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Gabapentin to Reduce Alcohol and Improve Viral Load Suppression

Study acronym: GRAIL
StatusActive, Not Recruiting
PhasePhase 2
Started
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Record History

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  1. Trial status: Recruiting to Active, Not Recruiting
    • Primary completion date: Aug 2026 to Oct 2026
    • Study completion date: May 2027 to Jun 2027
    • Site details revised
    v14
  2. Enrollment target: 300 to 220v13
  3. Re-verified, no change to tracked fieldsv12
  4. Primary completion date: Sep 2025 to Aug 2026
    • Study completion date: Jul 2026 to May 2027
    v11
  5. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Nov 2023 to Nov 20, 2023
    • Site details revised
    v10
Show 8 earlier versionsHide 8 earlier versions
  1. Start date: Oct 2023 to Nov 2023v9
  2. Start date: Sep 2023 to Oct 2023v8
  3. Start date: Aug 2023 to Sep 2023v7
  4. Start date: Jul 2023 to Aug 2023
    • Eligibility criteria shortened, about 28 words
    v6
  5. Primary completion date: Oct 2025 to Sep 2025v5
  6. Primary completion date: Sep 2025 to Oct 2025
    • Start date: Jun 2023 to Jul 2023
    v4
  7. Phase: Phase 2/3 to Phase 2v3
  8. Primary endpoint revised
    • Secondary endpoints revised (2)
    • Eligibility criteria expanded, about 2 words
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05443555
Lead Sponsor Boston Medical Center
Collaborators: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Conditions
(from sponsor)		 HIV, Heavy Drinking
Related terms Alcohol Drinking
Enrollment 220 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov