Drug Treatment for Alcoholics With Post-Traumatic Stress Disorder
Information source: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Alcoholism; Post-Traumatic Stress Disorder
Intervention: sertraline (Zoloft) (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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.
Clinical Details
Official title: Sertraline Treatment in Comorbid Post-Traumatic Stress Disorder and Alcoholism
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Efficacy Study
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Department of Psychiatry and Behavioral Science, Medical University of South Carolina, Charleston, South Carolina 29425, United States
Additional Information
Ending date: December 2000
Last updated: June 23, 2005
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