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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
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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)
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Secondary ID [1]
252869
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none
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Universal Trial Number (UTN)
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Trial acronym
ASCEND
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Smoking Cessation
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Condition category
Condition code
Public Health
258562
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0
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Epidemiology
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Mental Health
258587
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0
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Addiction
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
257393
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Treatment: Drugs
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Intervention code [2]
257416
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Treatment: Other
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Intervention code [3]
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Behaviour
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Comparator / control treatment
Usual Quitline (NZ) practice with 21mg Nicotine patch for 13 weeks and 8 weeks behavioural support
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Control group
Active
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Outcomes
Primary outcome [1]
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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).
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Assessment method [1]
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Timepoint [1]
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6 months post Quitday
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Secondary outcome [1]
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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.
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Assessment method [1]
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Timepoint [1]
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One and three months
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Secondary outcome [2]
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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
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Assessment method [2]
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Timepoint [2]
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1 week, 1 month, 3 months and 6 months post Quitday
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Secondary outcome [3]
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Number of cigarettes smoked per day: If the participant is still smoking, all time points.
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Assessment method [3]
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Timepoint [3]
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1 week, 1 month, 3 months and 6 months post Quitday
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Secondary outcome [4]
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The physical signs and symptoms associated with withdrawal: Measured using the AUTOS.
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Assessment method [4]
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Timepoint [4]
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1 week, 1 month, 3 months and 6 months post Quitday
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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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by computer
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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
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3 / Phase 4
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Type of endpoint/s
Safety/efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
1/08/2011
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Actual
6/09/2011
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Date of last participant enrolment
Anticipated
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Actual
30/01/2013
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
653
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Accrual to date
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Final
657
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Recruitment outside Australia
Country [1]
2970
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New Zealand
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State/province [1]
2970
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Funding & Sponsors
Funding source category [1]
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Government body
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Name [1]
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Health Research Council NZ
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Address [1]
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PO BOX 5541
Wellesley Street
Auckland 1141
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Country [1]
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New Zealand
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Primary sponsor type
Government body
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Name
Health Research Council NZ
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Address
PO BOX 5541
Wellesley Street
Auckland 1141
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Country
New Zealand
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Secondary sponsor category [1]
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University
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Name [1]
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National Institute for Health Innovation (NIHI)
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Address [1]
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University of Auckland, Private Bag 92019, Auckland Mail Centre, Auckland, 1142
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Country [1]
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New Zealand
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Northern X Regional Ethics Committee
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Ethics committee address [1]
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3rd floor, Unisys building
650 Great South Rd
Penrose
Private Bag 92-522, Wellesley St
Auckland, 1061
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Ethics committee country [1]
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New Zealand
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Date submitted for ethics approval [1]
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14/10/2010
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Approval date [1]
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30/08/2011
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Ethics approval number [1]
259861
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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
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Trial website
www.nihi.auckland.ac.nz
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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.
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Public notes
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Contacts
Principal investigator
Name
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Prof Chris Bullen
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Address
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NIHI, Auckland University, Private Bag 92019, Auckland Mail Centre, Auckland 1142
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Country
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New Zealand
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Phone
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+6493737599
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Prof Chris Bullen
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Address
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NIHI, Auckland University, Private Bag 92019, Auckland Mail Centre, Auckland 1142
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Country
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New Zealand
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Phone
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+64 9 923 4765
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Fax
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+64 9 373 1710
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Email
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[email protected]
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Contact person for scientific queries
Name
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Prof Chris Bullen
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Address
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NIHI, Auckland University, Private Bag 92019, Auckland Mail Centre, Auckland 1142
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Country
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New Zealand
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Phone
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+64 9 923 4730
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Fax
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+64 9 373 1710
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Email
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[email protected]
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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
Source
Title
Year of Publication
DOI
Embase
E-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.
2015
https://dx.doi.org/10.1186/s12971-015-0030-2
N.B. These documents automatically identified may not have been verified by the study sponsor.
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