Expired Study
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Minneapolis, Minnesota 55455


Purpose:

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


Study summary:

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.


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).


Study is Available At:


Original ID:

NIDA-09259-6


NCT ID:

NCT00000289


Secondary ID:

P50-09259-6


Study Acronym:


Brief Title:

Role of Metabolites in Nicotine Dependence (3) - 6


Official Title:

Role of Metabolites in Nicotine Dependence (3)


Overall Status:

Completed


Study Phase:

Phase 2


Genders:

Both


Minimum Age:

21 Years


Maximum Age:

45 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

National Institute on Drug Abuse (NIDA)


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Masking: Double-Blind, Primary Purpose: Treatment


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

0


Enrollment Type:


Overall Contact Information

Official Name:Dorothy Hatsukami, Ph.D.
Principal Investigator
University of Minnesota - Clinical and Translational Science Institute

Study Dates

Start Date:May 1998
Completion Date:December 2001
Verification Date:December 1998
Last Changed Date:January 11, 2017
First Received Date:September 20, 1999

Study Outcomes

Outcome Type:Primary Outcome
Measure:Subjective effects
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Physiological effects
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Performance effects
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:Ondansetron

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:NIH
Agency Type:Lead Sponsor
Agency Name:National Institute on Drug Abuse (NIDA)
Agency Class:Other
Agency Type:Collaborator
Agency Name:University of Minnesota - Clinical and Translational Science Institute

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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