- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00000442
Naltrexone for Relapse Prevention
June 17, 2011 updated by: UConn Health
Etiology and Treatment of Alcohol Dependence
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.
Study Overview
Study Type
Interventional
Enrollment
57
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19103
- Department of Psychiatry, University of Pennsylvania
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Interventional Model: PARALLEL
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Completion
December 1, 2002
Study Registration Dates
First Submitted
November 2, 1999
First Submitted That Met QC Criteria
November 2, 1999
First Posted (ESTIMATE)
November 3, 1999
Study Record Updates
Last Update Posted (ESTIMATE)
June 20, 2011
Last Update Submitted That Met QC Criteria
June 17, 2011
Last Verified
June 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NIAAAKRA3510
- P50AA003510 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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