Sertraline |
Zoloft |
Clinical Trial: Drug Treatment for Alcoholics with Post-Traumatic Stress Disorder
This study has been completed.
|
Purpose
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.
| Condition | Treatment or Intervention | Phase |
|---|---|---|
| Alcoholism Post-Traumatic Stress Disorder | Drug: sertraline (Zoloft) | Phase II |
MedlinePlus related topics: Alcoholism; Post-Traumatic Stress Disorder
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Efficacy Study
Official Title: Sertraline Treatment in Comorbid Post-Traumatic Stress Disorder and Alcoholism
Study completion: December 2000
Eligibility
Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both
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.
Location Information
South Carolina
Department of Psychiatry and Behavioral Science, Medical University of South Carolina, Charleston, South Carolina, 29425, United States
More Information
Record last reviewed: April 2004
Last Updated: October 13, 2004
Record first received: November 2, 1999
ClinicalTrials.gov Identifier: NCT00000446
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005
Resources
- Sertraline (Drug Digest)
- Zoloft (Drug Digest)

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