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Trial NCT00000294

Resource URI: http://static.linkedct.org/resource/trials/NCT00000294
linkedct:brief_title Effects of Carvedilol on Cocaine Use in Humans - 11
linkedct:collaborator_agency <http://static.linkedct.org/resource/collabagency/8800>
linkedct:condition <http://static.linkedct.org/resource/condition/2992>
linkedct:criteria Inclusion Criteria: Male/Female between 20 and 55. History of smoked or intravenous cocaine use on the average of at least once a week over a 6 month period. current history of good health and normal EKG. Not pregnant as determined by pregnancy screening nor breast feeding, using acceptable birth control methods (e.g. birth control pills diaphragm, condoms plus foam) Exclusion Criteria: Current problems with major psychiatric illnesses including bipolar disorder, schizophrenia, or anxiety disorders. History of major medical illnesses including asthma and chronic obstructive pulmonary disease. Currently on a drug related parole or probation. Treated for chemical dependency withing the past 6 months.
linkedct:description The purpose of this study was to determine whether carvedilol, and alpha and beta adrenergic blocker, would inhibit the priming effect of cocaine in a laboratory model. A total of 12 subjects were enrolled in this double blind, placebo controlled, outpatient study. After an adaptation session, three experimental sessions were held, 2-9 days apart. On each of 3 experimental sessions, a single oral dose of low (25mg) or high dose of carvedilol (50mg) or placebo were administered. Two hours following carvedilol or placebo treatment, subjects received a priming dose of smoked cocaine, 0.4 mg/kg. during the second part of the session, subjects had the option to earn up to 2 tokens by working on a computer task that could later be exchanged for money or deliveries of cocaine. We proposed that blockage of adrenergic receptors by carvedilol would significantly alter the subjective and physiological effects of cocaine.
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 55 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 NCT00000294
rdfs:label Trial NCT00000294
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 NCT00000294
linkedct:number_of_arms 0 (xsd:int)
linkedct:number_of_groups 0 (xsd:int)
linkedct:official_title Effects of Carvedilol on Cocaine Use in Humans
linkedct:org_study_id NIDA-09259-11
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/NCT00000294>
linkedct:phase Phase 2
linkedct:primary_outcomes <http://static.linkedct.org/resource/primary_outcomes/16244>
linkedct:primary_outcomes <http://static.linkedct.org/resource/primary_outcomes/20852>
linkedct:primary_outcomes <http://static.linkedct.org/resource/primary_outcomes/2542>
linkedct:secondary_id P50-09259-11
linkedct:source National Institute on Drug Abuse (NIDA)
linkedct:start_date September 1998
linkedct:study_design Treatment, Double-Blind, Placebo Control
linkedct:study_type Interventional
linkedct:summary The purpose of this study is to examine carvedilol effects in response to cocaine.
rdf:type linkedct:trials
linkedct:verification_date March 1999