Sertraline and Cognitive Therapy in Depressed Alcoholics

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. Identifier: NCT00000458
Recruitment Status : Completed
First Posted : November 3, 1999
Last Update Posted : June 24, 2005
Information provided by:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Brief Summary:
This study will assess whether individuals treated with sertraline (Zoloft) and cognitive behavior therapy will experience improvement with their depression and consume less alcohol than individuals treated with a placebo and cognitive behavior therapy. This is a 12-week, random assignment, placebo-controlled, double-blind study with followup assessments 1 and 3 months after treatment.

Condition or disease Intervention/treatment Phase
Alcoholism Depression Drug: sertraline (Zoloft) Behavioral: cognitive behavior therapy Phase 2

Study Type : Interventional  (Clinical Trial)
Enrollment : 100 participants
Allocation: Randomized
Masking: Double
Primary Purpose: Treatment
Official Title: Sertraline and Cognitive Therapy in Depressed Alcoholics
Study Completion Date : January 2002

Resource links provided by the National Library of Medicine

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Meets criteria for major depressive episode.
  • Meets criteria for alcohol abuse or dependence thirty days prior to entering the study.
  • Has had no more than one previous inpatient medical detoxification.
  • Able to maintain sobriety for ten days.
  • Able to read and understand questionnaires and informed consent.
  • Lives within 50 miles of the study site, has a stable living situation, and a reliable source of collateral reporting.

Exclusion Criteria:

  • Meets criteria for any other psychoactive substance dependence other than nicotine.
  • Any psychoactive substance abuse (other than nicotine or marijuana) within 30 days before beginning of study.
  • Meets criteria for other psychiatric disorders including: panic disorder, obsessive-compulsive disorder, bipolar affective disorder, cyclothymia, schizophrenia, any organic mental disorder, eating disorder, dissociative disorder, or post-traumatic stress disorder.
  • Has evidence of treatment resistant depression defined as more than one previous treatment episode for depression, which can include hospitalization and/or one course of antidepressant medication.
  • Patients may not have been prescribed a specific serotonergic medication within the month prior to study and may not have taken any antidepressant or antipsychotic within the two weeks prior to study.
  • Current use of disulfiram (Antabuse) or anti-seizure medications.
  • Clinically significant medical problems: cardiovascular, renal, gastrointestinal, or endocrine problems that would limit participation or limit medication ingestion.
  • Hepatocellular disease.
  • Females who are pregnant, nursing, or not using a reliable form of birth control.
  • Current charges pending for violent crime (excluding DUI related offenses).
  • Previous adverse experience with a serotonin reuptake inhibitor.
  • Current homicidal or suicidal ideation.

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 identifier (NCT number): NCT00000458

United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Sponsors and Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA) Identifier: NCT00000458     History of Changes
Other Study ID Numbers: NIAAAMOA10476
First Posted: November 3, 1999    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: August 2002

Additional relevant MeSH terms:
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Antidepressive Agents
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs