An interventional study of Promotion factors and Mitigation strategies in Cigarette Smoking and Nicotine Vaping, sponsored by Virginia Polytechnic Institute and State University. Completed at 1 site in United States. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2026-02-10.
Sponsored by Virginia Polytechnic Institute and State University · Not applicable, Interventional, and Basic science
This study will investigate the effects of promotion factors and mitigation strategies on legal and illegal tobacco purchases for different tobacco-user types.
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.
114 studies on the registry are indexed under Cigarette Smoking; 59 are open to participants now.
This study's enrollment of 65 is below the median of 100 across 101 interventional studies indexed under Cigarette Smoking.
Browse Cigarette Smoking studies →Virginia Polytechnic Institute and State University is the lead sponsor of 124 studies on the registry; 27 are open to participants now.
Counted across the registry records on this site, refreshed daily.
For exclusive cigarette smokers:
Exclusion criteria:
Exclusive cigarette smokers will be recruited and will be exposed to all of the conditions described in the intervention section.
Behavioral: Promotion factors · Behavioral: Mitigation strategies
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
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.
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.
Percent Budget Spent on Illegal Cigarettes Across Policy Conditions
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.
Time frame: 1 day
Percent Budget Spent on Legal Cigarettes Across Policy Conditions
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.
Time frame: 1 day
Percent Budget Spent on E-cigarettes Across Policy Conditions
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.
Time frame: 1 day
Percent Budget Spent on Nicotine Replacement Therapy Across Policy Conditions
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.
Time frame: 1 day
Percent Budget Spent on Oral Nicotine/Tobacco Across Policy Conditions
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.
Time frame: 1 day
| Milestone | Experimental: Exclusive Cigarette Smokers | Experimental: Dual Cigarette/ Nicotine Vaping Product Users |
|---|---|---|
| Started | 33 | 32 |
| No policy | 27 | 26 |
| Penalty only | 31 | 29 |
| Vlnc only | 27 | 26 |
| Penalty + vlnc | 31 | 29 |
| Completed | 27 | 26 |
| Not completed | 6 | 6 |
| Withdrew: Lost to follow-up | 4 | 4 |
| Withdrew: Withdrawal by subject | 0 | 2 |
| Withdrew: Screen fail | 2 | 0 |
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.
| percentage of budget spent | Experimental: Exclusive Cigarette Smokers | Experimental: Dual Cigarette/ Nicotine Vaping Product Users |
|---|---|---|
| No Policy | 40.78 ± 4.04 | 38.41 ± 3.63 |
| Penalty only | 12.14 ± 2.66 | 9.64 ± 2.32 |
| VLNC only | 71.20 ± 3.42 | 65.18 ± 2.84 |
| Penalty + VLNC | 26.31 ± 3.47 | 20.94 ± 3.09 |
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.
| percentage of budget spent | Experimental: Exclusive Cigarette Smokers | Experimental: Dual Cigarette/ Nicotine Vaping Product Users |
|---|---|---|
| No Policy | 37.97 ± 3.73 | 29.72 ± 3.28 |
| Penalty only | 57.30 ± 3.59 | 47.73 ± 3.30 |
| VLNC only | 4.32 ± 1.31 | 0.89 ± 0.37 |
| Penalty + VLNC | 19.71 ± 2.84 | 9.69 ± 2.06 |
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.
| percentage of budget spent | Experimental: Exclusive Cigarette Smokers | Experimental: Dual Cigarette/ Nicotine Vaping Product Users |
|---|---|---|
| No Policy | 10.01 ± 1.48 | 23.06 ± 2.27 |
| Penalty only | 20.16 ± 2.56 | 27.15 ± 2.41 |
| VLNC only | 11.49 ± 1.71 | 24.06 ± 2.39 |
| Penalty + VLNC | 37.63 ± 3.12 | 46.51 ± 3.16 |
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.
