Gabapentin to Reduce Alcohol and Improve Viral Load Suppression

Launched by BOSTON MEDICAL CENTER · Jun 29, 2022

Keywords

ClinConnect Summary

This clinical trial, called GRAIL, is studying whether gabapentin can help people with HIV who also struggle with heavy drinking. The goal is to see if taking gabapentin can lower the amount of HIV in the blood to undetectable levels and reduce alcohol consumption. The study will involve 300 participants who have been diagnosed with HIV for at least six months and currently have detectable HIV levels. Participants will be randomly assigned to receive either gabapentin or a placebo (a treatment with no active ingredients) for three months, along with counseling for alcohol use.

To be eligible, participants need to have a detectable HIV viral load, be over 18 years old, and able to travel to the study site. They should not be pregnant or breastfeeding and must not have taken gabapentin or any medications for alcohol use disorder in the past month. Throughout the trial, participants will undergo regular check-ups to monitor their HIV levels and overall health. This study is important as it could provide insights into better management of HIV and alcohol use, which can improve the quality of life for those affected.

Gender

ALL

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)