Drug Treatment for Alcoholics With Post-Traumatic Stress Disorder

Alcoholism Clinical Trial

Official title:

Sertraline Treatment in Comorbid Post-Traumatic Stress Disorder and Alcoholism

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00000446
• Other study ID #: NIAAABRA10761
• Status: Completed
• Phase: Phase 2
• First received: November 2, 1999
• Last updated: June 23, 2005
• Est. completion date: December 2000

Study information

• Verified date: April 2004
• Source: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: December 2000
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alcoholism
• Post-Traumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Drug:
• sertraline (Zoloft)

Locations

Country	Name	City	State
United States	Department of Psychiatry and Behavioral Science, Medical University of South Carolina	Charleston	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States,