| percentage of budget spent | Experimental: Exclusive Cigarette Smokers | Experimental: Dual Cigarette/ Nicotine Vaping Product Users |
|---|---|---|
| No Policy | 2.00 ± 0.44 | 3.67 ± 0.86 |
| Penalty only | 3.11 ± 0.70 | 4.56 ± 0.91 |
| VLNC only | 3.46 ± 0.94 | 4.38 ± 1.10 |
| Penalty + VLNC | 8.71 ± 1.41 | 6.89 ± 1.08 |
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.
| percentage of budget spent | Experimental: Exclusive Cigarette Smokers | Experimental: Dual Cigarette/ Nicotine Vaping Product Users |
|---|---|---|
| No Policy | 0.85 ± 0.40 | 0.12 ± 0.05 |
| Penalty only | 0.69 ± 0.32 | 0.89 ± 0.63 |
| VLNC only | 1.08 ± 0.50 | 0.21 ± 0.09 |
| Penalty + VLNC | 0.71 ± 0.31 | 0.37 ± 0.11 |
Collected over 9 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Experimental: Exclusive Cigarette Smokers | 0/27 (0%) | 0/27 (0%) | 0/27 (0%) |
| Experimental: Dual Cigarette/ Nicotine Vaping Product Users | 0/26 (0%) | 0/26 (0%) | 0/26 (0%) |
| Age, Continuous(years) | Experimental: Exclusive Cigarette Smokers | Experimental: Dual Cigarette/ Nicotine Vaping Product Users | Total |
|---|---|---|---|
| Mean | 44.74 ± 9.02 | 43.15 ± 8.04 | 43.94 ± 8.53 |
| Sex: Female, Male(Participants) | Experimental: Exclusive Cigarette Smokers | Experimental: Dual Cigarette/ Nicotine Vaping Product Users | Total |
|---|---|---|---|
| Female | 16 | 14 | 30 |
| Male | 11 | 12 | 23 |
| Ethnicity (NIH/OMB)(Participants) | Experimental: Exclusive Cigarette Smokers | Experimental: Dual Cigarette/ Nicotine Vaping Product Users | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 1 | 1 |
| Not Hispanic or Latino | 27 | 25 | 52 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Experimental: Exclusive Cigarette Smokers | Experimental: Dual Cigarette/ Nicotine Vaping Product Users | Total |
|---|---|---|---|
| American Indian or Alaska Native | 1 | 0 | 1 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 6 | 7 | 13 |
| White | 18 | 18 | 36 |
| More than one race | 2 | 1 | 3 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Household Income(Participants) | Experimental: Exclusive Cigarette Smokers | Experimental: Dual Cigarette/ Nicotine Vaping Product Users | Total |
|---|---|---|---|
| Less than $19,000 | 18 | 18 | 36 |
| $20,000-$39,999 | 4 | 5 | 9 |
| $40,000-$64,999 | 1 | 3 | 4 |
| $65,000-$99,999 | 2 | 0 | 2 |
| $100,000-$154,999 | 2 | 0 | 2 |
| Greater than $155,000 | 0 | 0 | 0 |
| Education(Participants) | Experimental: Exclusive Cigarette Smokers | Experimental: Dual Cigarette/ Nicotine Vaping Product Users | Total |
|---|---|---|---|
| < 12 years | 4 | 2 | 6 |
| 12 years | 8 | 8 | 16 |
| 13-15 years | 12 | 13 | 25 |
| 16+ years | 3 | 3 | 6 |
| Timeline Follow Back (TLFB)- Cigarettes(cigarettes per day) | Experimental: Exclusive Cigarette Smokers | Experimental: Dual Cigarette/ Nicotine Vaping Product Users | Total |
|---|---|---|---|
| Mean | 19.95 ± 7.77 | 17.71 ± 0.76 | 18.83 ± 4.26 |
| ETM Budget(dollars per week) | Experimental: Exclusive Cigarette Smokers | Experimental: Dual Cigarette/ Nicotine Vaping Product Users | Total |
|---|---|---|---|
| Mean | 53.10 ± 25.0 | 71.5 ± 28.2 | 62.3 ± 26.6 |
6 further baseline measures are reported on the registry.
Documents are hosted by the registry — open the source record to download them.
Plan to share: No — The study team will share de-identified data upon request.
This study is completed, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
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Virginia Polytechnic Institute and State University