Role of Metabolites in Nicotine Dependence (1) - 1
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ClinicalTrials.gov Identifier: NCT00000284 |
Recruitment Status :
Completed
First Posted : September 21, 1999
Last Update Posted : January 12, 2017
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Tracking Information | ||||
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First Submitted Date ICMJE | September 20, 1999 | |||
First Posted Date ICMJE | September 21, 1999 | |||
Last Update Posted Date | January 12, 2017 | |||
Study Start Date ICMJE | February 1995 | |||
Primary Completion Date | Not Provided | |||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE |
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Change History | ||||
Current Secondary Outcome Measures ICMJE | Not Provided | |||
Original Secondary Outcome Measures ICMJE | Not Provided | |||
Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Role of Metabolites in Nicotine Dependence (1) - 1 | |||
Official Title ICMJE | Role of Metabolites in Nicotine Dependence (1) | |||
Brief Summary | The purpose of this study is to determine the effects of cotinine with or without a transdermal nicotine replacement on tobacco withdrawal symptoms. | |||
Detailed 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. | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 2 | |||
Study Design ICMJE | Allocation: Randomized Masking: Double Primary Purpose: Treatment |
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Condition ICMJE | Tobacco Use Disorder | |||
Intervention ICMJE | Drug: Cotinine fumarate | |||
Study Arms ICMJE | Not Provided | |||
Publications * | presented at Society of Research on nicotine and tobacco Psychopharmacology 1998. Presented at Society of Research on Nicotine and Tobacco Psychopharmacology (in press) | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Enrollment ICMJE |
0 | |||
Original Enrollment ICMJE | Same as current | |||
Study Completion Date ICMJE | December 2001 | |||
Primary Completion Date | Not Provided | |||
Eligibility Criteria ICMJE | 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. |
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Sex/Gender ICMJE |
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Ages ICMJE | 21 Years to 45 Years (Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00000284 | |||
Other Study ID Numbers ICMJE | NIDA-09259-1 P50-09259-1 |
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Has Data Monitoring Committee | Not Provided | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Current Responsible Party | Not Provided | |||
Original Responsible Party | Same as current | |||
Current Study Sponsor ICMJE | National Institute on Drug Abuse (NIDA) | |||
Original Study Sponsor ICMJE | Same as current | |||
Collaborators ICMJE | University of Minnesota | |||
Investigators ICMJE |
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PRS Account | National Institute on Drug Abuse (NIDA) | |||
Verification Date | November 2016 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |