NCT01623505

Reducing Cardiovascular Disease by Combining Smoking Cessation Pharmacotherapy and Behavioural Counseling

Interventions for Cardiovascular Disease: "Real-World" Effectiveness of Combined Pharmacotherapy and Behavioural Counseling for Smoking Cessation

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 738 (actual)
• Sponsor: Ottawa Heart Institute Research Corporation · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

Research Aims The aims of this research study are: 1. To determine which of the following three smoking cessation medications is most effective in achieving cessation: * Nicotine Patch * Nicotine Patch + gum or inhaler * Varenicline (Champix; 2. To investigate how often participants experience neuropsychiatric symptoms over the course of their cessation attempt and to assess whether: * They occur more often when taking one medication versus another * They occur more often in those with or without psychiatric illnesses. Hypotheses to be Tested The hypotheses to be tested include the following: 1. The CO-confirmed continuous abstinence rate from 5 weeks to 52 weeks following a target quit date will be significantly higher in smokers receiving long-term transdermal NRT in combination with other NRT products or those receiving varenicline compared to those receiving transdermal NRT alone. 2. Some participants will experience neuropsychiatric symptoms during their cessation attempt, and those in the varenicline group will experience a greater incidence of neuropsychiatric symptoms than those in the groups receiving transdermal NRT alone or in combination with other NRT products. Patients with psychiatric illnesses will report higher levels of withdrawal symptoms than those without psychiatric illnesses.

Detailed description

Participants will be recruited from the UOHI Smoking Cessation Clinic and via media advertisements. Following the baseline assessment, participants will be randomly assigned to one of three groups: 1. 10-week standard regimen of transdermal NRT (NRT); 2. Long duration of transdermal NRT in combination with other NRT products (NRT+); or 3. Varenicline (VR). Participants assigned to the "NRT" standard regimen group will follow a 10-week treatment of nicotine patches alone. Participants assigned to the "NRT+" long-duration group will follow the same regimen as the NRT group, but will not be limited to a fixed declining dose strategy, nor limited to a 10-week duration (potential maximum dosage of 35mg/day and maximum treatment duration of up to 22 weeks). Participants will also be provided with other NRT products (i.e., gum or inhaler). Participants assigned to the "VR" group will start the medication on the day of the baseline assessment and set a target quit date any time within the 8 to 14 day period after baseline. Participants will receive a 12-week supply of varenicline with a possible extension of up to 24 weeks. All participants will receive six 15-minute counselling sessions from a nurse-counsellor specializing in smoking cessation in accordance with nursing best-practice guidelines. 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 and neuropsychiatric symptoms at 1, 3, 5, 8, and 10 weeks. These questionnaires will also be completed at 22 and 52 weeks after the target quit date.

Conditions

• Smoking Cessation
• Psychiatric Illness

Interventions

Type	Name	Description
DRUG	Champix	Participants receiving this treatment will start the medication on the day of the baseline assessment and set a target quit date within the 8 to 14 day period after baseline. Participants in this group will receive a 12-week supply of varenicline. Treatment will begin 2 weeks before the target quit date and continue for 10 weeks after the target quit date. Participants will be prescribed 0.5 mg once daily for 3 days, 0.5 mg twice daily for 4 days, and 1 mg twice daily for 11 weeks. Participants will be given the option of extending their treatment to a maximum of up to 24 weeks of varenicline. All participants will receive six 15-minute counselling sessions from a nurse-counsellor specializing in smoking cessation.
DRUG	Transdermal Nicoderm patch combined with gum or inhaler	Participants receiving this treatment will set a quit date within 2 weeks after baseline assessment and apply the patch on that day. This group will follow the same regimen as the "standard patch treatment", but is not limited to a fixed dosing strategy. Participants will be advised on the titration of patch (increase or decrease in dosage) to ensure elimination of withdrawal symptoms (maximum dosage of 35mg/day, maximum treatment of up to 22 weeks). Participants will be provided with either gum or inhaler to manage cravings. All participants will receive six 15-minute counselling sessions from a nurse-counsellor specializing in smoking cessation. \*Off-label dosage approved by Health Canada via "No Objection" letter.
DRUG	Transdermal Nicoderm patch	Participants receiving this treatment group (standard treatment)will set a target quit date within the 2 weeks after baseline assessment and start to apply the patch on that day. This treatment will consist of a 10-week supply of nicotine patches. The initial dosage will be determined from the average number of cigarettes smoked each day as per the manufacturer's recommendation. Participants smoking ≥ 20 cigarettes per day will be prescribed 21 mg/24 hours for 6 weeks, 14 mg/24 hours for 2 weeks, and 7 mg/24 hours for 2 weeks. Participants smoking 11 - 20 cigarettes per day will be prescribed 14 mg/24 hours for 6 weeks, and 7 mg/24 hours for 4 weeks. All participants will receive six 15-minute counselling sessions from a nurse-counsellor specializing in smoking cessation.

Timeline

• Start date: 2010-06-01
• Primary completion: 2014-06-01
• Completion: 2014-06-01
• First posted: 2012-06-20
• Last updated: 2017-04-13

Locations

1 site across 1 country: Canada