Cytisine versus varenicline for smoking cessation in Māori (the indigenous people of New Zealand) and their extended family: Study protocol for a randomised, non-inferiority trial

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 whānau [extended family] of Māori.

Design: Pragmatic, community-based, open-label randomised non-inferiority trial.

Setting: Lakes District Health Board region, NZ. Participants: Daily smokers (n=2,140) who self-identify as Māori or whānau of Māori, and are: aged ≥18 years, motivated to quit smoking in the next two weeks, eligible for subsidised 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 randomised (1:1 ratio) to receive a prescription for 12-weeks of cytisine tablets (following the manufacturer's dosing regimen for 25 days, then one 1.5mg tablet every six 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-oriented 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 four days of treatment, with day five their designated quit-date. Measurements: The primary outcome is carbon-monoxide verified, continuous abstinence at six months post-quit date. Secondary outcomes at one, three, six 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 healthcare utilisation/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.