Overview

Reducing Cardiovascular Disease by Combining Smoking Cessation Pharmacotherapy and Behavioural Counseling

Status:
Completed
Trial end date:
2014-06-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 4
Details
Lead Sponsor:
Ottawa Heart Institute Research Corporation
Collaborator:
Heart and Stroke Foundation of Ontario
Treatments:
Nicotine
Varenicline