Gabapentin for Alcohol Relapse Prevention

Study Overview
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Brief Summary
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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
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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.

Official Title
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Gabapentin for Relapse Prevention: Alcohol Withdrawal Effects

Conditions
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Alcohol Use Disorder, Alcohol Withdrawal

Intervention / Treatment
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* Drug: Gabapentin
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Gabapentin<br>Gabapentin up to 1200 mg per day in 3 divided doses | Drug: Gabapentin<br>* gaba potentiating medication<br>* Other names: neurontin;|
| Placebo Comparator: placebo<br>matching placebo | Drug: Placebo<br>* a pill that looks exactly like the active medication but does not contain medication<br>* Other names: Sugar Pill;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |