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Naltrexone for Relapse Prevention



Naltrexone for Relapse Prevention

For Condition: Alcoholism
Status: Completed
Sponsor(s): National Institute on Alcohol Abuse and Alcoholism (NIAAA) ,
Synopsis: This study is to evaluate the safety and effectiveness of an injectable slow releasing preparation of naltrexone to reduce alcohol consumption and risk of relapse in alcohol-dependent subjects. Individuals will receive either naltrexone or a placebo injection for a total of three months, with two subsequent followup visits spanning a 6- month period.
Details:
Eligibility:
Study Type:
  Interventional, Treatment, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/60 Years
Genders: Both
Protocol Entry Criteria: Inclusion Criteria: - Meets criteria for alcohol dependence. - Abstinent from alcohol for a period of at least 3 days prior to beginning of study. - Able to read English and complete study evaluations. - Females who are postmenopausal, have had surgical sterilization, or use reliable means of birth control. Exclusion Criteria: - Meets criteria for dependence on a psychoactive substance other than alcohol and nicotine and/or cannabis. - Prior history of opioid dependence. - Regular use of psychoactive drugs including anxiolytics and antidepressants. - Prior treatment with naltrexone. - Current use of disulfiram. - Psychotic or otherwise severely psychiatrically disabled (e.g., suicidal, current mania). - Significant underlying medical conditions such as hepatic, cerebral, renal, thyroid, or cardiac disease. - Abstinent longer than 28 days prior to randomization.
Total Enrollment: 57

Location and Contact Information:

Department of Psychiatry, University of Connecticut
Farmington,  Connecticut,  06030
United States
 


Additional Information:
Study ID Numbers:
  NIAAAKRA3510; 
Study Start Date: 
Record last reviewed: July 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000442

Other Alcoholism Studies:
1. Bupropion as a Smoking Cessation Aid in Alcoholics

2. Sertraline and Cognitive Therapy in Depressed Alcoholics

3. Acamprosate Treatment: Mechanisms of Action

4. Naltrexone for Relapse Prevention

5. Sertraline and Naltrexone for Alcohol Dependence

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