Status:
RECRUITING
Off-Label Medications for Alcohol Use Disorder Among Patients With HIV: Pilot Study 2
Lead Sponsor:
Yale University
Collaborating Sponsors:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Conditions:
Alcohol Use Disorder
Hiv
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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...
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 t...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 16 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06006143
Start Date
June 16 2025
End Date
December 31 2025
Last Update
June 18 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Atlanta VA Medical Center
Decatur, Georgia, United States, 30033