Expired Study
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Philadelphia, Pennsylvania 19103


Purpose:

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.


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.


Study is Available At:


Original ID:

NIAAAKRA3510


NCT ID:

NCT00000442


Secondary ID:

P50AA003510


Study Acronym:


Brief Title:

Naltrexone for Relapse Prevention


Official Title:

Etiology and Treatment of Alcohol Dependence


Overall Status:

Completed


Study Phase:

Phase 4


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

60 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of Connecticut Health Center


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Endpoint Classification: Safety/Efficacy Study, I


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

57


Enrollment Type:


Study Dates

Completion Date:December 2002
Verification Date:June 2011
Last Changed Date:June 17, 2011
First Received Date:November 2, 1999

Study Outcomes

There are no available Study Outcomes

Study Interventions

Intervention Type:Drug
Name:naltrexone (Revia)

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of Connecticut Health Center
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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