Cytisine Versus Varenicline for Smoking Cessation (RAUORA)

University of Auckland, New Zealand

Status and phase: Completed; Phase 3

Conditions: Smoking Cessation

Treatments: Behavioral: Behavioural support; Drug: Cytisine; Drug: Varenicline

Study type: Interventional

Funder types: Other

Identifiers

NCT02957786

UTN: U1111-1187-2838

Details and patient eligibility

About

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.

Full 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.

Enrollment: 679 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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679 participants in 2 patient groups

Cytisine plus behavioural support

Experimental group

Description:

12-week course of cytisine capsules (1.5mg), with a decreasing dosing regimen (9mg/day for days 1-3, 7.5mg/day for days 4-12, 6mg/day for days 13-16, 4.5mg/day for days 17-20, 3.0mg/day from days 21-week 12). Participants will be asked to reduce their smoking over the first four days of treatment so that they are not smoking at all by the fifth day, which will be their designated Quit date. Participants will also withdrawal-orientated behavioural support (delivered by cessation advisors), in addition to brief cessation advice from the study-specific doctor (at the point that the prescription is provided) and community pharmacist (at the point the participant redeems their prescription).

Treatment:

Behavioral: Behavioural support

Drug: Cytisine

Varenicline plus behavioural support

Active Comparator group

Description:

12-week course of Varenicline tablets (0.5mg/1mg), with an increasing dosing regimen (0.5mg/day for days 1-3, 1.0mg/day for days 4-7, 2.0mg/day for day 8-week 12). Participants will be asked to reduce their smoking over the first four days of treatment so that they are not smoking at all by the fifth day, which will be their designated Quit date. Participants will also receive withdrawal-orientated behavioural support (delivered by cessation advisors), in addition to brief cessation advice from the study-specific doctor (at the point that the prescription is provided) and community pharmacist (at the point the participant redeems their prescription).

Treatment:

Drug: Varenicline

Behavioral: Behavioural support