic and behavioral SUD treatment during pregnancy
Use of this guideline: Many aspects of SUD treatment are the same for pregnant and nonpregnant patients; the recommendations in this guideline are focused on pregnant patients. For recommendations on SUD screening and diagnosis and for additional recommendations on SUD treatment, see the NYSDOH AI guidelines:
- Substance Use Harm Reduction in Medical Care
- Substance Use Screening, Risk Assessment, and Use Disorder Diagnosis in Adults
- Treatment of Opioid Use Disorder
- Treatment of Alcohol Use Disorder
- Clinical Guidance: Stimulant Use
The recommendations presented here address the treatment of SUD in pregnant patients, not the management of pregnancy itself. Communication and coordination among healthcare providers are essential.
Perinatal Harm Reduction
Harm reduction is treatment: A harm reduction approach respects individual autonomy and engages patients in shared decision-making on individualized, practical treatment goals that may reduce the potential negative consequences of substance use. A harm reduction approach can increase patient engagement and improve outcomes. For pregnant patients who use substances or with a substance use disorder (SUD), treatment goals may include:
- Reducing or discontinuing substance use. Most individuals stop or reduce use when they become pregnant but some may be unwilling or unable to do so
- Preventing or minimizing the adverse effects of substance use for the pregnant individual and fetus
- Preventing overdose
- Engaging or staying in prenatal care
- Reducing potentially high-risk behaviors (e.g., injection drug use, use or reuse of unsterile equipment, and sharing drug use equipment) and related complications, such as infection
- Improving quality of life and other social conditions, such as employment and housing, and reducing risk of incarceration
- Providing an opportunity to address and treat other health conditions, such as sexually transmitted infections, HIV, diabetes mellitus, and cardiac issues, which could significantly affect the birth parent and developing fetus/infant
Evidence-based, individualized care for substance use during pregnancy and parenting improves outcomes for the birth parent and infant Barber and Terplan 2023. Even if pharmacologic or behavioral SUD treatment is declined, engaging pregnant individuals in prenatal care may improve pregnancy outcomes and increase engagement in harm reduction strategies. In a retrospective cohort study, pregnant individuals who used substances and obtained prenatal care delivered infants of greater weight and with larger head circumferences than did those who did not obtain care (P <.05) Berenson, et al. 1996. In another retrospective cohort study that stratified results by the level of prenatal care received and current injection drug use status among pregnant individuals, greater engagement in prenatal care improved outcomes El-Mohandes, et al. 2003. The risk of prematurity, low birth weight, and small for gestational age decreased in infants born to individuals engaged in prenatal care regardless of injection drug use status. For additional information, see the National Harm Reduction Coalition and American Perinatal Harm Reduction: Pregnancy and Substance Use: A Harm Reduction Toolkit.
Polysubstance use: Many people who use substances use multiple substances simultaneously. When addressing polysubstance use in pregnant individuals, consider which substance has the potential to cause the most harm to the individual and the developing fetus, which substance the individual is most open or adverse to addressing, and whether there are treatment options that might provide relief. Stimulant or alcohol use during pregnancy can cause harm to the individual and developing fetus. If possible, prioritize alcohol or stimulant use treatment and harm reduction efforts.
Overdose prevention: In the United States from 2018 through 2023, the leading cause of death among pregnant and postpartum individuals was unintentional drug overdose (1,152/7,901 deaths; 5.2 deaths per 100,000 live births) Azad, et al. 2026. As with overall overdose mortality in the United States, pregnancy-associated overdose deaths have been increasingly characterized by synthetic opioid and psychostimulant involvement Han, et al. 2023; Bruzelius and Martins 2022.
| KEY POINT |
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Discussing overdose prevention strategies with pregnant patients who use opioids or stimulants is essential. See Box 1, below.
| Box 1: Overdose Prevention [a] |
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Counsel patients to:
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Note:
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Barriers to care: Pregnant individuals with SUD may face substantial barriers to healthcare access, including lack of transportation and childcare; internalized, enacted, and anticipated stigma; and fear of legal consequences or involvement with child welfare services. Structural racism and bias in the healthcare, child welfare, and legal systems may further contribute to delays in prenatal care and SUD treatment until late in pregnancy or at the point of delivery, which may lead to negative health consequences for the birth parent and the neonate Goodman 2024; Hailu, et al. 2024; Schiff, et al. 2024; Schiff, et al. 2022; Schiff, et al. 2020; Jarlenski, et al. 2019; Angelotta, et al. 2016; House, et al. 2016; Stone 2015; Kunins, et al. 2007.
Efforts to increase engagement in care may involve co-locating and coordinating prenatal, substance use, mental health, harm reduction, and trauma and violence services. Integrating the different aspects of care, including social services, helps pregnant individuals attend appointments, address multiple needs, and participate in clinic programming Rutman, et al. 2020.
Addressing the many biopsychosocial and legal factors that may complicate access to care and treatment for pregnant patients with active substance use can be difficult for individual clinicians and healthcare teams Wakeman, et al. 2021. In outpatient nonspecialty settings, clinic staff can:
- Acknowledge and support the strength and vulnerability required to seek care. Pregnancy presents an opportunity for positive change, and individuals are often motivated to improve their own health and that of their fetus. Engaging patients with empathy and creativity in evidence-based, family-centered care can help channel this motivation.
- Prioritize the patient’s needs. Helping patients address their immediate needs and questions related to pregnancy is often an important starting point before discussing risks related to substance use.
- Be aware of personal bias. Healthcare providers who have conscious or unconscious bias against pregnant individuals who use substances, including alcohol, cannabis, and tobacco, may be reluctant to provide care or may make erroneous judgments about a patient’s fitness as a parent Schiff, et al. 2022; Terplan, et al. 2015. For additional information on addressing bias, see How to Identify, Understand, and Unlearn Implicit Bias in Patient Care.
- Use a trauma-informed care approach. Individuals who use substances are more likely to have experienced childhood emotional, physical, or sexual abuse SAMHSA 2026; Karabulut and Genç 2023; Gould, et al. 2021; Karsberg, et al. 2021; Lotzin, et al. 2019; Mills 2015 and to experience mental health diagnoses, such as anxiety, depression, and posttraumatic stress disorder SAMHSA 2025; Santo, et al. 2022; UNODC 2022; NIDA 2020.
- In all treatment decisions, consider the benefits and risks to both the patient and the fetus. Proactively elicit the patient’s questions about benefits and risks to both them and their fetus. Concern for fetal well-being should not be prioritized over the health of the pregnant patient.
- Advocate for patients. Advocacy includes healthcare providers becoming knowledgeable about protections for pregnant individuals who use substances. In New York State, reports to child protective services are not accepted for substance use during pregnancy, only after delivery. Substance use in parenting individuals, in the absence of other indications of abuse or neglect, should not be reported. For more information on New York State and national reporting requirements, see:
- NYSDOH Office of Addiction Services and Supports: Screening and Testing for Substance Use in Pregnancy
- New York State CAPTA CARA Information & Resources: CAPTA-CARA requires development of a Plan of Safe Care (POSC) for any pregnant patient who is diagnosed with an SUD, is receiving medication for addiction treatment for an SUD, or is under the care and supervision of a healthcare provider who has prescribed opioids.
- New York State Office of Children and Family Services: Guidance for Parents Using Substances or in Recovery: The Role of Child Protective Services (CPS) and Tips for Working Together
- RAND: State Policies Related to Substance Use in Pregnancy
Some pregnant individuals may not be interested in treatment or counseling and will continue using substances throughout their pregnancy. If the clinician focuses solely on treatment and becomes disappointed when a patient does not choose this goal, the patient may disengage from care. Clinicians should avoid shaming patients who continue to use substances and instead engage them in other services, such as prenatal care, supportive counseling, peer support, and harm reduction.
