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Use of Naltrexone in a Clinical Setting
This study has been completed.
Study NCT00000445   Information provided by National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First Received: November 2, 1999   Last Updated: June 23, 2005   History of Changes

November 2, 1999
June 23, 2005
 
 
 
 
Complete list of historical versions of study NCT00000445 on ClinicalTrials.gov Archive Site
 
 
 
Use of Naltrexone in a Clinical Setting
Effectiveness of Naltrexone in a Community Setting

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.

 
Phase IV
Interventional
Treatment, Randomized, Open Label, Placebo Control, Efficacy Study
Alcoholism
Drug: naltrexone (Revia)
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
300
September 2002
 

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00000445
 
NIAAABRA11747
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
 
 
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
July 2003

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP