Gabapentin to Reduce Alcohol and Improve Viral Load Suppression

NCT05443555 | Recruiting Phase 2 DMC

• 2 other identifiers: H-42904R01AA030460
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV; Heavy Drinking

Keywords

Uganda; Alcohol Use; ART; HIV; Gabapentin

Outcome Measures

Primary Outcomes (1)

• Number of participants with undetectable HIV viral load

  Assessed by study test

  3 months post randomization

Secondary Outcomes (2)

• Number of participants with undetectable HIV viral load

  6 months post randomization

• Number of participants with undetectable HIV viral load

  12 months post randomization

Other Outcomes (6)

• Number of heavy drinking days in the past month

  3, 6, and 12 months post randomization

• Number of participants with heavy alcohol consumption defined as Phosphatidylethanol (PEth) ≥50 ng/mL

  3, 6, and 12 months post randomization

• Adherence to ART

  3, 6, and 12 months post randomization

Study Arms (2)

Intervention: Gabapentin

ACTIVE COMPARATOR

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

Drug: Gabapentin

Control: Placebo

PLACEBO COMPARATOR

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.

Drug: Placebo

Interventions

Gabapentin DRUG

Dosing will be titrated up over 3 weeks, starting with a daily dose of 300mg (1 capsule/day) in week 1, followed by a daily dose of 900mg (3 capsules/day) in week 2, up to a target daily dose of 1800mg (6 capsules/day) in week 3. The target dose of 1800mg per day will be sustained from weeks 3 through day 4 of week 12. Then, dose will be tapered down to 900mg in days 5-7 of week 12, and medication will be discontinued at the end of week 12.

Intervention: Gabapentin

Placebo DRUG

Participants randomized to this group will receive a placebo medication for 3 months and will be instructed to follow the same pill regimen as the intervention arm.

Control: Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Boston Medical Center: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

Mbarara Regional Referral Hospital (MRRH): Immune Suppression Syndrome HIV

Mbarara, Uganda

RECRUITING

Related Publications (1)

• Truong V, Kekibiina A, Muyindike W, Gnatienko N, Tsui JI, Emenyonu NI, Cheng DM, Hahn J, Allison O, Bullard MJ, Lunze K, Samet JH. 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 [Preprint]. 2025 Oct 15:rs.3.rs-6856284. doi: 10.21203/rs.3.rs-6856284/v1.

  PMID: 41282191 DERIVED

MeSH Terms

Conditions

Alcohol Drinking

Interventions

Gabapentin

Condition Hierarchy (Ancestors)

Drinking Behavior; Behavior

Intervention Hierarchy (Ancestors)

Amines; Organic Chemicals; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Jeffrey Samet, MD MA MPH

  Boston University

  PRINCIPAL INVESTIGATOR

• Karsten Lunze, MD MPH DrPH

  Boston University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jeffrey Samet, MD MA MPH

CONTACT

(617) 414-7288; jsamet@bu.edu

Karsten Lunze, MD MPH DrPH

CONTACT

(617) 414-6933; lunze@bu.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2022
• First Posted: July 5, 2022
• Study Start: November 20, 2023
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): May 1, 2027
• Last Updated: November 6, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

UG (1)