Gabapentin for Alcohol Relapse Prevention

Alcohol Use Disorder Clinical Trial

Official title:

Gabapentin for Relapse Prevention: Alcohol Withdrawal Effects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02349477
• Other study ID #: Pro00032587
• Status: Completed
• Phase: Phase 2
• Start date: November 2014
• Est. completion date: August 27, 2018

Study information

• Verified date: October 2019
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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").

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: August 27, 2018
• Est. primary completion date: August 27, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Meets criteria for alcohol use disorder based on DSM-5 criteria

2. Meets criteria for history of alcohol withdrawal based on DSM-5 criteria

3. Able to maintain abstinence for a minimum of 3 days prior to randomization as verified by self report, urine ETG, and breathalyzer.

Exclusion Criteria:

1. Significant psychiatric or medical illness

2. No other substance abuse

3. Taking other medications known to treat alcohol use disorder

4. Unstable living arrangements

5. Significant legal problems pending

Related Conditions & MeSH terms

• Alcohol Use Disorder
• Alcohol Withdrawal
• Alcoholism

Intervention

Drug:
• Gabapentin
gaba potentiating medication
• Placebo
a pill that looks exactly like the active medication but does not contain medication

Locations

Country	Name	City	State
United States	Medical University of South Carolina	Charleston	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of South Carolina

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of Participants With No Drinking Days by AWS Score and Medication	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).	4 months
Primary	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.	4 months
Secondary	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.	4 months