Cytisine versus varenicline for smoking cessation for Māori (the indigenous people of New Zealand) and their extended family: Protocol for a randomized non‐inferiority trial

N. Walker*, B. Smith, J. Barnes, M. E. A. Verbiest, T. Kurdziel, V. Parag, S. Pokhrel, C. Bullen

*Corresponding author for this work

Research output: Contribution to journalArticleScientificpeer-review

6 Citations (Scopus)
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Abstract

Background and aims
Cytisine, a nicotinic acetylcholine receptor partial agonist (like varenicline) found in some plants, is a low-cost, effective smoking cessation medication that may appeal to Māori [the indigenous people of New Zealand (NZ)]. The RAUORA trial aims to determine the effectiveness, safety and cost-effectiveness of cytisine (Tabex®) versus varenicline (Champix®) for smoking cessation in Māori and the whānau (extended family) of Māori.
Design
Pragmatic, community-based, open-label randomized non-inferiority trial. Setting
Lakes District Health Board region, NZ.
Participants
Daily smokers (n = 2140) who self-identify as Māori or whānau of Māori, and are: aged ≥ 18 years, motivated to quit smoking in the next 2 weeks, eligible for subsidized varenicline, able to provide verbal consent and have daily access to a mobile phone/internet. Recruitment uses multi-media advertising.
Intervention and comparator
Participants are randomized (1 : 1 ratio) to receive a prescription for 12 weeks of cytisine tablets [following the manufacturer’s dosing regimen for 25 days, then one 1.5-mg tablet every 6 hours (two per day) until 12 weeks] or varenicline tablets (following the manufacturer’s dosing regimen). Both groups receive brief stop-smoking advice from the prescribing doctor and withdrawal-orientated behavioural support via community-based stop-smoking counselling services (frequency, duration and mode of delivery tailored for participants) or a research assistant (six weekly 10–15- minute calls). Participants are advised to reduce their smoking over the first 4 days of treatment, with day 5 as their designated quit-date.
Measurements
The primary outcome is carbon monoxide-verified continuous abstinence at 6 months post-quit date. Secondary outcomes at 1, 3, 6 and 12 months post-quit date include: self-reported continuous abstinence, 7-day point prevalence abstinence, cigarettes per day, time to (re)lapse, adverse events, treatment adherence/compliance, treatment acceptability, nicotine withdrawal/urge to smoke and health-care utilization/health- related quality of life.
Comments
This trial compares cytisine and varenicline when used by the indigenous people of NZ and their extended family for smoking cessation.
Original languageEnglish
Pages (from-to)344-352
JournalAddiction
Volume114
Issue number2
DOIs
Publication statusPublished - 2019

Keywords

  • COST-EFFECTIVENESS
  • Cytisine
  • DRUGS
  • EFFICACY
  • EXTENSION
  • FAGERSTROM TEST
  • NICOTINE
  • NONINFERIORITY
  • RECEPTOR PARTIAL AGONIST
  • SAFETY
  • STRATEGIES
  • effectiveness
  • indigenous
  • non-inferiority
  • randomized
  • safety trial
  • varenicline

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