Exploring the cessation efficacy and harm reduction potential of heated tobacco and nicotine pouch products in smokers and smokeless tobacco users: study protocol of a 6-month randomized controlled switching trial


  • Nikola Pluym ABF Analytisch-Biologisches Forschungslabor GmbH, Semmelweisstr 5, Planegg, Germany https://orcid.org/0000-0003-4954-591X
  • Therese Burkhardt ABF Analytisch-Biologisches Forschungslabor GmbH, Semmelweisstr 5, Planegg, Germany
  • Max Scherer ABF Analytisch-Biologisches Forschungslabor GmbH, Semmelweisstr 5, Planegg, Germany




Smoking cessation, Cessation efficacy, Compliance, Harm reduction, Heated tobacco product, Nicotine pouch


Background: Despite decades of research on pharmacological and behavioural smoking cessation treatments, current quit aids are of limited success. The introduction of new, combustion-free nicotine and tobacco products extended the tool kit for people who smoke to switch away from their risky habit. We performed a systematic review including 120 studies resulting in several recommendations for a robust study design to determine the cessation efficacy of a new nicotine or tobacco product. Consequently, we prepared this study protocol to assess the cessation efficacy of heated tobacco products (HTPs) and nicotine pouches (NPs).

Methods: 250 subjects (125 exclusive smokers and 125 exclusive smokeless tobacco (SLT) users) will be recruited and offered a choice of HTPs in case of smokers and a choice of NPs in case of SLT users in order to switch. Subjects will undergo four visits (baseline, 1, 3, and 6 months) to collect biospecimens and for physical examinations. Use behaviour and questionnaires will be monitored on a regular basis by means of a smartphone-app. We describe a sensitive and specific compliance monitoring using suitable biomarkers of exposure. The sample size of 250 subjects and duration of 6 months will allow the quit rates to be assessed with sufficient statistical power. Finally, the choice between different products shall reflect the individuals’ preferences.

Conclusions: This protocol can be applied generically, providing a robust determination of a products’ cessation efficacy.

Trial Registration: The trial will be registered in the International Clinical Trials Registry Platform.


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