Personalized Dosing of Nicotine Replacement (NRT to Effect)

Study Overview
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Brief Summary
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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
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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. Study follow-up visits can be conducted virtually if needed. 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.

Official Title
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Personalized Dosing of Nicotine Replacement for Smoking Cessation: An Effectiveness Randomized Placebo-controlled Trial

Conditions
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Tobacco Use Disorder, Nicotine Dependence

Intervention / Treatment
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* Drug: Nicotine Patch
* Drug: Placebos


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Daily tobacco smoker of ≥10 cigarettes per day Aged 18 to 75 years old Interested in using tNRT as the only smoking cessation aid Intending to quit smoking within the next 30 days Exclusion Criteria: At least weekly use of tobacco products other than cigarettes and not willing to stop for the duration of the study Breast feeding, pregnancy or not using a reliable form of birth control Any generalized skin disorders precluding the use of the patch Any life threatening arrhythmias or severe/worsening angina pectoris or within two weeks of experiencing a myocardial infarction or cerebral vascular accident Currently using or has used NRT or other smoking cessation pharmacotherapy within the past two weeks Any known hypersensitivity or allergies to any of the components comprising the nicotine patch Current active substance dependence (excluding caffeine) which would compromise study compliance Current unstable psychiatric condition which would compromise study compliance Diagnosis of terminal illness Current regular use of e-cigarettes or other vaping devices containing nicotine and not willing to stop for the duration of the study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental Condition<br>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<br>* Active nicotine patch of 21 mg, 14 mg and 7 mg<br>* Other names: Nicoderm;|
| Placebo Comparator: Placebo Condition<br>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. | Drug: Nicotine Patch<br>* Active nicotine patch of 21 mg, 14 mg and 7 mg<br>* Other names: Nicoderm;Drug: Placebos<br>* Matching placebo patches of 21 mg, 14 mg and 7 mg<br>* Other names: Placebo patch;|
| Active Comparator: Quit condition<br>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<br>* Active nicotine patch of 21 mg, 14 mg and 7 mg<br>* Other names: Nicoderm;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Short term continuous abstinence | YES, If self-reported 4 weeks of abstinence without a single puff of a cigarette or any other tobacco product. Else, NO. | weeks 9 to 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Long term continuous abstinence | YES, if self-reported abstinence without a single puff of cigarette and urine cotinine less than 200ng/ml. Else, NO. | weeks 9-26 | 
| Long term continuous abstinence | YES, if, self-reported abstinence without a single puff of cigarette and urine cotinine less than 200ng/ml. Else, NO. | weeks 9-52 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Abstinence, Placebo, Double blind, Nicotine Replacement Therapy, Smoking Cessation, Randomized Clinical Trial, Nicotine Patch