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Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
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Trial registered on ANZCTR
Registration number
ACTRN12625000179437
Ethics application status
Approved
Date submitted
18/12/2024
Date registered
14/02/2025
Date last updated
29/08/2025
Date data sharing statement initially provided
14/02/2025
Type of registration
Prospectively registered
Titles & IDs
Public title
Puff vs Pill: Break the Habit Study: Effect of Nicotine Vaping Products vs Varenicline on Smoking Cessation Among People Experiencing Social Disadvantage.
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Scientific title
Effect of Nicotine Vaping Product vs Varenicline on Smoking Cessation Among People Experiencing Social Disadvantage: A Randomised Controlled Trial
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Secondary ID [1]
313197
0
Nil known
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Universal Trial Number (UTN)
U1111-1257-3906
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Trial acronym
BHS - Break the Habit Study
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Tobacco Smoking
335469
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Condition category
Condition code
Public Health
332030
332030
0
0
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Health service research
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Mental Health
332031
332031
0
0
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Addiction
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Nicotine vaping products (NVPs) in the form of two “pod” devices either prefilled [alt.] and refillable [VAPO Rift Pro] with nicotine salt e-liquids containing nicotine (4%;40mg/ml) in tobacco or mint flavours for 12 weeks. For each device a USB charger and wall adapter will be provided. Participants will be provided with detailed instructions on how to use the vaping products, along with a wallet card and fridge magnet with product use and safety information for quick access. Participants are advised to use the study product ad libitum throughout the day to either mitigate or satiate the urge to smoke tobacco products. They are encouraged to stop using the devices once they no longer feel the urge to smoke.
The alt. device has replaceable pre-filled 2ml pods that contain 40mg/ml nicotine salt e-liquid in either tobacco or mint flavour. The VAPO Rift Pro device has a refillable 2ml pod and is supplied alongside 40mg/ml nicotine salt e-liquid (provided in 30ml bottles) in tobacco and mint flavours.
NVPs will be delivered to participants in two mailed deliveries. Both deliveries will be sent by a central pharmacy directly to participants. The first delivery (“Initiation Pack”) will be provided after the baseline interview. Participants will receive both prefilled (alt.) and refillable (VAPO Rift Pro) devices in mint and tobacco flavours as part of the initiation packs, as well as nicotine liquid in two flavours (tobacco, and mint) for both.
The second delivery (“Continuation Pack”) is optional, and will be available after the first check-in call, 2-4 weeks after baseline, up until the 12-month follow-up interview. Participants will have the choice of selecting either or both e-liquids, and in any combination of flavours, for the alt. and VAPO Rift Pro device respectively, plus 1 spare device. Participants who do not complete their first check-in call or are not using the study products at the time of the first check-in call, will receive a letter in place of the study products instructing them to call the study toll free number if they change their mind and wish to continue using the study products
The ingredients for tobacco and mint e-liquids are the same for both the alt and VAPO Rift Pro device, and include tobacco and mint flavouring respectively, as well as glycerol, propylene glycol, and nicotine (as benzoate).
Adherence will be monitored via two check-in calls, check-in call 1 and 2, occurring between 2-4 weeks and 8-10 weeks respectively.
After participants have received both study packs, they will also receive an email explaining to them how they can access further supply of vaping products outside of the study.
Follow ups will occur with the participant at 4 months and 12 months post-baseline. The former will be an online survey and the latter a telephone interview. They will measure participant’s adherence to the treatment and the additional behavioural support.
Participants are also provided 12-week text message behavioural quit support with the option to opt-out at any stage if desired. As part of the text message support program, participants will receive a mix of quit smoking support text messages with content including information on how to use the study products, coping with nicotine withdrawal symptoms, study progress s, and motivational ‘feel good’ messages. A mix of text, emojis, and links to resources such as videos, websites, and Graphics Interchange Format (GIF) images, will be used throughout the text program to promote engagement with the program.
The text message program has been developed based on similar programs used in two prior smoking cessation studies (Trial Id: ACTRN12621000076875, n = 1058 and (Trial Id: ACTRN12622000820707, n = 1246).
The development of the original program (Trial Id: ACTRN12621000076875) was informed by the World Health Organization’s (WHO) Be He@lthy, Be Mobile handbook (World Health Organization, 2015). This handbook outlines key considerations for implementing large-scale tobacco cessation messaging programs and guided the development of the text message support framework. An expert advisory group (clinical trialists, smoking cessation specialists and text messaging specialists) further refined the program and ensured both general quit support provision and also dedicated content was provided which was treatment-specific (i.e. text message support regarding use of allocated treatment group e.g. either nicotine replacement therapy of nicotine vaping products), The text program also provided support regarding strategies for managing nicotine withdrawal and side effects, study progress s, goal setting, relapse prevention, and motivational messages.
This original program was then adapted for a subsequent trial of a more tailored and longer text message program intervention (Trial Id: ACTRN12622000820707) and the current study. In the current study, the program was adjusted to include varenicline-specific messages for this treatment arm, as well as adjusted program length/text frequency. These amendments were made through consultation with the Trial Steering Committee and a Community and Consumer Advisory Committee (CCAC) (comprising current/ex-smokers from previous studies). The Trial Steering Committee reviewed the messaging to maintain consistency across treatment groups and enhance participant comprehension. The Community and Consumer Advisory Committee provided valuable insights and feedback that helped refine language, optimize message timing, and ensure messages were practical and supportive. Final content was endorsed by all CCAC members.
In summary, the current text message program is the result of iterative development, empirical testing, and extensive stakeholder consultation across multiple studies and advisory committees.
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Intervention code [1]
329773
0
Treatment: Devices
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Intervention code [2]
329774
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Behaviour
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Comparator / control treatment
Participants allocated to the varenicline group will be provided with varenicline tablets for up to 12 weeks. Dosage will be in accordance with the product information. For the first week the dosing schedule comprises the following:
• Days 1-3: one white 0.5mg tablet once a day
• Days 4-7: one white 0.5mg tablet twice daily (morning and night)
• Day 8 – end of treatment: one blue 1mg tablet twice a day (morning and night)
Treatments will be mailed to participants by a central pharmacy. The study products will be posted to participants on two occasions akin to the intervention schedule. The first delivery (Initiation Pack) will be mailed after the baseline interview and the second delivery (Continuation Pack) is optional and can be requested and sent between the completion of the first check-in call (2 to 4 weeks post-baseline interview) and the 12-month follow-up interview.
The Initiation Pack will include 11 x 0.5 mg tablets that will be sufficient supply for 7 days, and 42 x 1mg tablets (total of 53 tablets) which is sufficient for a further 21 days. The Continuation Pack will consist of 112 x 1 mg tablets (sufficient for 56 days). After receiving both packs, the participants will receive an email detailing how to obtain further supply outside of the study products.
Check-in calls, interviews, and surveys, as well as the 12-week text message program will be identical to the intervention group (except in that questions, information, and help will be regarding varenicline as opposed to NVPs)
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Control group
Active
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Outcomes
Primary outcome [1]
340186
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Carbon monoxide (CO) verified 6-month continuous abstinence at 12-month follow-up. Continuous 6- month abstinence will be defined as having remained quit for 6 months with the additional criterion of no slip-ups (not even a puff), and a CO level of less-than-or-equal-to 5 parts per million (ppm) in expired breath.
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Assessment method [1]
340186
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Only participants self-reporting continuous abstinence from smoking tobacco at final follow-up will be biochemically verified. Depending on the participants indicated preference, the CO breath test will be self- administered using a hand-held Bedfont iCO Smokerlyzer® (using provided instructions), or administered by a trained researcher using a hand-held Micro+™ Smokerlyzer® with a disposable, one-use mouthpiece. Both devices are non-invasive and require the participant to blow air into the device to measure their CO level. An exhaled CO level of less-than-or-equal-to 5 parts per million will be considered abstinent.
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Timepoint [1]
340186
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The breath test will take place shortly after the final follow up interview (if the participant meets the criterion of continuous abstinence) that will occur at 12 months after the baseline interview completion date.
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Secondary outcome [1]
443217
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Self-reported continuous abstinence for 6 months: defined as self-report of not smoking (not even a puff) for at least six months preceding final follow up at 12 months.
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Assessment method [1]
443217
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Self-reported by the participant collected during the final follow up at twelve month during telephone interview.
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Timepoint [1]
443217
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The final follow-up interview will occur 12 months after the baseline interview completion date.
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Secondary outcome [2]
443218
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Self-reported 7-day point prevalence abstinence: defined as self-report of having smoked no cigarettes (not even a puff) in the past 7 days.
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Assessment method [2]
443218
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This outcome is based on a standard criteria for measuring smoking cessation treatments, known as the Russell Standard, and also in conjunction with Society for Research on Nicotine and Tobacco (SRNT) guidance on outcome ascertainment and measurement for smoking cessation. The Russell Standard consists of six criteria, one of which is self-reported smoking abstinence over a specified period. "Point-prevalence abstinence" refers to smoking abstinence measured at a particular timepoint in a study. In this study, consistent with the above criteria point prevalence is measures over a 7- day period and measured at different points including Check-in Call 1, Check-in Call 2, 4 Month Follow Up, and 12 Month Follow Up. 7-day point-prevalence abstinence is defined as self-report of no cigarette use (not even a puff) in the past seven days. Citation: - West, R., Hajek, P., Stead, L., & Stapleton, J. (2005). Outcome criteria in smoking cessation trials: proposal for a common standard. Addiction (Abingdon, England), 100(3), 299–303. https://doi.org/10.1111/j.1360-0443.2004.00995.x - Piper, M. E., Bullen, C., Krishnan-Sarin, S., Rigotti, N. A., Steinberg, M. L., Streck, J. M., & Joseph, A. M. (2020). Defining and Measuring Abstinence in Clinical Trials of Smoking Cessation Interventions: An Updated Review. Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco, 22(7), 1098–1106. https://doi.org/10.1093/ntr/ntz110
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Timepoint [2]
443218
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4 timepoints: Check-in call 1 (2-4 weeks); check-in call 2 (8-10 weeks); 4-month follow-up survey and the final 12-month follow-up interview.
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Secondary outcome [3]
443219
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Change in number of cigarettes smoked from baseline to final follow up at 12 months.
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Assessment method [3]
443219
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Number of cigarettes smoked per day; change and proportion of participants that achieved greater-than-or-equal-to 50% reduction of baseline cigarette consumption at twelve-month follow-up telephone interview.
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Timepoint [3]
443219
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The final follow-up interview will occur 12 months after the baseline interview completion date.
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Secondary outcome [4]
443220
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Use of varenicline or NVP at final follow up
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Assessment method [4]
443220
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The questions adopted to assess NVP or varenicline use at final follow-up are study- specific questions that are not derived from validated scales as we are assessing study-specific products.
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Timepoint [4]
443220
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The final follow-up interview will occur 12 months after the baseline interview completion date.
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Secondary outcome [5]
443221
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Other health resource use: including hospital in- and out-patient visits, GP visits, pharmaceutical co- payments, home and continuing care (if any), and over the counter (OTC) medication use.
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Assessment method [5]
443221
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Measured by responses about use of other non-study quit support products, services or resources/support (e.g. counselling); collected during the baseline telephone interview and also involves (consented) provision of Medicare Benefits Schedule (MBS) and/or Pharmaceutical Benefits Scheme (PBS) claims information by the Services Australia. MBS data will provide item-by-item data on Medicare funded GP visits and other MBS services used, date of use and co-payment required. PBS data will provide item-by-item data on the prescriptions filled, the associated co-payments for each prescription and the date the prescription was filled. The questions adopted to assess other health resource use (including hospital in- and out-patient visits, GP visits, pharmaceutical co-payments, home and continuing care (if any), and over the counter (OTC) medication use), are study-specific questions that are not derived from validated scales as we are assessing study- specific products.
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Timepoint [5]
443221
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The questions on the access to different services are collected during the baseline interview and the PBS and MBS data will be provided to the study team by Services Australia.
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Secondary outcome [6]
443223
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The proportion of self-reported AEs and SAEs will be compared across the varenicline and NVP groups.
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Assessment method [6]
443223
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In this trial an adverse event will include any illness, sign, symptom, or clinically significant abnormality that has appeared or worsened during the course of the clinical trial, regardless of its causal relationship to the treatment(s) under evaluation. All AEs will be carefully evaluated and tabulated using both patients preferred terms and MedDRA (Medical Dictionary for Regulatory Activities) coding. The severity will be assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (grade 1 – Mild AE, grade 2 – moderate AE, grade 3 – severe AE, grade 4 – life-threatening or disabling AE and grade 5 – death related to AE). Causality will be assessed using WHO criteria for causality assessment (certain, probable/likely, possible, unlikely, conditional/unclassified and un- assessable/unclassifiable). All SAEs will be assessed and reported to the sponsor and HREC in accordance with the trial protocol and the “National Health and Medical Research Council. Guidance: Safety monitoring and reporting in clinical trials involving therapeutic goods.”
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Timepoint [6]
443223
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3 timepoints: Check-in call 1 will occur between 2-4 weeks; check-in call 2 will occur between 8-10 weeks; and the final follow-up interview will occur 12 months after the baseline interview completion date.
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Secondary outcome [7]
443224
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Change in self-reported respiratory symptoms.
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Assessment method [7]
443224
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Lower respiratory tract infections-Visual analogue scale (LRTI-VAS) collected during telephone interviews and online surveys.
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Timepoint [7]
443224
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4 timepoints: Check-in call 1 will occur between 2-4 weeks; check-in call 2 will occur between 8-10 weeks; 4 month follow-up; and the final follow-up interview will occur 12 months after the baseline interview completion date.
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Secondary outcome [8]
443225
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Participants’ treatment adherence and compliance measured by responses about their quit-attempt and study product use/adherence.
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Assessment method [8]
443225
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This is measured using study-specific questionnaires that are not derived from validated scales as we are assessing study-specific products. This will be collected during telephone interviews and online surveys.
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Timepoint [8]
443225
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4 timepoints: Check-in call 1 will occur between 2-4 weeks; check-in call 2 will occur between 8-10 weeks; 4 month follow-up; and the final follow-up interview will occur 12 months after the baseline interview completion date.
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Secondary outcome [9]
444683
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Change in self-reported respiratory symptoms.
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Assessment method [9]
444683
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Modified Medical Research Council (MRC) dyspnoea scale collected during telephone interviews and online surveys.
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Timepoint [9]
444683
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4 timepoints: Check-in call 1 will occur between 2-4 weeks; check-in call 2 will occur between 8-10 weeks; 4 month follow-up; and the final follow-up interview will occur 12 months after the baseline interview completion date.
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Eligibility
Key inclusion criteria
Participants can be included if they meet the following criteria:
1. Aged 18 years or older;
2. Receiving a government pension, support, or allowance (proxy for low-SES)*;
3. Person who currently smokes tobacco cigarettes daily and wanting to quit tobacco cigarettes smoking;
4. Willing to use varenicline or NVPs in next quit attempt;
5. Willing to make a quit attempt on designated quit day (~8-14 days post-randomisation);
6. Own a mobile phone that can receive and send text messages;
7. Agree to receive text message behavioural quit support;
8. Willing to complete telephone interviews for baseline, check-in calls and 12-month follow-up a 4- month online survey, and a potential post 12-month breath test;
9. Available for follow-up over a 12-month period;
10. Willing to allow research team to share the collected contact details for the purpose of:
-The Study Physician to make contact if more information about health status is required;
-Staff from central pharmacy (Chemist Warehouse, Virginia, QLD) mailing out the study
products;
