Gabapentin to Reduce Alcohol and Improve Viral Load Suppression

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.

Timeline

Start

2023-11-20

Primary completion

2026-10

Completion

2027-06

Publications

• Truong V, Kekibiina A, Muyindike WR, Gnatienko N, Tsui JI, Emenyonu NI, Cheng DM, Hahn JA, Allison O, Bullard MJ, Lunze K, Samet JH. Gabapentin to achieve HIV viral load suppression in people with risky drinking in Mbarara, Uganda: study protocol for a randomized, double-blinded, placebo-controlled trial (GRAIL). Trials. 2026 Jun 3;27(1):452. doi: 10.1186/s13063-026-09813-1.
• Truong V, Kekibiina A, Muyindike W, Gnatienko N, Tsui JI, Emenyonu NI, Cheng DM, Hahn J, Allison O, Bullard MJ, Lunze K, Samet JH. Gabapentin to achieve HIV viral load suppression in people with risky drinking in Mbarara, Uganda: study protocol for a randomized, double-blinded, placebo-controlled trial (GRAIL). Res Sq [Preprint]. 2025 Oct 15:rs.3.rs-6856284. doi: 10.21203/rs.3.rs-6856284/v1.

Drugs

Indications