Phase 2
N=150
Gabapentin Treatment of Alcohol Dependence
Alcoholism · Alcohol Dependence
Bottom Line
View on ClinicalTrials.gov: NCT00391716 ↗Enrolled (actual)
150
Serious AEs
1.3%
Results posted
Nov 2014
Primary outcome: Primary: Drinking — 6; 8; 2 participants — p=<0.04
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Gabapentin 900mg (Drug); behavioral counseling (Behavioral); placebo (Drug); gabapentin 1800mg (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- The Scripps Research Institute
- Primary completion
- Jul 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Drinking |
6; 8; 2 | <0.04 sig |
| SECONDARY Mood |
5.08; 3.62; 5.40 | <0.001 sig |
| SECONDARY Sleep |
4.04; 3.24; 4.50 | <0.001 sig |
| SECONDARY Craving |
33.66; 32.31; 34.27 | <0.003 sig |
Summary
Gabapentin treatment for alcohol dependence
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00391716). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.