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

Research output: Contribution to journalArticleScientificpeer-review

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

Fingerprint

Smoking Cessation
New Zealand
Lakes
Nicotine
Compliance
Cost-Benefit Analysis
Varenicline

Keywords

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

Cite this

@article{968d91d508544c8e99552064eeed8fb7,
title = "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",
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{\circledR}) versus varenicline (Champix{\circledR}) 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.",
keywords = "COST-EFFECTIVENESS, Cytisine, DRUGS, EFFICACY, EXTENSION, FAGERSTROM TEST, NICOTINE, NONINFERIORITY, RECEPTOR PARTIAL AGONIST, SAFETY, STRATEGIES, effectiveness, indigenous, non-inferiority, randomized, safety trial, varenicline",
author = "N. Walker and B. Smith and J. Barnes and Verbiest, {M. E. A.} and T. Kurdziel and V. Parag and S. Pokhrel and C. Bullen",
year = "2019",
doi = "10.1111/add.14449",
language = "English",
volume = "114",
pages = "344--352",
journal = "Addiction",
issn = "0965-2140",
publisher = "WILEY-BLACKWELL PUBLISHING, INC",
number = "2",

}

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

In: Addiction, Vol. 114, No. 2, 2019, p. 344-352.

Research output: Contribution to journalArticleScientificpeer-review

TY - JOUR

T1 - Cytisine versus varenicline for smoking cessation for Māori (the indigenous people of New Zealand) and their extended family

T2 - Protocol for a randomized non‐inferiority trial

AU - Walker, N.

AU - Smith, B.

AU - Barnes, J.

AU - Verbiest, M. E. A.

AU - Kurdziel, T.

AU - Parag, V.

AU - Pokhrel, S.

AU - Bullen, C.

PY - 2019

Y1 - 2019

N2 - 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.

AB - 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.

KW - COST-EFFECTIVENESS

KW - Cytisine

KW - DRUGS

KW - EFFICACY

KW - EXTENSION

KW - FAGERSTROM TEST

KW - NICOTINE

KW - NONINFERIORITY

KW - RECEPTOR PARTIAL AGONIST

KW - SAFETY

KW - STRATEGIES

KW - effectiveness

KW - indigenous

KW - non-inferiority

KW - randomized

KW - safety trial

KW - varenicline

U2 - 10.1111/add.14449

DO - 10.1111/add.14449

M3 - Article

VL - 114

SP - 344

EP - 352

JO - Addiction

JF - Addiction

SN - 0965-2140

IS - 2

ER -