Back to resultsEfficacy and Neural Correlates of Personalized Treatment With Transdermal Nicotine Replacement (iT-NRT)
Primary Purpose
Tobacco Use Disorder, Nicotine Dependence
Status
Terminated
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Nicotine patch
Nicotine mouthspray
Sponsored by
About this trial
This is an interventional treatment trial for Tobacco Use Disorder focused on measuring Nicotine Patch, Nicotine Mouth Spray, Smoking Cessation, Quit Smoking, Abstinence, Dependence, Nicotine, Tobacco, Transdermal Nicotine Replacement Therapy, Functional Magnetic Resonance Imaging, Neuroimaging, Cue Reactivity, Resting State, BOLD fMRI
Eligibility Criteria
Inclusion Criteria:
- Daily tobacco smoker of
- Aged 19 to 65 years old
- Intending to quit smoking within the next 30 days
- Interested in using transdermal nicotine replacement therapy (nicotine patch)
Exclusion Criteria:
- At least weekly use of tobacco products other than cigarettes
- Breast feeding, pregnancy or not using a reliable form of birth control
- Any generalized skin disorders precluding the use of the patch
- Immediate post-myocardial infarction period or life-threatening arrhythmias, severe or worsening angina pectoris or recent cerebral vascular accident
- Any clinically significant electrocardiogram (ECG) abnormalities
- Currently using NRT or other smoking cessation pharmacotherapy
- Any known hypersensitivity or allergies to any of the components comprising the nicotine patch
- MRI contraindications (e.g., metal in body, claustrophobia) as per the CAMH RIC screening questionnaire
- Diagnosis of terminal illness.
Sites / Locations
- Centre for Addiction and Mental Health, Nicotine Dependence Clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Experimental Arm
Positive Control Arm
Arm Description
Escalating nicotine patch dose to satiety over 6 weeks with dosage depending on the number of cigarettes smoked per day and the occurrence of adverse effects
Nicotine patch dose of 21mg coupled with nicotine mouthspray which is to be used as needed.
Outcomes
Primary Outcome Measures
4 weeks continuous smoking abstinence
4 weeks of abstinence without a single puff of a cigarette confirmed by self-report and exhaled carbon monoxide (CO less than or equal to 4ppm)
Secondary Outcome Measures
Cue induced brain activation
Brain activation in response to viewing emotional and smoking cues as measured by fMRI
Full Information
NCT ID
NCT02439944
First Posted
May 7, 2015
Last Updated
July 16, 2018
Sponsor
Centre for Addiction and Mental Health
1. Study Identification
Unique Protocol Identification Number
NCT02439944
Brief Title
Efficacy and Neural Correlates of Personalized Treatment With Transdermal Nicotine Replacement
Acronym
iT-NRT
Official Title
Efficacy and Neural Correlates of Personalized Treatment With Transdermal Nicotine Replacement: A Randomized, Controlled Pilot Study in Motivated Smokers Unable to Quit With Standard Dosing
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Terminated
Why Stopped
full RCT funded. no need to continue pilot data collection.
Study Start Date
July 2015 (Actual)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
December 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centre for Addiction and Mental Health
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study involves the use of personalized nicotine patch dosing as a treatment strategy for smokers who cannot quit smoking after 2 weeks of using the standard nicotine patch dose. Functional Magnetic Resonance Imaging scans will also be obtained from all study participants before and after treatment. The first aim of the study is to determine if the treatment method under investigation is safe and more effective at increasing quit rates in smokers who do not respond to standard therapy.The second aim is to determine if there are any treatment- or cessation-related changes in brain function.
Detailed Description
Nicotine Replacement Therapy (NRT) is limited in efficacy. One possible explanation for this limited efficacy is that the nicotine dose received in standard therapy is not enough to replace the amount of nicotine that smokers typically receive from their cigarettes. In an effort to counteract this problem, this study will increase the nicotine patch dose of smokers until they no longer feel the need to keep smoking or they cannot tolerate a higher nicotine dose. Smokers who cannot quit using 21 mg nicotine patch for 2 weeks will be randomized to either the experimental arm of the study where nicotine patch doses will be adjusted according to individual need or the positive control arm where standard NRT smoking cessation therapy will be employed. The primary outcome measure will be continuous abstinence during the last 4 weeks of treatment. In addition, participants will be assessed to see how treatment has impacted their resting state neural activity as well as their responsiveness to smoking and emotional cues. Follow up sessions will be used to assess long term abstinence as well as long term change in neural activation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tobacco Use Disorder, Nicotine Dependence
Keywords
Nicotine Patch, Nicotine Mouth Spray, Smoking Cessation, Quit Smoking, Abstinence, Dependence, Nicotine, Tobacco, Transdermal Nicotine Replacement Therapy, Functional Magnetic Resonance Imaging, Neuroimaging, Cue Reactivity, Resting State, BOLD fMRI
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental Arm
Arm Type
Experimental
Arm Description
Escalating nicotine patch dose to satiety over 6 weeks with dosage depending on the number of cigarettes smoked per day and the occurrence of adverse effects
Arm Title
Positive Control Arm
Arm Type
Active Comparator
Arm Description
Nicotine patch dose of 21mg coupled with nicotine mouthspray which is to be used as needed.
Intervention Type
Drug
Intervention Name(s)
Nicotine patch
Other Intervention Name(s)
Nicoderm
Intervention Type
Drug
Intervention Name(s)
Nicotine mouthspray
Other Intervention Name(s)
Nicorette Quickmist
Primary Outcome Measure Information:
Title
4 weeks continuous smoking abstinence
Description
4 weeks of abstinence without a single puff of a cigarette confirmed by self-report and exhaled carbon monoxide (CO less than or equal to 4ppm)
Time Frame
Treatment weeks 9-12 inclusive
Secondary Outcome Measure Information:
Title
Cue induced brain activation
Description
Brain activation in response to viewing emotional and smoking cues as measured by fMRI
Time Frame
up to 6 month follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Daily tobacco smoker of
Aged 19 to 65 years old
Intending to quit smoking within the next 30 days
Interested in using transdermal nicotine replacement therapy (nicotine patch)
Exclusion Criteria:
At least weekly use of tobacco products other than cigarettes
Breast feeding, pregnancy or not using a reliable form of birth control
Any generalized skin disorders precluding the use of the patch
Immediate post-myocardial infarction period or life-threatening arrhythmias, severe or worsening angina pectoris or recent cerebral vascular accident
Any clinically significant electrocardiogram (ECG) abnormalities
Currently using NRT or other smoking cessation pharmacotherapy
Any known hypersensitivity or allergies to any of the components comprising the nicotine patch
MRI contraindications (e.g., metal in body, claustrophobia) as per the CAMH RIC screening questionnaire
Diagnosis of terminal illness.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laurie Zawertailo, PhD
Organizational Affiliation
Centre for Addiction and Mental Health
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Peter 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, Nicotine Dependence Clinic
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T 1P7
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Neural Correlates of Personalized Treatment With Transdermal Nicotine Replacement
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