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Home > "R" Clinical Trials Conditions > Role of Metabolites in Nicotine Dependence (3) - 6  Role of Metabolites in Nicotine Dependence (3) - 6
Role of Metabolites in Nicotine Dependence (3) - 6
For Condition: Tobacco Use Disorder
Status: Completed
Sponsor(s): National Institute on Drug Abuse (NIDA) , University of Minnesota
Synopsis: To determine the effects of various doses of ondansetron transdermal nicotine replacement on tobacco withdrawal symptoms.
Details: Previous studies have shown that cotinine, a metabolite of nicotine, antagonizes the beneficial effects of the nicotine patch in redugin withdrawal symptoms. Studies have also shown that cotinine enhances serotonin levels. This study examined the effects of several doses of a 5HT3 antagonist, ondanstron, in combination with the nicotine patch. This medication has been observed to reduce nicotine withdrawal symptoms in rats. These effects were compared to the nicotine patch alone. The results of this study produced some modest effects showing that the 8mg dose of ondansetron suppressed tobacco withdrawal symptoms to a greater extent than the nicotine patch alone.
Eligibility:
Study Type: Interventional, Treatment, Double-Blind, Placebo Control
Minimum Age/Maximum Age: 21 Years/45 Years
Genders: Both
Protocol Entry Criteria: Inclusion Criteria: Male/Female subjects ages 18-55 years inclusive, with a smoking history of at least 15 cigarettes daily (greater than or equal to 50) for at least 1 yr. Subject is in good health as verified by medical history, screening examination, and screening laboratory tests as outlined above. Subject has provided written informed consent to participate in the study and is motivated to stop smoking. Subject has experienced at least 4 withdrawal symptoms upon abstinence. Exclusion Criteria: History of myocardial infarction, angina pectoris, sustained or episodic cardiac arrhythmias, symptomatic peripheral vascular disease, current peptic ulcer disease or any other medical condition which the physician investigator deems inappropriate for subject 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 (less than 1yr). Chronic use of systemic steroids or antihistamines. Abuse of alcohol or any other recreational or prescription drug (more than 3 drinks per day or 21 drinks per wk). use of any other nicotine products, including smokeless tobacco, cigars and nicotine replacement products. Inability to fulfill all scheduled visits and examination procedures throughout the study period. History of schizophrenia or manic depressive disorder. Recent history of other psychia tric illness (less than 1yr since last episode of major depressive episode).
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-09259-6; P50-09259-6
Study Start Date: May 1998
Record last reviewed: December 1998
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000289
Other Tobacco Use Disorder Studies:
1. Progesterone Treatment in Female Smokers - 12
2. Pilot study examining the effects of combined pharmacotherapy (Zyban/NRT)/behavioral treatment on smoking cessation among MMT patients. - 2
3. The effects of ERT on appetitive behavior and withdrawal in short-term smoking cessation in postmenopausal females on transdermal nicotine replacement - 2
4. Chemical Dependency and Smoking Cessation: Patient's Views - 1
5. Effects of Stimulant Dependence on Human Striatal Dopamine System - 15
Related Studies:
Other Tobacco Use Disorder Clinical Trials
Other Minnesota Clinical Trials
Other Minneapolis Clinical Trials
Role of Metabolites in Nicotine Dependence (3) - 6
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