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Trial NCT00000446

Resource URI: http://static.linkedct.org/resource/trials/NCT00000446
linkedct:brief_title Drug Treatment for Alcoholics With Post-Traumatic Stress Disorder
linkedct:condition <http://static.linkedct.org/resource/condition/10411>
linkedct:condition <http://static.linkedct.org/resource/condition/744>
linkedct: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.
linkedct:download_date Information obtained from ClinicalTrials.gov on December 30, 2009
linkedct:eligibility_gender Both
linkedct:eligibility_healthy_volunteers No
linkedct:eligibility_maximum_age N/A
linkedct:eligibility_minimum_age 18 Years
linkedct:end_date December 2000
linkedct:enrollment 0 (xsd:int)
linkedct:firstreceived_date November 2, 1999
linkedct:id NCT00000446
rdfs:label Trial NCT00000446
linkedct:lastchanged_date June 23, 2005
linkedct:lead_sponsor_agency National Institute on Alcohol Abuse and Alcoholism (NIAAA)
linkedct:location <http://static.linkedct.org/resource/location/168834>
linkedct:nct_id NCT00000446
linkedct:number_of_arms 0 (xsd:int)
linkedct:number_of_groups 0 (xsd:int)
linkedct:official_title Sertraline Treatment in Comorbid Post-Traumatic Stress Disorder and Alcoholism
linkedct:org_study_id NIAAABRA10761
linkedct:overall_status Completed
linkedct:oversight <http://static.linkedct.org/resource/oversight/2918>
foaf:page <http://clinicaltrials.gov/show/NCT00000446>
linkedct:phase Phase 2
linkedct:source National Institute on Alcohol Abuse and Alcoholism (NIAAA)
linkedct:study_design Treatment, Randomized, Double-Blind, Placebo Control, Efficacy Study
linkedct:study_type Interventional
linkedct: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.
rdf:type linkedct:trials
linkedct:verification_date April 2004