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

Feasibility, Acceptability, and Preliminary Efficacy of Off-Label Medications for Alcohol Use Disorder Among Patients With HIV: An Open-Label Pilot Study

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Tobacco Use Disorder; Hiv; Alcohol Use Disorder
• Intervention / Treatment: Drug: Varenicline

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 Type: Interventional
• Enrollment (Estimated): 30
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Decatur, Georgia, United States, 30033
      • Atlanta VA Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Varenicline; Participants will receive a prescription for generic varenicline	Drug: Varenicline; All participants will receive a prescription for varenicline and will meet with a clinical pharmacist and addiction psychiatrist for further support

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Yale University
• Collaborators: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
• Investigators: Principal Investigator: E. Jennifer Edelman, MD, MHS, Yale University

Study record dates

Study Major Dates

• Study Start (Actual): June 16, 2025
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2026

Study Registration Dates

• First Submitted: August 16, 2023
• First Submitted That Met QC Criteria: August 16, 2023
• First Posted (Actual): August 23, 2023

Study Record Updates

• Last Update Posted (Actual): April 16, 2026
• Last Update Submitted That Met QC Criteria: April 15, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Blood-Borne Infections; Urogenital Diseases; Genital Diseases; Mental Disorders; Immune System Diseases; Infections; RNA Virus Infections; Virus Diseases; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Substance-Related Disorders; Chemically-Induced Disorders; Alcohol-Related Disorders; Slow Virus Diseases; HIV Infections; Alcoholism; Acquired Immunodeficiency Syndrome; Tobacco Use Disorder; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Benzazepines; Quinoxalines; Varenicline
• Other Study ID Numbers: 2000033919_b; 1P01AA029545-01 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No