Reducing Cardiovascular Disease by Combining Smoking Cessation Pharmacotherapy and Behavioural Counseling

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.

Conditions

• Smoking Cessation
• Psychiatric Illness

Interventions

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.

Sponsors & Collaborators

• Heart and Stroke Foundation of Ontario

  collaborator OTHER

• Ottawa Heart Institute Research Corporation

  lead OTHER

Principal Investigators

• Heather E Tulloch, PhD · Ottawa Heart Institute Research Corporation

• Andrew Pipe, MD · Ottawa Heart Institute Research Corporation

• Robert Reid, MBA PhD · Ottawa Heart Institute Research Corporation

• Charl Els, MD · University of Alberta

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2010-06-30

Primary Completion

2014-06-30

Completion

2014-06-30

Countries

• Canada

Study Locations