University of Ottawa Heart Institute
Ottawa, Ontario, K1Y 4W7, Canada
NCT Number: NCT01622998
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.
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Notify Me18 year and older
All sexes
Interventional
Phase 4
Ottawa, Ontario, K1Y 4W7, Canada
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
13.) Participants who in the opinion of the investigator will be unlikely to commit to a year-long study;
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.
Other names: Nicoderm 21mg, NPN: #02093146, Nicoderm 14mg, NPN: #02093138, Nicoderm 7mg, NPN: #02093111
Nicorette Inhaler: Box, 42 cartridges (4mg/cartridge) Dosage: Ad libitum Maximum dosage: 6-12 cartridges/day
Other names: Nicorette Inahler, NPN: #02241742
Time frame: Week 52
Self-reported continuous abstinence at week 52 post target quit date will be confirmed with a carbon monoxide breath test.
Time frame: weeks 10, 26 and 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.
Ottawa Heart Institute Research Corporation
Other
Self-directed Titrated Transdermal Nicotine Patch Versus Standard Treatment for Smoking Cessation in Smokers Motivated to Quit
Acronym: STEP
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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