- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00000440
Sertraline and Naltrexone for Alcohol Dependence
June 23, 2005 updated by: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Sertraline and Naltrexone for Alcohol Dependents
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).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment
124
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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New York
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New York, New York, United States, 10029
- Department of Psychiatry, Mount Sinai School of Medicine
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 53 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Masking: Double
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Completion
September 1, 2002
Study Registration Dates
First Submitted
November 2, 1999
First Submitted That Met QC Criteria
November 2, 1999
First Posted (Estimate)
November 3, 1999
Study Record Updates
Last Update Posted (Estimate)
June 24, 2005
Last Update Submitted That Met QC Criteria
June 23, 2005
Last Verified
November 1, 2004
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Chemically-Induced Disorders
- Alcohol-Related Disorders
- Substance-Related Disorders
- Alcoholism
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Sensory System Agents
- Psychotropic Drugs
- Serotonin Uptake Inhibitors
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Serotonin Agents
- Antidepressive Agents
- Narcotic Antagonists
- Alcohol Deterrents
- Sertraline
- Naltrexone
Other Study ID Numbers
- NIAAAFAR11222
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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