Naltrexone, Craving, and Drinking - Tabular View

Tracking Information
First Received Date ^ICMJE	September 11, 2000
Last Updated Date	October 20, 2006
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 NCT00006203 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Naltrexone, Craving, and Drinking
Official Title ^ICMJE	Naltrexone, Craving, and Drinking: Ecological Assessment
Brief Summary	This 5-week study will examine the effects of naltrexone on alcohol craving, drinking rates, and reaction to drinking-related triggers, or cues, in participants' everyday environment and in laboratory sessions. Participants will monitor and record their daily desires to drink, environmental circumstances in which urges occur, and drinking behavior using a palm top computer. Participants will receive naltrexone or a placebo. One week after receiving medication, all participants will be asked to respond to alcohol-related cues that may or may not arouse the desire to drink.
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	186
Completion Date	May 2005
Primary Completion Date
Eligibility Criteria ^ICMJE	Inclusion Criteria: Drink at least 4 days per week with 2 heavy drinking days (more than 6 standard drinks for men, more than 5 drinks for women) per week on average during the month prior to the study. Exclusion Criteria: Current interest in treatment or a history of treatment for alcohol problems. History of liver disease or current liver function tests greater than five times normal. Opiate abuse or dependence, any opiate use two weeks before the study or a urine test screen that is positive for opiates. Females, who are pregnant, nursing, or not using reliable birth control method. Daily use of acetaminophen. Living with someone who participated in this study.
Gender	Both
Ages	21 Years and older
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	NCT00006203
Responsible Party
Study ID Numbers ^ICMJE	NIAAAMON0785011A1
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	October 2006
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP