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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 : April 6, 2018
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

November 17, 2016
December 22, 2016
April 6, 2018
January 23, 2018
December 2020   (Final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT03000387 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
Personalized Dosing of Nicotine Replacement (NRT to Effect)
Personalized Dosing of Nicotine Replacement for Smoking Cessation: An Effectiveness Randomized Placebo-controlled Trial
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).

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 breath carbon monoxide measures and a urine test for nicotine by-product (cotinine) levels.

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.

Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Tobacco Use Disorder
  • Nicotine Dependence
  • 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
  • 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; Maximun 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
500
Same as current
June 2021
December 2020   (Final data collection date for primary outcome measure)

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 unwilling to stop using 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. Currently using NRT or other smoking cessation pharmacotherapy
  5. Any known hypersensitivity or allergies to any of the components comprising the nicotine patch
  6. Current active substance dependence (excluding caffeine) which will compromise study compliance
  7. Current unstable psychiatric condition which would compromise study compliance
  8. Diagnosis of terminal illness
  9. Current regular use of e-cigarettes, or other vaping devices, and not willing to stop for the duration of the study
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Older Adult)
No
Contact: Emily Gilbert, Msc +1 416 535 8501 ext 39570 Emily.Gilbert@camh.ca
Canada
 
 
NCT03000387
039/2015
No
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: No
Laurie Zawertailo, Centre for Addiction and Mental Health
Centre for Addiction and Mental Health
  • Canadian Cancer Society Research Institute (CCSRI)
  • Ottawa Heart Institute Research Corporation
Principal Investigator: Laurie Zawertailo, PhD Centre for Addcition and Mental Health
Principal Investigator: Peter Selby, MBBS Centre for Addcition and Mental Health
Centre for Addiction and Mental Health
April 2018

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