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

Phase 2

Not yet recruiting

• Conditions: Hiv; Alcohol Use Disorder; Tobacco Use Disorder
• Interventions: Drug: Varenicline

• Registration Number: NCT06006143
• Lead Sponsor: Yale University

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.

Study Timeline

• Study First Submitted: 2023-08-16
• Study First Submitted QC: 2023-08-16
• Study First Posted: 2023-08-23
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-06
• Last Update Posted: 2025-05-08
• Study Start: 2025-06
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Varenicline	Varenicline	Participants will receive a prescription for generic varenicline

Primary Outcome Measures

Name	Time	Method
Proportion of participants who complete enrollment and duration of sessions	12 weeks	Proportion of participants who complete enrollment and duration of sessions to assess feasibility of study
Number of sessions completed	12 weeks	Number of sessions completed to assess acceptability of study
Adherence to Medication	12 weeks	Medication adherence will be measured by the number of prescriptions filled by electronic health record to assess acceptability of study
Safety of study assessed by adverse events reporting	12 weeks	Safety will be assessed by the percentage of study participants who report adverse events

Secondary Outcome Measures

Name	Time	Method
Efficacy of study - change in PEth (phosphatidylethanol) results	12 weeks	PEth is a biomarker for alcohol consumption. Change in PEth result from baseline PEth levels.
Efficacy of study - change in self-reported alcohol use	12 weeks	Change in self-reported alcohol use (# of days of alcohol use and # of drinks per day) on the Timeline Followback.

Trial Locations

Locations (1)

Atlanta VA Medical Center; 🇺🇸 Decatur, Georgia, United States