Gabapentin Treatment of Alcohol Dependence
- Conditions
- AlcoholismAlcohol Dependence
- Interventions
- Registration Number
- NCT00391716
- Lead Sponsor
- The Scripps Research Institute
- Brief Summary
Gabapentin treatment for alcohol dependence
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 150
- Men and women over age 18 with alcohol dependence
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description gabapentin 1800mg daily gabapentin 1800mg 1800 mg gabapentin daily for 12 weeks and weekly concomitant manualized behavioral counseling for 12 weeks gabapentin 900mg daily Gabapentin 900mg 900mg gabapentin daily for 12 weeks and weekly concomitant manualized behavioral counseling for 12 weeks. gabapentin 900mg daily behavioral counseling 900mg gabapentin daily for 12 weeks and weekly concomitant manualized behavioral counseling for 12 weeks. gabapentin 1800mg daily behavioral counseling 1800 mg gabapentin daily for 12 weeks and weekly concomitant manualized behavioral counseling for 12 weeks placebo daily behavioral counseling placebo capsules daily for 12 weeks and weekly concomitant manualized behavioral counseling for 12 weeks. placebo daily placebo placebo capsules daily for 12 weeks and weekly concomitant manualized behavioral counseling for 12 weeks.
- Primary Outcome Measures
Name Time Method Drinking 12-week 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).
- Secondary Outcome Measures
Name Time Method Mood 12-week 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.
Sleep 12-week 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.
Craving 12-week 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.
Trial Locations
- Locations (1)
The Scripps Research Institute
🇺🇸La Jolla, California, United States