Gabapentin to Reduce Alcohol and Improve Viral Load Suppression (GRAIL)

Boston Medical Center (BMC)

Status and phase: Enrolling; Phase 2

Conditions: HIV; Heavy Drinking

Treatments: Drug: Gabapentin; Drug: Placebo

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05443555

R01AA030460 (U.S. NIH Grant/Contract)

H-42904

Details and patient eligibility

About

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.

Full description

Ending the HIV epidemic requires achieving HIV viral load (HVL) suppression (i.e., undetectable viral load) for key populations. Unhealthy alcohol use by people with HIV (PWH) is a barrier to reaching HVL suppression at multiple stages of the HIV care cascade. Alcohol use is common among PWH and results in lower antiretroviral therapy (ART) adherence and HVL suppression, mitigating the effectiveness of Treatment as Prevention (TasP), a key strategy for preventing HIV transmission. Treating alcohol use is therefore a mechanism to support PWH with unhealthy alcohol use along the HIV care cascade (e.g., ART initiation, retention in care, medication adherence, and HVL suppression).

The investigators propose the Gabapentin to Reduce Alcohol and Improve Viral Load Suppression (GRAIL) trial to test the efficacy of gabapentin vs. placebo on achieving viral load suppression among PWH. The study population will be heavy drinkers with a detectable viral load at least 6 months after their HIV diagnosis. The rationale for this trial is that effective pharmacological alcohol treatment will help PWH with heavy alcohol use who have a known HIV diagnosis for at least 6 months to successfully engage in HIV care. The overarching strategy to achieve TasP is that gabapentin will reduce heavy alcohol use, thereby increasing HIV care engagement, ART use and adherence while decreasing pain, all of which ultimately promote viral load suppression.

GRAIL is a randomized, double-blinded, placebo-controlled clinical trial that will evaluate the efficacy of gabapentin in promoting HVL suppression via reducing alcohol use among PWH but not virally suppressed (i.e., The study population will be heavy drinkers with a detectable viral load for 6 months or more after their HIV diagnosis). Participants will be randomized 1:1 to receive either gabapentin (1800mg/day target dose) or placebo for 3 months; both arms will employ a brief intervention to reduce alcohol use.

Enrollment: 220 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

220 participants in 2 patient groups, including a placebo group

Intervention: Gabapentin

Active Comparator group

Description:

Participants randomized to the intervention group will receive active gabapentin for 3 months and brief (5-minute) evidence-based counseling for alcohol use.

Treatment:

Drug: Gabapentin

Control: Placebo

Placebo Comparator group

Description:

Participants randomized to the control group will receive placebo capsules, identical in appearance to gabapentin, and the same brief (5-minute) one-time evidence-based counseling for alcohol use as the intervention group.

Treatment:

Drug: Placebo