Treatment of Opioid Use Disorder During Pregnancy
| RECOMMENDATIONS |
Potential Adverse Effects of Opioid Use
Buprenorphine or Methadone
Initiating Buprenorphine
Postpartum: NOWS and Breast/Chestfeeding
|
Abbreviations: BUP, buprenorphine; ER, extended release; NOWS, neonatal opioid withdrawal syndrome; OUD, opioid use disorder. |
Potential Adverse Effects
Clinicians should advise pregnant individuals who use opioids to discontinue or minimize use during pregnancy and breast/chestfeeding to prevent harm to themselves and the developing fetus or infant and offer treatment, harm reduction counseling, and support. Using opioids during pregnancy has been associated with an increased risk of preterm birth and stillbirth Bosworth, et al. 2024; Kaltenbach, et al. 2018 and with NOWS Kocherlakota 2014.
Abruptly discontinuing opioids, including BUP or methadone, should be avoided during pregnancy to prevent or minimize withdrawal symptoms in the pregnant individual and potential effects on the fetus. Sudden changes in opioid levels during pregnancy may precipitate effects on the fetus that can harm placental function and increase the risks of NOWS (see discussion below), stunted growth, preterm labor, fetal convulsions, and fetal death Hudak and Tan 2012; Kaltenbach, et al. 1998.
Harm reduction: Individuals should be screened appropriately to identify co-occurring conditions and health risks. As part of a harm reduction approach, it is important to provide screening for bloodborne pathogens, sexually transmitted infections, depression, and nutritional deficiencies and educate patients regarding the risks of shared drug equipment, including pipes, stems, straws, and injection equipment. For discussion on harm reduction, see guideline section Perinatal Harm Reduction.
Buprenorphine or Methadone
BUP or methadone is the standard of care: Treatment with BUP or methadone during pregnancy is associated with reductions in use of opioids and opioid overdose. Treatment is further associated with reduced risk of preterm delivery, low infant birth weight, and transmission of HIV to the neonate Frankeberger, et al. 2023; Suarez, et al. 2022; Minozzi, et al. 2020; ACOG 2017; Binder and Vavrinková 2008. Although infants exposed to methadone or BUP may develop NOWS, use of these medications improves outcomes for the birth parent and neonate compared with no treatment Brogly, et al. 2014; Kocherlakota 2014.
| KEY POINT |
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Table 1, below, lists selected considerations for choosing BUP or methadone for OUD treatment during pregnancy. Methadone is available only through licensed opioid treatment programs (OTPs); see New York State Office of Addiction Services and Supports for OTPs in New York State. BUP can be prescribed in primary care and other outpatient settings; see Initiating Buprenorphine, below.
Patients using fentanyl may experience challenges with BUP initiation due to the lipophilicity of fentanyl and the increased risk of precipitated opioid withdrawal if BUP initiation is timed and/or dosed incorrectly Sue, et al. 2022; Varshneya, et al. 2022; Silverstein, et al. 2019. With low-dose initiation strategies, precipitated opioid withdrawal syndrome can be avoided and pregnant individuals may be able to successfully initiate BUP. Additionally, withdrawal from sedative adulterants (e.g., xylazine, medetomidine, synthetic benzodiazepines) in the unregulated opioid drug supply may complicate management. For newly pregnant individuals with untreated OUD, methadone may be easier to initiate and titrate Nguemeni Tiako, et al. 2024. If pregnant patients cannot successfully initiate BUP, methadone may be an alternative option.
| Abbreviations: BUP, buprenorphine; NOWS, neonatal opioid withdrawal syndrome; OB/GYN, obstetrics and gynecology; OTP, opioid treatment program; OUD, opioid use disorder.
Note: |
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| Table 1: Considerations for Choosing Methadone or Buprenorphine for Opioid Use Disorder Treatment During Pregnancy | ||
| Factor | Buprenorphine | Methadone |
| Setting | BUP is available through office-based care via prescription, at low-threshold harm reduction programs, or at OTPs. |
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| Initiation requirement |
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Withdrawal is not required. |
| Efficacy in pregnant patients |
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| Dosing |
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| Treatment duration |
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| Changing from one medication to the other | Switching from BUP to methadone can be considered if needed to control cravings and avoid opioid withdrawal. | Switching from methadone to BUP is not advised because of the potential for precipitated opioid withdrawal symptoms. If a switch is clinically necessary or preferred by the patient, consult a clinician experienced in OUD treatment. |
| Adverse effects |
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| Acute pain management |
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| Breast/chestfeeding | Both medications are safe for breast/chestfeeding LactMed 2026g; LactMed 2026b. | |
Naltrexone: The NYSDOH AI guideline Treatment of Opioid Use Disorder > Naltrexone recommends naltrexone as an alternative OUD treatment option for nonpregnant individuals who cannot take BUP or methadone or prefer naltrexone. However, if a pregnant individual is currently using opioids, initiating naltrexone is not recommended because it requires acute withdrawal from opioids and the evidence base is limited on naltrexone effects during pregnancy FDA 2025; Atluru, et al. 2024; Towers, et al. 2020; ACOG 2017; Jones, et al. 2013; Hulse, et al. 2004. If a patient taking naltrexone becomes pregnant, clinicians should inform them of the benefits and risks of naltrexone, discuss BUP and methadone as preferred options, and engage in shared decision-making. Naltrexone blocks the mu-opioid receptor, decreasing opioid cravings, and with no in utero opioid exposure, poses no risk of NOWS in the neonate. Data are insufficient regarding naltrexone’s teratogenicity, effect on milk production, or effects on infants exposed through breast/chestfeeding (see naltrexone prescribing information FDA 2025). Additionally, naltrexone reduces opioid tolerance, which could result in overdose if the patient resumes opioid use. If the patient opts to discontinue naltrexone and initiate BUP or methadone, clinicians should educate them about the potential for NOWS.
Initiating Buprenorphine
Initiating BUP: Ideally, BUP initiation in pregnant patients should be managed in a manner that minimizes the risks of precipitated opioid withdrawal (see the Clinical Opiate Withdrawal Scale and Subjective Opiate Withdrawal Scale) Wesson and Ling 2003; Handelsman, et al. 1987. Clinicians less experienced in treating pregnant patients with OUD should consult an expert in BUP treatment before initiating BUP in pregnant patients. Recommendations for BUP initiation in nonpregnant individuals have been revised in response to the increase in fentanyl and other highly potent synthetic opioids in the unregulated drug supply. Reports indicate that standard BUP initiation in patients taking synthetic opioids is associated with a higher risk of precipitated opioid withdrawal Sue, et al. 2022; Varshneya, et al. 2022; Silverstein, et al. 2019.
| KEY POINTS |
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Alternatives such as low-dose BUP initiation with opioid continuation (LDB-OC; previously known as microdosing or microinduction) and high-dose initiation have been explored Weimer, et al. 2023. Currently, the NYSDOH AI guideline Treatment of Opioid Use Disorder recommends that clinicians use LDB-OC or a standard initiation approach in nonpregnant adults. With LDB-OC, a small initial dose (e.g., BUP 0.5 mg/naloxone [NLX] 0.125 mg) is followed by incremental increases over 7 days; patients can continue to use other opioids until the therapeutic level of BUP/NLX is reached.
To date, LDB-OC has not been studied in pregnant individuals, but in a systematic review of 7 observational studies, 6 of the 25 patients analyzed experienced minimal, mild, or moderate withdrawal symptoms during LDB-OC initiation, and only 2 experienced precipitated withdrawal Grenier, et al. 2026; Koenigs, et al. 2024; Patel and Parilla 2024; Galati, et al. 2021; Irwin, et al. 2021. The median gestational age in the studies was 26 weeks (9 to 40 weeks), so initiation occurred at different gestational ages. Minimal, mild, or moderate withdrawal was not consistently reported in the studies reviewed. These findings align with those among nonpregnant individuals using LDB-OC initiation.
