Drug Treatment for Alcoholics With Post-Traumatic Stress Disorder

• Status: Completed
• Trial end date: 2000-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
• Treatments: Sertraline

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.