Personalized Dosing of Nicotine Replacement (NRT to Effect)

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

Sponsors

Lead Sponsor: Centre for Addiction and Mental Health

Collaborator: Canadian Cancer Society Research Institute (CCSRI)
Ottawa Heart Institute Research Corporation

Source 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).

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.

Overall Status Recruiting
Start Date January 23, 2018
Completion Date June 2021
Primary Completion Date December 2020
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
Short term continuous abstinence weeks 9 to 12
Secondary Outcome
Measure Time Frame
Long term continuous abstinence weeks 9-26
Long term continuous abstinence weeks 9-52
Enrollment 500
Condition
Intervention

Intervention Type: Drug

Intervention Name: Nicotine Patch

Description: Active nicotine patch of 21 mg, 14 mg and 7 mg

Other Name: Nicoderm

Intervention Type: Drug

Intervention Name: Placebos

Description: Matching placebo patches of 21 mg, 14 mg and 7 mg

Arm Group Label: Placebo Condition

Other Name: Placebo patch

Eligibility

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 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

Gender: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Healthy Volunteers: No

Overall Official
Overall Contact

Last Name: Emily Gilbert, Msc

Phone: +1 416 535 8501

Phone Ext.: 39570

Email: [email protected]

Location
Facility: Status: Contact: Investigator:
University of Ottawa Heart Institute | Ottawa, Ontario, K1Y 4E9, Canada Recruiting Evyanne Wooding, Bsc +1 613-798-5555 17596 [email protected] Andrew Pipe, MD Principal Investigator Robert D Reid, PhD, MBA Sub-Investigator
Centre for Addiction and Mental Health | Toronto, Ontario, M5T 1P7, Canada Recruiting Emily Gilbert, Msc +1 416 535 8501 39570 [email protected] Laurie Zawertailo, PhD Principal Investigator
Location Countries

Canada

Verification Date

October 2019

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Centre for Addiction and Mental Health

Investigator Full Name: Laurie Zawertailo

Investigator Title: Senior Scientist

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 3
Arm Group

Label: Experimental Condition

Type: Experimental

Description: 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

Label: Placebo Condition

Type: Placebo Comparator

Description: 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.

Label: Quit condition

Type: Active Comparator

Description: 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.

Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Source: ClinicalTrials.gov