Off-Label Medications for Alcohol Use Disorder Among Patients With HIV: Pilot Study 2

NCT06006143 | Active Not Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: 2000033919_b1P01AA029545-01
• 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

Tobacco Use Disorder; Alcohol Use Disorder; 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 events 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)

Varenicline

EXPERIMENTAL

Participants will receive a prescription for generic varenicline

Drug: Varenicline

Interventions

Varenicline DRUG

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

Varenicline

Eligibility Criteria

• Age: 18 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
• Are 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
• Currently smoking cigarettes
• 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) (e.g. nicotine replacement therapy for varenicline pilot study)
• 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

Location

MeSH Terms

Conditions

Alcoholism; Acquired Immunodeficiency Syndrome; Tobacco Use Disorder

Interventions

Varenicline

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Quinoxalines

Study Officials

• E. Jennifer Edelman, MD, MHS

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: Single arm

Study Record Dates

• First Submitted: August 16, 2023
• First Posted: August 23, 2023
• Study Start: June 16, 2025
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: April 16, 2026

Record last verified: 2026-04

Locations

US (1)