TY - JOUR
T1 - Effectiveness, safety and cost-effectiveness of vaporized nicotine products versus nicotine replacement therapy for tobacco smoking cessation in a low-socioeconomic status Australian population: a study protocol for a randomized controlled trial
AU - Howard, Bridget C.
AU - McRobbie, Hayden
AU - Petrie, Dennis
AU - Barker, Daniel
AU - Mendelsohn, Colin
AU - Anderson, Jack
AU - Borland, Ron
AU - Naughton, Felix
AU - Tutka, Piotr
AU - Zwar, Nick
AU - Boland, Veronica C.
AU - Aiken, Alexandra
AU - Shakeshaft, Anthony
AU - Gartner, Coral
AU - Richmond, Robyn L.
AU - Hall, Wayne
AU - Mattick, Richard P.
AU - Farrell, Michael
AU - Courtney, Ryan J.
N1 - Funding Information:
The research is funded by an Australian National Health and Medical Research Council (NHMRC) grant (APP1127390). The National Drug and Alcohol Research Centre at the University of New South Wales is supported by funding from the Australian Government under the Substance Misuse Prevention and Service Improvements Grants Fund. Senior author, Dr Ryan Courtney is supported by a NHMRC Career Development Fellowship (1148497). All study medications were purchased by the research team. The funder played no part in study design; collection, management, analysis, and interpretation of data; writing of the report; and the decision to submit the report for publication.
Funding Information:
We would like to thank our stakeholders, the Social Research Centre for conducting baseline and follow-up interviews (CRO), Genesis Research Services for storing and dispensing medications, vendors for providing VNPs and NRT, and Dr Ava Lam (our study physician). We would also like to thank the DSMC members: Dr Alix Hall, Dr Benjamin Kwan and Dr Natasha Weaver. We would also like to thank all research staff at the TCC for their work on the project. The outcomes of the study will be published in a peer-reviewed scientific journal. Authorship will be based on contribution to study design, management, data analysis and write-up. The trial will be conducted in accordance with the protocol. Any modifications to the protocol require approval from the Human Research Ethics Committee prior to implementation. All protocol amendments are recorded and communicated to relevant parties. All participants provide informed consent to take part in the trial. The consent form can be completed online or as a hard-copy version sent via post. Participants are provided with a verbal explanation (during screening telephone call) of the consent form by trained research staff at the TCC. The consent form has an optional section for consent to use of participant data in future studies. The confidentiality and privacy of participants is maintained in all trial procedures and publications. De-identifiable group data will be presented in scientific journals and at research conferences. Data will be collected and stored electronically on a password-protected database at the CRO and TCC. Re-identifiable information is stored using a unique identification number and is stored separately from study records.
Publisher Copyright:
© 2022, The Author(s).
PY - 2022/12
Y1 - 2022/12
N2 - Background: In Australia, tobacco smoking rates have declined but inequalities remain with significantly higher smoking prevalence among low-socioeconomic populations. Clinical trial data suggest vaporized nicotine products (VNPs) aid smoking cessation. Most VNP trials have used refillable tank systems, but newer generation (pod) devices now comprise the largest market share yet have limited clinical trial evidence on safety and effectiveness. This study evaluates the effectiveness, safety and cost-effectiveness of VNPs (pod and tank device) compared with nicotine replacement therapy ([NRT]—gum or lozenge) for smoking cessation. Methods: This is a two-arm, open-label, superiority, parallel group, randomized controlled trial (RCT) with allocation concealment and blinded outcome assessment. The RCT is conducted at the National Drug and Alcohol Research Centre at the University of New South Wales, Sydney, Australia. Participants are people who smoke daily, are interested in quitting and receive a government pension or allowance (N = 1058). Participants will be randomized (1:1 ratio) to receive 8 weeks of free: VNPs, with pod (40 mg/mL nicotine salt) and tank device (18 mg/mL freebase nicotine) in mixed flavours; or NRT (gum or lozenge; 4 mg). All participants will receive daily text message behavioural support for 5 weeks. Assessments will be undertaken by telephone at baseline, with three follow-up calls (two check-in calls within the first month and final follow-up at 7 months post randomization) to ascertain smoking status, treatment adherence and adverse events. The primary outcome is 6-month continuous abstinence verified by carbon monoxide breath test of ≤5ppm at 7-month follow-up. Safety and cost-effectiveness of VNPs versus NRT will also be evaluated. Discussion: Further data are required to strengthen certainty of evidence for VNPs aiding smoking cessation, particularly for newer generation pod devices. To our knowledge, this trial is the first to offer choice of VNPs and no comparative effectiveness trial data exists for new pod devices. If effective, the findings can inform wider implementation of VNPs to aid smoking cessation in a priority group. Trial registration: Australian New Zealand Clinical Trials Registry ACTRN12621000076875. Registered on 29 January 2021. https://www.anzctr.org.au.
AB - Background: In Australia, tobacco smoking rates have declined but inequalities remain with significantly higher smoking prevalence among low-socioeconomic populations. Clinical trial data suggest vaporized nicotine products (VNPs) aid smoking cessation. Most VNP trials have used refillable tank systems, but newer generation (pod) devices now comprise the largest market share yet have limited clinical trial evidence on safety and effectiveness. This study evaluates the effectiveness, safety and cost-effectiveness of VNPs (pod and tank device) compared with nicotine replacement therapy ([NRT]—gum or lozenge) for smoking cessation. Methods: This is a two-arm, open-label, superiority, parallel group, randomized controlled trial (RCT) with allocation concealment and blinded outcome assessment. The RCT is conducted at the National Drug and Alcohol Research Centre at the University of New South Wales, Sydney, Australia. Participants are people who smoke daily, are interested in quitting and receive a government pension or allowance (N = 1058). Participants will be randomized (1:1 ratio) to receive 8 weeks of free: VNPs, with pod (40 mg/mL nicotine salt) and tank device (18 mg/mL freebase nicotine) in mixed flavours; or NRT (gum or lozenge; 4 mg). All participants will receive daily text message behavioural support for 5 weeks. Assessments will be undertaken by telephone at baseline, with three follow-up calls (two check-in calls within the first month and final follow-up at 7 months post randomization) to ascertain smoking status, treatment adherence and adverse events. The primary outcome is 6-month continuous abstinence verified by carbon monoxide breath test of ≤5ppm at 7-month follow-up. Safety and cost-effectiveness of VNPs versus NRT will also be evaluated. Discussion: Further data are required to strengthen certainty of evidence for VNPs aiding smoking cessation, particularly for newer generation pod devices. To our knowledge, this trial is the first to offer choice of VNPs and no comparative effectiveness trial data exists for new pod devices. If effective, the findings can inform wider implementation of VNPs to aid smoking cessation in a priority group. Trial registration: Australian New Zealand Clinical Trials Registry ACTRN12621000076875. Registered on 29 January 2021. https://www.anzctr.org.au.
UR - http://www.scopus.com/inward/record.url?scp=85138445712&partnerID=8YFLogxK
U2 - 10.1186/s13063-022-06644-8
DO - 10.1186/s13063-022-06644-8
M3 - Article
C2 - 36104702
AN - SCOPUS:85138445712
SN - 1745-6215
VL - 23
JO - Trials
JF - Trials
IS - 1
M1 - 777
ER -