Reducing Cardiovascular Disease by Combining Smoking Cessation Pharmacotherapy and Behavioural Counseling

• Status: Completed
• Trial end date: 2014-06-01
• Target enrollment: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Ottawa Heart Institute Research Corporation
• Collaborator: Heart and Stroke Foundation of Ontario
• Treatments: Nicotine; Varenicline

Criteria

Inclusion Criteria:

• Participant is a current smoker (≥ 10 cigarettes per day in the preceding\ six months);

• Participant is willing to make a quit attempt in the 2-4 weeks after initial screening for eligibility;

• Participant is 18 years of age and older;

• Participant is willing to provide informed consent.

Exclusion Criteria:

• Participant is currently using or has used any intervention medications in the previous 6 months (i.e, Champix (varenicline); and/or Nicotine replacement therapy (patch, gum, inhaler, lozenge));

• Participant has contraindication(s) to any of the following smoking cessation medications:

• Nicotine replacement therapy (allergic reaction to adhesive; serious cardiac arrhythmias (e.g., tachycardia); participant is during the immediate post-myocardial infarction period (i.e. incident has occurred within the last 10 days); severe or worsening angina pectoris; participant has had a recent cerebral vascular accident);

• Varenicline (end-stage renal disease; use of cimetidine (by participants with severe renal impairment); previous allergic reaction to varenicline);

• Pregnant or breastfeeding women or those intending to become pregnant in the next year;

• Current or previous (in the last 3 months) substance abuse;

• Unable to provide informed consent due to unstable psychiatric symptoms (e.g., active, untreated psychosis or suicidality);

• Participant is unable to read and understand English or French;

• In order to prevent contamination across groups, only one person per household may participate.