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
  Purpose

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


Condition Intervention Phase
Alcoholism
Alcohol Abuse
Alcohol Dependence
Drug: Gabapentin
Behavioral: Standardized behavioral therapy
Other: placebo
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Gabapentin Treatment of Alcohol Dependence

Resource links provided by NLM:


Further study details as provided by The Scripps Research Institute:

Primary Outcome Measures:
  • Drinking quantity and frequency [ Time Frame: 12-week ] [ Designated as safety issue: Yes ]

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 ]

Enrollment: 150
Study Start Date: February 2004
Study Completion Date: February 2010
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
12-week, dose ranging study to evaluate the efficacy of gabapentin
Drug: Gabapentin
12-week, dose ranging study to evaluate the efficacy of gabapentin
Behavioral: Standardized behavioral therapy
12-week standardized behavioral therapy
Placebo Comparator: 2
12-week, dose ranging study
Behavioral: Standardized behavioral therapy
12-week standardized behavioral therapy
Other: placebo
12 week, dosage ranging study

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00391716

Locations
United States, California
The Scripps Research Institute
La Jolla, California, United States, 92037
Sponsors and Collaborators
The Scripps Research Institute
Investigators
Principal Investigator: Barbara J. Mason, PhD The Scripps Research Institute Pearson Center for Alcoholism and Addiction Research
  More Information

No publications provided by The Scripps Research Institute

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Barbara J. Mason, PI, The Scripps Research Institute
ClinicalTrials.gov Identifier: NCT00391716     History of Changes
Other Study ID Numbers: NIAAAMAS014028, R37AA014028, NIH Grant AA014028
Study First Received: October 20, 2006
Last Updated: July 19, 2012
Health Authority: United States: Federal Government

Keywords provided by The Scripps Research Institute:
Alcohol
Alcohol treatment
Alcoholism
Alcohol Abuse
Alcohol Dependence

Additional relevant MeSH terms:
Alcoholism
Alcohol-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Substance-Related Disorders
Gabapentin
Analgesics
Anti-Anxiety Agents
Anti-Dyskinesia Agents
Anticonvulsants
Antimanic Agents
Antiparkinson Agents
Calcium Channel Blockers
Cardiovascular Agents
Central Nervous System Agents
Central Nervous System Depressants
Excitatory Amino Acid Agents
Excitatory Amino Acid Antagonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Sensory System Agents
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on October 22, 2014