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

NCT ID: NCT07213947

Last Updated: 2025-11-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

4000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-30

Study Completion Date

2025-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Tobacco Use Nicotine Pouch Self-Administration

Keywords

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nicotine pouch behavioral economics substitution e-cigarettes nicotine concentration

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Individuals will be asked to purchase nicotine pouches across various prices. Nicotine pouch dosage will be randomly manipulated across pricing conditions. All participants will experience price and dosage changes, but in different orders.
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Nicotine pouch purchase

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

Group Type EXPERIMENTAL

Nicotine Pouch Dosage

Intervention Type OTHER

All participants will be experimentally manipulated by having nicotine dosage in hypothetical purchase tasks/ experimental marketplaces altered between market groups.

Interventions

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Nicotine Pouch Dosage

All participants will be experimentally manipulated by having nicotine dosage in hypothetical purchase tasks/ experimental marketplaces altered between market groups.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

William Middleton

OTHER

Sponsor Role lead

Responsible Party

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William Middleton

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Mikhail Koffarnus, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Kentucky

Locations

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University of Kentucky Turfland Medical Center, Department of Family and Community Medicine

Lexington, Kentucky, United States

Site Status

Countries

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United States

Central Contacts

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William A Middleton, PhD

Role: CONTACT

Phone: 4803041748

Email: [email protected]

Facility Contacts

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Mikhail Koffarnus Vice Chair for Research, PhD

Role: primary

Other Identifiers

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5U54DA058256-02

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2372

Identifier Type: -

Identifier Source: org_study_id