| ClinicalTrials.gov Identifier: NCT02957786 |
|
Recruitment Status :
Completed
First Posted : November 8, 2016
Last Update Posted : August 19, 2021
|
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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Smoking Cessation |
Drug: Cytisine Behavioral: Behavioural support Drug: Varenicline |
Phase 3 |
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.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
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
Source: http://classic.clinicaltrials.gov/ct2/show/NCT02957786?term=cytisine&rand=169