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Role of Metabolites in Nicotine Dependence (1) - 1
This study has been completed.
First Received: September 20, 1999   Last Updated: November 3, 2005   History of Changes
Sponsors and Collaborators: National Institute on Drug Abuse (NIDA)
University of Minnesota
Information provided by: National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier: NCT00000284
  Purpose

The purpose of this study is to determine the effects of cotinine with or without a transdermal nicotine replacement on tobacco withdrawal symptoms.


Condition Intervention Phase
Tobacco Use Disorder
Drug: Cotinine fumarate
Phase II

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control
Official Title: Role of Metabolites in Nicotine Dependence (1)

Resource links provided by NLM:


Further study details as provided by National Institute on Drug Abuse (NIDA):

Primary Outcome Measures:
  • Subjective effects
  • Physiological effects
  • Performance effects

Estimated Enrollment: 0
Study Start Date: February 1995
Estimated Study Completion Date: December 2001
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 well as different from those of nicotine, however, little research has been conducted examining the role cotinine plays in nicotine addiction. This study compared the effects of cotinine with the nicotine patch, and a combination thereof on tobacco withdrawal symptoms. The results showed that cotinine antagonizes the beneficial effects of the nicotine patch in reducing withdrawal symptoms.

  Eligibility

Ages Eligible for Study:   21 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00000284

Locations
United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Sponsors and Collaborators
University of Minnesota
Investigators
Principal Investigator: Dorothy Hatsukami, Ph.D. University of Minnesota
  More Information

No publications provided

Study ID Numbers: NIDA-09259-1, P50-09259-1
Study First Received: September 20, 1999
Last Updated: November 3, 2005
ClinicalTrials.gov Identifier: NCT00000284     History of Changes
Health Authority: United States: Federal Government

Study placed in the following topic categories:
Nicotine polacrilex
Nicotine
Mental Disorders
Tobacco Use Disorder
Substance-Related Disorders
Disorders of Environmental Origin

Additional relevant MeSH terms:
Mental Disorders
Tobacco Use Disorder
Substance-Related Disorders
Disorders of Environmental Origin

ClinicalTrials.gov processed this record on July 02, 2009