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Trial NCT00000291

Resource URI: http://static.linkedct.org/resource/trials/NCT00000291
linkedct:brief_title Effects of Labetalol on Human Cocaine Use - 8
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 ages 20-55. History of smoked or intravenous cocaine use on the average of at least once a week over a six month period. Current history of good health and normal EKG. 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) during the study. Exclusion Criteria: Current problems with major psychiatric illnesses including bipolar disorder, schizophrenia, or anxiety disorders. Current dependence on alcohol or on durgs other than cocaine. History of major medical illnesses including asthma and chronic obstructive pulmonary disease. Currently on a drug related parole or probation. Treated for chemical dependency within the past 6 months.
linkedct:description The goal of this study was to investigate the safety and utility of labetalol an alpha and beta adrenergic block, for cocaine dependence in humans. A total of 12 subjects were enrolled in this double blind, placebo controlled outpatient study. After baseline measures are obtained, three experimental sessions were held at least 2 days apart. Subjects were administered a single low (100 mg) or high dose of labetalol (200mg) or placebo on each of 3 experimental sessions. The labetalol doses were given in ascending order and the placebo treatment were randomly inserted into the sequence. A single dose of smoked cocaine (0.4 mg/kg) was administered 2 hrs after labetalol or placebo treatment. During the sessions, several subjective, behavioral and physiological measures were obtained.
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 NCT00000291
rdfs:label Trial NCT00000291
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 NCT00000291
linkedct:number_of_arms 0 (xsd:int)
linkedct:number_of_groups 0 (xsd:int)
linkedct:official_title Effects of Labetalol on Human Cocaine Use
linkedct:org_study_id NIDA-09259-8
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/NCT00000291>
linkedct:phase Phase 2
linkedct:primary_outcomes <http://static.linkedct.org/resource/primary_outcomes/16258>
linkedct:primary_outcomes <http://static.linkedct.org/resource/primary_outcomes/20852>
linkedct:secondary_id P50-09259-8
linkedct:source National Institute on Drug Abuse (NIDA)
linkedct:start_date October 1997
linkedct:study_design Treatment, Double-Blind, Placebo Control
linkedct:study_type Interventional
linkedct:summary The purpose of this study is to determine the effect of labetalol treatment on the subjective and physiological effects of cocaine.
rdf:type linkedct:trials
linkedct:verification_date August 1998