Clinical trial NCT02957786: Cytisine Versus Varenicline for Smoking Cessation
Official title: RAUORA: Cytisine Versus Varenicline for Smoking Cessation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Smoking Cessation
Keywords: cytisine
varenicline
smoking cessation
indigenous
Lead sponsor: University of Auckland, New Zealand
Sponsor class: OTHER
Collaborators: name: Lakes District Health Board
name: Brunel University
First posted: 2016-11-08
Enrollment: 679
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the effectiveness, safety, and cost-effectiveness of cytisine plus behavioural support compared to varenicline plus behavioural support for smoking cessation, in indigenous Māori (or family of Māori) who smoke and are motivated to quit.

Detailed description: Cytisine, a natural product, found in plants such as the Golden Rain and New Zealand Kowhai, partially blocks the effects of nicotine on the brain. Cytisine has been used as a smoking cessation treatment in several Central and Eastern European countries since the 1960s, is inexpensive compared to other cessation medications and has few known side effects. New Zealand research has shown cytisine to be more effective than nicotine replacement therapy at helping people quit smoking. Using a clinical trial design (N=2140) the investigators plan to investigate whether cytisine is at least as good as varenicline (the most effective, but most expensive, smoking cessation medication currently available in New Zealand) for helping Māori/family of Māori who smoke, to quit.

Eligibility criteria: Inclusion Criteria:

* daily tobacco smokers
* self-identify as Māori (indigenous New Zealander) or whānau (family) of Māori
* want to stop smoking in the next two weeks
* are at least 18 years of age
* are able to provide verbal consent
* reside in the Lakes District Health Board, Eastern Bay of Plenty or Tokoroa region at the time of enrolment
* have daily access to a mobile phone with text capability and/or email and access to the internet via computer or smartphone
* are eligible for subsidised varenicline under special authority conditions

Exclusion Criteria:

* are pregnant or breastfeeding
* are current users of other smoking cessation therapies (e.g. nicotine replacement therapy \[NRT\], buproprion \[Zyban\], clonidine, nortriptyline, e-cigarettes)
* are enrolled in another smoking cessation programme or another smoking cessation study
* have a contraindication for cytisine or varenicline
* have used varenicline or cytisine in the past 12 months
* have another person in their household involved in the trial
* have moderate or severe renal impairment,
* are being treated for active or latent TB
* have been treated for a heart attack, stroke, or severe angina within the last two weeks
* have uncontrolled high blood pressure (\> 150 mmHg systolic, \> 100 mmHg diastolic)
* have a history of seizures

Primary outcomes:
measure: Continuous abstinence from smoking
timeFrame: Six months post-quit date
Secondary outcomes:
measure: Continuous abstinence from smoking
timeFrame: One month post-quit date
measure: Continuous abstinence from smoking
timeFrame: Three months post-quit date
measure: Continuous abstinence from smoking
timeFrame: 12 months post-quit date (in 2/3 of sample)
measure: 7-day point prevalence abstinence from smoking
timeFrame: One month post-quit date
measure: 7-day point prevalence abstinence from smoking
timeFrame: Three month post-quit date
measure: 7-day point prevalence abstinence from smoking
timeFrame: Six month post-quit date
measure: 7-day point prevalence abstinence from smoking
timeFrame: 12 month post-quit date (in 2/3 of sample)
measure: Time to relapse back to smoking
timeFrame: One month post-quit date
measure: Time to relapse back to smoking
timeFrame: Three month post-quit date
measure: Time to relapse back to smoking
timeFrame: Six month post-quit date
measure: Time to relapse back to smoking
timeFrame: 12 month post-quit date (in 2/3 of sample)
measure: Cigarette withdrawal
timeFrame: One month post-quit date
measure: Cigarette withdrawal
timeFrame: Three months post-quit date
measure: Cigarette withdrawal
timeFrame: Six months post-quit date
measure: Cigarettes per day
timeFrame: One month post-quit date
measure: Cigarettes per day
timeFrame: Three month post-quit date
measure: Cigarettes per day
timeFrame: Six month post-quit date
measure: Cigarettes per day
timeFrame: 12 month post-quit date (in 2/3 of sample)
measure: Smoking satisfaction, if smoking
timeFrame: One month post-quit date
measure: Smoking satisfaction, if smoking
timeFrame: Three month post-quit date
measure: Smoking satisfaction, if smoking
timeFrame: Six month post-quit date
measure: Health-related quality of life
timeFrame: One month post-quit date
measure: Health-related quality of life
timeFrame: Three months post-quit date
measure: Health-related quality of life
timeFrame: Six months post-quit date
measure: Acceptability of allocated treatment
timeFrame: One month post-quit date
measure: Acceptability of allocated treatment
timeFrame: Three months post-quit date
measure: Use of other methods of cessation
timeFrame: One month post-quit date
measure: Use of other methods of cessation
timeFrame: Three months post-quit date
measure: Use of other methods of cessation
timeFrame: Six months post-quit date
measure: Medication compliance
timeFrame: One month post-quit date
measure: Medication compliance
timeFrame: Three months post-quit date
measure: Adverse events
timeFrame: One month post-quit date
measure: Adverse events
timeFrame: Three month post-quit date
measure: Adverse events
timeFrame: Six month post-quit date
measure: Adverse events
timeFrame: 12 month post-quit date (in 2/3 of sample)
Other outcomes:
Locations:
city: Auckland
country: New Zealand
facility: National Institute for Health Innovation, University of Auckland
state: North Island
Study officials:
affiliation: University of Auckland, New Zealand
name: Natalie Walker, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Walker N, Smith B, Barnes J, Verbiest M, Kurdziel T, Parag V, Pokhrel S, Bullen C. Cytisine versus varenicline for smoking cessation for Maori (the indigenous people of New Zealand) and their extended family: protocol for a randomized non-inferiority trial. Addiction. 2019 Feb;114(2):344-352. doi: 10.1111/add.14449. Epub 2018 Nov 9.
citation: Walker N, Smith B, Barnes J, Verbiest M, Parag V, Pokhrel S, Wharakura MK, Lees T, Cubillos Gutierrez H, Jones B, Bullen C. Cytisine versus varenicline for smoking cessation in New Zealand indigenous Maori: a randomized controlled trial. Addiction. 2021 Oct;116(10):2847-2858. doi: 10.1111/add.15489. Epub 2021 May 4.