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Sertraline and Naltrexone for Alcohol Dependence

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00000440
First Posted: November 3, 1999
Last Update Posted: December 9, 2005
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
  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 Intervention Phase
Alcoholism Drug: naltrexone (Revia) Drug: sertraline (Zoloft) Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Double
Primary Purpose: Treatment
Official Title: Sertraline and Naltrexone for Alcohol Dependents

Resource links provided by NLM:


Further study details as provided by National Institute on Alcohol Abuse and Alcoholism (NIAAA):

Estimated Enrollment: 124
Estimated Study Completion Date: September 2002
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00000440


Locations
United States, New York
Department of Psychiatry, Mount Sinai School of Medicine
New York, New York, United States, 10029
Sponsors and Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
  More Information

ClinicalTrials.gov Identifier: NCT00000440     History of Changes
Other Study ID Numbers: NIAAAFAR11222
First Submitted: November 2, 1999
First Posted: November 3, 1999
Last Update Posted: December 9, 2005
Last Verified: November 2004

Additional relevant MeSH terms:
Alcoholism
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Naltrexone
Sertraline
Narcotic Antagonists
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Antidepressive Agents
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents