Clinical trial NCT03000387: Personalized Dosing of Nicotine Replacement (NRT to Effect)
Official title: Personalized Dosing of Nicotine Replacement for Smoking Cessation: An Effectiveness Randomized Placebo-controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Tobacco Use Disorder
Nicotine Dependence
Keywords: Nicotine Replacement Therapy
Smoking Cessation
Randomized Clinical Trial
Nicotine Patch
Abstinence
Placebo
Double blind
Lead sponsor: Centre for Addiction and Mental Health
Sponsor class: OTHER
Collaborators: name: Canadian Cancer Society (CCS)
name: Ottawa Heart Institute Research Corporation
First posted: 2016-12-22
Enrollment: 211
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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. 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.

Eligibility criteria: Inclusion Criteria:

1. Daily tobacco smoker of ≥10 cigarettes per day
2. Aged 18 to 75 years old
3. Interested in using tNRT as the only smoking cessation aid
4. 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

Primary outcomes:
measure: Short term continuous abstinence
timeFrame: weeks 9 to 12
Secondary outcomes:
measure: Long term continuous abstinence
timeFrame: weeks 9-26
measure: Long term continuous abstinence
timeFrame: weeks 9-52
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: University of Ottawa Heart Institute
state: Ontario
city: Toronto
country: Canada
facility: Centre for Addiction and Mental Health
state: Ontario
Study officials:
affiliation: Centre for Addiction and Mental Health
name: Laurie Zawertailo, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre for Addiction and Mental Health
name: Peter Selby, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.