Use of Naltrexone in a Clinical Setting - 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 NCT00000445 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Use of Naltrexone in a Clinical Setting
Official Title ^ICMJE	Effectiveness of Naltrexone in a Community Setting
Brief Summary	This 12-week trial will compare individuals receiving naltrexone or placebo plus substance abuse counseling therapy versus those receiving only substance abuse counseling therapy in a rural, nonacademic setting. A followup period of 12 months is included. The effect on service utilization and the cost of the addition of naltrexone to treatment services for alcohol dependence also will be assessed. The study will expand existing research concerning the effectiveness of naltrexone in clinical trials versus a clinical setting.
Detailed Description
Study Phase	Phase IV
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Open Label, 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	300
Completion Date	September 2002
Primary Completion Date
Eligibility Criteria ^ICMJE	Inclusion Criteria: Meets criteria for alcohol dependence (within the past 3 months). Meets criteria for another substance use disorder (except narcotic dependence) but must identify alcohol as the primary substance of abuse. Must be able to provide an informed consent. Consent to random assignment and be willing to commit to possible medication treatment and research follow-up. Must be eligible for treatment at the Dorchester Alcohol and Drug Commission. Exclusion Criteria: Meets criteria for opiate dependence. Clinically significant medical problems such as collagen-vascular disease, cardiovascular, renal, gastrointestinal or endocrine problem that would impair participation or limit medication ingestion. Hepatocellular disease. Women who are pregnant, nursing, or not practicing an effective means of birth control. Currently being prescribed naltrexone. Known sensitivity or allergy to naltrexone.
Gender	Both
Ages	18 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	NCT00000445
Responsible Party
Study ID Numbers ^ICMJE	NIAAABRA11747
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	July 2003
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP