Clinical Trial

Gabapentin to Reduce Alcohol and Improve Viral Load Suppression

Study acronym: GRAIL
Active, Not Recruiting Phase 2
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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.
Protocol Amendment History 13 amendments
This ClinicalTrials.gov record has been amended 13 times since 2022-06-29; most recent amendment 2026-06-29.
Status change: Recruiting → Active, Not Recruiting 2026-06-29
Status change: Not Yet Recruiting → Recruiting 2023-11-20
Trial Details
NCT Number NCT05443555
Lead Sponsor Boston Medical Center
Collaborators: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Conditions HIV, Heavy Drinking
Enrollment 220 participants
Start Date 2023-11-20
Primary Completion 2026-10 (estimated)
Study Completion 2027-06 (estimated)
Updated on ClinicalTrials.gov 2026-07-01