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Trial registered on ANZCTR


Registration number
ACTRN12616001654448
Ethics application status
Approved
Date submitted
28/10/2016
Date registered
30/11/2016
Date last updated
7/02/2020
Date data sharing statement initially provided
7/02/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
A non-inferiority trial of cytisine versus varenicline for smoking cessation
Scientific title
A randomised controlled non-inferiority clinical trial to evaluate the cost-effectiveness and safety of cytisine compared to varenicline as a treatment for people who wish to stop smoking
Secondary ID [1] 290407 0
None
Universal Trial Number (UTN)
Trial acronym
A non-inferiority trial of Cytisine versus varEnicline for Smoking cesSATion – The CESSATE study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Tobacco use and dependence 300744 0
Condition category
Condition code
Public Health 300577 300577 0 0
Other public health
Mental Health 300678 300678 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All participants in the intervention arm will receive a 25-day supply of 1.5 mg cytisine capsules. The recommended dosing schedule includes:
1 to 3 days – 1 capsule every 2 hours (max 6 capsules/day);
4 to 12 days – 1 capsule every 2.5 hours (max 5 capsules/day);
13 to 16 days – 1 capsule every 3 hours (max 4 capsules/day);
17 to 20 days – 1 capsule every 5 hours (max 3 capsules/day);
21 to 25 days- 1 capsule every 6 hours (max 2 capsules/day.
All participants in the intervention arm will be advised to reduce their smoking over the first four days of treatment and quit completely on the fifth day which will be their designated quit date. Participants' self-reported adherence to the treatment will be assessed during follow-up interviews.
Intervention code [1] 296238 0
Treatment: Drugs
Comparator / control treatment
All participants in the control arm will receive a 12-week supply of varenicline tablet. The recommended dosing schedule includes:
1 to 3 days – One 0.5 mg tablet/day
4 to 7 days – One 0.5 mg tablet twice a day
Day 8 to week 12 – One 1.0 mg tablet twice a day
All participants in the varenicline arm will be advised to reduce their smoking over the first seven days of treatment and quit completely on the eighth day which will be their designated quit date. Participants' self-reported adherence to the treatment will be assessed during follow-up interviews.
Control group
Active

Outcomes
Primary outcome [1] 299996 0
Carbon monoxide validated continuous abstinence
Timepoint [1] 299996 0
6-month from the designated quit date
Secondary outcome [1] 328778 0
Self-reported continuous abstinence
Timepoint [1] 328778 0
1-month,3-month and 6-month from the designated quit date
Secondary outcome [2] 328779 0
Self-reported seven-day point prevalence abstinence
Timepoint [2] 328779 0
1-month, 3-month and 6-month from the designated quit date
Secondary outcome [3] 329014 0
Health-related quality of life using EQ-5D
Timepoint [3] 329014 0
Baseline and at 3-month and 6-month from the designated quit date
Secondary outcome [4] 329575 0
Healthcare resource use: Participants will be asked about their use of other healthcare resources such as other medications, clinic visits, hospital visits and Quitlines.
Timepoint [4] 329575 0
3-month and 6-month from the designated quit date
Secondary outcome [5] 329576 0
Safety of both medications: All self-reported adverse events will be recorded at all study assessments. The most common side effects reported for cytisine in previous studies were gastrointestinal disorders (mainly nausea, vomiting, stomach ache, dry mouth and dyspepsia) and sleep disturbance. Commonly reported side effects of varenicline include mood disturbance, nausea, headache, insomnia, sleep disturbance and vivid dreams.
Timepoint [5] 329576 0
1-month, 3-month and 6-month from the designated quit date

Eligibility
Key inclusion criteria
Participants will be at least 18 years of age; current daily smoker; motivated and willing to make a quit attempt using medications (cytisine/varenicline); able to provide informed consent; have access to a telephone; and willing to complete baseline and follow-up telephone interviews.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Women who are pregnant, breastfeeding or planning to become pregnant in the next six months will be excluded from this trial, as will current users of smoking cessation medications or those who are participating in another smoking cessation program or study. The current users of varenicline and cytisine, and those with known hypersensitivity to the active substance or to any of the excipients also will be excluded. People will also be excluded if they report any of the following medical conditions in the previous three months: arrhythmia, heart attack, stroke, or severe angina.People with pheochromocytoma and hyperthyroidism also will be excluded.

