Drug Treatment for Alcoholics With Post-Traumatic Stress Disorder

Phase 2

Completed

• Conditions: Alcoholism; Post-Traumatic Stress Disorder

• Registration Number: NCT00000446
• Lead Sponsor: National Institute on Alcohol Abuse and Alcoholism (NIAAA)

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 1999-11-02
• Study First Submitted QC: 1999-11-02
• Study First Posted: 1999-11-03
• Study Completion: 2000-12
• Status Verified: 2004-04
• Last Update Submitted: 2005-06-23
• Last Update Posted: 2005-06-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Department of Psychiatry and Behavioral Science, Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States