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Trial NCT00000284

Resource URI: http://static.linkedct.org/resource/trials/NCT00000284
linkedct:brief_title Role of Metabolites in Nicotine Dependence (1) - 1
linkedct:collaborator_agency <http://static.linkedct.org/resource/collabagency/8800>
linkedct:condition <http://static.linkedct.org/resource/condition/13077>
linkedct:criteria Inclusion Criteria: Male or female subjects, aged 21-45 yrs inclusive, with a smoking history of at least 1 pack of cigarettes daily for at least 1 year. Subject must be in good health as verified by medical history, screening exam, and screening laboratory tests. Subject must provide written informed consent to participate in the study and be motivated to stop smoking for a short term. Exclusion Criteria: History of myocardial infarction, angina pectoris, sustained or episodic cardiac arrhythmias, symptomatic peripheral vascular disease, peptic ulcer disease or any other medical condition which the physician or investigator deems inappropriate for participation, insulin-dependent diabetes; pregnant or lactating or not using adequate birth control methods; requirement of any form of regular psychotropic medication (antidepressants, antipsychotics, or anxiolytics) and recent psychiatric history; chronic use of systemic steroids or antihistamines; skin sensitivity which would preclude use of a transdermal system; abuse of alcohol or any other recreational or prescription drug; use of any other tobacco products, including smokeless tobacco and nicotine products; previous use of transdermal nicotine system; inability to fulfill all scheduled visits and examination procedures throughout the study period.
linkedct:description The purpose of this study was to determine the effects of a metabolite of nicotine, cotinine, on tobacco withdrawal symptoms. Cotinine has been shown to have psychoactive effects that are similar as well as different from those of nicotine, however, little research has been conducted examining the role cotinine plays in nicotine addiction. This study compared the effects of cotinine with the nicotine patch, and a combination thereof on tobacco withdrawal symptoms. The results showed that cotinine antagonizes the beneficial effects of the nicotine patch in reducing withdrawal symptoms.
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 NCT00000284
rdfs:label Trial NCT00000284
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 NCT00000284
linkedct:number_of_arms 0 (xsd:int)
linkedct:number_of_groups 0 (xsd:int)
linkedct:official_title Role of Metabolites in Nicotine Dependence (1)
linkedct:org_study_id NIDA-09259-1
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/NCT00000284>
linkedct:phase Phase 2
linkedct:primary_outcomes <http://static.linkedct.org/resource/primary_outcomes/15887>
linkedct:primary_outcomes <http://static.linkedct.org/resource/primary_outcomes/16254>
linkedct:primary_outcomes <http://static.linkedct.org/resource/primary_outcomes/20858>
linkedct:secondary_id P50-09259-1
linkedct:source National Institute on Drug Abuse (NIDA)
linkedct:start_date February 1995
linkedct:study_design Treatment, Randomized, Double-Blind, Placebo Control
linkedct:study_type Interventional
linkedct:summary The purpose of this study is to determine the effects of cotinine with or without a transdermal nicotine replacement on tobacco withdrawal symptoms.
rdf:type linkedct:trials
linkedct:verification_date March 1996