Drug Treatment for Alcoholics With Post-Traumatic Stress Disorder

National Institutes of Health (NIH)

Status and phase: Completed; Phase 2

Conditions: Alcoholism; Post-Traumatic Stress Disorder

Treatments: Drug: sertraline (Zoloft)

Study type: Interventional

Funder types: NIH

Identifiers

NCT00000446

NIAAABRA10761

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No 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.