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Role of Metabolites in Nicotine Dependence (2) - 5
This study has been completed.
Sponsors and Collaborators: National Institute on Drug Abuse (NIDA)
University of Minnesota
Information provided by: National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier: NCT00000288
  Purpose

The purpose of this study is to determine the effects of varying doses of cotinine on cigarette self-administration.


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

Drug Information available for: Nicotine polacrilex Nicotine tartrate Cotinine
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Double-Blind, Placebo Control, Crossover Assignment
Official Title: Role of Metabolites in Nicotine Dependence (2)

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

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

Estimated Enrollment: 0
Study Start Date: December 1995
Estimated Study Completion Date: December 2002
Detailed Description:

Previous studies have shown that cotinine, a metabolite of nicotine, antagonizes some of the effects of nicotine. One study showed that nicotine eliminates some of the beneficial effects of the nicotine patch in reducing withdrawal symptoms. The purpose of this study was to examine the effects of cotinine. The results generally showed no effects on self-administration of cigarettes, although higher serum nicotine levels were observed on the highest doses of cotinine compared to placebo or lower doses of cotinine.

  Eligibility

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

Inclusion Criteria:

Male/Female subjects ages 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 examination, 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: NCT00000288

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

Study ID Numbers: NIDA-09259-5, P50-09259-5
Study First Received: September 20, 1999
Last Updated: November 3, 2005
ClinicalTrials.gov Identifier: NCT00000288  
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

ClinicalTrials.gov processed this record on January 15, 2009