Gabapentin Treatment of Alcohol Dependence

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Barbara J. Mason, The Scripps Research Institute
ClinicalTrials.gov Identifier:
NCT00391716
First received: October 20, 2006
Last updated: July 19, 2012
Last verified: July 2012

October 20, 2006
July 19, 2012
February 2004
July 2009   (final data collection date for primary outcome measure)
Drinking quantity and frequency [ Time Frame: 12-week ] [ Designated as safety issue: Yes ]
  • Drinking frequency
  • Drinking quantity
Complete list of historical versions of study NCT00391716 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Mood
  • Sleep
  • Craving
Not Provided
Not Provided
 
Gabapentin Treatment of Alcohol Dependence
Gabapentin Treatment of Alcohol Dependence

This is a study to evaluate the efficacy of the medication gabapentin in treating persons with an alcohol problem.

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.

Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Alcoholism
  • Alcohol Abuse
  • Alcohol Dependence
  • 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
  • Active Comparator: 1
    12-week, dose ranging study to evaluate the efficacy of gabapentin
    Interventions:
    • Drug: Gabapentin
    • Behavioral: Standardized behavioral therapy
  • Placebo Comparator: 2
    12-week, dose ranging study
    Interventions:
    • Behavioral: Standardized behavioral therapy
    • Other: placebo
Mason BJ, Quello S, Goodell V, Shadan F, Kyle M, Begovic A. Gabapentin treatment for alcohol dependence: a randomized clinical trial. JAMA Intern Med. 2014 Jan;174(1):70-7. doi: 10.1001/jamainternmed.2013.11950.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
150
February 2010
July 2009   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00391716
NIAAAMAS014028, R37AA014028, NIH Grant AA014028
No
Barbara J. Mason, The Scripps Research Institute
The Scripps Research Institute
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Principal Investigator: Barbara J. Mason, PhD The Scripps Research Institute Pearson Center for Alcoholism and Addiction Research
The Scripps Research Institute
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP