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Trial NCT00000292

Resource URI: http://static.linkedct.org/resource/trials/NCT00000292
PropertyValue
linkedct:brief_title Acute Withdrawal From Smoked Cocaine - 9
linkedct:collaborator_agency <http://static.linkedct.org/resource/collabagency/8800>
linkedct:condition <http://static.linkedct.org/resource/condition/12660>
linkedct:condition <http://static.linkedct.org/resource/condition/12664>
linkedct:condition <http://static.linkedct.org/resource/condition/2992>
linkedct:criteria Inclusion Criteria: M/F ages 21-45 with a history of smoked cocaine use at least twice a week for the past six months, including 0.5 g of cocaine in a 24hr period on at least one occasion. In good health as evidenced by physical exam and complete blood count, chest X-ray and electrolyte and liver function tests, with a normal resting 12-lead electrocardiograph (ECG) and blood pressure of less than 140/90 mmHg. Using an acceptable method of birth control. Having a urine toxicology screen positive for cocaine metabolites. Exclusion Criteria: Any DSM-IV Axis I disorder other than cocaine abuse or dependence, or dependence or daily use of psychoactive drugs other than nicotine or caffeine. A history of violence and/or currently on probation, parole or awaiting trial. Pregnant as determined by serum pregnancy screen, lactating or having delivered a child in the past 12 months. Seropositive tests for the human immunodeficiency virus (HIV) or hepatitis B. History of seizure disorder.
linkedct:description Although there are clearly identifiable withdrawal syndromes following cessation of a number of abused drugs such as alcohol and heroin, it is unclear whether a withdrawal syndrome follows the cessation of crack cocaine. A laboratory model of withdrawal from smoked (crack) cocaine would provide a safe and systematic method of testing the efficacy of behavioral or pharmacological treatments for withdrawal symptoms following cocaine smoking cessation. Therefore, this study investigated acute behavioral, subjective, and physiological withdrawal symptomatology for 6 hrs following 7 deliveries of 2 dose sized (0.07 vs. 0.4 mg/kg) of smoked cocaine. The behavioral measure was performance on a computerized reaction time task, subjective measures included participant and observer ratings of mood and withdrawal symptomatology, and physiological measures comprised heart rate and blood pressure. It was hypothesized that signs and symptoms of withdrawal from smoked cocaine would be greater following the 0.4 mg/kg dose size, compared to the 0.07 mg/kg dose size.
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 21 Years
linkedct:end_date December 2001
linkedct:enrollment 0 (xsd:int)
linkedct:firstreceived_date September 20, 1999
linkedct:id NCT00000292
rdfs:label Trial NCT00000292
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 NCT00000292
linkedct:number_of_arms 0 (xsd:int)
linkedct:number_of_groups 0 (xsd:int)
linkedct:official_title Acute Withdrawal From Smoked Cocaine
linkedct:org_study_id NIDA-09259-9
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/NCT00000292>
linkedct:phase Phase 1
linkedct:primary_outcomes <http://static.linkedct.org/resource/primary_outcomes/16258>
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 P50-09259-9
linkedct:source National Institute on Drug Abuse (NIDA)
linkedct:start_date April 1996
linkedct:study_design Treatment, Double-Blind
linkedct:study_type Interventional
linkedct:summary The purpose of this study is to develop an experimental paradigm to examine acute withdrawal symptoms from cocaine.
rdf:type linkedct:trials
linkedct:verification_date April 1996