The National Institutes of Health has awarded a $3.8 million grant to UW-CTRI to see if nicotine pouches can replace smoking among participants in a randomized comparative effectiveness study.
“It’s a question of public health,” said Co-Principal Investigator and UW-CTRI Researcher Dr. Thomas Piasecki. “The toxic byproducts of tobacco combustion are responsible for a great deal of the health harms caused by smoking cigarettes. If people can switch from cigarettes to nicotine pouches, that would likely be a win for public health.”
Nicotine pouches—microfiber sachets containing powered nicotine but no tobacco leaf—are a new class of oral tobacco products rapidly growing in popularity. Popular brands include On!, Velo and Zyn.
“However, we currently know very little about how readily people who smoke will adopt nicotine pouches, how effectively pouches can substitute for cigarettes when participants are trying to avoid smoking, the importance of nicotine dose in effective cigarette substitution, and the mechanisms that may promote or hinder product transition,” Piasecki said.
To address these key gaps, researchers will enroll 284 adults who smoke daily and are not planning to quit in the next 30 days. Participants will be randomly assigned to one of four product conditions:
1) 3-mg nicotine pouches;
2) 6-mg nicotine pouches;
3) nicotine mini-lozenges (2- or 4-mg); or
4) no study product.
Participants receiving a study product (nicotine pouches or nicotine mini lozenges) will be asked to use them for four weeks, an initial experimentation week, and then for a three-week switching trial where they will be asked not to smoke their usual cigarettes and instructed instead to use their study product (if assigned one).
Before and after the switching trial, participants will come to the clinic following overnight abstinence and will use their assigned product (if any) during a 30-minute sampling test to assess the duration of product use, subjective evaluations of study products, and suppression of craving and withdrawal symptoms under controlled conditions.
During the four weeks of the study, participants will use a smartphone app to record, in real-time, each time they use cigarettes or a study product. For a random daily subset of use events, participants will answer additional questions about the context of their use (e.g., affect, any restrictions on smoking) and potential mechanisms driving use (e.g., withdrawal alleviation, satisfaction).
“This innovative, rigorous, and timely research will provide critical information regarding the potential impact of providing nicotine pouches on participants’ use of combusted cigarettes,” said Co-PI and Research Director Dr. Megan Piper, “as well as on whether the nicotine dose influences the ability of pouches to replace cigarette use. We’ll also examine whether pouches substitute for cigarettes more effectively than FDA-approved nicotine mini-lozenges. Finally, we’ll consider product usage patterns and effects that may promote or hinder cigarette substitution.”
These data could inform regulatory policy decisions regarding the potential public health impact of nicotine pouches.
The official study title is, A Randomized Comparative Effectiveness Trial of Nicotine Pouches for Cigarette Substitution: A Question of Public Health. It will be marketed as the Options 2 Study in spring 2025.