Sertraline Oral Solution |
Zoloft Oral Solution |
Clinical Trial: Sertraline and Naltrexone for Alcohol Dependence
This study has been completed.
|
Purpose
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).
| Condition | Treatment or Intervention | Phase |
|---|---|---|
| Alcoholism | Drug: naltrexone (Revia) Drug: sertraline (Zoloft) | Phase II |
MedlinePlus related topics: Alcoholism
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Efficacy Study
Official Title: Sertraline and Naltrexone for Alcohol Dependents
Expected Total Enrollment: 124
Study completion: September 2002
Eligibility
Ages Eligible for Study: 18 Years - 55 Years, Genders Eligible for Study: Both
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.
Location Information
New York
Department of Psychiatry, Mount Sinai School of Medicine, New York, New York, 10029, United States
More Information
Record last reviewed: November 2004
Last Updated: November 22, 2004
Record first received: November 2, 1999
ClinicalTrials.gov Identifier: NCT00000440
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005
Resources
- Sertraline Oral Solution (Drug Digest)
- Zoloft Oral Solution (Drug Digest)

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