Naltrexone Treatment for Alcoholism - 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 NCT00000438 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Naltrexone Treatment for Alcoholism
Official Title ^ICMJE	Naltrexone Treatment for Alcoholism: Predicting Outcome
Brief Summary	This study will evaluate the effectiveness of the medication naltrexone (Revia) for treating alcoholism. Individuals will be inpatients for a 2 week period and provide assessments of their alcohol withdrawal symptoms, craving, and mood. Following hospital discharge, individuals will be assigned randomly to receive naltrexone daily, naltrexone twice a day or a placebo. This part of the study will last 12 weeks, with regular measurements of drinking level, craving and mood. Assessments will be conducted 6 and 12 months after the beginning of the study.
Detailed Description
Study Phase	Phase IV
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Placebo Control, Efficacy Study
Condition ^ICMJE	Alcoholism
Intervention ^ICMJE	Drug: naltrexone (Revia)
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	192
Completion Date	March 2003
Primary Completion Date
Eligibility Criteria ^ICMJE	Inclusion Criteria: Meets criteria for alcohol dependence. Committed to alcohol abstinence as a treatment goal. Individuals will be required to identify two family members or close friends who are knowledgeable about their location, drinking behavior, and psychosocial status. Exclusion Criteria: Meets criteria for any other psychoactive substance use disorder (excluding nicotine and caffeine). Meets criteria for a major psychiatric disorder and are in need of or currently undergoing pharmacotherapy. Females who are pregnant, lactating, or not using a reliable method of contraception. Currently experiencing a serious medical condition that would place them at risk or interfere with study participation. Experiencing acute hepatitis or liver failure or whose liver function test is more than 3 times normal. Have a history of severe allergies, multiple adverse drug reactions or known allergy to naltrexone. Vocabulary below the 5th grade reading level. Abnormal MRI scan. HIV infection due to the neurological sequelae. Significant central nervous system diseases. Seizure disorder or history of closed head trauma. Neuroendocrine disorders. Treatment with opiates within the last six months.
Gender	Both
Ages	30 Years to 55 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	NCT00000438
Responsible Party
Study ID Numbers ^ICMJE	NIAAAMCC11855
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	November 2004
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP