Gabapentin to Reduce Alcohol and Improve Viral Load Suppression
NCT ID: NCT05443555
Last Updated: 2025-11-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
220 participants
INTERVENTIONAL
2023-11-20
2027-05-31
Brief Summary
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Detailed Description
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The investigators propose the Gabapentin to Reduce Alcohol and Improve Viral Load Suppression (GRAIL) trial to test the efficacy of gabapentin vs. placebo on achieving viral load suppression among PWH. The study population will be heavy drinkers with a detectable viral load at least 6 months after their HIV diagnosis. The rationale for this trial is that effective pharmacological alcohol treatment will help PWH with heavy alcohol use who have a known HIV diagnosis for at least 6 months to successfully engage in HIV care. The overarching strategy to achieve TasP is that gabapentin will reduce heavy alcohol use, thereby increasing HIV care engagement, ART use and adherence while decreasing pain, all of which ultimately promote viral load suppression.
GRAIL is a randomized, double-blinded, placebo-controlled clinical trial that will evaluate the efficacy of gabapentin in promoting HVL suppression via reducing alcohol use among PWH but not virally suppressed (i.e., The study population will be heavy drinkers with a detectable viral load for 6 months or more after their HIV diagnosis). Participants will be randomized 1:1 to receive either gabapentin (1800mg/day target dose) or placebo for 3 months; both arms will employ a brief intervention to reduce alcohol use.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Intervention: Gabapentin
Participants randomized to the intervention group will receive active gabapentin for 3 months and brief (5-minute) evidence-based counseling for alcohol use.
Gabapentin
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.
Control: Placebo
Participants randomized to the control group will receive placebo capsules, identical in appearance to gabapentin, and the same brief (5-minute) one-time evidence-based counseling for alcohol use as the intervention group.
Placebo
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.
Interventions
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Gabapentin
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.
Placebo
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.
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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)
18 Years
ALL
No
Sponsors
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National Institute on Alcohol Abuse and Alcoholism (NIAAA)
NIH
Boston Medical Center
OTHER
Responsible Party
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Principal Investigators
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Jeffrey Samet, MD MA MPH
Role: PRINCIPAL_INVESTIGATOR
Boston University
Karsten Lunze, MD MPH DrPH
Role: PRINCIPAL_INVESTIGATOR
Boston University
Locations
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Mbarara Regional Referral Hospital (MRRH): Immune Suppression Syndrome HIV
Mbarara, , Uganda
Countries
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Central Contacts
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Facility Contacts
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Winnie Muyindike, MBChB MMed DPAM
Role: primary
Other Identifiers
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H-42904
Identifier Type: -
Identifier Source: org_study_id