Status:

COMPLETED

Role of Metabolites in Nicotine Dependence (1) - 1

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 cotinine with or without a transdermal nicotine replacement on tobacco withdrawal symptoms.

Detailed Description

The purpose of this study was to determine the effects of a metabolite of nicotine, cotinine, on tobacco withdrawal symptoms. Cotinine has been shown to have psychoactive effects that are similar as w...

Eligibility Criteria

Inclusion Criteria:

Male or female subjects, aged 21-45 yrs inclusive, with a smoking history of at least 1 pack of cigarettes daily for at least 1 year. Subject must be in good health as verified by medical history, screening exam, and screening laboratory tests. Subject must provide written informed consent to participate in the study and be motivated to stop smoking for a short term.

Exclusion Criteria:

History of myocardial infarction, angina pectoris, sustained or episodic cardiac arrhythmias, symptomatic peripheral vascular disease, peptic ulcer disease or any other medical condition which the physician or investigator deems inappropriate for 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; chronic use of systemic steroids or antihistamines; skin sensitivity which would preclude use of a transdermal system; abuse of alcohol or any other recreational or prescription drug; use of any other tobacco products, including smokeless tobacco and nicotine products; previous use of transdermal nicotine system; inability to fulfill all scheduled visits and examination procedures throughout the study period.

Key Trial Info

Start Date :

February 1 1995

Trial Type :

INTERVENTIONAL

End Date :

December 1 2001

Estimated Enrollment :

Patients enrolled

Trial Details

Trial ID

NCT00000284

Start Date

February 1 1995

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