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Sertraline and Naltrexone for Alcohol Dependence

Primary Purpose

Alcoholism

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
naltrexone (Revia)
sertraline (Zoloft)
Sponsored by
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcoholism

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Meets the criteria for alcohol dependence. Abstinent from alcohol for a period of at least 5 days and not greater than 30 days. Able to read English and complete study evaluations. A stable residence and a telephone to ensure that subjects can be located during the study. Exclusion Criteria: Currently meets criteria for substance abuse or dependence with the exception of nicotine dependence. Current use of disulfiram (Antabuse) or a MAO Inhibitor. Psychotic or otherwise severely psychiatrically disabled (i.e., depressed, suicidal, current mania). Major depression at the time of assessment. Previous treatment with naltrexone (Revia) for alcohol dependence. Significant underlying medical conditions such as cerebral, renal, thyroid, or cardiac disease. Abstinent longer than 30 days prior to admission to program. Hepatocellular disease or elevated bilirubin levels. Females who are pregnant, nursing, or not using a reliable method of birth control.

Sites / Locations

  • Department of Psychiatry, Mount Sinai School of Medicine

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
June 23, 2005
Sponsor
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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1. Study Identification

Unique Protocol Identification Number
NCT00000440
Brief Title
Sertraline and Naltrexone for Alcohol Dependence
Official Title
Sertraline and Naltrexone for Alcohol Dependents
Study Type
Interventional

2. Study Status

Record Verification Date
November 2004
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2002 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

4. Oversight

5. Study Description

Brief Summary
This study is a double-blind, placebo-controlled outpatient trial to improve, through the addition of sertraline (Zoloft), the abstinence and relapse rates in alcohol- dependent individuals currently taking naltrexone (Revia).

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 2
Masking
Double
Allocation
Randomized
Enrollment
124 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
naltrexone (Revia)
Intervention Type
Drug
Intervention Name(s)
sertraline (Zoloft)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Meets the criteria for alcohol dependence. Abstinent from alcohol for a period of at least 5 days and not greater than 30 days. Able to read English and complete study evaluations. A stable residence and a telephone to ensure that subjects can be located during the study. Exclusion Criteria: Currently meets criteria for substance abuse or dependence with the exception of nicotine dependence. Current use of disulfiram (Antabuse) or a MAO Inhibitor. Psychotic or otherwise severely psychiatrically disabled (i.e., depressed, suicidal, current mania). Major depression at the time of assessment. Previous treatment with naltrexone (Revia) for alcohol dependence. Significant underlying medical conditions such as cerebral, renal, thyroid, or cardiac disease. Abstinent longer than 30 days prior to admission to program. Hepatocellular disease or elevated bilirubin levels. Females who are pregnant, nursing, or not using a reliable method of birth control.
Facility Information:
Facility Name
Department of Psychiatry, Mount Sinai School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States

12. IPD Sharing Statement

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Sertraline and Naltrexone for Alcohol Dependence

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