HIVPhase 2GRAILNCT05443555
Gabapentin to Reduce Alcohol and Improve Viral Load Suppression
A Phase 2 study testing Gabapentin in people with HIV and Heavy Drinking, run by Boston Medical Center at 1 site in Uganda.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV, Heavy Drinking
- What is being tested?
- Gabapentin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 220 participants
- Where
- 1 siteUganda
- Study dates
- 20 Nov 2023to Jun 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Uganda1 site
Mbarara Regional Referral Hospital (MRRH): Immune Suppression Syndrome HIV
Mbarara
About this study
Official title: Gabapentin to Reduce Alcohol and Improve Viral Load Suppression - Promoting "Treatment as Prevention"
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.
Read the detailed 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.
- Conditions
- HIV, Heavy Drinking
- Being tested
- Gabapentin, Placebo
- Keywords
- Uganda, Alcohol Use, ART, HIV, Gabapentin
- Medical subject headings
- Alcohol Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GabapentinDrug
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.
PlaceboDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with undetectable HIV viral load
Assessed by study test
Measured: 3 months post randomization
Secondary outcomes (2)
Number of participants with undetectable HIV viral load
Assessed by study test
Measured: 6 months post randomization
Number of participants with undetectable HIV viral load
Assessed by study test
Measured: 12 months post randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2022
- Study start20 Nov 2023
- Primary completion24 Sep 2026
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by Boston Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Sponsor
- Investigators
- Jeffrey Samet, MD MA MPH, Principal investigator, Boston UniversityKarsten Lunze, MD MPH DrPH, Principal investigator, Boston University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05443555
- Sponsor's protocol ID
- H-42904
- Other IDs
- R01AA030460
- Acronym
- GRAIL
- Status last verified
- Nov 2026
- First submitted
- 29 Jun 2022
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Truong V, Kekibiina A, Muyindike WR, Gnatienko N, Tsui JI, Emenyonu NI, Cheng DM, Hahn JA, 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). Trials. 2026 Jun 3;27(1):452. doi: 10.1186/s13063-026-09813-1.
PubMed 42237416Truong 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.
PubMed 41282191
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gabapentin to Reduce Alcohol and Improve Viral Load Suppression - Promoting "Treatment as Prevention"
- ClinicalTrials.gov ID
- NCT05443555
- Acronym / sponsor ID
- GRAIL / H-42904
- Conditions
- HIV, Heavy Drinking
- Keywords
- Uganda, Alcohol Use, ART, HIV, Gabapentin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 220 participants (actual)
- Lead sponsor
- Boston Medical CenterUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 20 Nov 2023 (actual)
- Primary completion
- 24 Sep 2026 (actual)
- Study completion
- Jun 2027 (estimated)
- First posted
- 5 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention: Gabapentin | Active comparator | Drug: GabapentinParticipants randomized to the intervention group will receive active gabapentin for 3 months and brief (5-minute) evidence-based counseling for alcohol use. |
| Control: Placebo | Placebo comparator | Drug: PlaceboParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GabapentinDosing 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. | Drug | Intervention: Gabapentin |
| PlaceboParticipants 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. | Drug | Control: Placebo |
Primary outcome
Number of participants with undetectable HIV viral load
Time frame: 3 months post randomization
Assessed by study test
2 secondary outcomes
Number of participants with undetectable HIV viral load
Time frame: 6 months post randomization
Number of participants with undetectable HIV viral load
Time frame: 12 months post randomization
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- Derived from this study: PubMed 42237416Truong V, Kekibiina A, Muyindike WR, Gnatienko N, Tsui JI, Emenyonu NI, Cheng DM, Hahn JA, 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). Trials. 2026 Jun 3;27(1):452. doi: 10.1186/s13063-026-09813-1.
- Derived from this study: PubMed 41282191Truong 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeffrey Samet, MD MA MPH principal investigator
Boston University
Karsten Lunze, MD MPH DrPH principal investigator
Boston University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Gabapentin in people with HIV and Heavy Drinking, run by Boston Medical Center at 1 site in Uganda.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with undetectable HIV viral load (time frame: 3 months post randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05443555, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.