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Trial NCT00000306

Resource URI: http://static.linkedct.org/resource/trials/NCT00000306
PropertyValue
linkedct:brief_title Dextroamphetamine as Adjunct in Cocaine/Opiate Dependent Patients - 3
linkedct:collaborator_agency <http://static.linkedct.org/resource/collabagency/8889>
linkedct:condition <http://static.linkedct.org/resource/condition/2992>
linkedct:condition <http://static.linkedct.org/resource/condition/9249>
linkedct:criteria Inclusion Criteria- Subject must: - Exhibit cocaine and opiate dependence through a DSM-IV diagnosis as determined by SCID. - Be between 18 and 45 years old - Women must agree to use contraception - Have an EKG that has been confirmed by a cardiologist - Give a cocaine positive urine during screening - Present with evidence of opiate withdrawal Exclusion Criteria- Subject must not: • Have a serious medical illness including, but not limited to the following: Hypertension Significant heart disease Clinically significant cardiovascular abnormality Angina Hepatic, renal, or gastrointestinal disorders that could result in an altered metabolism or excretion of study agent - Have any Axis I disorder that is not related to drug use - Have current dependence on any psychoactive disorder other than nicotine - Be on probation or parole for reasons other than those related to drug charges (ASI) - Be pregnant or lactating - Have been in any outside treatment in 3 months
linkedct:description This 27-week double-blind, placebo controlled treatment is designed to evaluate dextroamphetamine sulfate (sustained release) as an adjunct in concurrent cocaine and opiate dependent patients. All subjects will receive methadone. For the treatment of cocaine dependence, subjects will receive one of 2 doses of dextroamphetamine (15 or 30mg) or placebo. After 4 weeks of treatment the dose level of dextroamphetamine is doubled (30 or 60mg). This dose is maintained for 20 weeks; during which subjects attend twice weekly visits to the clinic and receive weekly cognitive behavioral therapy. Follow up evaluations will be conducted out to 3 months post treatment. Subjects will be assisted in transferring to Houston area methadone clinics to maintain treatment for opiate dependence following treatment completion.
linkedct:download_date Information obtained from ClinicalTrials.gov on December 30, 2009
linkedct:eligibility_gender Both
linkedct:eligibility_healthy_volunteers Accepts Healthy Volunteers
linkedct:eligibility_maximum_age 45 Years
linkedct:eligibility_minimum_age 18 Years
linkedct:end_date September 2001
linkedct:enrollment 140 (xsd:int)
linkedct:firstreceived_date September 20, 1999
linkedct:id NCT00000306
rdfs:label Trial NCT00000306
linkedct:lastchanged_date August 11, 2008
linkedct:lead_sponsor_agency National Institute on Drug Abuse (NIDA)
linkedct:location <http://static.linkedct.org/resource/location/202714>
linkedct:nct_id NCT00000306
linkedct:number_of_arms 0 (xsd:int)
linkedct:number_of_groups 0 (xsd:int)
linkedct:official_title Dextroamphetamine as an Adjunct in Cocaine/Opiate Dependent Patients
linkedct:org_study_id NIDA-09262-3
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/28912>
linkedct:overall_status Completed
linkedct:oversight <http://static.linkedct.org/resource/oversight/2918>
foaf:page <http://clinicaltrials.gov/show/NCT00000306>
linkedct:phase Phase 2
linkedct:primary_outcomes <http://static.linkedct.org/resource/primary_outcomes/13007>
linkedct:primary_outcomes <http://static.linkedct.org/resource/primary_outcomes/13204>
linkedct:primary_outcomes <http://static.linkedct.org/resource/primary_outcomes/1420>
linkedct:primary_outcomes <http://static.linkedct.org/resource/primary_outcomes/17476>
linkedct:primary_outcomes <http://static.linkedct.org/resource/primary_outcomes/19100>
linkedct:primary_outcomes <http://static.linkedct.org/resource/primary_outcomes/5965>
linkedct:primary_outcomes <http://static.linkedct.org/resource/primary_outcomes/7287>
linkedct:secondary_id P50-09262-3
linkedct:secondary_outcomes <http://static.linkedct.org/resource/secondary_outcomes/40741>
linkedct:source National Institute on Drug Abuse (NIDA)
linkedct:start_date September 1994
linkedct:study_design Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study
linkedct:study_type Interventional
linkedct:summary The purpose of this study is to evaluate dextroamphetamine sulfate (sustained release) as an adjunct in concurrent cocaine and opiate dependent patients.
rdf:type linkedct:trials
linkedct:verification_date August 2008