Gabapentin Treatment of Alcohol Dependence

Study Overview
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Brief Summary
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Gabapentin treatment for alcohol dependence

Detailed Description
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This is a 12-week, double blind, placebo controlled, dose ranging study to evaluate the efficacy of gabapentin in treating outpatients with alcohol dependence. Subjects receive 900mg or 1800mg gabapentin or placebo daily for 12 weeks accompanied by weekly standardized counseling for alcohol-related behavior, with assessments of alcohol consumption, mood, sleep and alcohol-craving performed each week.

Official Title
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Gabapentin Treatment of Alcohol Dependence

Conditions
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Alcohol Dependence, Alcoholism

Intervention / Treatment
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* Drug: Gabapentin 900mg
* Behavioral: behavioral counseling
* Drug: placebo
* Drug: gabapentin 1800mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men and women over age 18 with alcohol dependence Exclusion Criteria: Currently meets Diagnostic and Statistical Manual 4 Text Revision (DSM-IV-TR) criteria for dependence on illicit substances Significant medical disorders that will increase potential risk or interfere with study participation Women with childbearing potential who are pregnant, nursing, or refuse to use a reliable method of birth control Treatment with an investigational drug in the last month.

Ages Eligible for Study
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Minimum Age: 18 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 900mg daily<br>900mg gabapentin daily for 12 weeks and weekly concomitant manualized behavioral counseling for 12 weeks. | Drug: Gabapentin 900mg<br>* 900 mg gabapentin daily for 12 weeks<br>* Other names: Neurontin;Behavioral: behavioral counseling<br>* The manual for standardized alcohol-related behavioral counseling was developed by Drs. Barbara Mason and Anita Goodman. The manual is available at alcoholfree.info.<br>* Other names: alcoholfree.info;|
| Experimental: gabapentin 1800mg daily<br>1800 mg gabapentin daily for 12 weeks and weekly concomitant manualized behavioral counseling for 12 weeks | Behavioral: behavioral counseling<br>* The manual for standardized alcohol-related behavioral counseling was developed by Drs. Barbara Mason and Anita Goodman. The manual is available at alcoholfree.info.<br>* Other names: alcoholfree.info;Drug: gabapentin 1800mg<br>* 1800 mg gabapentin daily for 12 weeks<br>* Other names: Neurontin;|
| Placebo Comparator: placebo daily<br>placebo capsules daily for 12 weeks and weekly concomitant manualized behavioral counseling for 12 weeks. | Behavioral: behavioral counseling<br>* The manual for standardized alcohol-related behavioral counseling was developed by Drs. Barbara Mason and Anita Goodman. The manual is available at alcoholfree.info.<br>* Other names: alcoholfree.info;Drug: placebo<br>* lactose capsule compounded to mimic gabapentin capsules<br>* Other names: lactose capsule;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Drinking | Rate of complete abstinence was defined as the number of participants who drank no alcohol during 12 weeks of treatment, where the denominator is the intent to treat population. Rate of heavy drinking abstinence is defined as no heavy drinking days while on study (4 or more for women, 5 or more for men). | 12-week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mood | Beck Depression Inventory II consists of 21 questions assessing depression symptoms answered with scores between 0 and 3, summed for a weekly total score between 0 and 63; higher scores indicate more depression. The cumulative mean total depression scores over the 12 week study are tested by ANOVA for differences in cumulative means between treatment groups. | 12-week | 
| Sleep | The Pittsburgh Sleep Questionnaire Inventory consists of 9 questions about sleep habits which are answered on a scale of 0-3. Results are sorted into 7 sub scales re-scored 0-3, then sub scales are summed for a weekly total score between 0 and 21, with higher total scores indicating greater sleep impairment. Cumulative mean total sleep scores over the 12 weeks of study are assessed by ANOVA for differences between treatment groups. | 12-week | 
| Craving | Alcohol Craving Questionnaire has 12 questions about alcohol craving which are each scored 1-7, then summed for a weekly score between 7 and 84, with higher scores indicating greater craving. Cumulative mean total craving scores are tested by ANOVA for differences between treatment groups. | 12-week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Alcohol, Alcohol treatment, Alcoholism, Alcohol Dependence