Promotion and Mitigation Factors Leading to Illegal Tobacco Purchases

Sponsor

Virginia Polytechnic Institute and State University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06001840

Collaborator

Medical University of South Carolina (Other)

Enrollment

Location

Arms

10.9

Anticipated Duration (Months)

5.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study will investigate the effects of promotion factors and mitigation strategies on legal and illegal tobacco purchases for different tobacco-user types.

Condition or Disease	Intervention/Treatment	Phase
Cigarette Smoking Nicotine Vaping	Behavioral: Promotion factors Behavioral: Mitigation strategies	N/A

Detailed Description

In the present study, we propose to examine some promotion factors and mitigation strategies and how they impact tobacco product legal and illegal purchases. Specifically, we have developed an Illegal Experimental Tobacco Marketplace (iETM). The iETM permits us to identify the number, type, and characteristics of tobacco users who would seek illegal tobacco products and the conditions that would induce them to seek that option. The critical questions we seek to answer are whether changes in product standards and availability will engender illegal tobacco purchasing as a function of tobacco user type (e.g., exclusive combustible product users, and dual cigarette/NVP users). Understanding the user types and the relevant conditions will inform greater tailoring of policy to diminish consumer interest in an illegal market.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention Model Description:

We will examine two promotion policies. In the full nicotine conditions, participants' preferred cigarettes and NVP products will be available in the LETM and preferred cigarettes will be available in the iETM. In the low nicotine conditions, a ban will permit only very-low nicotine cigarettes (VLNCs) in the LETM and preferred cigarettes will be available in the iETM. Additionally, we will model three mitigation strategies that may reduce iETM purchases: health communications, availability of nicotine replacement, and penalties. The three mitigation factors will be applied during both promotion policies described above.We will examine two promotion policies. In the full nicotine conditions, participants' preferred cigarettes and NVP products will be available in the LETM and preferred cigarettes will be available in the iETM. In the low nicotine conditions, a ban will permit only very-low nicotine cigarettes (VLNCs) in the LETM and preferred cigarettes will be available in the iETM. Additionally, we will model three mitigation strategies that may reduce iETM purchases: health communications, availability of nicotine replacement, and penalties. The three mitigation factors will be applied during both promotion policies described above.

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

Promotion and Mitigation Factors Leading to Illegal Tobacco Purchases

Anticipated Study Start Date :

Sep 1, 2023

Anticipated Primary Completion Date :

Jul 30, 2024

Anticipated Study Completion Date :

Jul 30, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Experimental: Exclusive cigarette smokers Exclusive cigarette smokers will be recruited and will be exposed to all of the conditions described in the intervention section.	Behavioral: Promotion factors In the full nicotine conditions, participants' preferred cigarettes and NVP products will be available in the LETM and preferred cigarettes will be available in the iETM. In the low nicotine conditions, a ban will permit only VLNCs in the LETM and preferred cigarettes will be available in the iETM. Behavioral: Mitigation strategies Health Communications. The first narrative describes a person unknown to the participant who purchases from the illegal market and experiences negative life outcomes (e.g., ill health from contaminants). The second narrative incorporates cognitive biases of social proof (i.e., portraying a choice as the opinion of the majority). Availability of Nicotine Replacement Therapies (NRT): Transdermal NRT will be available in the LETM at two different prices. In one condition, transdermal NRT will be available at a 50% subsidy in the form of coupons. In the other condition, a five-day supply of NRT will be available for free. Penalties: Penalties will be presented in different fine magnitudes along with a description of the consequences of illegal purchases (i.e., a criminal record).
Experimental: Experimental: Dual cigarette/ nicotine vaping product users Dual cigarette and nicotine vaping product users will be recruited and will be exposed to all of the conditions described in the intervention section	Behavioral: Promotion factors In the full nicotine conditions, participants' preferred cigarettes and NVP products will be available in the LETM and preferred cigarettes will be available in the iETM. In the low nicotine conditions, a ban will permit only VLNCs in the LETM and preferred cigarettes will be available in the iETM. Behavioral: Mitigation strategies Health Communications. The first narrative describes a person unknown to the participant who purchases from the illegal market and experiences negative life outcomes (e.g., ill health from contaminants). The second narrative incorporates cognitive biases of social proof (i.e., portraying a choice as the opinion of the majority). Availability of Nicotine Replacement Therapies (NRT): Transdermal NRT will be available in the LETM at two different prices. In one condition, transdermal NRT will be available at a 50% subsidy in the form of coupons. In the other condition, a five-day supply of NRT will be available for free. Penalties: Penalties will be presented in different fine magnitudes along with a description of the consequences of illegal purchases (i.e., a criminal record).

Arm

Intervention/Treatment

Experimental: Experimental: Exclusive cigarette smokers

Exclusive cigarette smokers will be recruited and will be exposed to all of the conditions described in the intervention section.

Behavioral: Promotion factors

In the full nicotine conditions, participants' preferred cigarettes and NVP products will be available in the LETM and preferred cigarettes will be available in the iETM. In the low nicotine conditions, a ban will permit only VLNCs in the LETM and preferred cigarettes will be available in the iETM.

Behavioral: Mitigation strategies

Health Communications. The first narrative describes a person unknown to the participant who purchases from the illegal market and experiences negative life outcomes (e.g., ill health from contaminants). The second narrative incorporates cognitive biases of social proof (i.e., portraying a choice as the opinion of the majority). Availability of Nicotine Replacement Therapies (NRT): Transdermal NRT will be available in the LETM at two different prices. In one condition, transdermal NRT will be available at a 50% subsidy in the form of coupons. In the other condition, a five-day supply of NRT will be available for free. Penalties: Penalties will be presented in different fine magnitudes along with a description of the consequences of illegal purchases (i.e., a criminal record).

Experimental: Experimental: Dual cigarette/ nicotine vaping product users

Dual cigarette and nicotine vaping product users will be recruited and will be exposed to all of the conditions described in the intervention section

Behavioral: Promotion factors

Behavioral: Mitigation strategies

Outcome Measures

Primary Outcome Measures

Proportion spent in each marketplace (Legal and Illegal) [1 day]

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Provide informed consent
Be at least 21 years of age or older
Provide a breath sample for measuring carbon monoxide (CO ≥ 8 ppm)
Stable tobacco use patterns for at least two months

For exclusive cigarette smokers:

Smoke at least 10 cigarettes daily and do not use NVPs regularly (no more than 9 times in the last month).
For dual cigarette/NVP users:
Smoke at least 10 cigarettes daily and use NVPs at least 3 times in a week (report use of closed nicotine salt system)

Exclusion criteria:

Have plans to move out of the area
Have a serious or unstable physical or mental health condition
Taking a tobacco cessation medication or medication that interferes with nicotine metabolism, motivation or reinforcement
Report concrete, immediate plans to alter/quit using their usual nicotine products at the beginning of the study
Being pregnant or lactating

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Fralin Biomedical Research Institute at VTC	Roanoke	Virginia	United States	24016

Sponsors and Collaborators

Virginia Polytechnic Institute and State University
Medical University of South Carolina

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Virginia Polytechnic Institute and State University

ClinicalTrials.gov Identifier:

NCT06001840

Other Study ID Numbers:

5P01CA200512

First Posted:

Aug 21, 2023

Last Update Posted:

Aug 21, 2023

Last Verified:

Aug 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Aug 21, 2023