Alcohol Use DisorderPhase 2NCT02349477
Gabapentin for Alcohol Relapse Prevention
A Phase 2 study testing Gabapentin in people with Alcohol Use Disorder and Alcohol Withdrawal, run by Medical University of South Carolina at 1 site in United States.
Trial summary
This treatment study is a 16-weeks outpatient clinical trial where subjects with alcohol dependence will get medication, which might help them to reduce or stop their drinking, or a placebo ( placebo is a capsule that looks the same as the investigational drug, but has no real medication. It is a "sugar pill"). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Alcohol Use Disorder, Alcohol Withdrawal
- 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
- 96 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2014to 27 Aug 2018
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Meets criteria for alcohol use disorder based on DSM-5 criteria
- Meets criteria for history of alcohol withdrawal based on DSM-5 criteria
- Able to maintain abstinence for a minimum of 3 days prior to randomization as verified by self report, urine ETG, and breathalyzer.
Who cannot join
- Significant psychiatric or medical illness
- No other substance abuse
- Taking other medications known to treat alcohol use disorder
- Unstable living arrangements
- Significant legal problems pending
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical University of South Carolina
Charleston, South Carolina, 29425
About this study
Official title: Gabapentin for Relapse Prevention: Alcohol Withdrawal Effects
This treatment study is a 16-weeks outpatient clinical trial where subjects with alcohol dependence will get medication, which might help them to reduce or stop their drinking, or a placebo ( placebo is a capsule that looks the same as the investigational drug, but has no real medication. It is a "sugar pill").
Read the detailed description
This treatment study is a 16-weeks outpatient clinical trial where subjects will get medication, which might help them to reduce or stop their drinking or a placebo ( placebo is a capsule that looks the same as the investigational drug, but has no real medication. It is a "sugar pill"). This study will recruit and randomize subjects who have expressed an interest in receiving treatment for alcohol dependence. Upon enrollment into this study there will be 11 outpatient visits. Each visit will last about 1-1.5 hours.
- Conditions
- Alcohol Use Disorder, Alcohol Withdrawal
- Being tested
- Gabapentin, Placebo
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GabapentinDrug
Also called neurontin
gaba potentiating medication
PlaceboDrug
Also called Sugar Pill
a pill that looks exactly like the active medication but does not contain medication
| Study group | Role | What they receive |
|---|---|---|
| Gabapentin | Experimental | Gabapentin up to 1200 mg per day in 3 divided doses Receives: Drug: Gabapentin |
| placebo | Placebo comparator | matching placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of Subjects With no Heavy Drinking Days (PSNHDD)
The primary dependent variable will be the percent of subjects with no heavy drinking days (4 or more standard drinks for women and 5 or more standard drinks for men). Participants will report their daily alcohol use with using a daily calendar. No heavy drinking days is corrected for %dCDT.
Measured: 4 months
Secondary outcomes (1)
Percent of Subjects With no Drinking Days (PSNDD)
The secondary dependent variable will be percent of subjects with no drinking days (total abstinence). Participants will report their daily alcohol use with using a daily calendar. Abstinence is corrected for %dCDT.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2015 (estimated)
- Study startNov 2014
- Primary completion27 Aug 2018
- Study completion27 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Alcohol Use DisorderStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Raymond F Anton, MD, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02349477
- Sponsor's protocol ID
- Pro00032587
- Status last verified
- Oct 2019
- First submitted
- 15 Jan 2015
- Last updated
- 4 Nov 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Hoffman M, Voronin K, Book SW, Prisciandaro J, Bristol EJ, Anton RF. Sleep as an Important Target or Modifier in Alcohol Use Disorder Clinical Treatment: Example From a Recent Gabapentin Randomized Clinical Trial. J Addict Med. 2024 Sep-Oct 01;18(5):520-525. doi: 10.1097/ADM.0000000000001316. Epub 2024 May 31.
PubMed 38828963Prisciandaro JJ, Hoffman M, Brown TR, Voronin K, Book S, Bristol E, Anton RF. Effects of Gabapentin on Dorsal Anterior Cingulate Cortex GABA and Glutamate Levels and Their Associations With Abstinence in Alcohol Use Disorder: A Randomized Clinical Trial. Am J Psychiatry. 2021 Sep 1;178(9):829-837. doi: 10.1176/appi.ajp.2021.20121757. Epub 2021 Jul 14.
PubMed 34256607Anton RF, Latham P, Voronin K, Book S, Hoffman M, Prisciandaro J, Bristol E. Efficacy of Gabapentin for the Treatment of Alcohol Use Disorder in Patients With Alcohol Withdrawal Symptoms: A Randomized Clinical Trial. JAMA Intern Med. 2020 May 1;180(5):728-736. doi: 10.1001/jamainternmed.2020.0249.