High-dose BUP initiation (initial BUP dose of >8 mg and rapid up-titration within 1 day) requires onset of opioid withdrawal. Most published experience with high-dose BUP initiation has been with individuals with moderate to severe opioid withdrawal evaluated in the emergency department [D’Onofrio, et al. 2023; Snyder, et al. 2023; Herring, et al. 2019]. However, in a small retrospective case series among 6 pregnant individuals with OUD who initiated high-dose BUP, there were no instances of sedation, respiratory depression, supplemental oxygen use, or death, and all 6 individuals were successfully transitioned to BUP Berry, et al. 2024. The individuals received an initial 8 mg sublingual BUP dose and then an additional 8 mg BUP every 30 to 60 minutes as needed based on withdrawal severity (maximum of 32 mg/day). These findings provide support for high-dose BUP initiation in pregnancy, but data from larger studies are needed. A high-dose BUP initiation would be most appropriate in individuals who are already experiencing opioid withdrawal syndrome (e.g., post-NLX administration) and are in a controlled setting.
Initiation of other formulations of BUP (injectable, transdermal patch) and/or full-agonist opioids may have a role for pregnant individuals but has not been well studied. In a randomized controlled trial among pregnant individuals in an outpatient setting, abstinence from opioids was higher among those receiving ER injectable BUP (weekly) than those taking sublingual BUP Winhusen, et al. 2026.
| RESOURCE |
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Continuing OUD treatment through pregnancy, labor, delivery, and postpartum: Patients with OUD who initiate BUP or methadone during pregnancy or who become pregnant while taking either medication should continue treatment with the same medication throughout the intra- and postpartum periods Frankeberger, et al. 2023; Meyer, et al. 2015; Lund, et al. 2013; Jones, et al. 2010.
An increased dose or split dosing of BUP or methadone may be required in the second and third trimesters because of increased blood volume and metabolism later in pregnancy Bastian, et al. 2017; Albright, et al. 2011; Cleary, et al. 2010. Patients may opt to split their BUP dose during the day if it more effectively controls cravings and withdrawal symptoms. Clinicians should assess withdrawal symptoms and opioid cravings at every visit, and if pregnant patients report opioid withdrawal symptoms or opioid cravings, the BUP dose should be increased, typically in increments of 2 mg to 4 mg per day. Patients may require BUP dose increases up to 32 mg daily. It is essential to ensure the patient understands that increasing the dose of BUP or methadone is not associated with an increased risk of NOWS Wong, et al. 2018; Cleary, et al. 2010; Jones, et al. 2008.
If treatment goals are not being met with BUP during pregnancy, clinicians should discuss methadone with the patient and offer referral to an OTP for methadone treatment if available ACOG 2017. Transitioning from BUP to methadone does not pose a risk of precipitated opioid withdrawal SAMHSA 2024. However, during pregnancy, a switch from methadone to BUP is not recommended because the transition could cause precipitated opioid withdrawal symptoms and may require inpatient care and monitoring to decrease the risk of miscarriage or premature delivery. If, despite knowledge of these risks, a pregnant patient requests a change from methadone to BUP, consult with an expert in OUD treatment during pregnancy.
Acute pain management: At minimum, the OUD treatment dose of BUP or methadone is maintained ASAM 2019. Nonopioid medications are the first-line option for acute pain management during pregnancy, delivery, and postpartum (e.g., after cesarean section). Adding a short-acting full-agonist opioid can be considered when clinically indicated to manage moderate to severe acute pain. When adding a full-agonist opioid analgesic, patients with OUD will likely need higher dosing than opioid-naive patients to achieve adequate analgesia ASAM 2019. Additionally, if the patient is not already splitting their dose of methadone or BUP, split dosing can improve acute pain management.
Telehealth: Telehealth has emerged as a promising modality for increasing access to OUD care, but few outcomes have been reported for pregnant individuals within dedicated telehealth settings. In a nonrandomized controlled trial, pregnant participants receiving virtually integrated OUD care in obstetric practices had outcomes for themselves and their newborns similar to those of pregnant participants receiving in-person care Guille, et al. 2020. Outcomes included uninterrupted OUD treatment during pregnancy through 6 to 8 weeks postpartum, urine drug screening results at delivery and 6 to 8 weeks postpartum, and diagnosis of NOWS. A retrospective cohort study evaluated OUD treatment and pregnancy outcomes among individuals aged ≥18 years taking or initiating BUP or BUP/NLX who were engaged in a low-barrier, dedicated telehealth OUD care program Coffey, et al. 2024. Nearly 80% of participants received continuous OUD treatment throughout pregnancy.
Postpartum: Neonatal Opioid Withdrawal Syndrome and Breast/Chestfeeding
NOWS: Clinicians should inform pregnant individuals taking opioids, including BUP or methadone, that in utero exposure may result in NOWS Kraft, et al. 2016; McQueen and Murphy-Oikonen 2016; Gawronski, et al. 2014; Hall, et al. 2014. Prenatal treatment with BUP or methadone, compared with ongoing use of opioids, can reduce the severity of NOWS symptoms Brogly, et al. 2014; Fajemirokun-Odudeyi, et al. 2006. Advising patients early in the pregnancy that NOWS is an expected and treatable outcome may reduce stress after delivery. Treatment goals for an infant with NOWS are to minimize the severity and duration of withdrawal symptoms, reduce the length of hospital stay, and reduce the need for and duration of adjunctive therapies. See Table 2, below, for NOWS characteristics and treatment.
| Box 2: Characteristics and Treatment of Neonatal Opioid Withdrawal Syndrome (NOWS) |
Presentation
Diagnosis
Treatment Options
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Breast/chestfeeding: Advise individuals to discontinue breast/chestfeeding if actively using opioids LactMed 2026f; LactMed 2025; Harris, et al. 2023; ACOG 2017 and discuss harm reduction strategies (see the Washington State Department of Health guide Opioids and Lactation WADOH 2023).
Breast/chestfeeding is safe when a patient is taking BUP, methadone, or naltrexone LactMed 2026i; LactMed 2026g; LactMed 2026b. Additionally, breast/chestfeeding has been shown to decrease the risk of NOWS and decrease the initiation and duration of pharmacologic treatment and the length of hospital stay when NOWS does occur Chu, et al. 2022. This benefit is likely due to the skin-to-skin contact inherent in breast/chestfeeding rather than the minuscule amount of BUP or methadone in human milk. For postpartum individuals who also have HIV and are virally suppressed, breast/chestfeeding is an option if the birth parent chooses CDC 2025; Pollock and Levison 2023; see NYSDOH AI NYS Good Practices to Prevent Perinatal HIV Transmission > Infant Feeding. Hepatitis C virus infection is not a contraindication to breast/chestfeeding if the skin of the nipple and areola are intact. Active herpes simplex virus on or around the nipple is a contraindication to breast/chestfeeding.
Ongoing OUD treatment and patient support: In the postpartum period, the birthing parent should continue taking BUP or methadone for as long as a benefit is derived. If the patient’s dose of BUP or methadone was increased during pregnancy, the increase should be maintained until the clinician and patient can re-evaluate. Postpartum doses should not be decreased arbitrarily to pre-pregnancy doses.
Following delivery, a patient who is taking OUD treatment will require continued support. The postpartum period can be stressful for new parents, particularly if they lack social support and have comorbidities, such as mental health or chronic medical conditions. One study found that individuals who gave birth to infants with NOWS had a significantly higher incidence of major depression, postpartum depression, and anxiety in the 12 months postpartum than matched controls Corr, et al. 2020. During this period, individuals who use opioids are at increased risk for recurrence of use and unintentional overdoses Frankeberger, et al. 2023; Schiff, et al. 2018. A population-based study in Massachusetts found that overdose events decreased as pregnancy progressed and were lowest in the third trimester (3.3/100,000 person-days), with the highest risk of overdose at 7 to 12 months after delivery (12.3/100,000 person-days) Schiff, et al. 2018. See guideline section Perinatal Harm Reduction > Overdose prevention.
Treatment of Alcohol Use and Alcohol Use Disorder During Pregnancy
This section of the guideline addresses alcohol use and alcohol use disorder (AUD), because the risk of harm to the fetus is greater with any level of alcohol use than with non–physiological-dependent use of other substances.
Some aspects of AUD treatment for pregnant individuals are similar to those for nonpregnant individuals. The recommendations below focus on differences in treatment during pregnancy; consult the NYSDOH AI guideline Treatment of Alcohol Use Disorder for additional recommendations.
| RECOMMENDATIONS |
Potential Adverse Effects of Alcohol Use
Alcohol Withdrawal
AUD Treatment Options
|
Abbreviations: AUD, alcohol use disorder; CIWA-Ar, Clinical Institute Withdrawal Assessment for Alcohol scale, revised; OB/GYN, obstetrician/gynecologist; PAWSS, Prediction of Alcohol Withdrawal Severity Scale. |
Potential Adverse Effects
Healthcare providers should encourage pregnant individuals who use alcohol or have AUD to discontinue or minimize use during pregnancy and breast/chestfeeding. There is no known safe amount of alcohol use during pregnancy, and there is clear evidence that binge drinking and heavy drinking during pregnancy are associated with adverse fetal effects Carson, et al. 2017; Flak, et al. 2014; O'Leary and Bower 2012. Because of the potentially serious dose-dependent effect of in utero alcohol exposure on the fetus and neonate, discontinuing or minimizing use is recommended Chang 2026; May, et al. 2016. Patients with physiological dependence should not discontinue alcohol use abruptly—cessation for such patients may require expert consultation or inpatient treatment to safely manage alcohol withdrawal.
Alcohol use during pregnancy may increase the risk of miscarriage, stillbirth, and preterm delivery, and the risks may be more pronounced with heavy alcohol use Bailey and Sokol 2011. However, it remains unclear how sociodemographic factors that co-occur with alcohol use during pregnancy interact with alcohol use or contribute to outcomes. In a large cohort study from Korea, a diagnosis of AUD preceding delivery was associated with an increased risk of intrauterine growth restriction but not associated with other birth complications Oh, et al. 2020. The increased risk was more marked in individuals diagnosed with AUD in the 12 months preceding delivery.
According to the Centers for Disease Control and Prevention, up to 1 in 20 school-aged children in the United States may have fetal alcohol spectrum disorders (FASDs) CDC 2024; May, et al. 2018. Subtle manifestations of FASD include mild learning disabilities or physical abnormalities; severe manifestations include central nervous system dysfunction, low IQ, microcephaly, delayed growth, and facial abnormalities Miller 2018. A multisite study using active case ascertainment methods estimated an FASD prevalence rate of 1% to 5% among first graders exposed to alcohol in utero Muggli, et al. 2017. In a study that compared children aged 9 and 10 years with and without prenatal alcohol exposure, exposure was associated with increased psychopathology, attention deficits, and impulsiveness Lees, et al. 2020.
Harm reduction: There is substantial evidence that alcohol use during pregnancy can harm the individual, developing fetus, and child. If patients are using alcohol and other substances, alcohol use should be a priority for treatment and harm reduction efforts. Clinicians should discuss and encourage harm reduction strategies for pregnant individuals who use alcohol. Pregnant individuals who cannot or will not discontinue alcohol use may be able to decrease use or address other treatment goals. Harm reduction approaches during pregnancy have been shown to decrease alcohol use, reduce healthcare costs, improve engagement and retention in prenatal services and substance use treatment, and improve health outcomes for parents and their children Racine, et al. 2009; Poole and Greaves 2007. See guideline section Perinatal Harm Reduction.
Alcohol Withdrawal
Pregnancy is considered a relative contraindication for ambulatory management of alcohol withdrawal. For pregnant individuals with a score of ≥10 on the CIWA-Ar scale, a score of ≥4 on the PAWSS, or at risk of moderate, severe, or complicated alcohol withdrawal, a referral for inpatient withdrawal management is recommended ASAM 2020. Healthcare providers should consult with an OB/GYN during withdrawal management ASAM 2020.
Symptoms of alcohol withdrawal syndrome include autonomic hyperactivity (sweating, tachycardia); increased hand tremors; insomnia; nausea; vomiting; transient hallucinations or perceptual disturbances of the auditory, visual, or tactile type; psychomotor agitation; anxiety; and generalized seizures Kattimani and Bharadwaj 2013. Physiological and psychological stress during pregnancy can adversely affect the pregnant individual and the fetus and result in preterm birth and low birth weight DeVido, et al. 2015; Enlow, et al. 2009; Hobel, et al. 2008.
Benzodiazepines are commonly used to treat alcohol withdrawal in nonpregnant adults, but data on the safety of benzodiazepines during pregnancy are unclear DeVido, et al. 2015. In a review of 12 studies, fetal exposure to benzodiazepines in the first trimester was not associated with an increased risk of congenital disabilities Bellantuono, et al. 2013. The World Health Organization and the American Society of Addiction Medicine recommend short-term, limited use of benzodiazepines in pregnant individuals who require treatment for alcohol withdrawal, noting the need to balance the risk of fetal adverse events with the potential harm of complications of severe alcohol withdrawal ASAM 2020; WHO 2014. Management with benzodiazepines may begin with clonazepam in the first or second trimester and with lorazepam in the third trimester or during postpartum breast/chestfeeding because of the lower associated risk to the infant Habersham, et al. 2025.
Treatment Options
Pharmacologic treatment: Initiating pharmacologic treatment in pregnant patients with AUD, or continuing treatment in patients who become pregnant, requires a discussion of the benefits and risks and shared decision-making with patients Kelty, et al. 2019. With effective treatment, a pregnant individual may be able to reduce or discontinue alcohol use, which may improve birth-parent health and will minimize fetal exposure to alcohol and the risk of associated harms, such as FASD Reece-Stremtan and Marinelli 2015; WHO 2014. However, few data are available from well-controlled studies of pharmacologic AUD treatment in pregnant individuals, and the potential carcinogenic, mutagenic, or fertility effects in humans are unknown Minozzi, et al. 2024.
In nonpregnant individuals, acamprosate and naltrexone are preferred agents for treatment of AUD. Given the potential risks associated with alcohol consumption during pregnancy, the use of acamprosate and naltrexone may be considered for the treatment of pregnant individuals with AUD. Based on the available research of use during pregnancy, acamprosate and naltrexone do not appear to be associated with substantial risks of congenital malformations or other serious consequences Kelty, et al. 2021. Gabapentin and disulfiram are alternative agents for the treatment of AUD in nonpregnant adults. Gabapentin does not appear to be associated with substantial risks and may also be considered during pregnancy but should be used with caution during the third trimester, as its use is associated with a higher risk of preterm birth, small for gestational age, and NICU admission Kelty, et al. 2021; Patorno, et al. 2020. Disulfiram use may cause serious fetal harm and is not advised during pregnancy FDA 2020.
Breast/chestfeeding while taking acamprosate is not recommended. It is unknown whether breast/chestfed infants are exposed to acamprosate through human milk FDA 2012. Naltrexone use is not contraindicated during breast/chestfeeding; limited data indicate that naltrexone is minimally excreted into human milk LactMed 2026i.
Behavioral treatment: Clinicians should provide or refer pregnant individuals who use alcohol for counseling or other behavioral treatment. Meta-analyses have found that behavioral interventions effectively increase abstinence during pregnancy and prevent preterm birth Minozzi, et al. 2024; Popova, et al. 2023; Ujhelyi Gomez, et al. 2021; Minozzi, et al. 2020.
