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Trial registered on ANZCTR


Registration number
ACTRN12610000590066
Ethics application status
Approved
Date submitted
20/07/2010
Date registered
21/07/2010
Date last updated
5/07/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
CASCAID Study: Cytisine as a smoking cessation aid
Scientific title
A single-blind randomised controlled non-inferiority clinical trial to evaluate the efficacy and safety of cytisine compared to usual care (21mg, 14mg, or 7mg nicotine patch, 4mg or 2mg nicotine gum or 2mg or 1mg nicotine lozenge nicotine replacement therapy (NRT) plus behavioural support) as a treatment for people who wish to stop smoking
Secondary ID [1] 252261 0
none
Universal Trial Number (UTN)
Trial acronym
CASCAID
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Smoking Cessation 257765 0
Condition category
Condition code
Public Health 257940 257940 0 0
Epidemiology

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
1. Tabex (Registered Trademark) oral tablet - 1.5 mg of cytisine per tablet (Sopharma) for 28 days.

2. Including 8 weeks of smoking cessation behavioural support supplied via Quitline New Zealand (NZ) (usually 3 telephone counselling calls over an 8 week period)
Intervention code [1] 256825 0
Treatment: Drugs
Intervention code [2] 256826 0
Behaviour
Intervention code [3] 256827 0
Lifestyle
Comparator / control treatment
Usual Quitline New Zealand (NZ) practice with NRT (Patches 21mg, 14mg, 7mg, Gum (fruit or mint): 4mg or 2mg or Lozenge 2mg or 1mg Nicotine) as directed by a smoking cessation advisor for 8 weeks and 8 weeks of smoking cessation behavioural support supplied via Quitline New Zealand (NZ)
Control group
Active

Outcomes
Primary outcome [1] 258807 0
The proportion of participants that have been continuously abstinent at one month (self report of smoking not more than five cigarettes after the Quit date).
Timepoint [1] 258807 0
2 months post quit day
Secondary outcome [1] 264870 0
One month, two month and six month 7-day point prevalence abstinence rates via self reported questionnaires
Timepoint [1] 264870 0
One, two and six months post quit day
Secondary outcome [2] 264871 0
Two month and six month continuous abstinence rates via self reported questionnaires
Timepoint [2] 264871 0
Two and six months post quit day
Secondary outcome [3] 264872 0
Current smoking details, if still smoking (including daily consumption level) via self reported questionnaires
Timepoint [3] 264872 0
1 week post Quit Day, 1, 2 months & Six months (sub group)
Secondary outcome [4] 264873 0
Information related to the use of cytisine (treatment group only) via self reported questionnaires
Timepoint [4] 264873 0
1 week post Quit Day, 1, 2 months
Secondary outcome [5] 264874 0
All self-reported adverse events will be recorded at all study assessments ; 1 week, 1, 2, and 6 months post quit date. The physical signs and symptoms associated with withdrawal: Measured using the Mood and Physical Symptoms Scale (MPSS). Additional withdrawal questions will also be asked related to the frequency of disturbed sleep, anxiety, mouth ulcers, cough, impatience, dizziness and increased dreaming. Self-reported adverse events will be recorded at all assessment points.
Timepoint [5] 264874 0
1 week post Quit Day, 1, 2 months & Six months

Eligibility
Key inclusion criteria
1. they want to stop smoking,
2. they are at least 18 years of age,
3. they are able to provide verbal consent,
4. they have access to a telephone.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. they are pregnant or breastfeeding,
2. they are current users of NRT products,
3. they are current users of non-NRT smoking cessation therapies (e.g. buproprion [Zyban], clonidine, nortriptyline, or varenicline [Champix]),
4. they are enrolled in another smoking cessation programme (e.g. Txt2Quit but concurrent referral to a face-to-face provider from Quitline is acceptable) or other cessation study (e.g. Fit2Quit),
5. they have had a heart attack, stroke, or severe angina within the previous two weeks,
6. they have uncontrolled high blood pressure (> 150 mmHg systolic, > 100 mmHg diastolic),
7. they have phaeochromocytoma,
8. they suffer from schizophrenia.