PubMed 32150232
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gabapentin for Relapse Prevention: Alcohol Withdrawal Effects
- ClinicalTrials.gov ID
- NCT02349477
- Acronym / sponsor ID
- Pro00032587
- Conditions
- Alcohol Use Disorder, Alcohol Withdrawal
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- 27 Aug 2018 (actual)
- Study completion
- 27 Aug 2018 (actual)
- First posted
- 29 Jan 2015 (estimated)
- Results
- Posted 4 Nov 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This treatment study is a 16-weeks outpatient clinical trial where subjects with alcohol dependence will get medication, which might help them to reduce or stop their drinking, or a placebo ( placebo is a capsule that looks the same as the investigational drug, but has no real medication. It is a "sugar pill").
Detailed description
This treatment study is a 16-weeks outpatient clinical trial where subjects will get medication, which might help them to reduce or stop their drinking or a placebo ( placebo is a capsule that looks the same as the investigational drug, but has no real medication. It is a "sugar pill"). This study will recruit and randomize subjects who have expressed an interest in receiving treatment for alcohol dependence. Upon enrollment into this study there will be 11 outpatient visits. Each visit will last about 1-1.5 hours.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gabapentin | Experimental | Drug: GabapentinGabapentin up to 1200 mg per day in 3 divided doses |
| placebo | Placebo comparator | Drug: Placebomatching placebo |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Meets criteria for alcohol use disorder based on DSM-5 criteria
- Meets criteria for history of alcohol withdrawal based on DSM-5 criteria
- Able to maintain abstinence for a minimum of 3 days prior to randomization as verified by self report, urine ETG, and breathalyzer.
Key exclusion criteria (5 listed)
- Significant psychiatric or medical illness
- No other substance abuse
- Taking other medications known to treat alcohol use disorder
- Unstable living arrangements
- Significant legal problems pending
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 |
|---|---|---|
| GabapentinAlso: neurontingaba potentiating medication | Drug | Gabapentin |
| PlaceboAlso: Sugar Pilla pill that looks exactly like the active medication but does not contain medication | Drug | placebo |
Primary outcome
Percent of Subjects With no Heavy Drinking Days (PSNHDD)
Time frame: 4 months
The primary dependent variable will be the percent of subjects with no heavy drinking days (4 or more standard drinks for women and 5 or more standard drinks for men). Participants will report their daily alcohol use with using a daily calendar. No heavy drinking days is corrected for %dCDT.
1 secondary outcome
Percent of Subjects With no Drinking Days (PSNDD)
Time frame: 4 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38828963Hoffman M, Voronin K, Book SW, Prisciandaro J, Bristol EJ, Anton RF. Sleep as an Important Target or Modifier in Alcohol Use Disorder Clinical Treatment: Example From a Recent Gabapentin Randomized Clinical Trial. J Addict Med. 2024 Sep-Oct 01;18(5):520-525. doi: 10.1097/ADM.0000000000001316. Epub 2024 May 31.
- Derived from this study: PubMed 34256607Prisciandaro JJ, Hoffman M, Brown TR, Voronin K, Book S, Bristol E, Anton RF. Effects of Gabapentin on Dorsal Anterior Cingulate Cortex GABA and Glutamate Levels and Their Associations With Abstinence in Alcohol Use Disorder: A Randomized Clinical Trial. Am J Psychiatry. 2021 Sep 1;178(9):829-837. doi: 10.1176/appi.ajp.2021.20121757. Epub 2021 Jul 14.
- Derived from this study: PubMed 32150232Anton RF, Latham P, Voronin K, Book S, Hoffman M, Prisciandaro J, Bristol E. Efficacy of Gabapentin for the Treatment of Alcohol Use Disorder in Patients With Alcohol Withdrawal Symptoms: A Randomized Clinical Trial. JAMA Intern Med. 2020 May 1;180(5):728-736. doi: 10.1001/jamainternmed.2020.0249.
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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.
Raymond F Anton, MD principal investigator
Medical University of South Carolina
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 Alcohol Use Disorder and Alcohol Withdrawal, run by Medical University of South Carolina at 1 site in United States.
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 3 inclusion and 5 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: finished, as of the sponsor's last update on 4 Nov 2019. 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 United States. 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?
Yes. Results are posted in the registry (first posted 4 Nov 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percent of Subjects With no Heavy Drinking Days (PSNHDD) (time frame: 4 months). 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 NCT02349477, which also lists 3 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 4 Nov 2019.