Gabapentin for Alcohol Relapse Prevention
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|ClinicalTrials.gov Identifier: NCT02349477|
Recruitment Status : Completed
First Posted : January 29, 2015
Results First Posted : November 4, 2019
Last Update Posted : November 4, 2019
|Condition or disease||Intervention/treatment||Phase|
|Alcohol Use Disorder Alcohol Withdrawal||Drug: Gabapentin Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||96 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Gabapentin for Relapse Prevention: Alcohol Withdrawal Effects|
|Study Start Date :||November 2014|
|Actual Primary Completion Date :||August 27, 2018|
|Actual Study Completion Date :||August 27, 2018|
Gabapentin up to 1200 mg per day in 3 divided doses
gaba potentiating medication
Other Name: neurontin
Placebo Comparator: placebo
a pill that looks exactly like the active medication but does not contain medication
Other Name: Sugar Pill
- 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.
- Percent of Subjects With no Drinking Days (PSNDD) [ Time Frame: 4 months ]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.
- Number of Participants With No Drinking Days by AWS Score and Medication [ Time Frame: 4 months ]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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02349477
|United States, South Carolina|
|Medical University of South Carolina|
|Charleston, South Carolina, United States, 29425|
|Principal Investigator:||Raymond F Anton, MD||Medical University of South Carolina|