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)
Central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stratified minimisation by sex, ethnicity (Maori, Pacific, non-Maori non-Pacific), and level of nicotine dependence (as determined by the time to their first cigarette – a key question in the Fagerstrom Test of Nicotine Dependence (FTND) Questionnaire
Masking / blinding
Blinded (masking used)
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
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 2772 0
New Zealand
State/province [1] 2772 0

Funding & Sponsors
Funding source category [1] 257299 0
Government body
Name [1] 257299 0
Health Research Council NZ
Address [1] 257299 0
PO Box 5541, Wellesley Street, Auckland, 11414
Country [1] 257299 0
New Zealand
Primary sponsor type
Government body
Name
Health Research Council NZ
Address
PO Box 5541, Wellesley Street, Auckland, 11414
Country
New Zealand
Secondary sponsor category [1] 256542 0
University
Name [1] 256542 0
National Institute for Health Innovation (NIHI)
Address [1] 256542 0
University of Auckland, Private Bag 92019, Auckland Mail Centre, Auckland 1142
Country [1] 256542 0
New Zealand
Other collaborator category [1] 251391 0
University
Name [1] 251391 0
Centre for Tobacco Control Research
Address [1] 251391 0
Social and Community Health
School of Population Health
University of Auckland
Private Bag 92019
Auckland
Country [1] 251391 0
New Zealand
Other collaborator category [2] 251392 0
Other Collaborative groups
Name [2] 251392 0
Inspiring Ltd
Address [2] 251392 0
PO Box 28854
Remuera, Auckland
Country [2] 251392 0
New Zealand
Other collaborator category [3] 251393 0
Charities/Societies/Foundations
Name [3] 251393 0
The Quit Group
Address [3] 251393 0
PO Box 12-605
Wellington 6144
Country [3] 251393 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259327 0
Multi-region Ethics Committe
Ethics committee address [1] 259327 0
Ministry of Health, 2nd Floor, 1-3 The Terrace, PO Box 5013, Wellington
Ethics committee country [1] 259327 0
New Zealand
Date submitted for ethics approval [1] 259327 0
30/07/2010
Approval date [1] 259327 0
Ethics approval number [1] 259327 0

Summary
Brief summary
Cytisine is a medicine, derived from the Golden Rain Tree that partially blocks the effects of nicotine on the brain. Cytisine has been used as a smoking cessation treatment in several European countries since the 1960s, is inexpensive compared to other cessation medications and has few known side effects. Despite its long history of use there are few studies looking at whether cytisine actually works. Results from trials that have been undertaken suggest that taking cytisine almost doubles the chances of successfully quitting smoking, compared to a placebo. However, these studies were not conducted using modern research standards so their positive findings may not be valid. We propose to investigate the effectiveness of cytisine as a quit smoking aid and whether it is safe and acceptable to smokers.
Trial website
http://www.nihi.auckland.ac.nz
Trial related presentations / publications
Thompson-Evans TP, Glover MP, Walker N. Cytisine’s potential to be used as a traditional healing method to help indigenous people stop smoking: a qualitative study with Maori. Nicotine & Tobacco Research 2011.
Walker N, Howe C, Bullen C, McRobbie H, Glover M, Parag V, Williman J, Veale R, Nosa V, Barnes J. Study protocol for a non-inferiority trial of cytisine versus nicotine replacement therapy in people motivated to stop smoking. BMC Pubic Health 2011: 11; 880. doi:10.1186/1471-2458-11-880
Public notes

Contacts
Principal investigator
Name 31406 0
Address 31406 0
Country 31406 0
Phone 31406 0
Fax 31406 0
Email 31406 0
Contact person for public queries
Name 14653 0
Dr Colin Howe
Address 14653 0
NIHI, University of Auckland, Private Bag 92019, Auckland Mail Centre, Auckland 1142
Country 14653 0
New Zealand
Phone 14653 0
+64 9 923 4765
Fax 14653 0
+64 9 373 1710
Email 14653 0
c.howe@nihi.auckland.ac.nz
Contact person for scientific queries
Name 5581 0
Dr Natalie Walker
Address 5581 0
NIHI, University of Auckland, Private Bag 92019, Auckland Mail Centre, Auckland 1142
Country 5581 0
New Zealand
Phone 5581 0
+64 9 923 9884
Fax 5581 0
+64 9 373 1710
Email 5581 0
n.walker@nihi.auckland.ac.nz

No information has been provided regarding IPD availability
Summary results
No Results