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Sertraline and Cognitive Therapy in Depressed Alcoholics

Primary Purpose

Alcoholism, Depression

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
sertraline (Zoloft)
cognitive behavior therapy
Sponsored by
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcoholism

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Medical University of South Carolina

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
June 23, 2005
Sponsor
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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1. Study Identification

Unique Protocol Identification Number
NCT00000458
Brief Title
Sertraline and Cognitive Therapy in Depressed Alcoholics
Official Title
Sertraline and Cognitive Therapy in Depressed Alcoholics
Study Type
Interventional

2. Study Status

Record Verification Date
August 2002
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2002 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcoholism, Depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
Double
Allocation
Randomized
Enrollment
100 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
sertraline (Zoloft)
Intervention Type
Behavioral
Intervention Name(s)
cognitive behavior therapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States

12. IPD Sharing Statement

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