About the Substance Use Guidelines - AIDS Institute Clinical Guidelines

Substance Use Guidelines Committee, July 2021

The NYSDOH AI protects and promotes the health of NYS’s diverse population through disease surveillance and the provision of quality services for prevention, healthcare, and psychosocial support for those affected by HIV/AIDS, sexually transmitted diseases, viral hepatitis, and related health concerns. In addition, the NYSDOH AI promotes the health of LGBT populations, substance users, and the sexual health of all New Yorkers.

Makeup: The members of the Substance Use Guidelines Committee (see Box 1: Substance Use Guidelines Committee Leaders, Members, and External Reviewers) were appointed by the NYSDOH AI to ensure representation of clinical practice in all major regions of the state, relevant medical disciplines and sub-specialties, key NYS agencies, community stakeholders, and patient advocates. Individuals confirmed as Committee members are required to disclose any potential conflicts of interest; disclosures are reviewed and approved by the NYSDOH AI Office of the Medical Director (see Funding and Disclosure of Potential Conflicts of Interest).

Role: Committee members actively participate in guideline development, including evidence review, drafting of recommendations and text, manuscript review, consensus approval of all recommendations, and rating of recommendations.

Leadership: The Substance Use Planning Group of committee leaders refined the recommendations, facilitated consensus approval of all recommendations, reviewed manuscripts, and addressed feedback from external peer and consumer reviewers.

Substance Use Guidelines Committee Planning Group:

Chinazo O. Cunningham, MD, MS, Chair
Kelly S. Ramsey, MD, MPH, MA, FACP, Vice-Chair
Sharon L. Stancliff, MD, Harm Reduction in Health Care, NYSDOH AI
Annette Gaudino, Treatment Action Group (TAG) Representative
Christopher J. Hoffmann, MD, MPH, JHU Principal Investigator

Box 1: Substance Use Guidelines Committee: Leadership, Contributing Members, Liaisons, and Guideline Reviewers
Committee Leadership Chair: Chinazo O. Cunningham, MD, MS, Albert Einstein College of Medicine/Montefiore Medical Center, Bronx, NY Vice Chair: Kelly S. Ramsey, MD, MPH, MA, FACP, Hudson River HealthCare, Poughkeepsie, NY Consultant: Sharon L. Stancliff, MD, Office of the Medical Director/Harm Reduction in Health Care, NYSDOH AI, New York, NY Medical Director: Charles J. Gonzales, MD, NYSDOH AI, New York, NY Deputy Director: Lyn C. Stevens, MS, NP, ACRN, NYSDOH AI, Albany, NY Principal Investigator: Christopher J. Hoffmann, MD, JHU School of Medicine, Baltimore, MD Contributing Members Marcus Bachhuber, MD, MS, Albert Einstein College of Medicine/Montefiore Medical Center, Bronx, NY Michael L. Christie, MD, University of Rochester Medical Center, Rochester, NY Angela G. Giovanniello, PharmD, AAHIVP, Albert Einstein College of Medicine/Montefiore Medical Center, Bronx, NY Raymond Harvey, MD, Institute for Family Health, Kingston, NY Giliane Joseph, MD, Albert Einstein College of Medicine/Montefiore Medical Center, Bronx, NY Shadi Nahvi, MD, MS, Albert Einstein College of Medicine/Montefiore Medical Center, Bronx, NY David C. Perlman, MD, Icahn School of Medicine at Mount Sinai, New York, NY Paul Updike, MD, St. Vincent’s/Sisters Hospital, Buffalo, NY Susan D. Whitley, MD, New York City Health + Hospitals/Kings County, Brooklyn, NY Timothy J. Wiegand, MD, University of Rochester Medical Center, Rochester, NY Agency, Consumer, and Program Liaisons Allan Clear, MD/Narelle Ellendon, RN, Office of Drug User Health, NYSDOH AI, New York, NY Hillary Kunins, MD, MPH, MS, New York City Department of Health and Mental Hygiene, Queens, NY Marc Manseau, MD, MPH, New York State Office of Alcoholism and Substance Abuse Services, Albany, NY Annette Gaudino, TAG Community Liaison, New York, NY Jessica Gronachan, Consumer Reviewer, New York, NY AIDS Institute Staff Medical Director: Charles J. Gonzalez, MD, New York, NY Deputy Director: Lyn C. Stevens, MS, NP, ACRN, Albany, NY Guidelines Program Manager: Laura Duggan Russell, MPH, Albany, NY External Peer Reviewers Treatment of Opioid Use Disorder Jonathan Giftos, MD, NYC Health + Hospitals/Correctional Health Services, New York, NY Justine Waldman, MD, Cayuga Medical Center, Ithaca, NY Melissa Weimer, MD, St. Peter’s Health Partners, Albany, NY Treatment of Alcohol Use Disorder Jonathan Giftos, MD, NYC Health + Hospitals/Correctional Health Services, New York, NY Melissa Weimer, MD, St. Peter’s Health Partners, Albany, NY Substance Use Screening and Risk Assessment in Adults Jonathan Giftos, MD, NYC Health + Hospitals/Correctional Health Services, New York, NY Melissa Weimer, MD, St. Peter’s Health Partners, Albany, NY Substance Use Disorder Treatment in Pregnant Adults Mishka Terplan, MD, MPH, FACOG, Virginia Medicaid, Richmond, VA David Garry, DO, FACOG, Stony Brook University, NY

Box 1: Substance Use Guidelines Committee: Leadership, Contributing Members, Liaisons, and Guideline Reviewers

Committee Leadership

Chair: Chinazo O. Cunningham, MD, MS, Albert Einstein College of Medicine/Montefiore Medical Center, Bronx, NY
Vice Chair: Kelly S. Ramsey, MD, MPH, MA, FACP, Hudson River HealthCare, Poughkeepsie, NY
Consultant: Sharon L. Stancliff, MD, Office of the Medical Director/Harm Reduction in Health Care, NYSDOH AI, New York, NY
Medical Director: Charles J. Gonzales, MD, NYSDOH AI, New York, NY
Deputy Director: Lyn C. Stevens, MS, NP, ACRN, NYSDOH AI, Albany, NY
Principal Investigator: Christopher J. Hoffmann, MD, JHU School of Medicine, Baltimore, MD

Contributing Members

Marcus Bachhuber, MD, MS, Albert Einstein College of Medicine/Montefiore Medical Center, Bronx, NY
Michael L. Christie, MD, University of Rochester Medical Center, Rochester, NY
Angela G. Giovanniello, PharmD, AAHIVP, Albert Einstein College of Medicine/Montefiore Medical Center, Bronx, NY
Raymond Harvey, MD, Institute for Family Health, Kingston, NY
Giliane Joseph, MD, Albert Einstein College of Medicine/Montefiore Medical Center, Bronx, NY
Shadi Nahvi, MD, MS, Albert Einstein College of Medicine/Montefiore Medical Center, Bronx, NY
David C. Perlman, MD, Icahn School of Medicine at Mount Sinai, New York, NY
Paul Updike, MD, St. Vincent’s/Sisters Hospital, Buffalo, NY
Susan D. Whitley, MD, New York City Health + Hospitals/Kings County, Brooklyn, NY
Timothy J. Wiegand, MD, University of Rochester Medical Center, Rochester, NY

Agency, Consumer, and Program Liaisons

Allan Clear, MD/Narelle Ellendon, RN, Office of Drug User Health, NYSDOH AI, New York, NY
Hillary Kunins, MD, MPH, MS, New York City Department of Health and Mental Hygiene, Queens, NY
Marc Manseau, MD, MPH, New York State Office of Alcoholism and Substance Abuse Services, Albany, NY
Annette Gaudino, TAG Community Liaison, New York, NY
Jessica Gronachan, Consumer Reviewer, New York, NY

AIDS Institute Staff

Medical Director: Charles J. Gonzalez, MD, New York, NY
Deputy Director: Lyn C. Stevens, MS, NP, ACRN, Albany, NY
Guidelines Program Manager: Laura Duggan Russell, MPH, Albany, NY

External Peer Reviewers

Treatment of Opioid Use Disorder

Jonathan Giftos, MD, NYC Health + Hospitals/Correctional Health Services, New York, NY
Justine Waldman, MD, Cayuga Medical Center, Ithaca, NY
Melissa Weimer, MD, St. Peter’s Health Partners, Albany, NY

Treatment of Alcohol Use Disorder

Jonathan Giftos, MD, NYC Health + Hospitals/Correctional Health Services, New York, NY
Melissa Weimer, MD, St. Peter’s Health Partners, Albany, NY

Substance Use Screening and Risk Assessment in Adults

Jonathan Giftos, MD, NYC Health + Hospitals/Correctional Health Services, New York, NY
Melissa Weimer, MD, St. Peter’s Health Partners, Albany, NY

Substance Use Disorder Treatment in Pregnant Adults

Mishka Terplan, MD, MPH, FACOG, Virginia Medicaid, Richmond, VA
David Garry, DO, FACOG, Stony Brook University, NY

Johns Hopkins University Editorial Role

The JHU editorial team coordinated, guided, and documented all Committee activities and edited the guideline material for clarity, flow, and style.

JHU editorial team:

Mary Beth Hansen, MA, JHU Project Director
Jen Ham, MPH, JHU Medical Editor; Lead Editor
Hanna Gribble, MA, JHU Medical Editor
Rachel Lastra, JHU Medical Editor
Jesse Ciekot, Program Coordinator

Funding and Disclosure of Potential Conflicts of Interest

Funding: The Substance Use Guidelines were developed using NYS funds awarded as a grant to the JHU School of Medicine, Division of Infectious Diseases, from the NYSDOH AI.

Conflicts of interest: All active committee members, invited consultants and coauthors, peer reviewers, and program staff are required to disclose financial relationships with commercial entities, including gifts that may be actual conflicts of interest or may be perceived as conflicts. These individuals must disclose financial relationships annually, for themselves, their partners/spouses, and their organization/institution. On their annual disclosures, committee members are asked to report for the previous 12 months and upcoming 12 months.

No conflicts were reported by the Committee Chair and Vice-Chair, the consultant, the Committee members, and all NYSDOH AI and JHU program staff.

Management of potential conflicts of interest: All reported financial relationships with commercial entities are reviewed by the NYSDOH AI guidelines program to assess the potential for undue influence on guideline recommendations made by the Committee. No financial relationships were reported.

Any potential for undue influence is also mitigated by the consensus process. All guideline recommendations received consensus approval of the full Committee. The Committee Chairs and the NYSDOH AI Medical Director, none of whom reported conflicts of interest, performed the final review and approved the guideline.

All external reviewers, including peer reviewers and representatives from other NYSDOH AI clinical guidelines committees, were also required to submit conflict of interest/financial disclosure information, which were similarly screened. No conflicts were reported.

Evidence Collection and Review

The NYSDOH AI guideline development process is based on a systematic search and analysis of the published evidence. Box 2, below, illustrates the evidence review and selection process.

