Using gabapentin to help reduce alcohol use and improve HIV treatment outcomes
Gabapentin to Reduce Alcohol and Improve Viral Load Suppression - Promoting "Treatment as Prevention"
This study is testing if gabapentin can help people with HIV who drink heavily to reduce their alcohol use and improve their HIV treatment outcomes.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 220 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Boston Medical Center Academic / other |
| Locations | 1 site (Mbarara) |
| Trial ID | NCT05443555 on ClinicalTrials.gov |
What this trial studies
The GRAIL trial is a randomized controlled trial involving 300 HIV-positive individuals who consume heavy amounts of alcohol and have detectable HIV viral loads. Participants will be assigned to receive either gabapentin or a placebo for three months, alongside evidence-based counseling for alcohol use. The study aims to evaluate the effectiveness of gabapentin in achieving undetectable HIV viral loads and its impact on alcohol consumption, pain severity, ART adherence, and overall engagement in HIV care. HIV viral loads will be monitored at three, six, and twelve months post-intervention.
Who should consider this trial
Good fit: Ideal candidates for this study are HIV-positive individuals who have been diagnosed for at least six months and currently exhibit heavy alcohol consumption with detectable viral loads.
Not a fit: Patients who are not heavy drinkers or those with stable viral loads may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly improve HIV treatment outcomes for patients with heavy alcohol use by promoting viral load suppression.
How similar studies have performed: While the approach of using gabapentin for alcohol reduction in HIV-positive populations is innovative, similar studies have shown promise in addressing alcohol use disorders in other contexts.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Mbarara
- Mbarara Regional Referral Hospital (MRRH): Immune Suppression Syndrome HIV — Mbarara, Uganda (Recruiting)
Study contacts
- Principal investigator: Jeffrey Samet, MD MA MPH — Boston University
- Study coordinator: Jeffrey Samet, MD MA MPH
- Email: jsamet@bu.edu
- Phone: (617) 414-7288
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.