Comparison of Demand and Substitution for Nicotine Pouches as a Function of Nicotine Dosage

William Middleton

Status: Completed

Conditions: Nicotine Pouch Self-Administration; Tobacco Use

Treatments: Other: Nicotine Pouch Dosage

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07213947

5U54DA058256-02 (U.S. NIH Grant/Contract)

2372

Details and patient eligibility

About

Smoking is a prominent public health issue. Traditional nicotine replacement therapy suffers from being a poor substitute for cigarettes. Novel tobacco products, such as nicotine pouches, show promise as potential low-harm substitutes. Investigators wish to assess the substitutability of cigarettes for nicotine pouches at different dosages and price points. This study will consist of 4000 screened participants online on the crowdsourcing software Prolific, with roughly 400 eligible participants. This study will include the use of an electronic tobacco marketplace.

Full description

Participants will be recruited using the crowdsourcing platform Prolific. Prolific has been used by investigators in the past to rapidly recruit a large number of participants. Prolific is powerful due to its ability to sample for specific participant characteristics, such as rurality, while limiting the number of participants who can falsely qualify for the study. This study will screen 4000 tobacco users. Of these we expect to consent 400 nicotine pouch users to the main study. We will then identify their relative rurality through the index of relative rurality.

All potential participants will complete a series of demographic questions related to tobacco use, exposure to tobacco marketing, behavioral factors, and rurality, which will act as predictors of susceptibility to nicotine pouch initiation. All participants' Zip-code will be sampled and transformed into Index of Relative Rurality scores to assess rurality continuously. Data for nicotine pouch users will be assessed using multivariable regression-based analysis with interactions to determine which factors influence susceptibility to products other than nicotine pouches, and the effect of index of relative rurality on the relationship between predictors and initiation. Nicotine pouch users will continue on to an experimental tobacco marketplace (ETM) that will assess their valuation of nicotine pouches against other tobacco products, which will serve as a proxy to their likelihood to switch from nicotine pouches when the cost required to obtain nicotine pouches increases. Participants will complete 8 scenarios with escalating prices for nicotine pouches. Participants will be exposed to a virtual store and prompted to purchase as many tobacco products as they wish with an unlimited budget for their weekly supply of tobacco products. After making a set of purchases, participants will continue on to a subsequent marketplace where the price of their preferred product is increased. The degree to which participants purchase other tobacco products as nicotine pouch price increases will constitute demand. Demand will be analyzed using multilevel modeling methods to produce relevant demand indices. Participants will then have to complete 5 marketplaces of 8 price conditions. In each marketplace, the nicotine dosage of nicotine pouches will be randomly assigned to either 0 milligrams, 2 milligrams, 4 milligrams, 6 milligrams, or 8 milligrams.

Enrollment: 1,360 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• tobacco users will be eligible for a general screener
• nicotine pouch users will be eligible for the full marketplace study
• users of the crowdsourcing website Prolific

Exclusion criteria

• non nicotine pouch user
• <18+ years old

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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1,360 participants in 1 patient group

Nicotine pouch purchase

Experimental group

Description:

All participants will be experimentally manipulated by randomizing the dosage of nicotine pouches across varying pricing conditions.

Treatment:

Other: Nicotine Pouch Dosage