Use of Naltrexone in a Clinical Setting - Tabular View

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Use of Naltrexone in a Clinical Setting

This study has been completed.

Study NCT00000445. Last updated on June 23, 2005. Information provided by National Institute on Alcohol Abuse and Alcoholism (NIAAA)

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields
Brief Title ^†	Use of Naltrexone in a Clinical Setting
Official Title ^†	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 ^†	Interventional
Study Design ^†	Treatment, Randomized, Open Label, Placebo Control, Efficacy Study
Primary Outcome Measure ^†
Secondary Outcome Measure ^†
Condition ^†	Alcoholism
Intervention ^†	Drug: naltrexone (Revia)
MEDLINE PMIDs
Links

Recruitment Information Fields
Recruitment Status ^†	Completed
Enrollment ^†	300
Start Date ^†
Completion Date	September 2002
Eligibility Criteria ^†	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 ^††
Location Countries ^†	United States

Administrative Information Fields
NCT ID ^†	NCT00000445
Organization ID	NIAAABRA11747
Secondary IDs ^††
Study Sponsor ^†	National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Collaborators ^††
Investigators ^†
Information Provided By	National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Verification Date	July 2003
First Received Date ^†	November 2, 1999
Last Updated Date	June 23, 2005

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.