ANZCTR - Registration

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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]

none

Universal Trial Number (UTN)

Trial acronym

ASCEND

Linked study record

Health condition

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

Smoking Cessation

Condition category

Condition code

Public Health

Epidemiology

Mental Health

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]

Treatment: Drugs

Intervention code [2]

Treatment: Other

Intervention code [3]

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]

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]

6 months post Quitday

Secondary outcome [1]

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]

One and three months

Secondary outcome [2]

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]

1 week, 1 month, 3 months and 6 months post Quitday

Secondary outcome [3]

Number of cigarettes smoked per day: If the participant is still smoking, all time points.

Timepoint [3]

1 week, 1 month, 3 months and 6 months post Quitday

Secondary outcome [4]

The physical signs and symptoms associated with withdrawal: Measured using the AUTOS.

Timepoint [4]

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?

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]

New Zealand

State/province [1]

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

Health Research Council NZ

Address [1]

PO BOX 5541
Wellesley Street
Auckland 1141

Country [1]

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]

University

Name [1]

National Institute for Health Innovation (NIHI)

Address [1]

University of Auckland, Private Bag 92019, Auckland Mail Centre, Auckland, 1142

Country [1]

New Zealand

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Northern X Regional Ethics Committee

Ethics committee address [1]

3rd floor, Unisys building
650 Great South Rd
Penrose
Private Bag 92-522, Wellesley St
Auckland, 1061

Ethics committee country [1]

New Zealand

Date submitted for ethics approval [1]

14/10/2010

Approval date [1]

30/08/2011

Ethics approval number [1]

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

Prof Chris Bullen

Address

NIHI, Auckland University, Private Bag 92019, Auckland Mail Centre, Auckland 1142

Country

New Zealand

Phone

+6493737599

Fax

c.bullen@auckland.ac.nz

Contact person for public queries

Name

Chris Bullen

Address

NIHI, Auckland University, Private Bag 92019, Auckland Mail Centre, Auckland 1142

Country

New Zealand

Phone

+64 9 923 4765

Fax

+64 9 373 1710

c.bullen@auckland.ac.nz

Contact person for scientific queries

Name

Chris Bullen

Address

NIHI, Auckland University, Private Bag 92019, Auckland Mail Centre, Auckland 1142

Country

New Zealand

Phone

+64 9 923 4730

Fax

+64 9 373 1710

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

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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Documents added manually

Documents added automatically