Role of Metabolites in Nicotine Dependence (3) - 6

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ClinicalTrials.gov Identifier: NCT00000289

Recruitment Status : Completed

First Posted : September 21, 1999

Last Update Posted : January 12, 2017

Sponsor:

Collaborator:

University of Minnesota

Information provided by:

National Institute on Drug Abuse (NIDA)

Study Description

Brief Summary:

The purpose of this study is to determine the effects of various doses of ondansetron transdermal nicotine replacement on tobacco withdrawal symptoms.

Condition or disease	Intervention/treatment	Phase
Tobacco Use Disorder	Drug: Ondansetron	Phase 2

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 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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Enrollment :	0 participants
Masking:	Double
Primary Purpose:	Treatment
Official Title:	Role of Metabolites in Nicotine Dependence (3)
Study Start Date :	May 1998
Study Completion Date :	December 2001

Resource links provided by the National Library of Medicine

Drug Information available for: Ondansetron

U.S. FDA Resources

Arms and Interventions

Outcome Measures

Primary Outcome Measures :

Subjective effects
Physiological effects
Performance effects

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	21 Years to 45 Years (Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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).

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00000289

Locations

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United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55455

Sponsors and Collaborators

National Institute on Drug Abuse (NIDA)

University of Minnesota

Investigators

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Principal Investigator:	Dorothy Hatsukami, Ph.D.	University of Minnesota

More Information

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ClinicalTrials.gov Identifier:	NCT00000289
Other Study ID Numbers:	NIDA-09259-6 P50-09259-6
First Posted:	September 21, 1999 Key Record Dates
Last Update Posted:	January 12, 2017
Last Verified:	December 1998

Additional relevant MeSH terms:

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Tobacco Use Disorder Substance-Related Disorders Chemically-Induced Disorders Mental Disorders Ondansetron Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Gastrointestinal Agents Antipruritics	Dermatologic Agents Serotonin Antagonists Serotonin Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Antipsychotic Agents Tranquilizing Agents Central Nervous System Depressants Psychotropic Drugs Anti-Anxiety Agents

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