Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000866000
Ethics application status
Approved
Date submitted
14/10/2010
Date registered
15/10/2010
Date last updated
16/02/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
ASCEND: A Study of Cessation using Electronic Nicotine Devices
Scientific title
A three arm single blind parallel group randomised controlled clinical trial to evaluate the efficacy, acceptability, utilisation and safety of an electronic cigarette (ENDS) as a smoking cessation aid (ASCEND)
Secondary ID [1] 252869 0
none
Universal Trial Number (UTN)
Trial acronym
ASCEND
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Smoking Cessation 258389 0
Condition category
Condition code
Public Health 258562 258562 0 0
Epidemiology
Mental Health 258587 258587 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm 1. 16mg Nicotine Cartridges (max 2 cartridges/day) used in "e-cigarettes" (Electronic Nicotine Device (ENDS)) for 13 weeks plus 8 weeks of smoking behavioural support supplied by Quitline New Zealand (NZ) both from baseline.
Arm 2. 0mg Nicotine Cartridges (max 2 cartridges/day) used in "e-cigarettes" (Electronic Nicotine Device (ENDS)) for 13 weeks plus 8 weeks of smoking behavioural support supplied by Quitline New Zealand (NZ) both from baseline.
Arm 3. 21 mg Nicotine Patch (max 1 patch/day used for 13 weeks plus 8 weeks of smoking behavioural support supplied by Quitline New Zealand (NZ) both from baseline.
Intervention code [1] 257393 0
Treatment: Drugs
Intervention code [2] 257416 0
Treatment: Other
Intervention code [3] 257417 0
Behaviour
Comparator / control treatment
Usual Quitline (NZ) practice with 21mg Nicotine patch for 13 weeks and 8 weeks behavioural support
Control group
Active

Outcomes
Primary outcome [1] 259407 0
Continuous abstinence from smoking for six months after the quit day using the Russell Standard definition of abstinence (i.e. intention to treat analysis, biochemical verification of self-reported abstinence using an exhaled carbon monoxide (CO) measurement of <10 parts per million).
Timepoint [1] 259407 0
6 months post Quitday
Secondary outcome [1] 265945 0
Continuous abstinence assessed at one and three months: The proportion of participants that have stopped smoking, defined as self-report of smoking not more than five cigarettes from the Quit date.
Timepoint [1] 265945 0
One and three months
Secondary outcome [2] 265946 0
7-day point prevalence assessed: The proportion of participants that have stopped smoking, defined as self-report of having smoked no cigarettes (not even a puff) in the past seven days
Timepoint [2] 265946 0
1 week, 1 month, 3 months and 6 months post Quitday
Secondary outcome [3] 265947 0
Number of cigarettes smoked per day: If the participant is still smoking, all time points.
Timepoint [3] 265947 0
1 week, 1 month, 3 months and 6 months post Quitday
Secondary outcome [4] 265948 0
The physical signs and symptoms associated with withdrawal: Measured using the AUTOS.
Timepoint [4] 265948 0
1 week, 1 month, 3 months and 6 months post Quitday

Eligibility
Key inclusion criteria
1. Participants will be smokers from throughout Auckland
who want to stop smoking.
2. Are at least 18 years of age,
3. Have smoked on average at least 10 cigarettes a day for the past year
4. Are able to provide verbal consent
5. Have access to a phone
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Pregnant women and women who are breastfeeding will be excluded from the trial,
2. Current users of another smoking cessation medication ((e.g. other forms of NRT, buproprion [Zyban], clonidine, nortriptyline [Norpress] or vareniciline [Champix])
3. Those enrolled in another smoking cessation programme (e.g. Txt2Quit) or trial.
4. Had a heart attack, stroke or severe angina in the previous two weeks
5. Poorly controlled asthma or other airways disease (from history
6. Poorly controlled diabetes mellitus
7. Severe allergies
8. Poorly controlled psychiatric disorders
9. Current chemical dependence other than that involving nicotine.