There is wide variability in the efficacy of behavioral interventions, and recommendations and referrals should be tailored to the individual patient’s needs and preferences. Cognitive behavioral therapy, motivational interviewing, contingency management, or digital interventions may help a pregnant individual minimize substance use Oh, et al. 2022; WHO 2014. Referral options may include intensive outpatient substance use treatment, mental health treatment, peer support groups (e.g., 12-step, SMART Recovery), electronic apps (e.g., SMART Recovery, In the Rooms), public health services, recovery centers, other community-based recovery coaching, and other available psychosocial interventions. Based on the individual patient’s needs and preferences, inpatient or residential treatment may also be considered.
Alcohol Use and Breast/Chestfeeding
The effects of alcohol use during lactation are complex, and there is conflicting evidence on the effects of infant exposure to alcohol in human milk May, et al. 2016; Haastrup, et al. 2014. Alcohol is excreted into human milk in concentrations similar to those in birth-parental blood, meaning that the amount of alcohol ingested by an infant through human milk is a fraction of the amount consumed by the birth parent. Alcohol can disrupt breast/chestfeeding by decreasing milk production and let down LactMed 2026a. However, the effect of occasional alcohol consumption on milk production appears small, temporary, and clinically insignificant Haastrup, et al. 2014. See Box 3, below, for harm reduction strategies and LactMed > Alcohol for a full discussion on the effects of alcohol use during breast/chestfeeding.
| Box 3: Harm Reduction Strategies for Alcohol Use While Breast/Chestfeeding |
|
The National Harm Reduction Coalition and the Academy of Perinatal Harm Reduction Pregnancy and Substance Use: A Harm Reduction Toolkit advises that individuals who use alcohol and are breast/chestfeeding:
|
Treatment of Tobacco Use Disorder During Pregnancy
| RECOMMENDATION |
Treatment of Tobacco Use
|
Abbreviation: NRT, nicotine replacement therapy. |
Potential Adverse Effects
Clinicians should advise pregnant patients to discontinue or minimize tobacco use during pregnancy. The perinatal risks associated with tobacco use during pregnancy include orofacial clefts, fetal growth restriction, placenta previa, abruptio placentae, preterm birth, low birth weight, increased perinatal mortality, ectopic pregnancy, and decreased maternal thyroid function ACOG 2020. In addition, an estimated 22% of cases of sudden infant death syndrome in the United States can be directly attributed to maternal smoking during pregnancy Anderson, et al. 2019, and children born to women who smoke during pregnancy are at an increased risk of respiratory infections, asthma, bone fractures, infantile colic, and childhood obesity ACOG 2020.
Harm reduction: In addition to educating patients about the risks associated with perinatal tobacco/nicotine use, clinicians should offer treatment and provide harm reduction counseling. See guideline section Perinatal Harm Reduction.
Treatment Options
Pharmacologic treatment: Clinicians should provide information about available pharmacologic treatment and, if patient is unable to independently cease smoking, offer NRT, bupropion, varenicline, or a combination of these medications. The choice is guided by patient preference. Treatment considerations specific to pregnancy are outlined in Table 2, below.
| Table 2: Pharmacologic Treatment for Tobacco Use Disorder During Pregnancy | |
| Treatment | Considerations |
| Nicotine replacement therapy (NRT) (i.e., patch, gum, lozenge, nasal spray, or inhaler) |
|
| Bupropion |
|
| Varenicline |
|
E-cigarettes: Limited data are available on the effectiveness and safety of e-cigarettes for smoking cessation among adults Patnode, et al. 2021. In randomized studies, regular use of e-cigarettes was not associated with adverse pregnancy outcomes Pesola, et al. 2024; Przulj, et al. 2023.
Behavioral treatment: For pregnant individuals who use tobacco, clinicians should perform or refer for smoking cessation counseling or other behavioral treatment. In a systematic review, pharmacotherapy, behavioral interventions, and e-cigarettes for tobacco cessation were examined, and behavioral interventions (compared with no intervention) were associated with greater smoking cessation during late pregnancy Patnode, et al. 2021. An earlier meta-analysis found that counseling, feedback, and incentive-based programs (contingency management [CM]) increased the proportion of individuals who stopped smoking in late pregnancy and were associated with a 17% reduction in low birthweight, a significantly higher mean birthweight, and a 22% reduction in neonatal intensive care unit admissions infants Chamberlain, et al. 2017. In 2 CM studies, financial incentives were associated with an increased smoking abstinence rate in pregnant smokers in France Berlin, et al. 2021 and were highly effective as an addition to routine stop smoking services in the United Kingdom (although most participants who stopped smoking returned to use after delivery) Tappin, et al. 2022. Evidence is accumulating on the efficacy of CM as a component of treatment, but CM is not readily available in the clinical setting.
The efficacy of behavioral interventions varies widely, and recommendations and referrals should be tailored to the individual patient’s needs and preferences.
| RESOURCES |
Providers
Patients
|
Breast/Chestfeeding
Clinicians should advise patients to discontinue or minimize tobacco use while breast/chestfeeding and engage patients in harm reduction counseling. Smoking tobacco decreases milk supply and often causes individuals to stop breast/chestfeeding early LactMed 2026j; Hopkinson, et al. 1992; Vio, et al. 1991. See Table 3, above, for potential risks associated with breast/chestfeeding while taking medications used for tobacco use disorder treatment and LactMed > Nicotine for a full discussion on the effects of nicotine use during breast/chestfeeding.
| KEY POINT |
|
Treatment of Cannabis Use During Pregnancy
| RECOMMENDATIONS |
Cannabis Use
|
Potential adverse effects: Clinicians should discuss the potential risks, to the patient and their fetus or infant, associated with prenatal cannabis use and encourage patients to discontinue or minimize use during pregnancy. Prenatal cannabis use has been associated with an increased risk of low birth weight, small for gestational age, and preterm birth among other potential effects Young-Wolff, et al. 2024b; Avalos, et al. 2024; Baía and Domingues 2024; Lo, et al. 2024; Duko, et al. 2023; Marchand, et al. 2022. Some studies suggest a dose-dependent effect, with higher odds of negative outcomes among pregnant individuals who reported heavy use and with continued use during the second and third trimesters Baía and Domingues 2024. More evidence from controlled studies is needed on the effects of the timing and frequency of use, the route of administration, tetrahydrocannabinol level and potency of the cannabis, and polysubstance use, particularly tobacco use. Many studies related to prenatal cannabis use have mixed or inconclusive outcomes and are not well controlled for other confounders, such as tobacco use, socioeconomic status, and use of other substances Ainiti, et al. 2023; Delker, et al. 2023; Sujan, et al. 2023; Thompson, et al. 2023.
Harm reduction: Explore with patients the reasons why they are using cannabis. Many individuals use cannabis during pregnancy to counteract negative effects of pregnancy, such as nausea and vomiting, anxiety, sleep disturbances, and pain, and clinicians can discuss alternative treatment options with patients Young-Wolff, et al. 2024a; Chang, et al. 2019; Wang 2017; Young-Wolff, et al. 2017. Clinicians should help pregnant patients who use cannabis identify strategies for harm reduction, including reduced use and ongoing engagement in prenatal care Vanstone, et al. 2022 (see guideline section Perinatal Harm Reduction). There is no evidence to support use of medical cannabis to manage pregnancy-associated nausea and vomiting ACOG 2025. For pregnant patients who use unregulated cannabis to treat specific symptoms, such as those associated with posttraumatic stress disorder, medical cannabis may be the safer choice if they plan to continue using. See NYSDOH AI guideline Therapeutic Use of Medical Cannabis in New York State for more information.
Treatment: No pharmacologic treatments for cannabis use disorder (CUD) are approved by the U.S. Food and Drug Administration. For behavioral CUD treatment, a systematic review of interventions including brief counseling, cognitive behavioral therapy, motivational interviewing, motivational enhancement therapy with cognitive behavioral therapy, computer-delivered psychotherapy, and psychoeducation concluded that interventions involving cognitive behavioral therapy and motivational interviewing may help decrease cannabis use during pregnancy Groff, et al. 2023.
