Behavior and Naltrexone Treatment for Alcoholics - Tabular View

Tracking Information
First Received Date ^ICMJE	November 2, 1999
Last Updated Date	June 23, 2005
Start Date ^ICMJE
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00000449 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Behavior and Naltrexone Treatment for Alcoholics
Official Title ^ICMJE	Coping, Exposure, and Naltrexone Treatment With Alcoholics
Brief Summary	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.
Detailed Description
Study Phase	Phase IV
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Factorial Assignment, Efficacy Study
Condition ^ICMJE	Alcoholism
Intervention ^ICMJE	Drug: naltrexone (Revia) Behavioral: cognitive behavioral therapy Behavioral: cue exposure treatment
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	160
Completion Date	March 2000
Primary Completion Date
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	18 Years to 65 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00000449
Responsible Party
Study ID Numbers ^ICMJE	NIAAAMON7850
Study Sponsor ^ICMJE	National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Verification Date	August 2002
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP