Overview

Personalized Dosing of Nicotine Replacement (NRT to Effect)

Status:
Recruiting
Trial end date:
2023-06-01
Target enrollment:
0
Participant gender:
All
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).
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Centre for Addiction and Mental Health
Collaborators:
Canadian Cancer Society (CCS)
Canadian Cancer Society Research Institute (CCSRI)
Ottawa Heart Institute Research Corporation
Treatments:
Nicotine
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