Testing the effects of nicotine concentration and nicotine source claims on oral nicotine pouch packaging engagement, self-reported perceptions and use intentions, and product trial in young adults and adults: Protocol for a randomized trial

BACKGROUND: Oral nicotine pouches (ONPs) are novel nicotine products and evidence on how features of ONP packaging affect product engagement, perceptions, use intentions, and behavior is limited. OBJECTIVES: We outline the protocol for a randomized trial examining how nicotine concentration and nicotine source claims affect engagement with ONP packaging using psychophysiological measures, self-reported ONP perceptions and use intentions, and ONP trial (ClinicalTrials.gov: NCT06192316). METHODS: Between 2024 and 2027, we will recruit 450 participants, comprised of: 150 young adults ages 18-24 who are susceptible but do not use tobacco; 150 young adults ages 18-24 who use tobacco; and 150 adults ages 25-65 who use tobacco. Participants complete procedures at an in-person laboratory visit. During the visit, participants complete pre-exposure self-report measures and are randomized between subjects to one of nine conditions in a 3 (Nicotine Concentration: None, Low, or High) x 3 (Nicotine Source Claim: None, Tobacco Free, or Synthetic) design. Within conditions, participants view 16 ONP pack images, in random order, reflecting different ONP brands and flavors. During exposure, we collect psychophysiological measures including heart rate, skin conductance, and visual attention. After exposure, participants complete self-report measures of ONP perceptions and use intentions, and a timed behavioral task where they are presented with ONP packages corresponding to their randomized condition and brands and flavors shown in the stimuli. Participants can try one of the products, and ONP trial is the behavioral outcome of interest. However, the packages do not contain ONPs; they contain commercially available pouches with food grade ingredients. At visit conclusion, participants are de-briefed and receive their incentive for participating. CONCLUSIONS: This project will generate evidence on the effects of nicotine concentration and source claims on ONP packaging in young adults who are not using but susceptible to tobacco, young adults using tobacco, and adults using tobacco to inform potential regulations.