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| Name | Class |
|---|---|
| Heart and Stroke Foundation of Ontario | OTHER |
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The primary aim of this research study is to determine whether titrated, patient-directed transdermal patch NRT, based on smoking history and symptoms of nicotine withdrawal, improves long-term rates of smoking cessation in patients motivated to quit smoking when compared to patients using the standard transdermal NRT patch protocol. The following hypothesis will be tested: CO-validated continuous abstinence rate at 52 weeks post target quit date will be higher for the titrated, self-directed NRT group compared to the standard NRT treatment group.
Participants will be recruited from the UOHI Smoking Cessation Clinic and via media advertisements. Following their baseline assessment, participants will be randomly assigned to one of two groups:
Participants assigned to the "NRT" standard treatment group will follow a 10-week regimen of nicotine patches alone.
Participants assigned to the "NRT+" titrated treatment group will follow a 10-week regimen of tailored patch dosage. Participants will also be provided with the Nicorette inhaler.
All participants will receive five 15-minute counselling sessions from a smoking cessation counsellor. These sessions occur at 1, 3, 5, 8 and 10 weeks post target quit date. Counselling sessions will focus on practical counselling (problem solving and skills training) and social support.
During the treatment phase, participants will complete questionnaires measuring withdrawal symptoms, self-efficacy, use of cessation resources and the Beck Depression Inventory (BDI-II) at weeks 1, 3, 5, 8 and 10. These questionnaires will also be completed at 26 and 52 weeks post target quit date.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard transdermal NRT group (UC) | Active Comparator | 10 week standard transdermal nicotine replacement therapy patch protocol |
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| Titrated transdermal NRT group (EXP) | Experimental | 10 week titrated transdermal nicotine replacement therapy patch dose regimen based on smoking history with the option to increase dose, if withdrawal symptoms are unmanageable. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NicoDerm Patch | Drug | Dosage: 21mg patch; 14mg patch; 7 mg patch Frequency: NRT patch application once per day Duration: 10 week treatment period *Titration for experimental group (NRT+) based on smoking history, and option to increase dose if withdrawal symptoms are unmanageable. |
| Measure | Description | Time Frame |
|---|---|---|
| Validated continuous abstinence rate at week 52 | Self-reported continuous abstinence at week 52 post target quit date will be confirmed with a carbon monoxide breath test. | Week 52 |
| Measure | Description | Time Frame |
|---|---|---|
| Validated continuous abstinence rates at weeks 10 and 26 weeks and seven day point prevalence of abstinence rates at weeks 10, 26 & 52 | Self-reported continuous abstinence rates will be validated with a carbon monoxide breath test at weeks 10 and 26 post target quit date. Self-reported seven day point prevalence of abstinence will be validated at week 10, 26 and 52 weeks post target quite date. | weeks 10, 26 and 52 |
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Inclusion Criteria:
Exclusion Criteria:
13.) Participants who in the opinion of the investigator will be unlikely to commit to a year-long study;
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| Name | Affiliation | Role |
|---|---|---|
| Andrew Pipe, CM, MD | Ottawa Heart Institute Research Corporation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Ottawa Heart Institute | Ottawa | Ontario | K1Y 4W7 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 14678060 | Background | Hughes JR, Keely J, Naud S. Shape of the relapse curve and long-term abstinence among untreated smokers. Addiction. 2004 Jan;99(1):29-38. doi: 10.1111/j.1360-0443.2004.00540.x. | |
| 18617085 | Background | Clinical Practice Guideline Treating Tobacco Use and Dependence 2008 Update Panel, Liaisons, and Staff. A clinical practice guideline for treating tobacco use and dependence: 2008 update. A U.S. Public Health Service report. Am J Prev Med. 2008 Aug;35(2):158-76. doi: 10.1016/j.amepre.2008.04.009. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | May 22, 2026 | |
| Reset | Jun 17, 2026 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 22, 2026 | Jun 17, 2026 | |||
| Jun 25, 2026 |
| ID | Term |
|---|---|
| D016540 | Smoking Cessation |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D009538 | Nicotine |
| ID | Term |
|---|---|
| D012991 | Solanaceous Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D011725 | Pyridines |
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| Nicorette Inhaler | Drug | Nicorette Inhaler: Box, 42 cartridges (4mg/cartridge) Dosage: Ad libitum Maximum dosage: 6-12 cartridges/day |
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| 16295704 | Background | Slovinec D'Angelo ME, Reid RD, Hotz S, Irvine J, Segal RJ, Blanchard CM, Pipe A. Is stress management training a useful addition to physician advice and nicotine replacement therapy during smoking cessation in women? Results of a randomized trial. Am J Health Promot. 2005 Nov-Dec;20(2):127-34. doi: 10.4278/0890-1171-20.2.127. |
| 37335995 | Derived | Theodoulou A, Chepkin SC, Ye W, Fanshawe TR, Bullen C, Hartmann-Boyce J, Livingstone-Banks J, Hajizadeh A, Lindson N. Different doses, durations and modes of delivery of nicotine replacement therapy for smoking cessation. Cochrane Database Syst Rev. 2023 Jun 19;6(6):CD013308. doi: 10.1002/14651858.CD013308.pub2. |
| D006573 |
| Heterocyclic Compounds, 1-Ring |