11. Able to understand and communicate in English;
12. Able to provide informed consent.
*Low-SES is a diverse construct, and receipt of a pension or allowance will be used as a proxy for low-SES and marker for social disadvantage in this trial, as recipients must satisfy a government’s means-test which considers both an individual's and their partner's income and assets, where approval is only granted if both are below a specified threshold.
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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
• Pregnant, breast-feeding, or planning pregnancy in the next 12 months;
• Current participation in another quit smoking program or study, or previously enrolled in this study;
• Current use*** of any quit smoking medications or products (i.e., NRT, bupropion [Zyban], varenicline [Varenapix], cytisine, NVPs/ e-cigarettes containing nicotine, nicotine inhalers or any other quit smoking medications or products)***;
• Allergies or hypersensitivity to either varenicline or nicotine-containing e-liquids, or any excipients;
• End stage or severe renal diseased;****
• Deemed medically unfit, by the Study Physician, to participate at the time of screening.
***Current use will be defined as use of product on the same day as screening.
****Exclusion criterion specific to varenicline.
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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)
The database system (REDCap) will assign participants treatment groups using a computer pre-generated randomisation list embedded in the system. To conceal the allocation list from those at the Trial Coordinating Center, an independent statistician will have access to the pre-generated randomisation list and will upload this to REDCap.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Following baseline CATI completion, REDCap will randomly assign each participant to one of the treatment groups in a 1:1 ratio. The permuted block randomisation will use unequal block sizes of 4 and 8.
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
Safety/efficacy
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Statistical methods / analysis
Analysis will be pre-specified. Baseline characteristics of the varenicline and NVP groups will be presented using frequency and percentages for categorical variables and means/standard deviations or medians/interquartile ranges for continuous measures. A Bayesian beta-binomial posterior distribution for the quit proportions will be constructed for the varenicline and NVP groups separately and one million random draws from each posterior distribution will be taken. Superiority of NVPs over varenicline will be established if the posterior probability of quitting in the NVP arm is greater than corresponding posterior probability in the varenicline arm in 97.5% of random draws. A non-informative beta prior will be used for the primary analysis, but sensitivity analyses will use informative beta priors based on the most recently published Cochrane review data for varenicline and NVPs. A similar Bayesian analysis will be conducted for the proportions of SAEs and AEs in each study arm. 95% credible intervals (CrIs) will be reported for abstinence rates in each arm and for the difference in quit proportions.
The primary effectiveness outcome for this study will use the Russell Standard criteria. Primary analysis will be conducted considering individuals with missing smoking status at follow-up as treatment failures. Sensitivity analyses will involve: (1) using multiple imputation to account for missing data; (2) excluding participants with missing data; and (3) excluding participants with protocol deviations. Secondary cessation outcomes of all time points will be modelled using generalized linear mixed models, which include time as a fixed effect and a random intercept to adjust for correlation of observations among individuals over time. Further details of all statistical analyses will be included in the statistical analysis plan (SAP).