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
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
2/01/2017
Actual
16/11/2017
Date of last participant enrolment
Anticipated
28/02/2019
Actual
22/05/2019
Date of last data collection
Anticipated
17/02/2020
Actual
Sample size
Target
1450
Accrual to date
Final
1452
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 294815 0
Government body
Name [1] 294815 0
National Health and Medical Research Council (NHMRC)
Country [1] 294815 0
Australia
Primary sponsor type
University
Name
University of New South Wales
Address
University of New South Wales
National Drug and Alcohol Research Centre
Sydney NSW 2052 AUSTRALIA
Country
Australia
Secondary sponsor category [1] 293658 0
None
Name [1] 293658 0
Address [1] 293658 0
Country [1] 293658 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296205 0
The University of New South Wales Human Research Ethics Committee
Ethics committee address [1] 296205 0
UNSW Research Ethics & Compliance Support
The University of New South Wales
Sydney NSW 2052 Australia
Ethics committee country [1] 296205 0
Australia
Date submitted for ethics approval [1] 296205 0
31/10/2016
Approval date [1] 296205 0
09/01/2017
Ethics approval number [1] 296205 0

Summary
Brief summary
This study will evaluate the cost-effectiveness of cytisine in comparison with varenicline. A total of 1450 smokers will be recruited from state Quitline services. Participants will have an equal chance of being randomly allocated to either the intervention or control arm (1:1 ratio).

Participants in the intervention arm will receive a 25-day supply of cytisine capsules (1.5 mg cytisine). Participants in the varenicline arm will receive a 12-week supply of varenicline tablet (0.5 mg/1.0 mg varenicline). All participants will also receive standard Quitline behavioural support.

All participants will be followed-up for six months and the follow-up interviews will be held at one, three and six months after the quit date. The main outcome measures are abstinence from smoking at one, three and six months follow-ups.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 69994 0
Prof Michael Farrell
Address 69994 0
University of New South Wales
National Drug and Alcohol Research Centre
Sydney NSW 2052 AUSTRALIA
Country 69994 0
Australia
Phone 69994 0
+61 (02) 9385 0333
Fax 69994 0
Email 69994 0
[email protected]
Contact person for public queries
Name 69995 0
Ryan Courtney
Address 69995 0
University of New South Wales
National Drug and Alcohol Research Centre
Sydney NSW 2052 AUSTRALIA
Country 69995 0
Australia
Phone 69995 0
+61 02 89 361004
Fax 69995 0
Email 69995 0
[email protected]
Contact person for scientific queries
Name 69996 0
Ryan Courtney
Address 69996 0
University of New South Wales
National Drug and Alcohol Research Centre
Sydney NSW 2052 AUSTRALIA
Country 69996 0
Australia
Phone 69996 0
+61 (02) 893 61004
Fax 69996 0
Email 69996 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
6810Study protocolThomas D, Farrell M, McRobbie H, Tutka P, Petrie D, West R, Siahpush M, Gartner C, Walker N Mendelsohn CP, Hall W, Paul C, Zwar N, Ferguson SG, Boland VC, Richmond R, Doran CM, Shakeshaft A, Mattick RP, Courtney RJ. (2019). The effectiveness, safety and cost-effectiveness of cytisine versus varenicline for smoking cessation in an Australian population: a study protocol for a randomized controlled non-inferiority trial. Addiction, 114 (5), 923-933.   
6811Ethical approval    371734-(Uploaded-17-12-2019-15-29-54)-Study-related document.Pdf



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseEffect of Cytisine vs Varenicline on Smoking Cessation: A Randomized Clinical Trial.2021https://dx.doi.org/10.1001/jama.2021.7621
N.B. These documents automatically identified may not have been verified by the study sponsor.