Promotion and Mitigation Factors Leading to Illegal Tobacco Purchases

Study Overview
=================
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.

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.

Official Title
-----------------
Promotion and Mitigation Factors Leading to Illegal Tobacco Purchases

Conditions
-----------------
Cigarette Smoking, Nicotine Vaping

Intervention / Treatment
-----------------
* Behavioral: Promotion factors
* Behavioral: Mitigation strategies


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 21 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental: Exclusive cigarette smokers<br>Exclusive cigarette smokers will be recruited and will be exposed to all of the conditions described in the intervention section. | Behavioral: Promotion factors<br>* 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.<br>Behavioral: Mitigation strategies<br>* 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).<br>|
| Experimental: Experimental: Dual cigarette/ nicotine vaping product users<br>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<br>* 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.<br>Behavioral: Mitigation strategies<br>* 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).<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion spent in each marketplace (Legal and Illegal) |  | 1 day |