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NCT06006143Active, not recruitingPhase 2

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

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

Source: ClinicalTrials.gov · Last updated 16 Apr 2026

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
30 (estimated)
First submitted
16 Aug 2023
Start date
Jun 2025
Primary completion date
Aug 2026
Lead sponsor
Yale University
Diseases
HIV
NCT number
NCT06006143

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 30
  • From Jun 2025 to the primary completion date, Aug 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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
  • 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

Other illness

  • Active engagement in formal alcohol treatment including medications for alcohol use disorder at the time of enrollment
  • Untreated moderate to severe opioid use disorder
  • History of serious hypersensitivity or adverse reaction to study medication

Lab values

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

Other

  • Residence out of state
  • Inability to read or understand English

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Atlanta VA Medical Center
Coordinator of this site? Confirm its status		DecaturUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.