Cytisine and E-cigarettes With Supportive Text-messaging for Smoking Cessation (Cess@Tion)

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.

Conditions

• Smoking Cessation

Interventions

DRUG

Cytisine

Standard dosing of: * days 1-3: one tablet (1.5mg) every two hours through the waking day (six tablets/day) * days 4-12: one tablet every 2.5 hours (five tablets/day). Quit smoking date is day five. * days 13-16: one tablet every three hours (four tablets/day) * days 17-20: one tablet every 4-5 hours (three tablets/day) * days 21-25: one tablet every six hours (two tablets/day) Followed by a maintenance dose of cystine from day 26 to week 12 (one tablet every six hours: two tablets/day)

DRUG

Nicotine delivered via an e-cigarette

Pod device delivering nicotine. Nicotine strength: 30mg/ml (3%). Flavour: Tobacco

COMBINATION_PRODUCT

Cytisine plus nicotine delivered via an e-cigarette

Cytisine: Standard dosing of: * days 1-3: one tablet (1.5mg) every two hours through the waking day (six tablets/day) * days 4-12: one tablet every 2.5 hours (five tablets/day). Quit smoking date is day five. * days 13-16: one tablet every three hours (four tablets/day) * days 17-20: one tablet every 4-5 hours (three tablets/day) * days 21-25: one tablet every six hours (two tablets/day) Followed by a maintenance dose of cystine from day 26 to week 12 (one tablet every six hours: two tablets/day) Nicotine e-cigarette: Pod device delivering nicotine. Nicotine strength: 30mg/ml (3%). Flavour: Tobacco

Sponsors & Collaborators

• University of Auckland, New Zealand

  lead OTHER

Principal Investigators

• Natalie Walker, PhD · University of Auckland, New Zealand

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2022-05-05

Primary Completion

2024-05-02

Completion

2024-07-26

Countries

• New Zealand

Study Locations