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
1/09/2025
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Actual
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Date of last participant enrolment
Anticipated
1/09/2026
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Actual
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Date of last data collection
Anticipated
1/09/2027
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Actual
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Sample size
Target
872
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment postcode(s) [1]
44625
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2031 - Randwick
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Funding & Sponsors
Funding source category [1]
317632
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Government body
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Name [1]
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NHMRC Clinical Trials and Cohort Studies
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Address [1]
317632
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Country [1]
317632
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Australia
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Primary sponsor type
University
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Name
UNSW
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Address
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
319943
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Address [1]
319943
0
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Country [1]
319943
0
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
316331
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The University of New South Wales Research Ethics Committee A
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Ethics committee address [1]
316331
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https://research.unsw.edu.au/research-ethics-and-compliance-support-recs
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Ethics committee country [1]
316331
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Australia
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Date submitted for ethics approval [1]
316331
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22/12/2023
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Approval date [1]
316331
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11/04/2024
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Ethics approval number [1]
316331
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iRECS4324
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Ethics committee name [2]
317014
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Aboriginal Health & Medical Research Council Ethics Committee
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Ethics committee address [2]
317014
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https://www.ahmrc.org.au/ethics-at-ahmrc/
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Ethics committee country [2]
317014
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Australia
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Date submitted for ethics approval [2]
317014
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17/09/2024
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Approval date [2]
317014
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19/12/2024
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Ethics approval number [2]
317014
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2339-24
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Summary
Brief summary
This clinical trial will evaluate the effectiveness, safety and cost-effectiveness of NVPs compared to the pharmacotherapy, varenicline, for smoking cessation among people experiencing social disadvantage. The trial is a two-group superiority randomised controlled trial (RCT) that compares smoking rates between two groups of 436 low-socioeconomic status smokers (N = 872), randomly allocated to either: 1) standard varenicline treatment; or 2) NVPs treatment. Both groups will be provided text message behavioural support. This work is of national and international significance as it will provide much-needed data on the effectiveness, safety and cost-effectiveness of latest generation vaping products at achieving smoking cessation amongst a priority population. This will directly address peak health bodies’ calls for high quality large-scale RCT evidence and contribute significantly to existing knowledge in this research area. Furthermore, the outcomes of this study will help guide government and policy decision-making in the future.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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A/Prof Ryan Courtney
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Address
137550
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National Drug and Alcohol Research Centre, The University of New South Wales, Sydney NSW 2052
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Country
137550
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Australia
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Phone
137550
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+61 02 9065 7655
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Fax
137550
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Email
137550
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[email protected]
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Contact person for public queries
Name
137551
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Ryan Courtney
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Address
137551
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National Drug and Alcohol Research Centre, The University of New South Wales, Sydney NSW 2052
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Country
137551
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Australia
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Phone
137551
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+61 02 9065 7655
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Fax
137551
0
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Email
137551
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[email protected]
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Contact person for scientific queries
Name
137552
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Ryan Courtney
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Address
137552
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National Drug and Alcohol Research Centre, The University of New South Wales, Sydney NSW 2052
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Country
137552
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Australia
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Phone
137552
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+61 02 9065 7655
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Fax
137552
0
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Email
137552
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[email protected]
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Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
•
Only bona fide research groups will be eligible to access data. Data access requests will be made via an application form detailing the specific requirements and the proposed research and publication plan. Data access requests will be reviewed against specific eligibility criteria by data custodians. Participants will consent for their anonymised data to be used in this way.
Conditions for requesting access:
•
-
What individual participant data might be shared?
•
We plan to share fully anonymised individual participant data (IPD). All de-identified data of primary and secondary outcomes will be shared, excluding identifiable personal information (i.e., address details, contact information/details) and any relevant SAE/AE information.
What types of analyses could be done with individual participant data?
•
Each application will be reviewed based on scientific quality and robustness of the proposed statistical analysis plan. Data request will be appraised by the Principal Investigator and wider Trial Steering Committee on a case-by-case basis with oversight of the Study Statistician.
When can requests for individual participant data be made (start and end dates)?
From:
Following publication, no end date
To:
-
Where can requests to access individual participant data be made, or data be obtained directly?
•
Access subject to approvals by Principal Investigator (
[email protected]
) and following approval will be sent via secure file transfer.
Are there extra considerations when requesting access to individual participant data?
No
What supporting documents are/will be available?
No Supporting Document Provided
Type
Citation
Link
Email
Other Details
Attachment
Study protocol
The Study Protocol will be submitted to a peer rev...
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Results publications and other study-related documents
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