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Personalized Dosing of Nicotine Replacement (NRT to Effect)

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ClinicalTrials.gov Identifier: NCT03000387
Recruitment Status : Recruiting
First Posted : December 22, 2016
Last Update Posted : October 4, 2019
Sponsor:
Collaborators:
Canadian Cancer Society Research Institute (CCSRI)
Ottawa Heart Institute Research Corporation
Information provided by (Responsible Party):
Laurie Zawertailo, Centre for Addiction and Mental Health

Tracking Information
First Submitted Date  ICMJE November 17, 2016
First Posted Date  ICMJE December 22, 2016
Last Update Posted Date October 4, 2019
Actual Study Start Date  ICMJE January 23, 2018
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 2, 2019)
Short term continuous abstinence [ Time Frame: weeks 9 to 12 ]
YES, If self-reported 4 weeks of abstinence without a single puff of a cigarette or any other tobacco product. Else, NO.
Original Primary Outcome Measures  ICMJE
 (submitted: December 21, 2016)
Short term continuous abstinence [ Time Frame: weeks 9 to 12 ]
YES, If self-reported 4 weeks of abstinence without a single puff of a cigarette or any other tobacco product and exhaled carbon monoxide less than or equal to 4ppm. Else , NO.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 2, 2019)
  • Long term continuous abstinence [ Time Frame: weeks 9-26 ]
    YES, if self-reported abstinence without a single puff of cigarette and urine cotinine less than 200ng/ml. Else, NO.
  • Long term continuous abstinence [ Time Frame: weeks 9-52 ]
    YES, if, self-reported abstinence without a single puff of cigarette and urine cotinine less than 200ng/ml. Else, NO.
Original Secondary Outcome Measures  ICMJE
 (submitted: December 21, 2016)
  • Long term continuous abstinence [ Time Frame: weeks 9-26 ]
    YES, if self-reported abstinence without a single puff of cigarette and exhaled carbon monoxide less than or equal to 4ppm and urine cotinine less than 200ng/ml. Else, NO.
  • Long term continuous abstinence [ Time Frame: weeks 9-52 ]
    YES, if, self-reported abstinence without a single puff of cigarette and exhaled carbon monoxide less than or equal to 4ppm and urine cotinine less than 200ng/ml. Else, NO.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Personalized Dosing of Nicotine Replacement (NRT to Effect)
Official Title  ICMJE Personalized Dosing of Nicotine Replacement for Smoking Cessation: An Effectiveness Randomized Placebo-controlled Trial
Brief Summary Medications for smoking cessation are currently only effective in helping a minority of smokers quit. Drug development is slow and expensive, so there is much interest in optimizing the effectiveness of existing treatments and medications. Current standard doses of nicotine replacement therapy (NRT) are not effective for many smokers and in many cases provide less nicotine compared to when a smoker is smoking their usual number of cigarettes. The proposed study will test if a personalized dose of nicotine patch (up to 84mg) will improve quitting success in those who do not respond to a standard dose of NRT (21mg).
Detailed Description

A total of 500 smokers will be enrolled from two smoking cessation clinics to participate in this study. After 2 weeks of usual treatment with 21mg patch, participants who fail to quit smoking will be randomized to receive either escalating doses of active nicotine patches, or placebo patches, for 10 weeks. Those who stop smoking during the first 2 weeks of usual treatment will continue with 21mg patch treatment for 10 weeks as an additional comparison group. In addition to the medication, participants in all groups will receive brief behavioral counselling. Subjects will return to the clinic at weeks 26 and 52 to assess whether or not they are still abstinent from smoking and self-reports of non-smoking will be confirmed using a urine test for nicotine by-product (cotinine) levels. Exhaled carbon monoxide (CO) will be recorded as an additional measure.

The goal of the proposed study is to optimize the current gold standard smoking cessation treatment (nicotine patch plus brief counseling) in order to further increase quit rates. Evidence supporting the effectiveness of personalized doses of NRT could change current practice in a wide variety of healthcare settings. Given the strong link between smoking and cancer, and evidence that quitting smoking at any age diminishes this risk, even small increases in absolute quit rates can have a substantial population-level impact on reducing the incidence of smoking-related cancers, reducing mortality rates and associated healthcare costs.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Tobacco Use Disorder
  • Nicotine Dependence
Intervention  ICMJE
  • Drug: Nicotine Patch
    Active nicotine patch of 21 mg, 14 mg and 7 mg
    Other Name: Nicoderm
  • Drug: Placebos
    Matching placebo patches of 21 mg, 14 mg and 7 mg
    Other Name: Placebo patch
Study Arms  ICMJE
  • Experimental: Experimental Condition
    Participants unable to quit smoking after 2 weeks of treatment with 21mg nicotine patch will get 21mg nicotine patches plus additional active nicotine patches until achieving 7 consecutive days of abstinence over the next 5 weeks; maximum daily patch dose, 84mg/day
    Intervention: Drug: Nicotine Patch
  • Placebo Comparator: Placebo Condition
    Participant unable to quit smoking after 2 weeks of treatment with 21mg nicotine patch will get 21mg nicotine patches plus placebo patches until 7 consecutive days of abstinence over the next 5 weeks; Maximum daily patch dose, 21mg active nicotine patch plus 3 placebo 21mg patches.
    Interventions:
    • Drug: Nicotine Patch
    • Drug: Placebos
  • Active Comparator: Quit condition
    Participants able to quit for 7 consecutive days during the first 2 weeks of treatment with 21mg nicotine patch will continue open label 21mg active nicotine patches for the remaining 10 weeks.
    Intervention: Drug: Nicotine Patch
Publications * Zawertailo L, Hendershot CS, Tyndale RF, Le Foll B, Samokhvalov AV, Thorpe KE, Pipe A, Reid RD, Selby P. Personalized dosing of nicotine replacement therapy versus standard dosing for the treatment of individuals with tobacco dependence: study protocol for a randomized placebo-controlled trial. Trials. 2020 Jun 29;21(1):592. doi: 10.1186/s13063-020-04532-7.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 21, 2016)
500
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2021
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Daily tobacco smoker of ≥10 cigarettes per day
  2. Aged 18 to 75 years old
  3. Intending to quit smoking within the next 30 days

Exclusion Criteria:

  1. At least weekly use of tobacco products other than cigarettes and not willing to stop for the duration of the study
  2. Breast feeding, pregnancy or not using a reliable form of birth control
  3. Any generalized skin disorders precluding the use of the patch
  4. Any life threatening arrhythmias or severe/worsening angina pectoris or within two weeks of experiencing a myocardial infarction or cerebral vascular accident
  5. Currently using or has used NRT or other smoking cessation pharmacotherapy within the past two weeks
  6. Any known hypersensitivity or allergies to any of the components comprising the nicotine patch
  7. Current active substance dependence (excluding caffeine) which would compromise study compliance
  8. Current unstable psychiatric condition which would compromise study compliance
  9. Diagnosis of terminal illness
  10. Current regular use of e-cigarettes or other vaping devices containing nicotine and not willing to stop for the duration of the study
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Emily Gilbert, Msc +1 416 535 8501 ext 39570 Emily.Gilbert@camh.ca
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03000387
Other Study ID Numbers  ICMJE 039/2015
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Laurie Zawertailo, Centre for Addiction and Mental Health
Study Sponsor  ICMJE Centre for Addiction and Mental Health
Collaborators  ICMJE
  • Canadian Cancer Society Research Institute (CCSRI)
  • Ottawa Heart Institute Research Corporation
Investigators  ICMJE
Principal Investigator: Laurie Zawertailo, PhD Centre for Addiction and Mental Health
Principal Investigator: Peter Selby, MBBS Centre for Addiction and Mental Health
PRS Account Centre for Addiction and Mental Health
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP