Gabapentin to Reduce Alcohol and Improve Viral Load Suppression
Gabapentin to Reduce Alcohol and Improve Viral Load Suppression - Promoting "Treatment as Prevention"
Boston Medical Center
220 participants
Nov 20, 2023
INTERVENTIONAL
Conditions
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
Inclusion Criteria5
- 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
Exclusion Criteria8
- 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/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 (i.e., answered yes to any of the following: past three month active hallucinations; mental health symptoms prompting a visit to the emergency department (ED) or hospital; mental health medication changes due to worsening symptoms; presence of suicidal ideations)
Interventions
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.
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.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05443555