RecruitingPhase 2NCT05443555

Gabapentin to Reduce Alcohol and Improve Viral Load Suppression

Gabapentin to Reduce Alcohol and Improve Viral Load Suppression - Promoting "Treatment as Prevention"

Sponsor

Boston Medical Center

Enrollment

220 participants

Start Date

Nov 20, 2023

Study Type

INTERVENTIONAL

Conditions

HIV Heavy Drinking

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether gabapentin (a medication commonly used for nerve pain and seizures) can help people living with HIV who drink alcohol reduce their drinking and improve their HIV viral load control. **You may be eligible if...** - You have been living with HIV for at least 6 months - Your HIV viral load is currently detectable (not suppressed) - A urine test confirms recent alcohol use - You live within 2 hours of the study site - You are able and willing to follow study procedures **You may NOT be eligible if...** - You are not fluent in English or Runyankole - You are pregnant, planning to become pregnant, or breastfeeding - You have taken gabapentin or pregabalin in the past 30 days - You are already taking medication for alcohol use disorder - You have a known allergy to gabapentin Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGGabapentin

Dosing will be titrated up over 3 weeks, starting with a daily dose of 300mg (1 capsule/day) in week 1, followed by a daily dose of 900mg (3 capsules/day) in week 2, up to a target daily dose of 1800mg (6 capsules/day) in week 3. The target dose of 1800mg per day will be sustained from weeks 3 through day 4 of week 12. Then, dose will be tapered down to 900mg in days 5-7 of week 12, and medication will be discontinued at the end of week 12.

DRUGPlacebo

Participants randomized to this group will receive a placebo medication for 3 months and will be instructed to follow the same pill regimen as the intervention arm.