Breast/chestfeeding: Few data are available on the risks of active cannabis use in any form while breast/chestfeeding, and no clear guidance is available on the length of time to wait after cannabis use before breast/chestfeeding. When counseling patients with CUD who are breast/chestfeeding their infant, it is important to discuss potential risks, reasons for cannabis use, and possible alternatives to use LactMed 2026d; ACOG 2025; Metz and Borgelt 2018. Extrapolating from the association between tobacco smoking and sudden infant death syndrome, patients should be advised to avoid smoking cannabis around infants Anderson, et al. 2019.
| RESOURCES |
|
Treatment of Methamphetamine and Cocaine Use During Pregnancy
The recommendations and text below focus on use of methamphetamine and cocaine. For full recommendations and evidence review, see the American Society of Addiction Medicine/American Academy of Addiction Psychiatry (ASAM/AAAP) stimulant use disorder guideline.
| RECOMMENDATIONS |
Treatment of Methamphetamine and Cocaine Use Disorder
|
Potential adverse effects: Clinicians should discuss the risks, to the patient and the fetus or infant, associated with prenatal methamphetamine or cocaine use and encourage patients to discontinue or minimize use during pregnancy.
Prenatal stimulant use has been associated with lower birth weight, preterm delivery, and other complications Perez, et al. 2022; Graves, et al. 2021; Oni-Orisan, et al. 2021; Dos Santos, et al. 2018; Kalaitzopoulos, et al. 2018; Gouin, et al. 2011. Results from studies examining the effects of prenatal methamphetamine exposure on early childhood outcomes (up to 7.5 years) are mixed but point to the influence of other factors (e.g., quality of home, caregiver psychological symptoms) on child behavior in this population Chu, et al. 2020; Eze, et al. 2016. The association between the amount and duration of cocaine use and long-term effects on infants exposed in utero is unclear Cestonaro, et al. 2022. Many studies related to prenatal stimulant use have mixed or inconclusive outcomes and are not well controlled for other confounders, such as tobacco use, socioeconomic status, and use of other substances Suarez, et al. 2024b; Kunkler, et al. 2022; Pham, et al. 2020.
Educate pregnant patients who use stimulants that newborns exposed in utero may exhibit symptoms, such as irritability, hypertonia, tremors, high-pitched crying, and poor sleep regulation, which generally peak 2 to 3 days after birth. These symptoms reflect neurotoxicity or direct substance effects rather than neonatal withdrawal syndrome as observed with opioid exposure Shah, et al. 2025. Preferred treatment strategies for the newborn include low-stimulation environments (quiet with low lighting), on-demand feeding, parental presence, swaddling, calming, and cuddling Yazı, et al. 2025. Consider involving a neonatologist as needed for infant symptoms. Advising patients of the potential for these symptoms and the treatment approach early in the pregnancy may reduce stress after delivery.
Harm reduction: Clinicians should provide harm reduction counseling, including overdose prevention, and referrals for pregnant individuals who use methamphetamines. Persons using stimulants may be either accidentally or intentionally exposed to opioids, so should be educated regarding and provided with naloxone and fentanyl test strips. Evidence suggests that individuals using methamphetamines are more vulnerable, marginalized, and low-income and experience more sexually transmitted infections, sexual and domestic violence, unintended pregnancies, and mental health conditions than pregnant individuals who use other substances Perez, et al. 2022; Graves, et al. 2021; Wakeman, et al. 2021. Individuals should be screened appropriately to identify risks. As part of a harm reduction approach, it is important to provide screening for bloodborne pathogens, sexually transmitted infections, depression, and nutritional deficiencies and to educate patients regarding the risks of shared drug equipment, including pipes, stems, straws, and injection equipment.
There is substantial evidence that stimulant use during pregnancy can harm the individual, developing fetus, and infant. If patients are using stimulants and other substances, stimulant use may be a priority for treatment and harm reduction efforts.
Treatment for intoxication and withdrawal: Stimulant intoxication and withdrawal can result in acute issues and complications that require urgent medical management. Overamping is the term for a stimulant “overdose” and can involve both physical and psychological symptoms, such as agitation, psychosis, and risk of harm to self or others. A basic assessment of vital signs and focused mental status evaluation can determine the need for urgent or emergent treatment or referral for further medical evaluation ASAM/AAAP 2024.
Mild stimulant intoxication can typically be managed with behavioral and environmental interventions meant to help the patient feel calm and safe, including isolation in a non-stimulating environment (quiet with low lighting); supportive care such as vitamins, fluids, electrolytes, and nutrition; and reassuring communication with the patient ASAM/AAAP 2024.
For recommendations and a full discussion on managing intoxication and withdrawal, see ASAM/AAAP Clinical Practice Guideline on the Management of Stimulant Use Disorder.
Pharmacologic treatment for stimulant use disorder (StUD): No medications are approved by the U.S. Food and Drug Administration to treat StUD in pregnant or nonpregnant patients. However, several treatment regimens have been associated with reductions in stimulant use in some nonpregnant individuals with cocaine or methamphetamine use disorder. See NYSDOH AI Clinical Guidance: Stimulant Use > Treatment. There is minimal direct evidence on the efficacy and safety of medications for treatment of StUD in pregnant patients. Clinicians should seek guidance from substance use treatment specialists on treatment options and engage in shared decision-making with patients on the benefits and risks, including the risk of ongoing use of stimulants. Risk level may vary based on trimester. Concern for fetal well-being should not be prioritized over the health of the pregnant patient ASAM/AAAP 2024. Bupropion with or without naltrexone and mirtazapine are reasonable StUD treatment options during pregnancy Chavan, et al. 2025. Patients should be referred to substance use treatment specialists if psychostimulant treatment for StUD is being considered. Topiramate, valproic acid, modafinil, and amphetamine/dextroamphetamine are generally contraindicated during pregnancy.
Behavioral treatment: In agreement with the current ASAM/AAAP guidelines, this committee recommends that clinicians offer or refer pregnant patients who use stimulants for behavioral treatment, including parent-focused and family-based treatment to address other needs. When available, evidence-based contingency management (CM) programs should be used to incentivize attendance at prenatal appointments ASAM/AAAP 2024; Washio, et al. 2021; Ronsley, et al. 2020. In nonpregnant adults, evidence indicates that CM is more effective than other behavioral or pharmacologic treatments for stimulant use disorder ASAM/AAAP 2024; Bentzley, et al. 2021; De Crescenzo, et al. 2018, but studies are limited among pregnant adults Hand, et al. 2017. Evidence supports the efficacy of CM as a component of treatment, but CM is not readily available in many clinical settings.
Telemedicine and digital therapeutics or web-based platforms to deliver behavioral interventions may help individuals with challenges accessing care ASAM/AAAP 2024. Based on the individual patient’s needs and preferences, inpatient or residential treatment may also be considered.
For discussion of behavioral treatment for StUD, see ASAM/AAAP Clinical Practice Guideline on the Management of Stimulant Use Disorder > Population-Specific Considerations > Pregnant and Postpartum Patients.
Breast/chestfeeding: Breast/chestfeeding is not recommended for individuals actively using cocaine or methamphetamines. Both substances are excreted in human milk LactMed 2026h; LactMed 2026e; Graves, et al. 2021. Based on very limited data, waiting 48 to 100 hours after methamphetamine use LactMed 2026h; Chomchai, et al. 2016; Bartu, et al. 2009 and 24 hours after cocaine use LactMed 2026e; Cressman, et al. 2012a to breast/chestfeed have been suggested to allow for drug elimination.
Ongoing support: Provide additional treatment support around the time of birth, as the postpartum period may be a time of increased stress and risk of return to stimulant use ASAM/AAAP 2024.
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Updates, Authorship, and Related Guidelines
| Updates, Authorship, and Related Guidelines | |
| Date of original publication | July 16, 2021 |
| Date of current publication | August , 2026 |
| Highlights of changes, additions, and updates in the August , 2026 edition |
Comprehensive update |
| Intended users | Primary care clinicians and care providers in other adult outpatient care settings |
| Lead author |
Kelly S. Ramsey, MD, MPH, MA, FACP, DFASAM |
| Writing group |
Susan D. Whitley, MD; Timothy J. Wiegand, MD, FACMT, FAACT, DFASAM; Leah L. Habersham, MD, MBA, MSCR, MSLIS, FACOG, FASAM; Sharon L. Stancliff, MD, DFASAM; Brianna L. Norton, DO, MPH; Narelle Ellendon, RN; Christopher J. Hoffmann, MD, MPH, MSc, FACP; Charles J. Gonzalez, MD |
| Author and writing group conflict of interest disclosures | There are no author or writing group conflict of interest disclosures. |
| Committee | |
| Developer and funder |
New York State Department of Health AIDS Institute (NYSDOH AI) |
| Development process |
See Guideline Development and Recommendation Ratings Scheme, below. |
| Related NYSDOH AI guidelines |
Guidelines
GuidancePodcast |
Guideline Development and Recommendation Ratings
| Guideline Development: New York State Department of Health AIDS Institute Clinical Guidelines Program | |
| Program manager | Clinical Guidelines Program, Johns Hopkins University School of Medicine, Division of Infectious Diseases. See Program Leadership and Staff. |
| Mission | To produce and disseminate evidence-based, state-of-the-art clinical practice guidelines that establish uniform standards of care for practitioners who provide prevention or treatment of HIV, viral hepatitis, other sexually transmitted infections, and substance use disorders for adults throughout New York State in the wide array of settings in which those services are delivered. |
| Expert committees | The NYSDOH AI Medical Director invites and appoints committees of clinical and public health experts from throughout New York State to ensure that the guidelines are practical, immediately applicable, and meet the needs of care providers and stakeholders in all major regions of New York State, all relevant clinical practice settings, key New York State agencies, and community service organizations. |
| Committee structure |
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| Disclosure and management of conflicts of interest |
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| Evidence collection and review |
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| Recommendation development |
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| Review and approval process |
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| External reviews |
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| Update process |
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| Recommendation Ratings Scheme | |||
| Strength | Quality of Evidence | ||
| Rating | Definition | Rating | Definition |
| A | Strong | 1 | Based on published results of at least 1 randomized clinical trial with clinical outcomes or validated laboratory endpoints. |
| B | Moderate | * | Based on either a self-evident conclusion; conclusive, published, in vitro data; or well-established practice that cannot be tested because ethics would preclude a clinical trial. |
| C | Optional | 2 | Based on published results of at least 1 well-designed, nonrandomized clinical trial or observational cohort study with long-term clinical outcomes. |
| 2† | Extrapolated from published results of well-designed studies (including nonrandomized clinical trials) conducted in populations other than those specifically addressed by a recommendation. The source(s) of the extrapolated evidence and the rationale for the extrapolation are provided in the guideline text. One example would be results of studies conducted predominantly in a subpopulation (e.g., one gender) that the committee determines to be generalizable to the population under consideration in the guideline. | ||
| 3 | Based on committee expert opinion, with rationale provided in the guideline text. | ||
Shared Decision-Making
Download Printable PDF of Shared Decision-Making Statement
Date of current publication: August 8, 2023
Lead authors: Jessica Rodrigues, MS; Jessica M. Atrio, MD, MSc; and Johanna L. Gribble, MA
Writing group: Steven M. Fine, MD, PhD; Rona M. Vail, MD; Samuel T. Merrick, MD; Asa E. Radix, MD, MPH, PhD; Christopher J. Hoffmann, MD, MPH; Charles J. Gonzalez, MD
Committee: Medical Care Criteria Committee
Date of original publication: August 8, 2023
Rationale
Throughout its guidelines, the New York State Department of Health (NYSDOH) AIDS Institute (AI) Clinical Guidelines Program recommends “shared decision-making,” an individualized process central to patient-centered care. With shared decision-making, clinicians and patients engage in meaningful dialogue to arrive at an informed, collaborative decision about a patient’s health, care, and treatment planning. The approach to shared decision-making described here applies to recommendations included in all program guidelines. The included elements are drawn from a comprehensive review of multiple sources and similar attempts to define shared decision-making, including the Institute of Medicine’s original description [Institute of Medicine 2001]. For more information, a variety of informative resources and suggested readings are included at the end of the discussion.
Benefits
The benefits to patients that have been associated with a shared decision-making approach include:
- Decreased anxiety [Niburski, et al. 2020; Stalnikowicz and Brezis 2020]
- Increased trust in clinicians [Acree, et al. 2020; Groot, et al. 2020; Stalnikowicz and Brezis 2020]
- Improved engagement in preventive care [McNulty, et al. 2022; Scalia, et al. 2022; Bertakis and Azari 2011]
- Improved treatment adherence, clinical outcomes, and satisfaction with care [Crawford, et al. 2021; Bertakis and Azari 2011; Robinson, et al. 2008]
- Increased knowledge, confidence, empowerment, and self-efficacy [Chen, et al. 2021; Coronado-Vázquez, et al. 2020; Niburski, et al. 2020]
Approach
Collaborative care: Shared decision-making is an approach to healthcare delivery that respects a patient’s autonomy in responding to a clinician’s recommendations and facilitates dynamic, personalized, and collaborative care. Through this process, a clinician engages a patient in an open and respectful dialogue to elicit the patient’s knowledge, experience, healthcare goals, daily routine, lifestyle, support system, cultural and personal identity, and attitudes toward behavior, treatment, and risk. With this information and the clinician’s clinical expertise, the patient and clinician can collaborate to identify, evaluate, and choose from among available healthcare options [Coulter and Collins 2011]. This process emphasizes the importance of a patient’s values, preferences, needs, social context, and lived experience in evaluating the known benefits, risks, and limitations of a clinician’s recommendations for screening, prevention, treatment, and follow-up. As a result, shared decision-making also respects a patient’s autonomy, agency, and capacity in defining and managing their healthcare goals. Building a clinician-patient relationship rooted in shared decision-making can help clinicians engage in productive discussions with patients whose decisions may not align with optimal health outcomes. Fostering open and honest dialogue to understand a patient’s motivations while suspending judgment to reduce harm and explore alternatives is particularly vital when a patient chooses to engage in practices that may exacerbate or complicate health conditions [Halperin, et al. 2007].
Options: Implicit in the shared decision-making process is the recognition that the “right” healthcare decisions are those made by informed patients and clinicians working toward patient-centered and defined healthcare goals. When multiple options are available, shared decision-making encourages thoughtful discussion of the potential benefits and potential harms of all options, which may include doing nothing or waiting. This approach also acknowledges that efficacy may not be the most important factor in a patient’s preferences and choices [Sewell, et al. 2021].
Clinician awareness: The collaborative process of shared decision-making is enhanced by a clinician’s ability to demonstrate empathic interest in the patient, avoid stigmatizing language, employ cultural humility, recognize systemic barriers to equitable outcomes, and practice strategies of self-awareness and mitigation against implicit personal biases [Parish, et al. 2019].
Caveats: It is important for clinicians to recognize and be sensitive to the inherent power and influence they maintain throughout their interactions with patients. A clinician’s identity and community affiliations may influence their ability to navigate the shared decision-making process and develop a therapeutic alliance with the patient and may affect the treatment plan [KFF 2023; Greenwood, et al. 2020]. Furthermore, institutional policy and regional legislation, such as requirements for parental consent for gender-affirming care for transgender people or insurance coverage for sexual health care, may infringe upon a patient’s ability to access preventive- or treatment-related care [Sewell, et al. 2021].
