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Drug Treatment for Alcoholics With Post-Traumatic Stress Disorder

Primary Purpose

Alcoholism, Post-Traumatic Stress Disorder

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
sertraline (Zoloft)
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 - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Meets criteria for alcohol abuse or dependence and post-traumatic stress disorder. Laboratory tests for blood and urinalysis must be within normal limits. Must be clearly motivated to obtain benefit from treatment and keep appointments for study visits and therapy sessions. Females who use an acceptable method of birth control, are sterilized, or are at least 2 years post-menopausal. Exclusion Criteria: Have a diagnosis of schizophrenia, bipolar affective disorder, dissociative identity disorder, eating disorder, substance dependence in the last 60 days. Currently suicidal. Medical reasons not to receive drug therapy. Allergy or hypersensitivity to selective serotonin inhibitor antidepressants. Significant hematological, endocrine, cardiovascular, renal, hepatic, neurological, or gastrointestinal disease. Liver function test greater than 2 times the normal level Require ongoing therapy with another psychoactive drug during the study period. Females who are pregnant or lactating.

Sites / Locations

  • Department of Psychiatry and Behavioral Science, 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
NCT00000446
Brief Title
Drug Treatment for Alcoholics With Post-Traumatic Stress Disorder
Official Title
Sertraline Treatment in Comorbid Post-Traumatic Stress Disorder and Alcoholism
Study Type
Interventional

2. Study Status

Record Verification Date
April 2004
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2000 (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 investigate the use of sertraline (Zoloft) to decrease alcohol consumption and crime-related post-traumatic stress disorder in those individuals with both disorders. This will be a 12-week, placebo-controlled, double-blind outpatient trial. All subjects will receive cognitive behavioral therapy in addition to a placebo or sertraline. Comprehensive evaluation will be done at study entry; treatment termination; and 6, 9, and 12 months after study entry.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcoholism, Post-Traumatic Stress Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
Double
Allocation
Randomized

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
sertraline (Zoloft)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Meets criteria for alcohol abuse or dependence and post-traumatic stress disorder. Laboratory tests for blood and urinalysis must be within normal limits. Must be clearly motivated to obtain benefit from treatment and keep appointments for study visits and therapy sessions. Females who use an acceptable method of birth control, are sterilized, or are at least 2 years post-menopausal. Exclusion Criteria: Have a diagnosis of schizophrenia, bipolar affective disorder, dissociative identity disorder, eating disorder, substance dependence in the last 60 days. Currently suicidal. Medical reasons not to receive drug therapy. Allergy or hypersensitivity to selective serotonin inhibitor antidepressants. Significant hematological, endocrine, cardiovascular, renal, hepatic, neurological, or gastrointestinal disease. Liver function test greater than 2 times the normal level Require ongoing therapy with another psychoactive drug during the study period. Females who are pregnant or lactating.
Facility Information:
Facility Name
Department of Psychiatry and Behavioral Science, Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Drug Treatment for Alcoholics With Post-Traumatic Stress Disorder

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