Abstract
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 language | English |
|---|---|
| Pages (from-to) | 344-352 |
| Journal | Addiction |
| Volume | 114 |
| Issue number | 2 |
| DOIs | |
| Publication status | Published - 2019 |
Fingerprint
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
}
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 journal › Article › Scientific › peer-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 -