Figure 1: Elements of Shared Decision-Making
Health equity: Adapting a shared decision-making approach that supports diverse populations is necessary to achieve more equitable and inclusive health outcomes [Castaneda-Guarderas, et al. 2016]. For instance, clinicians may need to incorporate cultural- and community-specific considerations into discussions with women, gender-diverse individuals, and young people concerning their sexual behaviors, fertility intentions, and pregnancy or lactation status. Shared decision-making offers an opportunity to build trust among marginalized and disenfranchised communities by validating their symptoms, values, and lived experience. Furthermore, it can allow for improved consistency in patient screening and assessment of prevention options and treatment plans, which can reduce the influence of social constructs and implicit bias [Castaneda-Guarderas, et al. 2016].
Clinician bias has been associated with health disparities and can have profoundly negative effects [FitzGerald and Hurst 2017; Hall, et al. 2015]. It is often challenging for clinicians to recognize and set aside personal biases and to address biases with peers and colleagues. Consciously or unconsciously, negative or stigmatizing assumptions are often made about patient characteristics, such as race, ethnicity, gender, sexual orientation, mental health, and substance use [Avery, et al. 2019; van Boekel, et al. 2013; Livingston, et al. 2012]. With its emphasis on eliciting patient information, a shared decision-making approach encourages clinicians to inquire about patients’ lived experiences rather than making assumptions and to recognize the influence of that experience in healthcare decision-making.
Stigma: Stigma may prevent individuals from seeking or receiving treatment and harm reduction services [Tsai, et al. 2019]. Among people with HIV, stigma and medical mistrust remain significant barriers to healthcare utilization, HIV diagnosis, and medication adherence and can affect disease outcomes [Turan, et al. 2017; Chambers, et al. 2015], and stigma among clinicians against people who use substances has been well-documented [Stone, et al. 2021; Tsai, et al. 2019; van Boekel, et al. 2013]. Sexual and reproductive health, including strategies to prevent HIV transmission, acquisition, and progression, may be subject to stigma, bias, social influence, and violence.
| SHARED DECISION-MAKING IN HIV CARE |
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Resources and Suggested Reading
In addition to the references cited below, the following resources and suggested reading may be useful to clinicians.
| RESOURCES |
References
Acree ME, McNulty M, Blocker O, et al. Shared decision-making around anal cancer screening among black bisexual and gay men in the USA. Cult Health Sex 2020;22(2):201-16. [PMID: 30931831]
Avery JD, Taylor KE, Kast KA, et al. Attitudes toward individuals with mental illness and substance use disorders among resident physicians. Prim Care Companion CNS Disord 2019;21(1):18m02382. [PMID: 30620451]
Bertakis KD, Azari R. Patient-centered care is associated with decreased health care utilization. J Am Board Fam Med 2011;24(3):229-39. [PMID: 21551394]
Castaneda-Guarderas A, Glassberg J, Grudzen CR, et al. Shared decision making with vulnerable populations in the emergency department. Acad Emerg Med 2016;23(12):1410-16. [PMID: 27860022]
Chambers LA, Rueda S, Baker DN, et al. Stigma, HIV and health: a qualitative synthesis. BMC Public Health 2015;15:848. [PMID: 26334626]
Chen CH, Kang YN, Chiu PY, et al. Effectiveness of shared decision-making intervention in patients with lumbar degenerative diseases: a randomized controlled trial. Patient Educ Couns 2021;104(10):2498-2504. [PMID: 33741234]
Coronado-Vázquez V, Canet-Fajas C, Delgado-Marroquín MT, et al. Interventions to facilitate shared decision-making using decision aids with patients in primary health care: a systematic review. Medicine (Baltimore) 2020;99(32):e21389. [PMID: 32769870]
Coulter A, Collins A. Making shared decision-making a reality: no decision about me, without me. 2011. https://www.kingsfund.org.uk/sites/default/files/Making-shared-decision-making-a-reality-paper-Angela-Coulter-Alf-Collins-July-2011_0.pdf
Crawford J, Petrie K, Harvey SB. Shared decision-making and the implementation of treatment recommendations for depression. Patient Educ Couns 2021;104(8):2119-21. [PMID: 33563500]
FitzGerald C, Hurst S. Implicit bias in healthcare professionals: a systematic review. BMC Med Ethics 2017;18(1):19. [PMID: 28249596]
Greenwood BN, Hardeman RR, Huang L, et al. Physician-patient racial concordance and disparities in birthing mortality for newborns. Proc Natl Acad Sci U S A 2020;117(35):21194-21200. [PMID: 32817561]
Groot G, Waldron T, Barreno L, et al. Trust and world view in shared decision making with indigenous patients: a realist synthesis. J Eval Clin Pract 2020;26(2):503-14. [PMID: 31750600]
Hall WJ, Chapman MV, Lee KM, et al. Implicit racial/ethnic bias among health care professionals and its influence on health care outcomes: a systematic review. Am J Public Health 2015;105(12):e60-76. [PMID: 26469668]
Halperin B, Melnychuk R, Downie J, et al. When is it permissible to dismiss a family who refuses vaccines? Legal, ethical and public health perspectives. Paediatr Child Health 2007;12(10):843-45. [PMID: 19043497]
Institute of Medicine. Crossing the quality chasm: a new health system for the 21st century. 2001. https://www.ncbi.nlm.nih.gov/books/NBK222274/
KFF. Key data on health and health care by race and ethnicity. 2023 Mar 15. https://www.kff.org/racial-equity-and-health-policy/report/key-data-on-health-and-health-care-by-race-and-ethnicity/ [accessed 2023 May 19]
Livingston JD, Milne T, Fang ML, et al. The effectiveness of interventions for reducing stigma related to substance use disorders: a systematic review. Addiction 2012;107(1):39-50. [PMID: 21815959]
McNulty MC, Acree ME, Kerman J, et al. Shared decision making for HIV pre-exposure prophylaxis (PrEP) with black transgender women. Cult Health Sex 2022;24(8):1033-46. [PMID: 33983866]
Niburski K, Guadagno E, Abbasgholizadeh-Rahimi S, et al. Shared decision making in surgery: a meta-analysis of existing literature. Patient 2020;13(6):667-81. [PMID: 32880820]
Parish SJ, Hahn SR, Goldstein SW, et al. The International Society for the Study of Women’s Sexual Health process of care for the identification of sexual concerns and problems in women. Mayo Clin Proc 2019;94(5):842-56. [PMID: 30954288]
Robinson JH, Callister LC, Berry JA, et al. Patient-centered care and adherence: definitions and applications to improve outcomes. J Am Acad Nurse Pract 2008;20(12):600-607. [PMID: 19120591]
Scalia P, Durand MA, Elwyn G. Shared decision-making interventions: an overview and a meta-analysis of their impact on vaccine uptake. J Intern Med 2022;291(4):408-25. [PMID: 34700363]
Sewell WC, Solleveld P, Seidman D, et al. Patient-led decision-making for HIV preexposure prophylaxis. Curr HIV/AIDS Rep 2021;18(1):48-56. [PMID: 33417201]
Stalnikowicz R, Brezis M. Meaningful shared decision-making: complex process demanding cognitive and emotional skills. J Eval Clin Pract 2020;26(2):431-38. [PMID: 31989727]
Stone EM, Kennedy-Hendricks A, Barry CL, et al. The role of stigma in U.S. primary care physicians’ treatment of opioid use disorder. Drug Alcohol Depend 2021;221:108627. [PMID: 33621805]
Tsai AC, Kiang MV, Barnett ML, et al. Stigma as a fundamental hindrance to the United States opioid overdose crisis response. PLoS Med 2019;16(11):e1002969. [PMID: 31770387]
Turan B, Budhwani H, Fazeli PL, et al. How does stigma affect people living with HIV? The mediating roles of internalized and anticipated HIV stigma in the effects of perceived community stigma on health and psychosocial outcomes. AIDS Behav 2017;21(1):283-91. [PMID: 27272742]
van Boekel LC, Brouwers EP, van Weeghel J, et al. Stigma among health professionals towards patients with substance use disorders and its consequences for healthcare delivery: systematic review. Drug Alcohol Depend 2013;131(1-2):23-35. [PMID: 23490450]
Last updated on August 3, 2026
