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

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.
 
ClinicalTrials.gov Identifier: NCT00289653
Recruitment Status : Completed
First Posted : February 10, 2006
Results First Posted : October 5, 2018
Last Update Posted : October 5, 2018
Sponsor:
Information provided by (Responsible Party):
Dr. Peter Selby, Centre for Addiction and Mental Health

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Nicotine Dependence Drug: Nicoderm Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: N/A
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
Actual Study Start Date : September 2005
Actual Primary Completion Date : December 2006
Actual Study Completion Date : July 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Smoking

Arms and Interventions
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Arm Intervention/treatment
Experimental: single open-label treatment arm
Adult smokers willing to quit were treated with escalating doses of transdermal nicotine patch (Nicoderm) and brief counselling if they continued to smoke over a 9-week treatment period.
 Drug: Nicoderm
Other Names:
  • NRT patch
  • nicotine patch


Outcome Measures
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Primary Outcome Measures :
  1. Carbon Monoxide Levels [ Time Frame: measured at week 10 ]
    Expired Co levels were measured to confirm smoking status


Secondary Outcome Measures :
  1. Smoking Cessation [ Time Frame: Week 10 ]
    self reported # cigarettes per day


Eligibility Criteria
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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
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
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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
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Canada, Ontario
Centre for Addiction and Mental Health
Toronto, Ontario, Canada, M5S 2S1
Sponsors and Collaborators
Centre for Addiction and Mental Health
Investigators
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Principal Investigator: Peter L. Selby, MBBS Centre for Addiction and Mental Health
More Information
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Publications of Results:

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Responsible Party: Dr. Peter Selby, Dr. P. Selby, Centre for Addiction and Mental Health
ClinicalTrials.gov Identifier: NCT00289653    
Other Study ID Numbers: 205/2005
First Posted: February 10, 2006    Key Record Dates
Results First Posted: October 5, 2018
Last Update Posted: October 5, 2018
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr. Peter Selby, Centre for Addiction and Mental Health:
nicotine dependence,
transdermal nicotine patch,
smoking while receiving nicotine replacement,
comorbidities
Additional relevant MeSH terms:
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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