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

Sponsor

Ottawa Heart Institute Research Corporation (Other)

Overall Status

Completed

CT.gov ID

NCT01623505

Collaborator

Heart and Stroke Foundation of Ontario (Other)

738

Enrollment

Location

Arms

Duration (Months)

15.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Research Aims

The aims of this research study are:

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;

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:

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.
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.

Condition or Disease	Intervention/Treatment	Phase
Smoking Cessation Psychiatric Illness	Drug: Champix Drug: Transdermal Nicoderm patch combined with gum or inhaler Drug: Transdermal Nicoderm patch	Phase 4

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:

10-week standard regimen of transdermal NRT (NRT);
Long duration of transdermal NRT in combination with other NRT products (NRT+); or
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 Design

Study Type:

Interventional

Actual Enrollment :

738 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

Jun 1, 2010

Actual Primary Completion Date :

Jun 1, 2014

Actual Study Completion Date :

Jun 1, 2014

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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. [5-10 weeks, 5-22 weeks, and 5-52 weeks post target quit date]

Secondary Outcome Measures

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. [1, 3, 5, 8, 10, 22, and 52 weeks post target quit date]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Ottawa Heart Insitute - Prevention and Wellness Centre	Ottawa	Ontario	Canada	K1Y 4W7

Sponsors and Collaborators

Ottawa Heart Institute Research Corporation
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