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Trial NCT00000288

Resource URI: http://static.linkedct.org/resource/trials/NCT00000288
linkedct:brief_title Role of Metabolites in Nicotine Dependence (2) - 5
linkedct:collaborator_agency <http://static.linkedct.org/resource/collabagency/8800>
linkedct:condition <http://static.linkedct.org/resource/condition/13077>
linkedct:criteria Inclusion Criteria: Male/Female subjects ages 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 examination, 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 Previous studies have shown that cotinine, a metabolite of nicotine, antagonizes some of the effects of nicotine. One study showed that nicotine eliminates some of the beneficial effects of the nicotine patch in reducing withdrawal symptoms. The purpose of this study was to examine the effects of cotinine. The results generally showed no effects on self-administration of cigarettes, although higher serum nicotine levels were observed on the highest doses of cotinine compared to placebo or lower doses of cotinine.
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 2002
linkedct:enrollment 0 (xsd:int)
linkedct:firstreceived_date September 20, 1999
linkedct:id NCT00000288
rdfs:label Trial NCT00000288
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 NCT00000288
linkedct:number_of_arms 0 (xsd:int)
linkedct:number_of_groups 0 (xsd:int)
linkedct:official_title Role of Metabolites in Nicotine Dependence (2)
linkedct:org_study_id NIDA-09259-5
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/NCT00000288>
linkedct:phase Phase 2
linkedct:primary_outcomes <http://static.linkedct.org/resource/primary_outcomes/16254>
linkedct:primary_outcomes <http://static.linkedct.org/resource/primary_outcomes/20852>
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 P50-09259-5
linkedct:source National Institute on Drug Abuse (NIDA)
linkedct:start_date December 1995
linkedct:study_design Treatment, Double-Blind, Placebo Control, Crossover Assignment
linkedct:study_type Interventional
linkedct:summary The purpose of this study is to determine the effects of varying doses of cotinine on cigarette self-administration.
rdf:type linkedct:trials
linkedct:verification_date December 1996