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

NCT ID: NCT06006143

Last Updated: 2025-06-18

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-16
• Study Completion Date: 2025-12-31

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.

Detailed Description

This is a series of three open-label pilot studies that consist of a 12-week intervention including off-label use of medication with MM and a clinical pharmacist-delivered behavioral intervention to treat AUD. Participants will receive counseling that incorporates brief feedback and advice with motivational enhancement techniques to assist the participant in changing their behaviors with respect to alcohol consumption and/or polypharmacy defined as taking five or more medications, particularly if those medications interact with alcohol. In addition, participants will be offered varenicline in the first pilot study. The rationale for utilizing an open-label pilot study design is to determine the feasibility, acceptability, safety, and preliminary efficacy of this intervention for the management of AUD. Participants will be interviewed with regards to their perspectives on feasibility and acceptability. They will be instructed to have medication bottles at study visits to assess medication adherence and will be assessed with readiness to change metrics and questions regarding quantity and frequency of alcohol use. Patients will also be asked to complete an AUDIT-C screen and the Alcohol Symptom Checklist at the start of the study period to screen for mild, moderate, or severe AUD. Several assessments including interviews and laboratory testing will be done at study visits.

Conditions

Alcohol Use Disorder; Hiv; Tobacco Use Disorder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Varenicline

Participants will receive a prescription for generic varenicline

Group Type: EXPERIMENTAL

Varenicline

Intervention Type: DRUG

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

Interventions

Varenicline

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

NIH

Sponsor Role: collaborator

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

E. Jennifer Edelman, MD, MHS

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

Atlanta VA Medical Center

Decatur, Georgia, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

E. Jennifer Edelman, MD, MHS

Role: CONTACT

ejennifer.edelman@yale.edu

203-737-7115

June-Marie Weiss, MA, MEd

Role: CONTACT

junemarie.weiss@yale.edu

203-737-3347

Facility Contacts

Julie Costello

Role: primary

julie.costello2@va.gov

404-321-6111 ext. 203875

Other Identifiers

1P01AA029545-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2000033919_b

Identifier Type: -

Identifier Source: org_study_id