Gabapentin Treatment of Alcohol Dependence
Information source: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information obtained from ClinicalTrials.gov on November 03, 2008 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Alcoholism; Alcohol Abuse; Alcohol Dependence
Intervention: Gabapentin (Drug); Standardized behavioral therapy (Behavioral); placebo (Other)
Phase: Phase 1/Phase 2
Status: Recruiting
Sponsored by: National Institute on Alcohol Abuse and Alcoholism (NIAAA) Official(s) and/or principal investigator(s): Barbara J. Mason, PhD, Principal Investigator, Affiliation: The Scripps Research Institute Pearson Center for Alcoholism and Addiction Research
Overall contact: Susan Quello, Phone: 858-784-7327, Email: squello@scripps.edu
Summary
This is a study to evaluate the efficacy of the medication gabapentin in treating persons
with an alcohol problem.
Clinical Details
Official title: Gabapentin Treatment of Alcohol Dependence
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Drinking quantity and frequency
Secondary outcome: MoodSleep Craving
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. Counseling and
research assessments occur weekly throughout the 12-week treatment phase.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Men and women over age 18 with alcohol dependence
Exclusion Criteria:
- Currently meets 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.
Locations and Contacts
Susan Quello, Phone: 858-784-7327, Email: squello@scripps.edu
The Scripps Research Institute, La Jolla, California 92037, United States; Recruiting Susan Quello, Phone: 858-784-7327, Email: squello@scripps.edu Barbara J. Mason, PhD, Principal Investigator
Additional Information
Starting date: February 2004
Ending date: February 2008
Last updated: September 26, 2008
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