Clinical Research Directory

Acute Effects of Oral Nicotine Pouches

The present human laboratory study will recruit cigarette smokers (n=60) and adult infrequent nicotine users (n=60) to complete two counterbalanced lab sessions in which the participants use nicotine pouches under controlled conditions. The investigators are recruiting both frequent and infrequent nicotine users because FDA regulates tobacco products based on a public health standard, meaning FDA must consider the impact a regulation may have on the population as a whole (e.g., people who use and do not use tobacco products currently).

Effects of Nicotine Pouch Characteristics on Perceptions and Behavior

There is a growing sector of modern tobacco-free oral nicotine pouches that are federally regulated as non-medicinal nicotine/tobacco products. While nicotine pouches employ marketing approaches that may attract current tobacco users, such as marketing themes connoting minimal harm, information on the long-term health effects of nicotine pouches is lacking. nicotine pouches may appeal to younger adults because they are available in similar product characteristics (e.g., nicotine concentration, protonated nicotine) that many younger people prefer to use in e-cigarettes. In addition, nicotine pouches may be of particular interest to younger adult e-cigarette users because these products can be used discreetly where vaping is not allowed, which may translate into an increased likelihood of becoming dual users of e-cigarettes and nicotine pouches. Indeed, approximately 15% young adults who used e-cigarettes in the past 30 days were past 30-day nicotine pouch users. Manufacturers of modern nicotine pouches use acid additives to lower pH, which changes nicotine from a free-base to a protonated nicotine, resulting in improved appeal and sensory experience and higher abuse liability. Thus, nicotine concentration and pH in modern nicotine pouches should be focal targets for regulatory policies. Evidence is also lacking on mechanisms mediating differences in product appeal and abuse liability of nicotine pouches across products varying in nicotine concentration and pH level. The scientific objective of this research is to assess the effect of variation in nicotine concentration in nicotine pouches and its interaction effect with pH level on the proximal outcomes of relevance to the U.S. Food and Drug Administration regulation: sensory attributes and product appeal among younger adults who use nicotine pouches in the past 30 days (current dual users of nicotine pouches and e-cigarettes and/or combustible cigarettes will be eligible) and are unmotivated to quit nicotine use. This innovative project proposes to conduct a double-blind within-subject randomized study in which participants (N = 72) will administer nicotine pouches varied by nicotine concentration (e.g., 3 vs 6 mg) and pH (e.g., 8.5 or greater vs. less than 8.5) to achieve the project aim: to evaluate the effects of nicotine concentration and pH on subjective product appeal and sensory attributes of nicotine pouches. The findings of this proposed research will provide the U.S. Food and Drug Administration with new evidence necessary to inform regulatory restrictions on product characteristics and constituents of nicotine pouches, which may put young adults at risk of using a novel class of oral nicotine products.