Varenicline for Alcoholism
(HARP Trial)

Recruiting in Palo Alto (17 mi)

Overseen byE. Jennifer Edelman, MD, MHS

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Yale University

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

This trial is for adults over 18 with HIV and moderate to severe alcohol use disorder, receiving care at the Atlanta VA Healthcare System. Participants must be current smokers, on multiple medications, have a high level of recent alcohol use indicated by PEth test, and able to consent. Pregnant or nursing individuals, those with life-threatening conditions or untreated opioid disorders are excluded.

Inclusion Criteria

Receive care at the Atlanta VA Healthcare System

I am 18 years old or older.

Meet criteria for moderate to severe alcohol use disorder by the DSM-5 Alcohol Symptom Checklist

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Exclusion Criteria

History of serious hypersensitivity or adverse reaction to study medication

Self-report or laboratory test confirming pregnancy, nursing, or trying to conceive

I do not have any severe health or mental conditions that would stop me from participating.

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Treatment Details

Interventions

Varenicline (Other)

Trial OverviewThe study tests Varenicline's off-label effectiveness in reducing alcohol consumption among HIV patients with AUD. It combines medication with medical management and behavioral interventions delivered by a clinical pharmacist.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: VareniclineExperimental Treatment1 Intervention

Participants will receive a prescription for generic varenicline