Behavior and Naltrexone Treatment for Alcoholics

This study has been completed.

First Received: November 2, 1999 Last Updated: June 23, 2005 History of Changes

Sponsor:	National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by:	National Institute on Alcohol Abuse and Alcoholism (NIAAA)
ClinicalTrials.gov Identifier:	NCT00000449

Purpose

The study's purpose is to improve alcoholism treatment by investigating the combined effectiveness of a psychotherapy (Coping Skills Training and Cue Exposure Treatment - CSTCET) with naltrexone in a randomized clinical trial. Individuals will receive 2 weeks of CSTCET or a control treatment as inpatients followed by 12 consecutive weeks of receiving either naltrexone or placebo as outpatients. Followups at 24, 48, and 72 weeks after treatment is completed.

Condition	Intervention	Phase
Alcoholism	Drug: naltrexone (Revia) Behavioral: cognitive behavioral therapy Behavioral: cue exposure treatment	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Factorial Assignment, Efficacy Study
Official Title:	Coping, Exposure, and Naltrexone Treatment With Alcoholics

Resource links provided by NLM:

MedlinePlus related topics: Alcoholism

Drug Information available for: Naltrexone Naltrexone hydrochloride

U.S. FDA Resources

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

Estimated Enrollment:	160
Estimated Study Completion Date:	March 2000

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Meets criteria for alcohol dependence.

Exclusion Criteria:

Current diagnosis of dependence on other substances except nicotine.
A history of psychosis or current psychotic symptoms.
Current suicidality, homocidality, or psychiatric symptoms that require additional medication.
Current use of disulfiram (Antabuse).
Evidence of significant cerebral, renal, thyroid, or cardiac disease.
History of opioid abuse in the previous year.
History of cirrhosis, hepatocellular disease, or elevated bilirubin.
Females who are pregnant, nursing, or not using a reliable method of birth control.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00000449

Locations

United States, Rhode Island
Brown University, Center for Alcohol and Addiction Studies
Providence, Rhode Island, United States, 02912

Sponsors and Collaborators

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

More Information

No publications provided

Study ID Numbers:	NIAAAMON7850
Study First Received:	November 2, 1999
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00000449 History of Changes
Health Authority:	United States: Federal Government

Additional relevant MeSH terms:

Narcotic Antagonists
Physiological Effects of Drugs
Disorders of Environmental Origin
Pharmacologic Actions
Mental Disorders
Sensory System Agents
Therapeutic Uses

Alcoholism
Naltrexone
Substance-Related Disorders
Alcohol-Related Disorders
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on November 25, 2009