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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05311085

Registration number

NCT05311085

Ethics application status

Date submitted

5/11/2021

Date registered

5/04/2022

Date last updated

13/11/2023

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]

21/323

Universal Trial Number (UTN)

Trial acronym

Cess@Tion

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Smoking Cessation

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
Combination Product - 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

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

Intervention code [1]

Treatment: Drugs

Intervention code [2]

Combination Product

Comparator / control treatment

Control group

Outcomes

Primary outcome [1]

Proportion of participants with verified continuous smoking abstinence

Timepoint [1]

Six months post-quit date

Secondary outcome [1]

Age

Timepoint [1]

Assessed at baseline

Secondary outcome [2]

Gender

Timepoint [2]

Assessed at baseline

Secondary outcome [3]

Ethnicity (self-reported)

Timepoint [3]

Assessed at baseline

Secondary outcome [4]

Education

Timepoint [4]

Assessed at baseline

Secondary outcome [5]

Age started smoking

Timepoint [5]

Assessed at baseline

Secondary outcome [6]

Number of years of continuous smoking

Timepoint [6]

Assessed at baseline

Secondary outcome [7]

Type of cigarettes smoked

Timepoint [7]

Assessed at baseline

Secondary outcome [8]

Number of cigarettes smoked per day

Timepoint [8]

Assessed at baseline

Secondary outcome [9]

Mean pack size (Factory-made cigarettes)

Timepoint [9]

Assessed at baseline

Secondary outcome [10]

Median pack size (Factory-made cigarettes)

Timepoint [10]

Assessed at baseline

Secondary outcome [11]

Mean pouch size (Roll your-own tobacco)

Timepoint [11]

Assessed at baseline

Secondary outcome [12]

Median pouch size (Roll your-own tobacco)

Timepoint [12]

Assessed at baseline

Secondary outcome [13]

Time taken to smoke the contents of a pack or pouch

Timepoint [13]

Assessed at baseline

Secondary outcome [14]

Level of cigarette dependence

Timepoint [14]

Assessed at baseline

Secondary outcome [15]

At least one quit attempt in the past 12 months

Timepoint [15]

Assessed at baseline

Secondary outcome [16]

Time quit, for last quit attempt

Timepoint [16]

Assessed at baseline

Secondary outcome [17]

Methods used in previous quit attempt

Timepoint [17]

Assessed at baseline

Secondary outcome [18]

Reduction in the number of cigarettes smoked in the past 12 months

Timepoint [18]

Assessed at baseline

Secondary outcome [19]

Motivation to quit

Timepoint [19]

Assessed at baseline

Secondary outcome [20]

Chances of giving up smoking

Timepoint [20]

Assessed at baseline

Secondary outcome [21]

Living with other people who smoke tobacco

Timepoint [21]

Assessed at baseline

Secondary outcome [22]

Living with other people who use nicotine e-cigarettes (vapes)

Timepoint [22]

Assessed at baseline

Secondary outcome [23]

Has close friends who use nicotine e-cigarettes (vapes)

Timepoint [23]

Assessed at baseline

Secondary outcome [24]

Alcohol use

Timepoint [24]

Assessed at baseline

Secondary outcome [25]

Cannabis use

Timepoint [25]

Assessed at baseline

Secondary outcome [26]

Self-reported continuous smoking abstinence

Timepoint [26]

Assessed at one, three, and six months post-quit date (and at 12 months post-quit date in a subsample)

Secondary outcome [27]

Self-reported 7-day point prevalence smoking abstinence

Timepoint [27]

Assessed at one, three, and six months post-quit date (and at 12 months post-quit date in a subsample)

Secondary outcome [28]

Change from baseline in the number of cigarettes smoked per day (if smoking) by participants

Timepoint [28]

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]

Reduction in smoking by participants

Timepoint [29]

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]

Time to first lapse back to smoking by participants

Timepoint [30]

Assessed at one, three, and six months post-quit date (and at 12 months post-quit date in a subsample)

Secondary outcome [31]

Time to first relapse back to smoking by participants

Timepoint [31]

Assessed at one, three, and six months post-quit date (and at 12 months post-quit date in a subsample)

Secondary outcome [32]

Proportion of participants who use other smoking cessation methods

Timepoint [32]

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]

Health-related quality of life (five domains)

Timepoint [33]

Assessed at baseline, three, six and 12 months post-quit date

Secondary outcome [34]

Health-related quality of life (self-rated health)

Timepoint [34]

Assessed at baseline, three, six and 12 months post-quit date

Secondary outcome [35]

Participant compliance with cytisine use

Timepoint [35]

Measured at three months post quit date.

