Reducing Cardiovascular Disease by Combining Smoking Cessation Pharmacotherapy and Behavioural Counseling

Phase 4

Completed

• Conditions: Smoking Cessation; Psychiatric Illness
• Interventions: Drug: Transdermal Nicoderm patch combined with gum or inhaler; Drug: Transdermal Nicoderm patch; Drug: Champix

• Registration Number: NCT01623505
• Lead Sponsor: Ottawa Heart Institute Research Corporation

Brief 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.

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 Timeline

• Study Start: 2010-06
• Study First Submitted: 2011-07-13
• Study First Submitted QC: 2012-06-19
• Study First Posted: 2012-06-20
• Primary Completion: 2014-06
• Study Completion: 2014-06
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-12
• Last Update Posted: 2017-04-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 738

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Long & Combination patch treatment	Transdermal Nicoderm patch combined with gum or inhaler	-
Standard patch treatment	Transdermal Nicoderm patch	-
Champix	Champix	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

University of Ottawa Heart Insitute - Prevention and Wellness Centre; 🇨🇦 Ottawa, Ontario, Canada