Cigarette Smoking, Nicotine Vaping
Conditions
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.
Interventions
BEHAVIORALPromotion 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.
BEHAVIORALMitigation strategies
Penalties: Penalties will be presented as a 60% chance of getting caught making illegal purchases. The consequences of illegal purchases include not receiving any study products from the ETM if they were caught and randomly drew that trial.
Sponsors
Virginia Polytechnic Institute and State University
Medical University of South Carolina
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Budget Spent on Illegal Cigarettes Across Policy Conditions | 1 day | The study has 4 policy conditions with combinations of promotion strategy (VLNC standard) and mitigation strategy (penalties), and each combination: No Policy, Penalty only, VLNC only, and Penalty + VLNC. The average percentage of the budget spent on illegal cigarettes across all trials was calculated for each policy scenario. |
| Percent Budget Spent on Legal Cigarettes Across Policy Conditions | 1 day | The study has 4 policy conditions with combinations of promotion strategy (VLNC standard) and mitigation strategy (penalties), and each combination: No Policy, Penalty only, VLNC only, and Penalty + VLNC. The average percentage of the budget spent on legal cigarettes across all trials was calculated for each policy scenario. |
| Percent Budget Spent on E-cigarettes Across Policy Conditions | 1 day | The study has 4 policy conditions with combinations of promotion strategy (VLNC standard) and mitigation strategy (penalties), and each combination: No Policy, Penalty only, VLNC only, and Penalty + VLNC. The average percentage of the budget spent on e-cigarettes across all trials was calculated for each policy scenario. |
| Percent Budget Spent on Nicotine Replacement Therapy Across Policy Conditions | 1 day | The study has 4 policy conditions with combinations of promotion strategy (VLNC standard) and mitigation strategy (penalties), and each combination: No Policy, Penalty only, VLNC only, and Penalty + VLNC. The average percentage of the budget spent on nicotine replacement theray across all trials was calculated for each policy scenario. |
| Percent Budget Spent on Oral Nicotine/Tobacco Across Policy Conditions | 1 day | The study has 4 policy conditions with combinations of promotion strategy (VLNC standard) and mitigation strategy (penalties), and each combination: No Policy, Penalty only, VLNC only, and Penalty + VLNC. The average percentage of the budget spent on oral nicotine/tobacco across all trials was calculated for each policy scenario. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORRoberta Freitas-Lemos, Ph.D.
Fralin Biomedical Research Institute at Virginia Tech Carilion
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 44.74 years STANDARD_DEVIATION 9.02 |
| Education < 12 years | 6 Participants |
| Education 12 years | 16 Participants |
| Education 13-15 years | 25 Participants |
| Education 16+ years | 6 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 52 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| ETM Budget | 62.3 dollars per week STANDARD_DEVIATION 26.6 |
| Heavines of Vaping Index (HVI) | 2.56 units on a scale STANDARD_DEVIATION 2.29 |
| Heaviness of Smoking Index (HSI) | 3.81 units on a scale STANDARD_DEVIATION 2.56 |
| Household Income $100,000-$154,999 | 2 Participants |
| Household Income $20,000-$39,999 | 4 Participants |
| Household Income $40,000-$64,999 | 3 Participants |
| Household Income $65,000-$99,999 | 0 Participants |
| Household Income Greater than $155,000 | 0 Participants |
| Household Income Less than $19,000 | 18 Participants |
| Intention to quit cigarettes | 6.00 units on a scale STANDARD_DEVIATION 1.41 |
| Intention to quit e-cigarettes | 2.24 units on a scale STANDARD_DEVIATION 2.54 |
| Questionairre on Smoking Urges (QSU)- brief Cigarettes | 49.18 units on a scale STANDARD_DEVIATION 14.87 |
| Questionairre on Smoking Urges (QSU)- brief E-cigarettes | 17.22 units on a scale STANDARD_DEVIATION 12.58 |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 13 Participants |
| Race (NIH/OMB) More than one race | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 18 Participants |
| Sex: Female, Male Female | 30 Participants |
| Sex: Female, Male Male | 11 Participants |
| Timeline Follow Back (TLFB)- Cigarettes | 18.83 cigarettes per day STANDARD_DEVIATION 4.26 |
| Timeline Follow Back (TLFB)- E-cigarettes | 0.00 mL per day STANDARD_DEVIATION 0.01 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 27 | 0 / 26 |
| other Total, other adverse events | 0 / 27 | 0 / 26 |
| serious Total, serious adverse events | 0 / 27 | 0 / 26 |
Outcome results
None listed