Reducing Cardiovascular Disease by Combining Smoking Cessation Pharmacotherapy and Behavioural Counseling (RW)

April 12, 2017 updated by: Heather Tulloch, Ottawa Heart Institute Research Corporation

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

738

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Ottawa, Ontario, Canada, K1Y 4W7
        • University of Ottawa Heart Insitute - Prevention and Wellness Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Champix
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.

Other Names:
  • Chantix
Experimental: Long & Combination patch treatment
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.

Other Names:
  • Habitrol
Experimental: Standard patch treatment
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.

Other Names:
  • Habitrol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The primary outcome will be measured at 5, 10, 22, and 52 weeks after the target quit date and include: CO confirmed continuous abstinence from 5-10 weeks, 5-22 weeks and 5-52 weeks.
Time Frame: 5-10 weeks, 5-22 weeks, and 5-52 weeks post target quit date
5-10 weeks, 5-22 weeks, and 5-52 weeks post target quit date

Secondary Outcome Measures

Outcome Measure
Time Frame
The secondary outcome will include withdrawal and neuropsychiatric symptoms (e.g., depression, anxiety, suicidal ideation, anger/aggression). These variables will be measured at 1, 3, 5, 8, 10, 22, and 52 weeks following the target quit date.
Time Frame: 1, 3, 5, 8, 10, 22, and 52 weeks post target quit date
1, 3, 5, 8, 10, 22, and 52 weeks post target quit date

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ottawa Heart Institute Research Corporation

Collaborators

Heart and Stroke Foundation of Ontario

Investigators

  • Principal Investigator: Heather E Tulloch, PhD, Ottawa Heart Institute Research Corporation
  • Study Chair: Andrew Pipe, MD, Ottawa Heart Institute Research Corporation
  • Study Chair: Robert Reid, MBA PhD, Ottawa Heart Institute Research Corporation
  • Study Chair: Charl Els, MD, University of Alberta

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2010

Primary Completion (Actual)

June 1, 2014

Study Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

July 13, 2011

First Submitted That Met QC Criteria

June 19, 2012

First Posted (Estimate)

June 20, 2012

Study Record Updates

Last Update Posted (Actual)

April 13, 2017

Last Update Submitted That Met QC Criteria

April 12, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HIPRC-6614

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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