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Please enable JavaScript in your browser to complete this form. Identifier: NCT05311085
Recruitment Status :
Not yet recruiting

First Posted : April 5, 2022
Last Update Posted : April 5, 2022

Brief Summary:
This research focuses on maximizing the benefits of proven smoking cessation interventions to support people who smoke to quit, as part of the strategy to help New Zealand become smoke-free. A large, pragmatic community-based clinical trial is planned which draws on 15 years of smoking cessation research undertaken by the study team. This research has shown that both cytisine and nicotine e-cigarettes are more effective than nicotine replacement therapy at helping people to quit smoking, and are more acceptable to users. New Zealand research has also shown that text-messages offering advice and support around quitting smoking are highly effective and acceptable. The planned trial will test whether using cytisine and nicotine e-cigarettes together will help more New Zealanders to quit smoking long-term, compared to using cytisine alone or nicotine e-cigarettes alone. Participants in all three groups will also receive smoking cessation text-messaging behavioral support.

Condition or disease Intervention/treatment Phase
Smoking Cessation Drug: Cytisine
Drug: Nicotine delivered via an e-cigarette
Combination Product: Cytisine plus nicotine delivered via an e-cigarette
Phase 3

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Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Daily smokers who live in New Zealand
  • Aged ≥18 years
  • Motivated to quit smoking within the next two weeks
  • Able to provide consent
  • Have daily access to a mobile telephone that can text
  • Have access to the internet via a computer or smart phone
  • Are willing to use cytisine or an e-cigarette or both products to help quit smoking

Exclusion Criteria:

  • Have another person in their household currently enrolled in the study
  • Are pregnant/breastfeeding, or are women trying to become pregnant in the next three months
  • Are currently using smoking cessation medication (including using e-cigarettes daily for the last month)
  • Are enrolled in another cessation programme/trial
  • Have a known hypersensitivity to cytisine or nicotine e-cigarettes
  • Self-report moderate/severe renal impairment
  • Are undergoing treatment for active/latent tuberculosis
  • Have experienced a myocardial infarction, stroke, or severe angina within the previous two weeks
  • Have uncontrolled high blood pressure (>150 mmHg systolic, >100 mmHg diastolic)
  • Have a history of seizures / epilepsy
  • Have a strong preference to use or not to use cytisine and/or e-cigarettes in their quit attempt.