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Smoking While on Transdermal Nicotine Replacement Therapy: Effects on Craving and Cessation

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00289653
First Posted: February 10, 2006
Last Update Posted: November 20, 2017
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.
Information provided by:
Centre for Addiction and Mental Health
  Purpose
Smoking while on nicotine patches will help subjects to reduce their expired carbon monoxide levels from the levels they were before they started using the patch. Subjects will also decrease their daily consumption of cigarettes, change how they smoke the cigarette, and will show reduced reactivity to smoking-related cues and reduced craving.

Condition Intervention
Nicotine Dependence Drug: Nicoderm

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Smoking While on Transdermal Nicotine Replacement Therapy: Effects on Craving and Cessation

Resource links provided by NLM:


Further study details as provided by Centre for Addiction and Mental Health:

Primary Outcome Measures:
  • carbon monoxide levels

Secondary Outcome Measures:
  • craving
  • cessation

Estimated Enrollment: 60
Study Start Date: September 2005
Estimated Study Completion Date: June 2006
Detailed Description:
Subjects who smoke while on an individually dosed tNRT will reduce their expired carbon monoxide levels from pre- to post-treatment conditions. They will also decrease their daily consumption of cigarettes, change their smoking topography, and will show reduced reactivity to smoking-related cues and reduced craving.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • at least 19 years of age
  • male or female
  • have intention to quit smoking within the next 6 months
  • smoke 10 or more cigarettes per day

Exclusion Criteria:

  • Pregnant or not using an adequate enough method of birth control to ensure that they are not at risk of becoming pregnant
  • breastfeeding
  • have any generalized skin disorders
  • are in an immediate post-myocardial infarction period or have life-threatening arrhythmias, have severe or worsening angina pectoris or have had a recent cerebral vascular accident
  • are using additional nicotine replacement therapies or any other smoking cessation pharmacotherapy
  • any clinically significant ECG abnormalities
  • any known hypersensitivity to components of the transdermal system
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00289653


Locations
Canada, Ontario
Centre for Addiction and Mental Health
Toronto, Ontario, Canada, M5S 2S1
Sponsors and Collaborators
Centre for Addiction and Mental Health
Investigators
Principal Investigator: Peter Selby, MD Centre for Addiction and Mental Health
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00289653     History of Changes
Other Study ID Numbers: 205/2005
First Submitted: February 8, 2006
First Posted: February 10, 2006
Last Update Posted: November 20, 2017
Last Verified: May 2009

Keywords provided by Centre for Addiction and Mental Health:
nicotine dependence,
transdermal nicotine patch,
smoking while receiving nicotine replacement,
comorbidities

Additional relevant MeSH terms:
Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action