History of Changes for Study: NCT00000284
Role of Metabolites in Nicotine Dependence (1) - 1
Latest version (submitted January 11, 2017) on
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Study Record Versions
Version A B Submitted Date Changes
1 June 23, 2005 None (earliest Version on record)
2 June 30, 2005 Study Status
3 August 16, 2005 Study Status
4 September 16, 2005 Study Status
5 November 3, 2005 Study Status
6 November 1, 2016 Study Status and Conditions
7 January 11, 2017 Study Status and Study Identification
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Study NCT00000284
Submitted Date:  June 23, 2005 (v1)

Open or close this module Study Identification
Unique Protocol ID: NIDA-09259-1
Brief Title: Role of Metabolites in Nicotine Dependence (1) - 1
Official Title: Role of Metabolites in Nicotine Dependence (1)
Secondary IDs: P50-09259-1
Open or close this module Study Status
Record Verification: March 1996
Overall Status: Completed
Study Start: February 1995
Primary Completion:
Study Completion: December 2001
First Submitted: September 20, 1999
First Submitted that
Met QC Criteria:
September 20, 1999
First Posted: September 21, 1999 [Estimate]
Last Update Submitted that
Met QC Criteria:
June 23, 2005
Last Update Posted: June 24, 2005 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: National Institute on Drug Abuse (NIDA)
Responsible Party:
Collaborators: University of Minnesota
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring:
Open or close this module Study Description
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 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.
Open or close this module Conditions
Conditions: Tobacco Use Disorder
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 2
Interventional Study Model:
Number of Arms:
Masking: Double (masked roles unspecified)
Allocation: Randomized
Enrollment: 0
Open or close this module Arms and Interventions
Intervention Details:
Drug: Cotinine fumarate
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Physiological effects
2. Performance effects
3. Subjective effects
Open or close this module Eligibility
Minimum Age: 21 Years
Maximum Age: 45 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: No

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.

Open or close this module Contacts/Locations
Study Officials: Dorothy Hatsukami, Ph.D.
Principal Investigator
University of Minnesota
Locations: United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations: presented at Society of Research on nicotine and tobacco Psychopharmacology 1998. Presented at Society of Research on Nicotine and Tobacco Psychopharmacology (in press)
Available IPD/Information:

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