Drug Treatment for Alcoholics With Post-Traumatic Stress Disorder
Completed · Phase 2
Conditions studied: Alcoholism, Post-Traumatic Stress Disorder
In brief
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.
Key facts
- Study ID
- NCT00000446
- Run by
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Expected to finish
- 2000-12-01
- Last updated by the study team
- 2005-06-24
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Department of Psychiatry and Behavioral Science, Medical University of South Carolina — Charleston, South Carolina, United States
Full record on ClinicalTrials.gov
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