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Trial registered on ANZCTR


Registration number
ACTRN12617001324303
Ethics application status
Approved
Date submitted
30/08/2017
Date registered
15/09/2017
Date last updated
30/09/2020
Date data sharing statement initially provided
8/04/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Vaporised nicotine products versus oral forms of nicotine replacement therapy (NRT) products for tobacco smoking cessation among low-socioeconomic status (low-SES) smokers
Scientific title
Vaporised nicotine products versus oral forms of nicotine replacement therapy (NRT) products for tobacco smoking cessation among low-socioeconomic status (low-SES) smokers
Secondary ID [1] 292781 0
nil known
Universal Trial Number (UTN)
U1111-1201-4903
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Smoking 304581 0
Condition category
Condition code
Mental Health 303914 303914 0 0
Addiction
Public Health 303915 303915 0 0
Other public health

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Vaporised nicotine product (VNP) containing e-liquid nicotine (18mg/ml nicotine) for 8 weeks plus Quitline behavioural support.
The VNP used is the Innokin Endura T18 Personal Vaporizer, which has a refill-able 2.5ml tank for the e-liquid. The e-liquid will be provided in 10ml dropper bottles with childproof caps and three flavours will be offered to participants tobacco (containing nicotine (18mg/ml), vegetable glycerol (25mg/ml), propylene glycol (73mg/ml) and flavouring (1mg/ml)), strawberry (containing nicotine (18mg/ml), vegetable glycerol (33mg/ml), propylene glycol (71mg/ml) and flavouring (0.6mg/ml)) and menthol (containing nicotine (18mg/ml), vegetable glycerol (23mg/ml), propylene glycol (71mg/ml) and flavouring (2mg/ml)). Participants are permitted to use the study product ad libitum throughout the day and encouraged to stop smoking completely, or reduce smoking if unable to stop completely. Participants will be provided with detailed instructions on how to use the e-cigarette device effectively.
Adherence will be monitored via weekly text message surveys and in check-in calls 2 weeks and 6 weeks into the treatment period. These check in calls will also assess smoking status, short term outcomes, and adverse events at these time points.
Intervention code [1] 299016 0
Treatment: Drugs
Intervention code [2] 299017 0
Treatment: Devices
Intervention code [3] 299021 0
Behaviour
Comparator / control treatment
Oral nicotine replacement therapy (NRT) (2mg or 4mg nicotine gum/lozenge) for 8 weeks plus Quitline behavioural support..
For the oral NRT, participants can choose gum or lozenge, and will be allocated to 2mg or 4mg depending on heaviness of smoking: 2 mg are suitable for smokers with a low nicotine dependency e.g those smoking their first cigarette of the day more than 30 minutes after waking up, or those who smoke fewer than 20 cigarettes per day). Those receiving the lozenge will be instructed to use 9-15 lozenges per day, approximately one every 2 hours or when they have an urge to smoke. Those receiving the gum will be instructed to use 10 to 20 pieces per day for the 2mg gum and 4 to 10 pieces per day for the 4mg gum, approximately one every 2 hours or when they have an urge to smoke. Participants will be provided with detailed instructions on how to use the NRT effectively and encouraged to to stop smoking completely, or reduce smoking if unable to stop completely.
Adherence will be monitored via weekly text message surveys and in check-in calls 2 weeks and 6 weeks into the treatment period. These check in calls will also assess smoking status, short term outcomes, and adverse events at these time points.
Control group
Active

