Cytisine Versus Varenicline for Smoking Cessation

• Status: Completed
• Trial end date: 2019-10-10
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Auckland, New Zealand
• Collaborators: Brunel University; Lakes District Health Board
• Treatments: Varenicline

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