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: 1. 10-week standard treatment of transdermal nicotine replacement therapy (NRT);or 2. 10-week titrated transdermal nicotine replacement therapy (NRT) treatment with additional NRT product (NRT+) 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
303
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.
Nicorette Inhaler: Box, 42 cartridges (4mg/cartridge) Dosage: Ad libitum Maximum dosage: 6-12 cartridges/day
University of Ottawa Heart Institute
Ottawa, Ontario, Canada
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.
Time frame: Week 52
Validated Continuous Abstinence Rates at Weeks 10 and 26 Weeks
Self-reported continuous abstinence rates will be validated with a carbon monoxide breath test at weeks 10 and 26 post target quit date.
Time frame: weeks 10, 26
Self Reported 7-day Point Prevalence at Weeks 10, 26 and 52.
Time frame: Self-reported seven day point prevalence of abstinence will be validated at week 10, 26 and 52 weeks post target quite date.
Self-reported Continuous Abstinence at Weeks 10, 26 and 52
Time frame: Week 1 to 52
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