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Sponsors and Collaborators: |
National Institute on Drug Abuse (NIDA) University of Minnesota |
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Information provided by: | National Institute on Drug Abuse (NIDA) |
ClinicalTrials.gov Identifier: | NCT00000289 |
The purpose of this study is to determine the effects of various doses of ondansetron transdermal nicotine replacement on tobacco withdrawal symptoms.
Condition | Intervention | Phase |
---|---|---|
Tobacco Use Disorder |
Drug: Ondansetron |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Double-Blind, Placebo Control |
Official Title: | Role of Metabolites in Nicotine Dependence (3) |
Estimated Enrollment: | 0 |
Study Start Date: | May 1998 |
Estimated Study Completion Date: | December 2001 |
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.
Ages Eligible for Study: | 21 Years to 45 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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).
United States, Minnesota | |
University of Minnesota | |
Minneapolis, Minnesota, United States, 55455 |
Principal Investigator: | Dorothy Hatsukami, Ph.D. | University of Minnesota |
Study ID Numbers: | NIDA-09259-6, P50-09259-6 |
Study First Received: | September 20, 1999 |
Last Updated: | November 3, 2005 |
ClinicalTrials.gov Identifier: | NCT00000289 |
Health Authority: | United States: Federal Government |
Nicotine polacrilex Nicotine Mental Disorders Tobacco Use Disorder |
Substance-Related Disorders Disorders of Environmental Origin Ondansetron Serotonin |
Neurotransmitter Agents Tranquilizing Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Psychotropic Drugs Gastrointestinal Agents Central Nervous System Depressants Antiemetics Antipsychotic Agents Pharmacologic Actions |
Serotonin Antagonists Serotonin Agents Autonomic Agents Therapeutic Uses Antipruritics Anti-Anxiety Agents Peripheral Nervous System Agents Central Nervous System Agents Dermatologic Agents |