Off-Label Medications for Alcohol Use Disorder Among Patients With HIV: Pilot Study 3 Semaglutide

NCT07040592 | Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: 2000033919_c1P01AA029545-01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This study seeks to determine the feasibility, acceptability, and preliminary efficacy of an intervention consisting of off-label use of a medication with strong efficacy data for alcohol use disorder (AUD) with medical management and a clinical pharmacist-delivered behavioral intervention in reducing alcohol use among individuals with HIV and AUD.

Conditions

Alcohol Use Disorder (AUD); HIV

Outcome Measures

Primary Outcomes (4)

• Proportion of participants who complete enrollment and duration of sessions

  Proportion of participants who complete enrollment and duration of sessions to assess feasibility of study

  12 weeks

• Number of sessions completed

  Number of sessions completed to assess acceptability of study

  12 weeks

• Adherence to Medication

  Medication adherence will be measured by the number of prescriptions filled by electronic health record to assess acceptability of study

  12 weeks

• Safety of study assessed by adverse event reporting

  Safety will be assessed by the percentage of study participants who report adverse events.

  12 weeks

Secondary Outcomes (2)

• Efficacy of study - change in self-reported alcohol use

  12 weeks

• Efficacy of study - change in PEth (phosphatidylethanol) results

  12 weeks

Study Arms (1)

Semaglutide

EXPERIMENTAL

Participants will receive a prescription for semaglutide.

Drug: semaglutide

Interventions

semaglutide DRUG

All participants will receive a prescription for semaglutide and will meet with a clinical pharmacist and addiction psychiatrist for further support

Semaglutide

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• diagnosed with HIV
• Receive care at the Atlanta VA Healthcare System
• Age 18 or over
• Meet criteria for mild, moderate, or severe alcohol use disorder by the DSM-5 Alcohol Symptom Checklist and the Alcohol Use Disorders Identification Test-Consumption (AUDIT-C) screen
• Have evidence of significant alcohol use: PEth \> 20ng/ml
• Prescribed \>=5 medications
• Have cell phone or reliable contact number
• Can provide written informed consent

You may not qualify if:

• Active engagement in formal alcohol treatment including medications for alcohol use disorder at the time of enrollment
• Self-report or laboratory test confirming pregnancy, nursing, or trying to conceive
• Life-threatening or unstable medical, surgical, or psychiatric condition that prohibits participation (including current or past intent to harm oneself or others within the prior 12 months and not receiving treatment)
• Untreated moderate to severe opioid use disorder
• Residence out of state
• Inability to read or understand English
• History of serious hypersensitivity or adverse reaction to study medication
• Taking potentially interactive medication(s) for diabetes
• BMI\<23
• Diagnosis of type 1 Diabetes
• Personal or family history of medullary thyroid carcinoma, Multiple Endocrine Neoplasia syndrome type 2, Severe gastrointestinal dysmotility, including gastroparesis, History of pancreatitis (does not pertain to patients for whom the cause of pancreatitis is known and no longer presents a risk), severe gallbladder disease
• Known Proliferative Diabetic Retinopathy, severe Non-Proliferative Diabetic Retinopathy, clinically significant Macular Edema, or Cystoid Macular Edema
• Already prescribed the pilot medication at the time of study recruitment.

Sponsors & Collaborators

• Yale University: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

Atlanta VA Medical Center

Decatur, Georgia, 30033, United States

RECRUITING

MeSH Terms

Conditions

Alcoholism

Interventions

semaglutide

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• E. Jennifer Edelman, MD, MHS

  Yale University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

E. Jennifer Edelman, MD, MHS

CONTACT

203-737-7115; ejennifer.edelman@yale.edu

June-Marie Weiss, MA, MEd

CONTACT

203-737-3347; junemarie.weiss@yale.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2025
• First Posted: June 27, 2025
• Study Start: January 15, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: March 24, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)