Gabapentin to Reduce Alcohol and Improve Viral Load Suppression
Status:
Not yet recruiting
Trial end date:
2026-07-01
Target enrollment:
Participant gender:
Summary
GRAIL is a Randomized Controlled Trial (RCT) among 300 HIV-positive persons with heavy
alcohol consumption (by NIAAA definition) who have had detectable HIV viral load (HVL) at
least 6 months after their HIV diagnosis. This trial aims to test the efficacy of gabapentin
versus placebo to achieve undetectable HVL and assess the impact of gabapentin compared to
placebo on alcohol consumption, pain severity, ART adherence, and engagement in HIV care. HIV
viral load will be assessed at 3 (primary), 6 and 12 months via laboratory test. Eligible
participants will be randomly assigned into one of two study arms: 1) gabapentin (1800mg/day
target dose) for 3 months vs. 2) placebo for 3 months. All participants will receive
evidence-based counseling for alcohol and either an active medication or placebo.
Phase:
Phase 2/Phase 3
Details
Lead Sponsor:
Boston Medical Center
Collaborator:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)