Promotion and Mitigation Factors Leading to Illegal Tobacco Purchases

Cigarette Smoking Clinical Trial

Official title:

Promotion and Mitigation Factors Leading to Illegal Tobacco Purchases

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06001840
• Other study ID #: 5P01CA200512
• Status: Recruiting
• Phase: N/A
• Start date: January 4, 2024
• Est. completion date: July 30, 2024

Study information

• Verified date: January 2024
• Source: Virginia Polytechnic Institute and State University
• Contact: Daniel Cabral, Ph.D.
• Phone: 540-526-2136
• Email: danielcabral[@]vtc.vt.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: July 30, 2024
• Est. primary completion date: July 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cigarette Smoking

Intervention

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.
• 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).

Locations

Country	Name	City	State
United States	Fralin Biomedical Research Institute at VTC	Roanoke	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
Virginia Polytechnic Institute and State University	Medical University of South Carolina

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion spent in each marketplace (Legal and Illegal)		1 day