A Double-Blind, Randomized, Controlled Phase III Trial Investigating Efficacy and Safety of Varenicline for Vaping Cessation in Adult Users

Abstract

Background: Vaping cessation is virtually unexplored. The efficacy and safety of varenicline for vaping cessation has not been studied and rigorous research is required to advance best practice and outcomes for e-cigarettes users who want to quit. Methods: Eligible patients were randomized to either varenicline (1 mg, administered twice daily for 12 weeks) or placebo treatment (administered twice daily, for 12 weeks) combined with vaping cessation counseling. The trial consisted of a 12-week treatment phase followed by a 12-week follow-up, nontreatment phase. The primary efficacy endpoint of the study was biochemically validated continuous abstinence rate (CAR) at weeks 4 to 12. Secondary efficacy end points were the CAR at weeks 4 to 24 and 7-day point prevalence of vaping abstinence at weeks 12 and 24. Results: CAR was significantly higher for varenicline vs placebo at each interval: weeks 4-12, 40.0% and 20.0%, respectively (OR = 2.67, 95% CI = [1.25 - 5.68], P = 0.011); weeks 4-24, 34.3% for varenicline and 17.2% for placebo (OR = 2.52, 95% CI = [1.14 - 5.58], P = 0.0224). The 7-day point prevalence of vaping abstinence was also higher for the varenicline than placebo at each time point. Serious adverse events were infrequent in both groups and not treatment-related. Conclusions: Inclusion of varenicline and counseling in a vaping cessation program for EC users intending to quit may result in prolonged abstinence. These positive findings may also help guiding future recommendations for vaping cessation by health authorities and healthcare providers.

Competing Interest Statement

RP has received grants from U-BIOPRED and AIRPROM, Integral Rheumatology & Immunology Specialists Network (IRIS), Foundation for a Smoke Free World, that is interested parties of PMI. Pfizer, GlaxoSmithKline, CV Therapeutics, NeuroSearch A/S, Sandoz, Merk Sharp & Dohme, Boehringer Ingelheim, Novartis, Arbi Group Srl., Duska Therapeutics, and Forest Laboratories. He is founder of the Center for Tobacco Prevention and Treatment (CPCT) at the University of Catania and of the Center of Excellence for the Acceleration of Harm Reduction at the same university. He receives consultancy fees from Pfizer, Boehringer Ingelheim, Duska Therapeutics, Forest Laboratories, CV Therapeutics, and Sermo Inc. He is being paid textbook royalties from Elsevier. He is also involved in a patent application for ECLAT Srl. He is an unpaid scientific advisor for Lega Italiana Anti Fumo (LIAF) and the International Network of Nicotine Consumers Organizations (INNCO); and he is Chair of the European Technical Committee for Standardization on Requirements and test methods for emissions of electronic cigarettes (CEN/TC 437; WG4). PC has been affiliated to the CoEHAR since December 2019 in a pro bono role. He is coauthor of a protocol paper supported by an Investigator-Initiated Study award program established by Philip Morris International in 2017. The other authors have no conflict of interests to declare. In the past three years, CR's organization, Russell Burnett Research & Consultancy Ltd, has received funding from e‑cigarette/tobacco product manufacturers to conduct behavioral research on population use, use intentions, and perceptions of e‑cigarettes/vaping products, and on the effects of e‑cigarette use/vaping on tobacco use transitions. JSA received sponsored funds for travel expenses as a speaker for the 2021 and 2022 annual GTNF conference. JSA serves as a consultant and has equity in Qnovia, a start-up company. All other authors have no conflict of interests to declare

Clinical Trial

EUDRACT ID: 2016-000339-42

Funding Statement

This investigator-initiated research is supported by grant WS53232647 from GRAND (Global Research Award for Nicotine Dependence), an independently reviewed competitive grants program funded by Pfizer Inc (USA). Editorial support for the editing of this manuscript was provided by Mike Coughlan with funding from ECLAT Srl. Support for open access was provided by Università degli Studi di Catania under the CRUI-CARE Agreement.

Author Declarations

I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.

Yes

The details of the IRB/oversight body that provided approval or exemption for the research described are given below:

The ethical review board of the leading site, Azienda Ospedaliero Universitaria Policlinico-Vittorio Emanuele, Università di Catania, reviewed and approved this RCT (approval reference number: n.88/2016/PO, 11/07/2016). All participants provided written informed consent. The study has been registered in EUDRACT with Trial registration ID: 2016-000339-42 (https://www.clinicaltrialsregister.eu/ctr-search/search?query=varevape).

I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals.

Yes

I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).

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I have followed all appropriate research reporting guidelines and uploaded the relevant EQUATOR Network research reporting checklist(s) and other pertinent material as supplementary files, if applicable.

Yes

Data Availability

All data produced in this work are contained in the manuscript

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