Box 2: Evidence Collection and Review Processes

Substance Use Guidelines Committee defined the goal of the guideline: To provide evidence-based clinical recommendations for primary care management of SUD, including screening, diagnosis, pretreatment assessment, treatment options, and post-treatment monitoring.
With individual authors, JHU editorial staff conducted a targeted literature search in PubMed using MESH terms. All searches were limited to studies that 1) were published in the 5 years prior to the date of the literature search; 2) involved only human subjects; and 3) were published in English.
Authors reviewed studies identified in searches.
Authors and editorial staff conducted additional searches using PubMed and online databases to identify:
- Studies published prior to the 5-year search limit.
- Studies published during the guideline development process.
- NYS epidemiologic data.
Development of guideline recommendations:
- Authors reviewed evidence and drafted recommendations.
- Planning Group members reviewed, refined, and approved draft recommendations.
- Full Committee reviewed and reached consensus on recommendations.
- Rating subcommittee reviewed the cited evidence and assigned a two-part rating to each recommendation to indicate the strength of the recommendation and the quality of the supporting evidence; consensus was reached on ratings.
Step 6: Ongoing update process:
- JHU editorial staff continues to collect evidence related to original searches and monitor for new drug approval.
- Planning Group reviews new evidence at least 3 times per year, more often if newly published studies, new drug approval, or drug-related warning indicates need for an immediate change to the published guideline.
- Committee reviews and approves changes to the guideline
- Committee initiates a full review of guideline 4 years after the original publication date.
- NYSDOH AI publishes an update 5 years after the previous publication date.

Recommendation Development and Rating Process

The clinical recommendations presented in this guideline were developed by consensus based on a synthesis of the current evidence collected through the systematic search described above. If no data were available, the recommendations are based on expert opinion, and this status is indicated in the rating and in the text.

The Planning Group met via monthly teleconferences over 24 months to finalize the guideline and reach consensus on recommendations and rationale. Once consensus among the Planning Group members was reached, the guideline was reviewed by the full SUD Committee, including consumer liaisons, and consensus was reached on all recommendations. These deliberations were conducted by teleconference; committee members were invited to submit comments in writing as well. Full Committee review discussions were recorded, and recordings were reviewed carefully to ensure that all decisions and changes were captured and integrated into the manuscript.

Members of the Planning Group then individually reviewed the evidence for each recommendation and assigned a two-part rating (see below). The individual ratings were compiled into a report distributed to all raters, and conference call discussions were held to deliberate ratings for which consensus was needed. Once all raters agreed on the interpretation of evidence and ratings for all recommendations, the guideline was sent to the NYSDOH AI for review and approval.

AIDS Institute HIV Clinical Guidelines Program Recommendations Rating Scheme
Strength of Recommendation	Quality of Supporting Evidence
A = Strong	1 = At least 1 randomized trial with clinical outcomes and/or validated laboratory endpoints
B = Moderate	2 = One or more well-designed, nonrandomized trial or observational cohort study with long-term clinical outcomes
C = Optional	3 = Expert opinion

External Review

External peer reviewers recognized for their experience and expertise in the treatment of SUD were identified by program leaders (see Box 1: Substance Use Guidelines Committee: Leadership, Contributing Members, Liaisons, and Guideline Reviewers). These individuals submitted a financial disclosure statement for the purpose of identifying potential conflicts of interest before participating as peer reviewers. No conflicts were reported by peer reviewers.

Peer reviewers were asked to review the SUD guidelines for accuracy, balance, clarity, and practicality of the recommendations for primary care providers. The Planning Group addressed peer review feedback; any conflicting opinions were resolved by the Committee chairs.

Guideline Updates

Members of the Substance Use Guidelines Committee will monitor developments in the field to maintain guideline currency. Once the guidelines are published on the program website, www.hivguidelines.org, any updates will be made to the document as needed.

Notification of newly published studies will be automated, and the Planning Group will review new data at least every 4 months. Newly published data that provide support for existing recommendations will be cited in the text, and the studies will be added to the reference list(s).

If newly published data prompt a revision to recommendations or rationale, the Planning Group will propose appropriate edits and determine whether the changes warrant full Committee review and approval. If full Committee review is required, a conference call will be convened for that purpose.

If a new medication or formulation is approved, the Planning Group will be convened via conference call to examine the data, consider inclusion in the guideline, and determine the need for full Committee review and approval.

The full guideline will be reviewed and updated on the 4th anniversary of publication to prepare for publication of an updated guideline on or before the 5th anniversary of publication.