Sertraline Oral Solution |
Zoloft Oral Solution |
Clinical Trial: Drug Therapy for Alcohol Dependence in Alaska Natives (naltrexone/sertraline)
This study is no longer recruiting patients.
|
Purpose
This study will assess the ability of naltrexone (Revia) to reduce the risk of relapse in Alaska natives with alcohol dependence. The study will also examine whether a combination of naltrexone and sertraline (Zoloft) yields better abstinence rates than naltrexone used alone. Alaska Native individuals will be recruited into a 16 week outpatient study.
| Condition | Treatment or Intervention | Phase |
|---|---|---|
| Alcoholism | Drug: sertraline (Zoloft) Drug: naltrexone (Revia) | Phase II |
MedlinePlus related topics: Alcoholism
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Official Title: Naltrexone and SSRI Therapy for Alcohol Dependence in Alaska Natives
Expected Total Enrollment: 198
Study completion: September 2004
Eligibility
Ages Eligible for Study: 18 Years - 65 Years, Genders Eligible for Study: Both
Criteria
Inclusion Criteria:
- Alaska Native having biological Alaska Native ancestry.
- Meets criteria for alcohol dependence.
- Prior to entering the study must be abstinent between 3 and 14 days and have a withdrawal assessment.
- Stable residence to ensure that subjects can be located during the study.
Exclusion Criteria:
- Currently meets criteria for abuse or dependence on substances other than alcohol or nicotine.
- Current use of disulfiram.
- Psychotic or otherwise severely psychiatrically disabled.
- Use of other psychotropic medications including antidepressants and anxiolytics.
- Medical conditions that would not permit the use of sertraline or naltrexone, such as a history of unstable or severe hepatic, cardiovascular, metabolic, endocrine, gastrointestinal or kidney disease.
- Hepatocellular disease or elevated bilirubin levels.
- Females who are pregnant, nursing, or not using a reliable method of birth control.
- Probation or parole requirements that might interfere with participation in the study.
- Involvement in alcohol treatment other than provided by the study or AA.
- Use of monoamine oxidase inhibitors in the past month.
- Current use of Type 1C antiarrhythmics propafenone and flecainide.
Location Information
Dr. Stephanie O'Malley, Principal Investigator, Yale University, New Haven, CT
More Information
Record last reviewed: November 2004
Last Updated: November 22, 2004
Record first received: November 2, 1999
ClinicalTrials.gov Identifier: NCT00000451
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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