Secondary outcome [36]

Number of cytisine tablets taken by participants

Timepoint [36]

Measured at one and three months post quit date.

Secondary outcome [37]

Daily use of the allocated treatment by participants

Timepoint [37]

Measured at quit date (day 0), then at one month post quit date.

Secondary outcome [38]

Reasons for not using allocated treatment

Timepoint [38]

Measured at quit date (day 0), then at one month post quit date.

Secondary outcome [39]

Frequency of use of the e-cigarette, by participants allocated e-cigarettes

Timepoint [39]

Measured at three months post quit date.

Secondary outcome [40]

Number of nicotine pods used, by participants allocated e-cigarettes

Timepoint [40]

Measured at one and three months post quit date.

Secondary outcome [41]

Signs and symptoms of nicotine withdrawal in participants

Timepoint [41]

Measured at baseline and at three months (end of treatment).

Secondary outcome [42]

Urge to smoke in participants

Timepoint [42]

Measured at baseline and at three months (end of treatment).

Secondary outcome [43]

Treatment switching (crossover from cytisine-only to e-cigarette)

Timepoint [43]

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]

Treatment switching (crossover from cytisine-only to e-cigarette): nicotine content of e-cigarette

Timepoint [44]

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]

Treatment switching (crossover from e-cigarette-only to cytisine)

Timepoint [45]

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]

Treatment switching (crossover from e-cigarette-only to cytisine): source of cytisine

Timepoint [46]

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]

Change in e-cigarette use

Timepoint [47]

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]

Dual use of treatment and tobacco by participants

Timepoint [48]

Assessed at one, three, and six months post-quit date (and at 12 months post-quit date in a subsample)

Secondary outcome [49]

Continuation of product use by participants

Timepoint [49]

Measured at six (in all) and 12 months (in a subsample).

Secondary outcome [50]

Acceptability of allocated product

Timepoint [50]

Measured at three months post-quit date (end of treatment)

Secondary outcome [51]

Participants recommendations regarding the allocated product

Timepoint [51]

Measured at three months post-quit date (end of treatment)

Secondary outcome [52]

Number of participants with self-reported adverse events

Timepoint [52]

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]

Number of self-reported adverse events

Timepoint [53]

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]

Change from baseline in body mass index

Timepoint [54]

Asked at three and six months post-quit date

Secondary outcome [55]

Change from baseline in frequency of shortness of breath in participants

Timepoint [55]

Measured at three and six months post-quit date (and at 12 months post-quit date in a subsample)

Secondary outcome [56]

Change from baseline in frequency of coughing in participants

Timepoint [56]

Measured at three and six months post-quit date (and at 12 months post-quit date in a subsample)

Secondary outcome [57]

Change from baseline in asthma severity, in those participants with asthma

Timepoint [57]

Measured at three and six months post-quit date (and at 12 months post-quit date in a subsample)

Secondary outcome [58]

Change from baseline in severity of chronic pain, in those participants with chronic pain.

Timepoint [58]

Measured at three and six months post-quit date (and at 12 months post-quit date in a subsample)

Secondary outcome [59]

Change from baseline in severity of Chronic Obstructive Pulmonary Disease (COPD), in those participants with COPD.

Timepoint [59]

Measured at three and six months post-quit date (and at 12 months post-quit date in a subsample)

Secondary outcome [60]

Change from baseline in severity of mental health concerns, in those participants with mental health concerns.

Timepoint [60]

Measured at three and six months post-quit date (and at 12 months post-quit date in a subsample)

Secondary outcome [61]

Concomitant medication

Timepoint [61]

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]

Mean number of text-based behavioral support messages received by participants

Timepoint [62]

Assessed at six months

Secondary outcome [63]

Median number of text-based behavioral support messages received by participants

Timepoint [63]

Assessed at six months

Secondary outcome [64]

Marginal cost per quitter

Timepoint [64]

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.

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

Active, not recruiting

Data analysis

Reason for early stopping/withdrawal

Other reasons

Date of first participant enrolment

Anticipated

Actual

6/05/2022

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

1/04/2024

Actual

Sample size

Target

Accrual to date

Final

807

Recruitment in Australia

Recruitment state(s)

Recruitment outside Australia

Country [1]

New Zealand

State/province [1]

Auckland

Funding & Sponsors

Primary sponsor type

Other

Name

University of Auckland, New Zealand

Address

Country

Ethics approval

Ethics application status

Summary

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.

Trial website

https://clinicaltrials.gov/ct2/show/NCT05311085

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Natalie Walker, PhD

Address

University of Auckland, New Zealand

Country

Phone

Fax

Contact person for public queries

Name

Address

Country

Phone

Fax

Contact person for scientific queries

Trial Review

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05311085