Actively Recruiting
Gabapentin to Reduce Alcohol and Improve Viral Load Suppression
Led by Boston Medical Center · Updated on 2025-11-06
220
Participants Needed
1
Research Sites
179 weeks
Total Duration
On this page
Sponsors
B
Boston Medical Center
Lead Sponsor
N
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Gabapentin to Reduce Alcohol and Improve Viral Load Suppression
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Having an HIV diagnosis for at least 6 months
- Current (within 2 months) detectable HIV viral load at least 6 months after HIV diagnosis
- Positive EtG urine test
- Able and willing to comply with all study protocols and procedures
- Living within 2 hours travel time of the study site
You will not qualify if you...
- Not fluent in English or Runyankole
- Cognitive impairment resulting in inability to provide informed consent based on research assessor assessment
- Pregnancy, planning to become pregnant in next 3 months, or breast feeding
- Taking gabapentin or pregabalin in past 30 days
- Taking any medication for alcohol use disorder
- Enrolled in another HIV research study seeking viral load suppression
- Known hypersensitivity to gabapentin
- Unstable psychiatric illness including recent hallucinations, emergency visits for mental health, medication changes due to worsening symptoms, or suicidal ideation
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Mbarara Regional Referral Hospital (MRRH): Immune Suppression Syndrome HIV
Mbarara, Uganda
Actively Recruiting
Research Team
J
Jeffrey Samet, MD MA MPH
CONTACT
K
Karsten Lunze, MD MPH DrPH
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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