Gabapentin Treatment of Alcohol Dependence | RxWiki

Gabapentin Treatment of Alcohol Dependence

Overview[ - collapse ][ - ]

Purpose	This is a study to evaluate the efficacy of the medication gabapentin in treating persons with an alcohol problem.
Condition	Alcoholism Alcohol Abuse Alcohol Dependence
Intervention	Drug: Gabapentin Behavioral: Standardized behavioral therapy Other: placebo
Phase	Phase 1/Phase 2
Sponsor	The Scripps Research Institute
Responsible Party	The Scripps Research Institute
ClinicalTrials.gov Identifier	NCT00391716
First Received	October 20, 2006
Last Updated	July 19, 2012
Last verified	July 2012

Tracking Information[ + expand ][ + ]

First Received Date	October 20, 2006
Last Updated Date	July 19, 2012
Start Date	February 2004
Estimated Primary Completion Date	February 2010
Current Primary Outcome Measures	Drinking quantity and frequency [Time Frame: 12-week] [Designated as safety issue: Yes]
Current Secondary Outcome Measures	Mood [Time Frame: 12-week] [Designated as safety issue: Yes] Sleep [Time Frame: 12-week] [Designated as safety issue: Yes] Craving [Time Frame: 12-week] [Designated as safety issue: Yes]

Descriptive Information[ + expand ][ + ]

Brief Title	Gabapentin Treatment of Alcohol Dependence
Official Title	Gabapentin Treatment of Alcohol Dependence
Brief Summary	This is a study to evaluate the efficacy of the medication gabapentin in treating persons with an alcohol problem.
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.
Study Type	Interventional
Study Phase	Phase 1/Phase 2
Study Design	Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Condition	Alcoholism Alcohol Abuse Alcohol Dependence
Intervention	Drug: Gabapentin 12-week, dose ranging study to evaluate the efficacy of gabapentin Behavioral: Standardized behavioral therapy 12-week standardized behavioral therapy Other: placebo 12 week, dosage ranging study
Study Arm (s)	Active Comparator: 1 12-week, dose ranging study to evaluate the efficacy of gabapentin Placebo Comparator: 2 12-week, dose ranging study

Recruitment Information[ + expand ][ + ]

Recruitment Status	Completed
Estimated Enrollment	150
Estimated Completion Date	February 2010
Estimated Primary Completion Date	July 2009
Eligibility 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.
Gender	Both
Ages	18 Years
Accepts Healthy Volunteers	No
Contacts	Not Provided
Location Countries	United States

Administrative Information[ + expand ][ + ]

NCT Number	NCT00391716
Other Study ID Numbers	NIAAAMAS014028
Has Data Monitoring Committee	No
Information Provided By	The Scripps Research Institute
Study Sponsor	The Scripps Research Institute
Collaborators	National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Investigators	Principal Investigator: Barbara J. Mason, PhD The Scripps Research Institute Pearson Center for Alcoholism and Addiction Research
Verification Date	July 2012

Locations[ + expand ][ + ]