Naltrexone for Relapse Prevention

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Primary Purpose

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

naltrexone (Revia)

About this trial

This is an interventional treatment trial for Alcoholism

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Department of Psychiatry, University of Pennsylvania

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00000442

First Posted

November 2, 1999

Last Updated

June 17, 2011

Sponsor

UConn Health

Collaborators

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

1. Study Identification

Unique Protocol Identification Number

NCT00000442

Brief Title

Naltrexone for Relapse Prevention

Official Title

Etiology and Treatment of Alcohol Dependence

Study Type

Interventional

2. Study Status

Record Verification Date

June 2011

Overall Recruitment Status

Completed

Study Start Date

undefined (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

December 2002 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

UConn Health

Collaborators

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

4. Oversight

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Alcoholism

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Enrollment

57 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

naltrexone (Revia)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

No

Eligibility 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.

Facility Information:

Facility Name

Department of Psychiatry, University of Pennsylvania

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19103

Country

United States

Alcoholism

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

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