Status:
COMPLETED
Role of Metabolites in Nicotine Dependence (3) - 6
Lead Sponsor:
National Institute on Drug Abuse (NIDA)
Collaborating Sponsors:
University of Minnesota
Conditions:
Tobacco Use Disorder
Eligibility:
All Genders
21-45 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine the effects of various doses of ondansetron transdermal nicotine replacement on tobacco withdrawal symptoms.
Detailed Description
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 enha...
Eligibility Criteria
Inclusion Criteria:
Male/Female subjects ages 21-45 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 psychiatric illness (less than 1yr since last episode of major depressive episode).
Key Trial Info
Start Date :
May 1 1998
Trial Type :
INTERVENTIONAL
End Date :
December 1 2001
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00000289
Start Date
May 1 1998
End Date
December 1 2001
Last Update
January 12 2017
Active Locations (1)
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1
University of Minnesota
Minneapolis, Minnesota, United States, 55455