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Trial NCT00000317

Resource URI: http://static.linkedct.org/resource/trials/NCT00000317
linkedct:arm_group <http://static.linkedct.org/resource/arm_group/21363>
linkedct:arm_group <http://static.linkedct.org/resource/arm_group/9262>
linkedct:brief_title Early Phase II Trials for Cocaine Medication Development - 1
linkedct:collaborator_agency <http://static.linkedct.org/resource/collabagency/6721>
linkedct:condition <http://static.linkedct.org/resource/condition/12664>
linkedct:condition <http://static.linkedct.org/resource/condition/2992>
linkedct:criteria Please contact site for information.
linkedct:description This was an 18-week prospective, randomized, placebo-controlled crossover design with placebo lead-in phase and terminal placebo phase. After two weeks of single-blind placebo, patients were randomly assigned to one of two schedules of medication: 2 Week Baseline Weeks 1-6 Weeks 7-12 Weeks 13-18 Group 1 placebo risperidone placebo placebo Group 2 placebo placebo risperidone placebo The first 6-week phase provided an initial double-blind medication-placebo comparison. In the second six-week phase (weeks 7-12), patients crossed over to the opposite treatment. During weeks 13-18, Group 1 patients remained on placebo while Group 2 patients were tapered from risperidone to placebo. For six weeks after the end of the trial, patients were offered routine clinical treatment with counseling and psychiatrist visits as needed. Medication dosage was titrated upwards on a fixed-flexible schedule to a maximum dose of 4 mg per day. Medication began at ½ mg risperidone for 3 days, then 1 mg for four days, 2 mg per day during week 2, 3 mg per day during week 3, and 4 mg per day during weeks 4-6. The titration schedule for risperidone in weeks 7-12 was the same as for weeks 1-6. In addition to treatment as usual, patients received a modified manual-guided relapse prevention counseling program in weekly meetings lasting approximately 20 minutes; these sessions provided cognitive and behavioral skills that were found to be helpful to patients in reducing cocaine use.
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 60 Years
linkedct:eligibility_minimum_age 18 Years
linkedct:end_date July 1999
linkedct:enrollment 31 (xsd:int)
linkedct:firstreceived_date September 20, 1999
linkedct:has_dmc No
linkedct:id NCT00000317
linkedct:intervention <http://static.linkedct.org/resource/intervention/47779>
linkedct:intervention <http://static.linkedct.org/resource/intervention/49697>
rdfs:label Trial NCT00000317
linkedct:lastchanged_date September 10, 2008
linkedct:lead_sponsor_agency National Institute on Drug Abuse (NIDA)
linkedct:location <http://static.linkedct.org/resource/location/154079>
linkedct:nct_id NCT00000317
linkedct:number_of_arms 2 (xsd:int)
linkedct:number_of_groups 0 (xsd:int)
linkedct:official_title Early Phase II Trials for Cocaine Medication Development
linkedct:org_study_id NIDA-09582-1
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/15569>
linkedct:overall_status Completed
linkedct:oversight <http://static.linkedct.org/resource/oversight/2918>
linkedct:oversight <http://static.linkedct.org/resource/oversight/2920>
foaf:page <http://clinicaltrials.gov/show/NCT00000317>
linkedct:phase Phase 2
linkedct:primary_completion_date July 1999
linkedct:primary_outcomes <http://static.linkedct.org/resource/primary_outcomes/19101>
linkedct:primary_outcomes <http://static.linkedct.org/resource/primary_outcomes/34497>
linkedct:primary_outcomes <http://static.linkedct.org/resource/primary_outcomes/42916>
linkedct:primary_outcomes <http://static.linkedct.org/resource/primary_outcomes/42917>
linkedct:secondary_id R01-09582-1
linkedct:source National Institute on Drug Abuse (NIDA)
linkedct:start_date August 1996
linkedct:study_design Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Crossover Assignment, Safety/Efficacy Study
linkedct:study_type Interventional
linkedct:summary The purpose of this study is to develop models for early Phase II testing of potential medications for cocaine dependence: amoxapine, risperidone and other agents. The study was a controlled pilot trial of risperidone in opiate-dependent patients on methadone maintenance. The study explored whether risperidone reduced cocaine use, cocaine craving, and cocaine subjective effects in patients on methadone maintenance who abused cocaine and whether it had an acceptable side effect profile. This
rdf:type linkedct:trials
linkedct:verification_date September 2008