Gabapentin Treatment of Alcohol Dependence - Full Text View

Sponsor:	The Scripps Research Institute
Collaborator:	National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by:	The Scripps Research Institute
ClinicalTrials.gov Identifier:	NCT00391716

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 I Phase II

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:

MedlinePlus related topics: Alcoholism

Drug Information available for: Ethanol Gabapentin Gabapentin enacarbil

U.S. FDA Resources

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 ]

Estimated Enrollment:	150
Study Start Date:	February 2004
Estimated Study Completion Date:	April 2010
Estimated Primary Completion Date:	October 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

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

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

More Information

No publications provided

Responsible Party:	Barbara J. Mason, PhD, Principal Investigator, TSRI Pearson Center for Alcoholism and Addiction Research
ClinicalTrials.gov Identifier:	NCT00391716 History of Changes
Other Study ID Numbers:	NIAAAMAS014028, R37AA014028, NIH Grant AA014028
Study First Received:	October 20, 2006
Last Updated:	April 28, 2010
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
Substance-Related Disorders
Mental Disorders
Gabapentin
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anticonvulsants
Antiparkinson Agents

Anti-Dyskinesia Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Antimanic Agents

ClinicalTrials.gov processed this record on February 09, 2012