Role of Metabolites in Nicotine Dependence (3) - 6
Information source: National Institute on Drug Abuse (NIDA)
Information obtained from ClinicalTrials.gov on March 24, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Tobacco Use Disorder
Intervention: Ondansetron (Drug)
Phase: Phase 2
Sponsored by: National Institute on Drug Abuse (NIDA)
Official(s) and/or principal investigator(s):
Dorothy Hatsukami, Ph.D., Principal Investigator, Affiliation: University of Minnesota
The purpose of this study is to determine the effects of various doses of ondansetron
transdermal nicotine replacement on tobacco withdrawal symptoms.
Official title: Role of Metabolites in Nicotine Dependence (3)
Study design: Treatment, Double-Blind, Placebo Control
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.
Minimum age: 21 Years.
Maximum age: 45 Years.
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
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).
Locations and Contacts
University of Minnesota, Minneapolis, Minnesota 55455, United States
Starting date: May 1998
Ending date: December 2001
Last updated: November 3, 2005