Gabapentin for Alcohol Relapse Prevention
Primary Purpose
Alcohol Use Disorder, Alcohol Withdrawal
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Gabapentin
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Alcohol Use Disorder
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Sites / Locations
- Medical University of South Carolina
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Gabapentin
placebo
Arm Description
Gabapentin up to 1200 mg per day in 3 divided doses
matching placebo
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT02349477
First Posted
January 15, 2015
Last Updated
October 15, 2019
Sponsor
Medical University of South Carolina
1. Study Identification
Unique Protocol Identification Number
NCT02349477
Brief Title
Gabapentin for Alcohol Relapse Prevention
Official Title
Gabapentin for Relapse Prevention: Alcohol Withdrawal Effects
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
November 2014 (undefined)
Primary Completion Date
August 27, 2018 (Actual)
Study Completion Date
August 27, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical University of South Carolina
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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").
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Use Disorder, Alcohol Withdrawal
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
96 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Gabapentin
Arm Type
Experimental
Arm Description
Gabapentin up to 1200 mg per day in 3 divided doses
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
matching placebo
Intervention Type
Drug
Intervention Name(s)
Gabapentin
Other Intervention Name(s)
neurontin
Intervention Description
gaba potentiating medication
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Sugar Pill
Intervention Description
a pill that looks exactly like the active medication but does not contain medication
Primary Outcome Measure Information:
Title
Percent of Subjects With no Heavy Drinking Days (PSNHDD)
Description
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.
Time Frame
4 months
Secondary Outcome Measure Information:
Title
Percent of Subjects With no Drinking Days (PSNDD)
Description
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.
Time Frame
4 months
Other Pre-specified Outcome Measures:
Title
Number of Participants With No Drinking Days by AWS Score and Medication
Description
This analysis examines the interaction of medication group with a median split of the baseline Alcohol Withdrawal Scale (AWS) scores on the primary outcome variable (no heavy drinking days, corrected for %dCDT). Participants will report their daily alcohol use with using a daily calendar. AWS ranges from 0 to 44 where higher values correspond with more serious withdrawal (worse outcome).
Time Frame
4 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raymond F Anton, MD
Organizational Affiliation
Medical University of South Carolina
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
34256607
Citation
Prisciandaro 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.
Results Reference
derived
PubMed Identifier
32150232
Citation
Anton 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.
Results Reference
derived
Learn more about this trial
Gabapentin for Alcohol Relapse Prevention
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