Back to resultsSmoking While on Transdermal Nicotine Replacement Therapy: Effects on Craving and Cessation
Primary Purpose
Nicotine Dependence
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Nicoderm
Sponsored by
About this trial
This is an interventional treatment trial for Nicotine Dependence focused on measuring nicotine dependence,, transdermal nicotine patch,, smoking while receiving nicotine replacement,, comorbidities
Eligibility 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
Sites / Locations
- Centre for Addiction and Mental Health
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
single open-label treatment arm
Arm Description
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.
Outcomes
Primary Outcome Measures
Carbon Monoxide Levels
Expired Co levels were measured to confirm smoking status
Secondary Outcome Measures
Smoking Cessation
self reported # cigarettes per day
Full Information
NCT ID
NCT00289653
First Posted
February 8, 2006
Last Updated
December 4, 2017
Sponsor
Centre for Addiction and Mental Health
1. Study Identification
Unique Protocol Identification Number
NCT00289653
Brief Title
Smoking While on Transdermal Nicotine Replacement Therapy: Effects on Craving and Cessation
Official Title
Smoking While on Transdermal Nicotine Replacement Therapy: Effects on Craving and Cessation
Study Type
Interventional
2. Study Status
Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
September 2005 (Actual)
Primary Completion Date
December 2006 (Actual)
Study Completion Date
July 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centre for Addiction and Mental Health
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nicotine Dependence
Keywords
nicotine dependence,, transdermal nicotine patch,, smoking while receiving nicotine replacement,, comorbidities
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
23 (Actual)
8. Arms, Groups, and Interventions
Arm Title
single open-label treatment arm
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Nicoderm
Other Intervention Name(s)
NRT patch, nicotine patch
Primary Outcome Measure Information:
Title
Carbon Monoxide Levels
Description
Expired Co levels were measured to confirm smoking status
Time Frame
measured at week 10
Secondary Outcome Measure Information:
Title
Smoking Cessation
Description
self reported # cigarettes per day
Time Frame
Week 10
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter L. Selby, MBBS
Organizational Affiliation
Centre for Addiction and Mental Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre for Addiction and Mental Health
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5S 2S1
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
23963055
Citation
Selby P, Andriash K, Zawertailo L, Persad D, Zack M, Busto UE. Escalating doses of transdermal nicotine in heavy smokers: effects on smoking behavior and craving. J Clin Psychopharmacol. 2013 Oct;33(5):667-74. doi: 10.1097/JCP.0b013e31829a829d.
Results Reference
result
Learn more about this trial
Smoking While on Transdermal Nicotine Replacement Therapy: Effects on Craving and Cessation
We'll reach out to this number within 24 hrs