Gabapentin Treatment of Alcohol Dependence - Full Text View

Sponsor:	National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by:	National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Gabapentin Treatment of Alcohol Dependence

Resource links provided by NLM:

MedlinePlus related topics: Alcoholism

Drug Information available for: Ethanol Gabapentin

U.S. FDA Resources

Further study details as provided by National Institute on Alcohol Abuse and Alcoholism (NIAAA):

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
1: Active Comparator 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
2: Placebo Comparator 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

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:	TSRI Pearson Center for Alcoholism and Addiction Research ( Barbara J. Mason, PhD, Principal Investigator )
Study ID Numbers:	NIAAAMAS014028, NIH Grant AA014028
Study First Received:	October 20, 2006
Last Updated:	September 1, 2009
ClinicalTrials.gov Identifier:	NCT00391716 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Institute on Alcohol Abuse and Alcoholism (NIAAA):

Alcohol
Alcohol treatment
Alcoholism
Alcohol Abuse
Alcohol Dependence

Additional relevant MeSH terms:

Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Gabapentin
Anti-Dyskinesia Agents
Physiological Effects of Drugs
Psychotropic Drugs
Disorders of Environmental Origin
Antiparkinson Agents
Calcium Channel Blockers
Excitatory Amino Acid Agents
Membrane Transport Modulators
Sensory System Agents
Mental Disorders
Therapeutic Uses

Substance-Related Disorders
Alcohol-Related Disorders
Analgesics
Excitatory Amino Acid Antagonists
Tranquilizing Agents
Central Nervous System Depressants
Cardiovascular Agents
Antimanic Agents
Pharmacologic Actions
Alcoholism
Anti-Anxiety Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Anticonvulsants

ClinicalTrials.gov processed this record on February 08, 2010