NCT05443555Active, not recruitingPhase 2
Gabapentin to Reduce Alcohol and Improve Viral Load Suppression
Gabapentin to Reduce Alcohol and Improve Viral Load Suppression - Promoting "Treatment as Prevention"
Source: ClinicalTrials.gov · Last updated 1 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 220 (actual)
- First submitted
- 29 Jun 2022
- Start date
- 20 Nov 2023
- Primary completion date
- Oct 2026
- Lead sponsor
- Boston Medical Center
- Diseases
- HIV
- NCT number
- NCT05443555
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 220
- From 20 Nov 2023 to the primary completion date, Oct 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Cognitive impairment resulting in inability to provide informed consent based on research assessor (RA) assessment
- 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)
Other
- Not fluent in English or Runyankole
- Pregnancy, planning to become pregnant in next 3 months, or breast feeding
- Taking gabapentin/pregabalin in past 30 days
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Mbarara Regional Referral Hospital (MRRH): Immune Suppression Syndrome HIV Coordinator of this site? Confirm its status | Mbarara | Uganda | Unknown status |
Related publications
- Gabapentin to achieve HIV viral load suppression in people with risky drinking in Mbarara, Uganda: study protocol for a randomized, double-blinded, placebo-controlled trial (GRAIL).Trials · 2026 · PMID 42237416
- Gabapentin to achieve HIV viral load suppression in people with risky drinking in Mbarara, Uganda: study protocol for a randomized, double-blinded, placebo-controlled trial (GRAIL).Res Sq · 2025 · PMID 41282191
This page is information, not medical advice. Discuss any trial with your doctor.