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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

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).

Condition or disease Intervention/treatment Phase
Tobacco Use Disorder Nicotine Dependence Drug: Nicotine Patch Drug: Placebos Phase 3

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 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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Personalized Dosing of Nicotine Replacement for Smoking Cessation: An Effectiveness Randomized Placebo-controlled Trial
Actual Study Start Date : January 23, 2018
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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
Drug: Nicotine Patch
Active nicotine patch of 21 mg, 14 mg and 7 mg
Other Name: Nicoderm

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.
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

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.
Drug: Nicotine Patch
Active nicotine patch of 21 mg, 14 mg and 7 mg
Other Name: Nicoderm




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT03000387


Contacts
Contact: Emily Gilbert, Msc +1 416 535 8501 ext 39570 Emily.Gilbert@camh.ca

Locations
Canada, Ontario
University of Ottawa Heart Institute Recruiting
Ottawa, Ontario, Canada, K1Y 4E9
Contact: Evyanne Wooding, Bsc    +1 613-798-5555 ext 17596    ewooding@ottawaheart.ca   
Principal Investigator: Andrew Pipe, MD         
Sub-Investigator: Robert D Reid, PhD, MBA         
Center for Addcition and Mental Health Recruiting
Toronto, Ontario, Canada, M5T 1P7
Contact: Emily Gilbert, Msc    +1 416 535 8501 ext 39570    Emily.Gilbert@camh.ca   
Principal Investigator: Laurie Zawertailo, PhD         
Sponsors and Collaborators
Centre for Addiction and Mental Health
Canadian Cancer Society Research Institute (CCSRI)
Ottawa Heart Institute Research Corporation
Investigators
Principal Investigator: Laurie Zawertailo, PhD Centre for Addcition and Mental Health
Principal Investigator: Peter Selby, MBBS Centre for Addcition and Mental Health

Responsible Party: Laurie Zawertailo, Senior Scientist, Centre for Addiction and Mental Health
ClinicalTrials.gov Identifier: NCT03000387     History of Changes
Other Study ID Numbers: 039/2015
First Posted: December 22, 2016    Key Record Dates
Last Update Posted: April 6, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Laurie Zawertailo, Centre for Addiction and Mental Health:
Nicotine Replacement Therapy
Smoking Cessation
Randomized Clinical Trial
Nicotine Patch
Abstinence
Placebo
Double blind

Additional relevant MeSH terms:
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