Gabapentin to Reduce Alcohol and Improve Viral Load Suppression

• Status: Not yet recruiting
• Trial end date: 2026-07-01
• Target enrollment: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Boston Medical Center
• Collaborator: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
• Treatments: Gabapentin

Criteria

Inclusion Criteria:

• Having an HIV diagnosis for at least 6 months

• Detectable HIV viral load at least 6 months after HIV diagnosis

• ≥5 heavy drinking days [i.e., NIAAA at-risk drinking levels] in the past 30 days

• Able and willing to comply with all study protocols and procedures

• Provision of contact information for 2 contacts to assist with follow-up

• Living within 2 hours travel time of the study site

Exclusion Criteria:

• Not fluent in English or Runyankole

• Cognitive impairment resulting in inability to provide informed consent based on research assessor (RA) assessment

• Pregnancy, planning to become pregnant in next 3 months, or breast feeding

• Taking gabapentin/pregablin in past 30 days

• Plans to move out of the catchment area within 6 months

• Taking any medication for alcohol use disorder

• Enrolled in another HIV research study seeking viral load suppression

• Known hypersensitivity to gabapentin

• Unstable psychiatric illness (i.e., answered yes to any of the following: past three month active hallucinations; mental health symptoms prompting a visit to the ED or hospital; mental health medication changes due to worsening symptoms; presence of suicidal ideations)