NCT01622998

Self-directed Titrated Transdermal Nicotine Patch Versus Standard Treatment for Smoking Cessation

Self-directed Titrated Transdermal Nicotine Patch Versus Standard Treatment for Smoking Cessation in Smokers Motivated to Quit

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 303 (actual)
• Sponsor: Ottawa Heart Institute Research Corporation · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Smoking Cessation

Interventions

Type	Name	Description
DRUG	NicoDerm Patch	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.
DRUG	Nicorette Inhaler	Nicorette Inhaler: Box, 42 cartridges (4mg/cartridge) Dosage: Ad libitum Maximum dosage: 6-12 cartridges/day

Timeline

• Start date: 2011-01-01
• Primary completion: 2014-08-01
• Completion: 2014-09-01
• First posted: 2012-06-19
• Last updated: 2022-03-10

Locations

1 site across 1 country: Canada