Outcomes
Primary outcome [1] 303249 0
Carbon monoxide verified six-month continuous abstinence (smoking not more than five cigarettes) from the quit date
Timepoint [1] 303249 0
8 month follow-up from baseline
Secondary outcome [1] 338355 0
Self-reported 7-day point prevalence abstinence at each follow-up (self-report of having smoked no cigarettes [not even a puff])
Timepoint [1] 338355 0
2 week and 6 week check-in calls and 8-month follow-up
Secondary outcome [2] 338357 0
Self-reported continuous abstinence: defined as self-report of smoking not more than five cigarettes from the designated quit date
Timepoint [2] 338357 0
2 week and 6 week check-in calls and 8-month follow-up
Secondary outcome [3] 338358 0
Self-reported number of cigarettes smoked per day among continuing smokers
Timepoint [3] 338358 0
2 week and 6 week check-in calls and 8-month follow-up
Secondary outcome [4] 338642 0
Self-reported 30-day point prevalence abstinence at each follow-up (self-report of having smoked no cigarettes [not even a puff])
Timepoint [4] 338642 0
2 week and 6 week check-in calls and 8-month follow-up
Secondary outcome [5] 338643 0
Mean reduction in number of cigarettes smoked per day based on participant self-report
Timepoint [5] 338643 0
2 week and 6 week check-in calls and 8-month follow-up
Secondary outcome [6] 338644 0
Proportion of participants that achieved a 50% reduction of baseline cigarette consumption based on participant self-report
Timepoint [6] 338644 0
8-month follow-up
Secondary outcome [7] 338645 0
Self-reported continued use of nicotine products to assess maintenance use and dual use
Timepoint [7] 338645 0
8-month follow-up

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 (NRT/VNP); speak English; able to provide verbal informed consent; receipt of government pension or allowance (proxy for low-SES); have a phone we contact them on; and willing to complete two telephone check-in calls and baseline and follow-up telephone interviews. The term “current smoker” in this trial will refer to those who use either factory-made or roll-own cigarettes.
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 12 months will be excluded from this trial, as will current users of smoking cessation medications (i.e., NRT, buproprion [Zyban], clonidine, nortriptyline, electronic nicotine cigarettes ), or those who are participating in another smoking cessation program or study. People will also be excluded if they report any of the following medical conditions in the previous three months: serious chronic lung diseases, arrhythmia, heart attack, stroke, or severe angina.

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)
Allocation will be completed by an external contract research organisation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Immediately after baseline data collection, all eligible participants will be randomised (block randomisation with unequal block sizes of 12 and 16) to either of the treatment arms in 1:1 ratio.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
The trial will be single-blinded. The person collecting outcome data and the trial statistician will be blinded until database is locked and the primary analysis completed. The participants and the administrative staff who perform day to day activities cannot be blinded due to the nature of the study and dissimilarities between treatment arms (i.e. treatment type and dosage form).
Phase
Phase 3 / Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
To replicate a changing VNP market this trial will now be withdrawn and a new trial commenced owing to additional changes to standard care provision and other changes owing to COVID-19 required.
Date of first participant enrolment
Anticipated
30/04/2019
Actual
Date of last participant enrolment
Anticipated
30/10/2020
Actual
Date of last data collection
Anticipated
30/07/2021
Actual
Sample size
Target
868
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 297412 0
Government body
Name [1] 297412 0
National Health and Medical Research Centre
Country [1] 297412 0
Australia
Primary sponsor type
University
Name
University of New South Wales
Address
UNSW Sydney, NSW 2052
Australia
Country
Australia
Secondary sponsor category [1] 296403 0
None
Name [1] 296403 0
NA
Address [1] 296403 0
NA
Country [1] 296403 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298516 0
UNSW HREC
Ethics committee address [1] 298516 0
Ethics committee country [1] 298516 0
Australia
Date submitted for ethics approval [1] 298516 0
30/09/2017
Approval date [1] 298516 0
23/11/2017
Ethics approval number [1] 298516 0
HC17909

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 77330 0
Dr Ryan Courtney
Address 77330 0
National Drug and Alcohol Research Centre
The University of New South Wales
Sydney NSW 2052 Australia
Country 77330 0
Australia
Phone 77330 0
+61 02 9065 7655
Fax 77330 0
Email 77330 0
r.courtney@unsw.edu,au
Contact person for public queries
Name 77331 0
Alexandra Aiken
Address 77331 0
National Drug and Alcohol Research Centre
The University of New South Wales
Sydney NSW 2052 Australia
Country 77331 0
Australia
Phone 77331 0
+612 9385 0111
Fax 77331 0
Email 77331 0
a.aiken@unsw.edu.au
Contact person for scientific queries
Name 77332 0
Alexandra Aiken
Address 77332 0
National Drug and Alcohol Research Centre
The University of New South Wales
Sydney NSW 2052 Australia
Country 77332 0
Australia
Phone 77332 0
+612 9385 0111
Fax 77332 0
Email 77332 0
a.aiken@unsw.edu.au

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


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
No additional documents have been identified.