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Trial NCT00000285

Resource URI: http://static.linkedct.org/resource/trials/NCT00000285
linkedct:brief_title Effects of Phenytoin on Cocaine Use in Humans - 2
linkedct:collaborator_agency <http://static.linkedct.org/resource/collabagency/8800>
linkedct:condition <http://static.linkedct.org/resource/condition/2992>
linkedct:criteria Inclusion Criteria: Males/Females between the ages of 20-40. History of smoked cocaine use on the avg. of at least 2 times/week over a 6 month period. Have currently used at least 1 g of cocaine within a 4-6 hr period. Current history of good health, normal serum albumin levels and normal QTc intervals. Nonreactive for HIV. No participation in any of our studies for the past 6 months. For females: not pregnant as determined by pregnancy screening nor breat feeding, and using acceptable birth control methods (e.g. birth control pills, diaphragm, condoms plus foam). Exclusion Criteria: History of suicide attempt, bipolar disorder, schizophrenia, or generalized anxiety disorder. Current problem with major depressive disorder. Current use of alcohol or other durgs on a daily basis. History of major medical illnesses. Currently on parole, probation or a legal history of violence. Treated for chemical dependency within the past 6 months. Use of any psychotropic drugs including MAOIs in the past 6 months.
linkedct:description The purpose of this study was to determine the effects of phenytoin on smoked cocaine-base self-administration using our laboratory self-administration model. A total of 12 patients randomized, 6 to phenytoin and 6 to placebo treatment group. There were 2 phases in this 10-day inpatient study. Phase 1 subjects underwent one cocaine self-admin session. Randomization took place at the start of Phase 2, Day 4 where subjects received either placebo or phenytoin. The subjects assigned to phenytoin treatment received an oral loading dose (20mg/kg) aimed at achieving plasma phenytoin concentration of (10-20 mg/L). During Phase 2, subjects had the opportunity to self-administer cocaine on Days 5, 7, and 9. The plasma phenytoin levels were expected to decrease gradually during Phase 2 which provided an opportunity to study the effect of decreasing phenytoin plasma concentrations on cocaine self-administration.
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 45 Years
linkedct:eligibility_minimum_age 20 Years
linkedct:end_date December 2001
linkedct:enrollment 0 (xsd:int)
linkedct:firstreceived_date September 20, 1999
linkedct:id NCT00000285
rdfs:label Trial NCT00000285
linkedct:lastchanged_date November 3, 2005
linkedct:lead_sponsor_agency National Institute on Drug Abuse (NIDA)
linkedct:location <http://static.linkedct.org/resource/location/190347>
linkedct:nct_id NCT00000285
linkedct:number_of_arms 0 (xsd:int)
linkedct:number_of_groups 0 (xsd:int)
linkedct:official_title Effects of Phenytoin on Cocaine Use in Humans
linkedct:org_study_id NIDA-09259-2
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/14647>
linkedct:overall_status Completed
linkedct:oversight <http://static.linkedct.org/resource/oversight/2918>
foaf:page <http://clinicaltrials.gov/show/NCT00000285>
linkedct:phase Phase 1
linkedct:primary_outcomes <http://static.linkedct.org/resource/primary_outcomes/16254>
linkedct:primary_outcomes <http://static.linkedct.org/resource/primary_outcomes/20858>
linkedct:primary_outcomes <http://static.linkedct.org/resource/primary_outcomes/2542>
linkedct:secondary_id P50-09259-2
linkedct:source National Institute on Drug Abuse (NIDA)
linkedct:start_date May 1996
linkedct:study_design Treatment, Double-Blind, Placebo Control, Parallel Assignment
linkedct:study_type Interventional
linkedct:summary The purpose of this study is to determine the effects of phenytoin on the self-administration of smoked cocaine.
rdf:type linkedct:trials
linkedct:verification_date May 1997