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

NCT05311085 | Completed Phase 3 DMC

• 1 other identifier: 21/323
• Study Type: interventional
• Target: 807
• Locations: 1 country
• Sites: 1

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.

Conditions

Smoking Cessation

Keywords

smoking cessation; e-cigarette; cytisine; vaping; pragmatic; effectiveness

Outcome Measures

Primary Outcomes (1)

• Proportion of participants with verified continuous smoking abstinence

  Defined as self-report of smoking not more than five cigarettes from the Quit date (day 0) and confirmed by standardized exhaled carbon-monoxide (CO) measurement with a Bedfont Smokerlyzer, (≤9 ppm signifying abstinence). Sensitivity analysis will be undertaken looking at different cut-offs for the CO measurement, given lack of consensus about the best reading to use.

  Six months post-quit date

Secondary Outcomes (64)

• Age

  Assessed at baseline

• Gender

  Assessed at baseline

• Ethnicity (self-reported)

  Assessed at baseline

• Education

  Assessed at baseline

• Age started smoking

  Assessed at baseline

Study Arms (3)

Monotherapy (Cytisine only)

ACTIVE COMPARATOR

12 weeks of cytisine: Participants allocated cytisine will be instructed to follow the manufacturer's 25-day dosing regimen, then follow a maintenance dose of cytisine from day 26 to week 12. Participants will also receive six months of text-based smoking cessation support.

Drug: Cytisine

Monotherapy (Nicotine e-cigarette only)

ACTIVE COMPARATOR

12 weeks of a nicotine e-cigarette. Participants will also receive six months of text-based smoking cessation support.

Drug: Nicotine delivered via an e-cigarette

Combination therapy (Cytisine plus a nicotine e-cigarette)

ACTIVE COMPARATOR

12 weeks of cytisine (as above) and 12 weeks of a nicotine e-cigarette. Participants will also receive six months of text-based smoking cessation support.

Combination Product: Cytisine plus nicotine delivered via an e-cigarette

Interventions

Cytisine DRUG

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)

Also known as: Brand name: Tabex

Monotherapy (Cytisine only)

Nicotine delivered via an e-cigarette DRUG

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

Also known as: Brand name: UpOx

Monotherapy (Nicotine e-cigarette only)

Cytisine plus nicotine delivered via an e-cigarette COMBINATION_PRODUCT

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

Also known as: Brand names: Tabex and UpOx

Combination therapy (Cytisine plus a nicotine e-cigarette)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.
• Have a history of severe allergy and/or poorly controlled asthma.

Sponsors & Collaborators

• University of Auckland, New Zealand: lead

Study Sites (1)

National Institute for Health Innovation, School of Population Health, Faculty of Medical and Health Sciences, University of Auckland

Auckland, 1142, New Zealand

Location

Related Publications (1)

• Walker N, Calder A, Barnes J, Laking G, Parag V, Bullen C. Effectiveness of nicotine salt vapes, cytisine, and a combination of these products, for smoking cessation in New Zealand: protocol for a three-arm, pragmatic, community-based randomised controlled trial. BMC Public Health. 2023 Sep 11;23(1):1760. doi: 10.1186/s12889-023-16665-w.

  PMID: 37697327 DERIVED

MeSH Terms

Conditions

Smoking Cessation; Vaping

Interventions

cytisine

Condition Hierarchy (Ancestors)

Health Behavior; Behavior; Smoking

Study Officials

• Natalie Walker, PhD

  University of Auckland, New Zealand

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor in Population Health

Study Record Dates

• First Submitted: November 5, 2021
• First Posted: April 5, 2022
• Study Start: May 5, 2022
• Primary Completion: May 2, 2024
• Study Completion: July 26, 2024
• Last Updated: December 19, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Data requests can be submitted starting nine months after article publication and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis.
• Access Criteria: Requests for access to individual participant data, or trial documents, will be considered where: 1) the request is from qualified researchers engaging in independent scientific research; 2) the proposed use aligns with public good purposes; 3) a research proposal and Statistical Analysis Plan are provided for review and approval; 4) the request does not conflict with other requests or planned use by members of the trial steering committee; and 5) the requestor is willing to sign a data access agreement. Please send all requests to the principal investigator.

Locations

NZ (1)