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Home > "R" Clinical Trials Conditions > Role of Metabolites in Nicotine Dependence (1) - 1  Role of Metabolites in Nicotine Dependence (1) - 1
Role of Metabolites in Nicotine Dependence (1) - 1
For Condition: Tobacco Use Disorder
Status: Completed
Sponsor(s): National Institute on Drug Abuse (NIDA) , University of Minnesota
Synopsis: To determine the effects of continine with or without a transdermal nicotine replacement on tobacco withdrawal symptoms.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment, Randomized, Double-Blind, Placebo Control
Minimum Age/Maximum Age: 21 Years/45 Years
Genders: Both
Protocol Entry 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.
Total Enrollment: 0
Location and Contact Information:
Overall Study Official:
DorothyHatsukami, Principal Investigator, University of Minnesota
University of Minnesota
Minneapolis, Minnesota, 55455
United States
Additional Information:
Study ID Numbers: NIDA-09259-1; P50-09259-1
Study Start Date: February 1995
Record last reviewed: March 1996
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000284
Other Tobacco Use Disorder Studies:
1. Effects of Stimulant Dependence on Human Striatal Dopamine System - 15
2. Smoking Cessation Treatment with Transdermal Nicotine Replacement Therapy - 1
3. Maintenance treatment for Prevention of Smoking Relapse - 1
4. Combining a Smoke Ending Aid with Behavioral Treatment - 1
5. Chemical Dependency and Smoking Cessation: Patient's Views - 1
Related Studies:
Other Tobacco Use Disorder Clinical Trials
Other Minnesota Clinical Trials
Other Minneapolis Clinical Trials
Role of Metabolites in Nicotine Dependence (1) - 1
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