NCT06988371

Brief Summary

The goal of this project is to learn about the potential impact of tobacco regulations that could affect the availability of tobacco products among adults who smoke nondaily and daily. Nondaily smoking is increasingly common and tobacco regulation research should consider how FDA actions may impact this group. Participants will be asked to complete online surveys and tests, online shopping sessions in a simulated Experimental Tobacco Marketplace. Reactions and decisions of adults who smoke nondaily and daily will be compared.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
695

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2025

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 29, 2025

Completed
24 days until next milestone

First Posted

Study publicly available on registry

May 23, 2025

Completed
3 months until next milestone

Study Start

First participant enrolled

August 18, 2025

Completed
11 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 29, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 29, 2025

Completed
Last Updated

October 14, 2025

Status Verified

October 1, 2025

Enrollment Period

11 days

First QC Date

April 29, 2025

Last Update Submit

October 9, 2025

Conditions

Keywords

tobaccocigarettesnondaily smokingbehavioral economics

Outcome Measures

Primary Outcomes (2)

  • Aggregate behavioral economic demand across all participants under the proposed regulatory environments

    Participants will complete trials of the Experimental Tobacco Marketplace wherein the price of a target commodity will be increased. Nonlinear mixed effects modeling will be used to fit a curve to estimate the number of products purchased at each price and the analysis will result in an measure of overall price sensitivity under each of the regulatory conditions.

    Baseline

  • Aggregate behavioral economic substitution across all participants under the proposed regulatory environments

    Participants will complete trials of the Experimental Tobacco Marketplace wherein the price of alternative products will be fixed across trials and their usual product will change price. Mixed effects modeling will be used to fit a curve to estimate the slopes and intercepts of these alternative products, revealing the degree to which participants will choose to purchase each alternative product as the price of the participant's usual product increases.

    Baseline

Secondary Outcomes (2)

  • Hypothetical quantity purchased in purchase tasks

    Baseline

  • Delay Discounting Tasks

    Baseline

Study Arms (2)

Daily smoking

EXPERIMENTAL

Participants who smoke cigarettes every day

Behavioral: Reduced nicotine regulatory environmentBehavioral: Restriction on characterizing flavors in combustible nicotine productsBehavioral: Restriction on characterizing flavors in noncombustible nicotine products

Nondaily smoking

EXPERIMENTAL

Participants who smoke cigarettes some days but not every day in a month

Behavioral: Reduced nicotine regulatory environmentBehavioral: Restriction on characterizing flavors in combustible nicotine productsBehavioral: Restriction on characterizing flavors in noncombustible nicotine products

Interventions

In this regulatory environment, participants' usual combustible cigarette will not be available in the Experimental Tobacco Marketplace and reduced nicotine content cigarettes will be the only available combustible cigarette.

Daily smokingNondaily smoking

In this regulatory environment, menthol and other characterizing flavors in combustible nicotine products will not be available in the Experimental Tobacco Marketplace. Tobacco- or no-flavored combustible nicotine products will be the only combustible nicotine products available.

Daily smokingNondaily smoking

In this regulatory environment, menthol and other characterizing flavors in noncombustible nicotine products will not be available in the Experimental Tobacco Marketplace. Tobacco- or no-flavored noncombustible nicotine products will be the only noncombustible nicotine products available.

Daily smokingNondaily smoking

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • At least 18 years old
  • Consume cigarettes 4-30 days per month
  • Have no plans to quit nicotine/tobacco products
  • Read and understand English

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Kentucky

Lexington, Kentucky, 40504, United States

Location

MeSH Terms

Conditions

Tobacco Use

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Bethany Shorey Fennell, PhD

    University of Kentucky

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Mixed crossover-factorial
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

April 29, 2025

First Posted

May 23, 2025

Study Start

August 18, 2025

Primary Completion

August 29, 2025

Study Completion

August 29, 2025

Last Updated

October 14, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

Only deidentified data will be shared.

Locations