Alcoholism, Post-Traumatic Stress Disorder
Conditions
Brief 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.
Interventions
Sponsors
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Study design
Allocation
RANDOMIZED
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Countries
United States
Outcome results
None listed