Try the modernized beta website. Learn more about the modernization effort.
Working… Menu

Role of Metabolites in Nicotine Dependence (2) - 5

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00000288
Recruitment Status : Completed
First Posted : September 21, 1999
Last Update Posted : January 12, 2017
University of Minnesota
Information provided by:
National Institute on Drug Abuse (NIDA)

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

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

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Enrollment : 0 participants
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Role of Metabolites in Nicotine Dependence (2)
Study Start Date : December 1995
Study Completion Date : December 2002

Primary Outcome Measures :
  1. Subjective effects
  2. Physiological effects
  3. Behavioral
  4. Subjective

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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

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.

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 identifier (NCT number): NCT00000288

Layout table for location information
United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Sponsors and Collaborators
National Institute on Drug Abuse (NIDA)
University of Minnesota
Layout table for investigator information
Principal Investigator: Dorothy Hatsukami, Ph.D. University of Minnesota
Presented at Society for Research on Nicotine and Tobacco Scientific Meeting, 1997 and Psychopharmacology 1998. Presented at Society for Research on Nicotine and Tobacco Scientific Meeting, 1997.

Layout table for additonal information Identifier: NCT00000288    
Other Study ID Numbers: NIDA-09259-5
First Posted: September 21, 1999    Key Record Dates
Last Update Posted: January 12, 2017
Last Verified: November 2016
Keywords provided by National Institute on Drug Abuse (NIDA):
nicotine dependence
Additional relevant MeSH terms:
Layout table for MeSH terms
Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders