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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05311085




Registration number
NCT05311085
Ethics application status
Date submitted
5/11/2021
Date registered
5/04/2022

Titles & IDs
Public title
Cytisine and E-cigarettes With Supportive Text-messaging for Smoking Cessation (Cess@Tion)
Scientific title
Cytisine and E-cigarettes With Supportive Text-messaging for Smoking Cessation
Secondary ID [1] 0 0
21/323
Universal Trial Number (UTN)
Trial acronym
Cess@Tion
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Smoking Cessation 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Cytisine
Treatment: Drugs - Nicotine delivered via an e-cigarette
Other interventions - Cytisine plus nicotine delivered via an e-cigarette

Active comparator: Monotherapy (Cytisine only) - 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.

Active comparator: Monotherapy (Nicotine e-cigarette only) - 12 weeks of a nicotine e-cigarette. Participants will also receive six months of text-based smoking cessation support.

Active comparator: Combination therapy (Cytisine plus a nicotine e-cigarette) - 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.


Treatment: Drugs: 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)

Treatment: Drugs: Nicotine delivered via an e-cigarette
Pod device delivering nicotine. Nicotine strength: 30mg/ml (3%). Flavour: Tobacco

Other interventions: 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
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Proportion of participants with verified continuous smoking abstinence
Timepoint [1] 0 0
Six months post-quit date
Secondary outcome [1] 0 0
Age
Timepoint [1] 0 0
Assessed at baseline
Secondary outcome [2] 0 0
Gender
Timepoint [2] 0 0
Assessed at baseline
Secondary outcome [3] 0 0
Ethnicity (self-reported)
Timepoint [3] 0 0
Assessed at baseline
Secondary outcome [4] 0 0
Education
Timepoint [4] 0 0
Assessed at baseline
Secondary outcome [5] 0 0
Age started smoking
Timepoint [5] 0 0
Assessed at baseline
Secondary outcome [6] 0 0
Number of years of continuous smoking
Timepoint [6] 0 0
Assessed at baseline
Secondary outcome [7] 0 0
Type of cigarettes smoked
Timepoint [7] 0 0
Assessed at baseline
Secondary outcome [8] 0 0
Number of cigarettes smoked per day
Timepoint [8] 0 0
Assessed at baseline
Secondary outcome [9] 0 0
Mean pack size (Factory-made cigarettes)
Timepoint [9] 0 0
Assessed at baseline
Secondary outcome [10] 0 0
Median pack size (Factory-made cigarettes)
Timepoint [10] 0 0
Assessed at baseline
Secondary outcome [11] 0 0
Mean pouch size (Roll your-own tobacco)
Timepoint [11] 0 0
Assessed at baseline
Secondary outcome [12] 0 0
Median pouch size (Roll your-own tobacco)
Timepoint [12] 0 0
Assessed at baseline
Secondary outcome [13] 0 0
Time taken to smoke the contents of a pack or pouch
Timepoint [13] 0 0
Assessed at baseline
Secondary outcome [14] 0 0
Level of cigarette dependence
Timepoint [14] 0 0
Assessed at baseline
Secondary outcome [15] 0 0
At least one quit attempt in the past 12 months
Timepoint [15] 0 0
Assessed at baseline
Secondary outcome [16] 0 0
Time quit, for last quit attempt
Timepoint [16] 0 0
Assessed at baseline
Secondary outcome [17] 0 0
Methods used in previous quit attempt
Timepoint [17] 0 0
Assessed at baseline
Secondary outcome [18] 0 0
Reduction in the number of cigarettes smoked in the past 12 months
Timepoint [18] 0 0
Assessed at baseline
Secondary outcome [19] 0 0
Motivation to quit
Timepoint [19] 0 0
Assessed at baseline
Secondary outcome [20] 0 0
Chances of giving up smoking
Timepoint [20] 0 0
Assessed at baseline
Secondary outcome [21] 0 0
Living with other people who smoke tobacco
Timepoint [21] 0 0
Assessed at baseline
Secondary outcome [22] 0 0
Living with other people who use nicotine e-cigarettes (vapes)
Timepoint [22] 0 0
Assessed at baseline
Secondary outcome [23] 0 0
Has close friends who use nicotine e-cigarettes (vapes)
Timepoint [23] 0 0
Assessed at baseline
Secondary outcome [24] 0 0
Alcohol use
Timepoint [24] 0 0
Assessed at baseline
Secondary outcome [25] 0 0
Cannabis use
Timepoint [25] 0 0
Assessed at baseline
Secondary outcome [26] 0 0
Self-reported continuous smoking abstinence
Timepoint [26] 0 0
Assessed at one, three, and six months post-quit date (and at 12 months post-quit date in a subsample)
Secondary outcome [27] 0 0
Self-reported 7-day point prevalence smoking abstinence
Timepoint [27] 0 0
Assessed at one, three, and six months post-quit date (and at 12 months post-quit date in a subsample)
Secondary outcome [28] 0 0
Change from baseline in the number of cigarettes smoked per day (if smoking) by participants
Timepoint [28] 0 0
Assessed at quit date (day 0), then one, three, and six months post-quit date (and at 12 months post-quit date in a subsample)
Secondary outcome [29] 0 0
Reduction in smoking by participants
Timepoint [29] 0 0
Assessed at quit date (day 0), then one, three, and six months post-quit date (and at 12 months post-quit date in a subsample)
Secondary outcome [30] 0 0
Time to first lapse back to smoking by participants
Timepoint [30] 0 0
Assessed at one, three, and six months post-quit date (and at 12 months post-quit date in a subsample)
Secondary outcome [31] 0 0
Time to first relapse back to smoking by participants
Timepoint [31] 0 0
Assessed at one, three, and six months post-quit date (and at 12 months post-quit date in a subsample)
Secondary outcome [32] 0 0
Proportion of participants who use other smoking cessation methods
Timepoint [32] 0 0
Assessed at quit date (day 0), then one, three, and six months post-quit date (and at 12 months post-quit date in a subsample)
Secondary outcome [33] 0 0
Health-related quality of life (five domains)
Timepoint [33] 0 0
Assessed at baseline, three, six and 12 months post-quit date
Secondary outcome [34] 0 0
Health-related quality of life (self-rated health)
Timepoint [34] 0 0
Assessed at baseline, three, six and 12 months post-quit date
Secondary outcome [35] 0 0
Participant compliance with cytisine use
Timepoint [35] 0 0
Measured at three months post quit date.
Secondary outcome [36] 0 0
Number of cytisine tablets taken by participants
Timepoint [36] 0 0
Measured at one and three months post quit date.
Secondary outcome [37] 0 0
Daily use of the allocated treatment by participants
Timepoint [37] 0 0
Measured at quit date (day 0), then at one month post quit date.
Secondary outcome [38] 0 0
Reasons for not using allocated treatment
Timepoint [38] 0 0
Measured at quit date (day 0), then at one month post quit date.
Secondary outcome [39] 0 0
Frequency of use of the e-cigarette, by participants allocated e-cigarettes
Timepoint [39] 0 0
Measured at three months post quit date.
Secondary outcome [40] 0 0
Number of nicotine pods used, by participants allocated e-cigarettes
Timepoint [40] 0 0
Measured at one and three months post quit date.
Secondary outcome [41] 0 0
Signs and symptoms of nicotine withdrawal in participants
Timepoint [41] 0 0
Measured at baseline and at three months (end of treatment).
Secondary outcome [42] 0 0
Urge to smoke in participants
Timepoint [42] 0 0
Measured at baseline and at three months (end of treatment).
Secondary outcome [43] 0 0
Treatment switching (crossover from cytisine-only to e-cigarette)
Timepoint [43] 0 0
Assessed at quit date (day 0), then one, three, and six months post-quit date (and at 12 months post-quit date in a subsample)
Secondary outcome [44] 0 0
Treatment switching (crossover from cytisine-only to e-cigarette): nicotine content of e-cigarette
Timepoint [44] 0 0
Assessed at quit date (day 0), then one, three, and six months post-quit date (and at 12 months post-quit date in a subsample)
Secondary outcome [45] 0 0
Treatment switching (crossover from e-cigarette-only to cytisine)
Timepoint [45] 0 0
Assessed at quit date (day 0), then one, three, and six months post-quit date (and at 12 months post-quit date in a subsample)
Secondary outcome [46] 0 0
Treatment switching (crossover from e-cigarette-only to cytisine): source of cytisine
Timepoint [46] 0 0
Assessed at quit date (day 0), then one, three, and six months post-quit date (and at 12 months post-quit date in a subsample)
Secondary outcome [47] 0 0
Change in e-cigarette use
Timepoint [47] 0 0
Assessed at quit date (day 0), then one, three, and six months post-quit date (and at 12 months post-quit date in a subsample)
Secondary outcome [48] 0 0
Dual use of treatment and tobacco by participants
Timepoint [48] 0 0
Assessed at one, three, and six months post-quit date (and at 12 months post-quit date in a subsample)
Secondary outcome [49] 0 0
Continuation of product use by participants
Timepoint [49] 0 0
Measured at six (in all) and 12 months (in a subsample).
Secondary outcome [50] 0 0
Acceptability of allocated product
Timepoint [50] 0 0
Measured at three months post-quit date (end of treatment)
Secondary outcome [51] 0 0
Participants recommendations regarding the allocated product
Timepoint [51] 0 0
Measured at three months post-quit date (end of treatment)
Secondary outcome [52] 0 0
Number of participants with self-reported adverse events
Timepoint [52] 0 0
Assessed at quit date (day 0), then one, three, and six months post-quit date (and at 12 months post-quit date in a subsample)
Secondary outcome [53] 0 0
Number of self-reported adverse events
Timepoint [53] 0 0
Assessed at quit date (day 0), then one, three, and six months post-quit date (and at 12 months post-quit date in a subsample)
Secondary outcome [54] 0 0
Change from baseline in body mass index
Timepoint [54] 0 0
Asked at three and six months post-quit date
Secondary outcome [55] 0 0
Change from baseline in frequency of shortness of breath in participants
Timepoint [55] 0 0
Measured at three and six months post-quit date (and at 12 months post-quit date in a subsample)
Secondary outcome [56] 0 0
Change from baseline in frequency of coughing in participants
Timepoint [56] 0 0
Measured at three and six months post-quit date (and at 12 months post-quit date in a subsample)
Secondary outcome [57] 0 0
Change from baseline in asthma severity, in those participants with asthma
Timepoint [57] 0 0
Measured at three and six months post-quit date (and at 12 months post-quit date in a subsample)
Secondary outcome [58] 0 0
Change from baseline in severity of chronic pain, in those participants with chronic pain.
Timepoint [58] 0 0
Measured at three and six months post-quit date (and at 12 months post-quit date in a subsample)
Secondary outcome [59] 0 0
Change from baseline in severity of Chronic Obstructive Pulmonary Disease (COPD), in those participants with COPD.
Timepoint [59] 0 0
Measured at three and six months post-quit date (and at 12 months post-quit date in a subsample)
Secondary outcome [60] 0 0
Change from baseline in severity of mental health concerns, in those participants with mental health concerns.
Timepoint [60] 0 0
Measured at three and six months post-quit date (and at 12 months post-quit date in a subsample)
Secondary outcome [61] 0 0
Concomitant medication
Timepoint [61] 0 0
Assessed at baseline, quit date (day 0), then one, three, and six months post-quit date (and at 12 months post-quit date in a subsample)
Secondary outcome [62] 0 0
Mean number of text-based behavioral support messages received by participants
Timepoint [62] 0 0
Assessed at six months
Secondary outcome [63] 0 0
Median number of text-based behavioral support messages received by participants
Timepoint [63] 0 0
Assessed at six months
Secondary outcome [64] 0 0
Marginal cost per quitter
Timepoint [64] 0 0
Assessed at six months

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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.
* Have a history of severe allergy and/or poorly controlled asthma.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
5/05/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
26/07/2024
Sample size
Target
Accrual to date
Final
807
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland

Funding & Sponsors
Primary sponsor type
Other
Name
University of Auckland, New Zealand
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Natalie Walker, PhD
Address 0 0
University of Auckland, New Zealand
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
This plan is currently being developed and will be made available soon.

Please note that at least 25% of trial participants are likely to be Indigenous Maori. In New Zealand "indigenous data sovereignty recognizes that Maori data should be subject to Maori governance. Maori data sovereignty supports tribal sovereignty and the realization of Maori and Iwi aspirations." Requests to access trial data provided by Maori participants will be reviewed and considered by the Maori Research Advisory Committee at the National Institute for Health Innovation, University of Auckland.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF), Analytic code
When will data be available (start and end dates)?
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.
Available to whom?
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.
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

TypeOther DetailsAttachment
Statistical analysis plan https://cdn.clinicaltrials.gov/large-docs/85/NCT05311085/SAP_000.pdf



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05311085