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Home > "R" Clinical Trials Conditions > Role of Metabolites in Nicotine Dependence (2) - 5  Role of Metabolites in Nicotine Dependence (2) - 5
Role of Metabolites in Nicotine Dependence (2) - 5
For Condition: Tobacco Use Disorder
Status: Completed
Sponsor(s): National Institute on Drug Abuse (NIDA) , University of Minnesota
Synopsis: To determine the effects of varying doses of cotinine on cigarette self-administration.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment, Double-Blind, Placebo Control, Crossover Assignment
Minimum Age/Maximum Age: 21 Years/45 Years
Genders: Both
Protocol Entry 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.
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-09259-5; P50-09259-5
Study Start Date: December 1995
Record last reviewed: December 1996
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000288
Other Tobacco Use Disorder Studies:
1. The effects of ERT on appetitive behavior and withdrawal in short-term smoking cessation compared to smoking ad lib in postmenopausal female smokers. - 1
2. Chemical Dependency and Smoking Cessation: Patient's Views - 1
3. The effects of ERT on appetitive behavior and withdrawal in short-term smoking cessation in postmenopausal females on transdermal nicotine replacement - 2
4. Role of Metabolites in Nicotine Dependence (2) - 5
5. Tobacco Use Among Arab American Youth
Related Studies:
Other Tobacco Use Disorder Clinical Trials
Other Minnesota Clinical Trials
Other Minneapolis Clinical Trials
Role of Metabolites in Nicotine Dependence (2) - 5
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