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. 2019 Mar 26;2019(3):CD004705. doi: 10.1002/14651858.CD004705.pub5

NCT02351167.

Methods Randomised controlled trial with parallel assignment (triple‐blinded)
Participants 822 participants aged 21 years and older
Inclusion criteria:

  1. Adult (>= 21 years of age), seeking treatment for smoking cessation

  2. Able to speak English

  3. Active smoking (cigarettes per day >= 5) and exhaled carbon monoxide >= 8 ppm

  4. Agree to participate in this randomised smoking cessation trial with follow‐up assessments up to 12 months


Exclusion criteria:

  1. Pregnancy or breastfeeding

  2. Active use or recent use (< or equal to 1 month) of medication or e‐cigarettes for nicotine dependence/smoking cessation, or use of e‐cigarettes for more than 9 days in the prior month

  3. Allergy to nicotine patch, lozenge, or varenicline

  4. Unwillingness to prevent pregnancy during the medication phase and 1 month afterwards (women only)

  5. Significant cardiac conditions (myocardial infarction, unstable angina, coronary angioplasty, cardiac bypass) or serious arrhythmia in past 6 months

  6. Current heavy alcohol consumption (>= 6 drinks/day, 6 days/week)

  7. Active psychosis or poorly controlled depression within the past 6 months

  8. Any prior suicide attempt or suicidal ideation within the past 6 months

  9. End‐stage renal disease with haemodialysis
Interventions The investigators propose a prospective, genotype‐based stratified randomisation trial to compare 2 smoking cessation medications (combination NRT (patch and lozenge), varenicline vs placebo) for 3 months in 720 smokers with known genotypes.
Outcomes Primary outcome measures

  1. 7‐day point‐prevalence quit rate (Time Frame: Week 12). The definition of this measure requires:

    1. no self‐reported smoking (not even a puff of a cigarette) for at least the 7 days prior to the assessment; and

    2. biochemical verification of abstinence.


Secondary outcome measures

  1. Continuous abstinence (Time Frame: 12 weeks (with first week initial grace period)). The definition of this measure requires: not taking even 1 cigarette puff from target quit date to end of treatment.

  2. 7‐day point‐prevalence quit rate (Time Frame: Week 24). The definition of this measure requires:

    1. no self‐reported smoking (not even a puff of a cigarette) for at least the 7 days prior to the assessment; and

    2. biochemical verification of abstinence.
Notes 7‐day point‐prevalence abstinence at 6 months should be available. Genotype‐based randomisation, but apparently no biofeedback