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), sex (male/female) 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 / Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/08/2011
Actual
6/09/2011
Date of last participant enrolment
Anticipated
Actual
30/01/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
653
Accrual to date
Final
657
Recruitment outside Australia
Country [1] 2970 0
New Zealand
State/province [1] 2970 0

Funding & Sponsors
Funding source category [1] 257832 0
Government body
Name [1] 257832 0
Health Research Council NZ
Country [1] 257832 0
New Zealand
Primary sponsor type
Government body
Name
Health Research Council NZ
Address
PO BOX 5541
Wellesley Street
Auckland 1141
Country
New Zealand
Secondary sponsor category [1] 257034 0
University
Name [1] 257034 0
National Institute for Health Innovation (NIHI)
Address [1] 257034 0
University of Auckland, Private Bag 92019, Auckland Mail Centre, Auckland, 1142
Country [1] 257034 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259861 0
Northern X Regional Ethics Committee
Ethics committee address [1] 259861 0
3rd floor, Unisys building
650 Great South Rd
Penrose
Private Bag 92-522, Wellesley St
Auckland, 1061
Ethics committee country [1] 259861 0
New Zealand
Date submitted for ethics approval [1] 259861 0
14/10/2010
Approval date [1] 259861 0
30/08/2011
Ethics approval number [1] 259861 0

Summary
Brief summary
Most smokers know smoking is harmful to their health but find it hard to stop, largely because of addiction to nicotine and the habit of using cigarettes for many years. Medical nicotine (such as nicotine patch, the most widely used quit smoking product) doubles the chances of successfully quitting but doesn’t deal with smoking habits. This study tests a new nicotine delivery system, the e-cigarette or ENDS, to see if it is better than nicotine patch at helping smokers quit. Participants will be randomly allocated to one of three groups: e-cigarettes with 16mg nicotine cartridges, nicotine patches, or e-cigarettes with 0 mg nicotine cartridges, used for 13 weeks. We will phone them at one, three and six months after quit day to compare quitting, acceptability, use and side effects. Even if only modestly effective at helping smokers quit, e-cigarettes have potential for a positive health impact because of their popularity among smokers
Trial website
www.nihi.auckland.ac.nz
Trial related presentations / publications
Bullen C, Williman J, Howe C, Laugesen M, McRobbie H, Parag V, et al. Study protocol for a randomised controlled trial of electronic cigarettes versus nicotine patch for smoking cessation. BMC Public Health. 2013;13(1).

Bullen C, Howe C, Laugesen M, McRobbie H, Parag V, Williman J, et al. Electronic cigarettes for smoking cessation: a randomised controlled trial. Lancet. 2013;382:1629-37

Bullen C, Howe C, Laugesen M, McRobbie H, Parag V, Williman J, et al. Electronic cigarettes and smoking cessation: a quandary? Reply. Lancet. 2014;383(9915):408-9.

O'Brien B, Knight-West O, Walker N, Parag V, Bullen C. E-cigarettes versus NRT for smoking reduction or cessation in people with mental illness: secondary analysis of data from the ASCEND trial. Tobacco induced diseases. 2015;13(1):5.
Public notes

Contacts
Principal investigator
Name 31769 0
Prof Chris Bullen
Address 31769 0
NIHI, Auckland University, Private Bag 92019, Auckland Mail Centre, Auckland 1142
Country 31769 0
New Zealand
Phone 31769 0
+6493737599
Fax 31769 0
Email 31769 0
c.bullen@auckland.ac.nz
Contact person for public queries
Name 15016 0
Prof Chris Bullen
Address 15016 0
NIHI, Auckland University, Private Bag 92019, Auckland Mail Centre, Auckland 1142
Country 15016 0
New Zealand
Phone 15016 0
+64 9 923 4765
Fax 15016 0
+64 9 373 1710
Email 15016 0
c.bullen@auckland.ac.nz
Contact person for scientific queries
Name 5944 0
Prof Chris Bullen
Address 5944 0
NIHI, Auckland University, Private Bag 92019, Auckland Mail Centre, Auckland 1142
Country 5944 0
New Zealand
Phone 5944 0
+64 9 923 4730
Fax 5944 0
+64 9 373 1710
Email 5944 0
c.bullen@auckland.ac.nz

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseE-cigarettes versus NRT for smoking reduction or cessation in people with mental illness: Secondary analysis of data from the ASCEND trial Dr Maciej L. Goniewicz.2015https://dx.doi.org/10.1186/s12971-015-0030-2
N.B. These documents automatically identified may not have been verified by the study sponsor.