NCT05443555 Gabapentin to Reduce Alcohol and Improve Viral Load Suppression
| NCT ID | NCT05443555 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Boston Medical Center |
| Condition | HIV |
| Study Type | INTERVENTIONAL |
| Enrollment | 220 participants |
| Start Date | 2023-11-20 |
| Primary Completion | 2026-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 220 participants in total. It began in 2023-11-20 with a primary completion date of 2026-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: * 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 Criteria: * 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)
Contact & Investigator
Jeffrey Samet, MD MA MPH
PRINCIPAL INVESTIGATOR
Boston University
Frequently Asked Questions
Who can join the NCT05443555 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying HIV. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05443555 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05443555 currently recruiting?
Yes, NCT05443555 is actively recruiting participants. Contact the research team at jsamet@bu.edu for enrollment information.
Where is the NCT05443555 trial being conducted?
This trial is being conducted at Mbarara, Uganda.
Who is sponsoring the NCT05443555 clinical trial?
NCT05443555 is sponsored by Boston Medical Center. The principal investigator is Jeffrey Samet, MD MA MPH at Boston University. The trial plans to enroll 220 participants.
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