Cigarette Smoking, Nicotine Vaping
Conditions
Brief summary
This study will investigate the relative appeal (abuse liability) of novel tobacco products, how the appeal is modulated by relative price, user type, and how novel products may substitute for one another.
Detailed description
An important aim of tobacco control is to reduce demand for the most harmful products. Therefore, a priori knowledge of substitutability across novel and widely used tobacco products may forecast the impact of policies on product switching. This study will use a novel method, the Experimental Tobacco Marketplace (ETM), to characterize the relative substitutability and appeal (abuse liability) of tobacco products (e.g., conventional cigarettes, nicotine vaping products \[NVP\], heated tobacco products \[HTP\], and nicotine pouch products \[NPP\]), and how the appeal is modulated by relative price and user type. Exclusive cigarette smokers and dual cigarette/NVP users, stratified by age, will complete multiple scenarios in the ETM.
Interventions
Nicotine/tobacco products available in the Experimental Tobacco Marketplace at market price. Note that all participants will complete all the specified conditions.
Availability of nicotine vaping products in the Experimental Tobacco Marketplace at 1/2 market price. Other nicotine/tobacco products at market price. Note that all participants will complete all the specified conditions.
OTHERNicotine vaping products at 2x market price
Availability of nicotine vaping products in the Experimental Tobacco Marketplace at 2x market price. Other nicotine/tobacco products at market price. Note that all participants will complete all the specified conditions.
Availability of heated tobacco products in the Experimental Tobacco Marketplace at 1/2 market price. Other nicotine/tobacco products at market price. Note that all participants will complete all the specified conditions.
OTHERHeated tobacco products at 2x market price.
Availability of heated tobacco products in the Experimental Tobacco Marketplace at 2x market price. Other nicotine/tobacco products at market price. Note that all participants will complete all the specified conditions.
Availability of heated tobacco products in the Experimental Tobacco Marketplace at 1/2 market price. Other nicotine/tobacco products at market price. Note that all participants will complete all the specified conditions.
OTHERNicotine pouch products at 2x market price.
Availability of heated tobacco products in the Experimental Tobacco Marketplace at 2x market price. Other nicotine/tobacco products at market price. Note that all participants will complete all the specified conditions.
Sponsors
Medical University of South Carolina
National Cancer Institute (NCI)
Virginia Polytechnic Institute and State University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Intervention model description
Participants will complete seven Experimental Tobacco Marketplace conditions. Conventional cigarette price will be parametrically increased, and the purchasing of alternative products measured. Alternative products (i.e. nicotine vaping products, heated tobacco products and nicotine pouches) will be available at different prices in separate conditions (i.e., ½ market price, market price, and 2x market price).
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 three months * Be willing to sample NVPs, HTPs, and NPPs * 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 5 cigarettes daily and use NVPs for 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Nicotine/Tobacco Products Substitution | 1 day | Participants will complete purchasing trials in an Experimental Tobacco Marketplace (ETM) with cigarettes increasing in price. Other product prices in the ETM will depend on the experimental condition. The degree to which other nicotine/tobacco products substitute for conventional cigarettes as a function of novel product (e.g. nicotine vaping products, heated tobacco products, nicotine pouch products) prices will be assessed. To obtain estimates of substitution of price-constant products in the different ETM conditions, the investigators will use ordinary least squares regression to model the relationship of the price-manipulated product to predict total quantity purchased of the price-constant product. |
| Cigarette Demand | 1 day | Participants will complete purchasing trials in an Experimental Tobacco Marketplace (ETM) with cigarettes increasing in price. Other product prices in the ETM will depend on the experimental condition. The degree to which other nicotine/tobacco products substitute for conventional cigarettes as a function of novel product (e.g. nicotine vaping products, heated tobacco products, nicotine pouch products) prices will be assessed. To obtain dependent measures of demand, participants' purchasing of the price-manipulated commodity in the ETM task will be fit to a modified exponential equation to quantify the relationship between the price of each commodity and purchasing: Q=Q0\*10k(exp(-αQ0C)-1) where Q is purchasing of the commodity, C is the price, Q0 is the derived initial purchasing without cost constraints (demand intensity), k is the span of the function in logarithmic units, and α is the demand elasticity. |
Countries
United States
Participant flow
Pre-assignment details
Participants are assigned to exclusive smokers or dual cigarette/nicotine vaping product users groups based on the screening form.
Participants by arm
| Arm | Count |
|---|---|
| Exclusive Cigarette Smokers Exclusive smokers will be recruited and exposed to all conditions described in the intervention section.
All nicotine/ tobacco products at market price: Nicotine/tobacco products available in the Experimental Tobacco Marketplace (ETM) at market price.
Nicotine vaping products at 1/2 market price: Availability of nicotine vaping products in the ETM at 1/2 market price. Other nicotine/tobacco products at market price.
Nicotine vaping products at 2x market price: Availability of nicotine vaping products in the ETM at 2x market price. Other nicotine/tobacco products at market price.
Heated tobacco products at 1/2 market price.: Availability of heated tobacco products in the ETM at 1/2 market price. Other nicotine/tobacco products at market price.
Heated tobacco products at 2x market price.: Availability of heated tobacco products in the ETM at 2x market price. Other nicotine/tobacco products at market price.
Nicotine pouch products at 1/2 market price.: Availability of heated tobacco products in the ETM at 1/2 market price. Other nicotine/tobacco products at market price.
Nicotine pouch products at 2x market price.: Availability of heated tobacco products in the ETM at 2x market price. Other nicotine/tobacco products at market price. | 26 |
| Dual Cigarette/ Nicotine Vaping Product Users Dual cigarette and nicotine vaping product users will be recruited and exposed to all conditions described in the intervention section.
All nicotine/ tobacco products at market price: Nicotine/tobacco products available in the Experimental Tobacco Marketplace (ETM) at market price. Note that all participants will complete all the specified conditions.
Nicotine vaping products at 1/2 market price: Availability of nicotine vaping products in the ETM at 1/2 market price. Other nicotine/tobacco products at market price.
Nicotine vaping products at 2x market price: Availability of nicotine vaping products in the ETM at 2x market price. Other nicotine/tobacco products at market price.
Heated tobacco products at 1/2 market price.: Availability of heated tobacco products in the ETM at 1/2 market price. Other nicotine/tobacco products at market price.
Heated tobacco products at 2x market price.: Availability of heated tobacco products in the ETM at 2x market price. Other nicotine/tobacco products at market price.
Nicotine pouch products at 1/2 market price.: Availability of heated tobacco products in the ETM at 1/2 market price. Other nicotine/tobacco products at market price.
Nicotine pouch products at 2x market price.: Availability of heated tobacco products in the ETM at 2x market price. Other nicotine/tobacco products at market price. | 26 |
| Total | 52 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Discontinued | 2 | 1 |
| Overall Study | Lost to Follow-up | 1 | 4 |
Baseline characteristics
| Characteristic | Exclusive Cigarette Smokers | Dual Cigarette/ Nicotine Vaping Product Users | Total |
|---|---|---|---|
| Age, Continuous | 35.19 years STANDARD_DEVIATION 10.63 | 37.00 years STANDARD_DEVIATION 9.98 | 36.10 years STANDARD_DEVIATION 10.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 24 Participants | 25 Participants | 49 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants | 1 Participants | 3 Participants |
| Number of cigarettes smoked per day | 18.22 cigarettes smoked per day STANDARD_DEVIATION 7.31 | 19.74 cigarettes smoked per day STANDARD_DEVIATION 8.97 | 18.97 cigarettes smoked per day STANDARD_DEVIATION 8.14 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 4 Participants | 7 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 22 Participants | 21 Participants | 43 Participants |
| Sex: Female, Male Female | 11 Participants | 16 Participants | 27 Participants |
| Sex: Female, Male Male | 15 Participants | 10 Participants | 25 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 26 | 0 / 26 |
| other Total, other adverse events | 0 / 26 | 0 / 26 |
| serious Total, serious adverse events | 0 / 26 | 0 / 26 |
Outcome results
Primary
Cigarette Demand
Participants will complete purchasing trials in an Experimental Tobacco Marketplace (ETM) with cigarettes increasing in price. Other product prices in the ETM will depend on the experimental condition. The degree to which other nicotine/tobacco products substitute for conventional cigarettes as a function of novel product (e.g. nicotine vaping products, heated tobacco products, nicotine pouch products) prices will be assessed. To obtain dependent measures of demand, participants' purchasing of the price-manipulated commodity in the ETM task will be fit to a modified exponential equation to quantify the relationship between the price of each commodity and purchasing: Q=Q0\*10k(exp(-αQ0C)-1) where Q is purchasing of the commodity, C is the price, Q0 is the derived initial purchasing without cost constraints (demand intensity), k is the span of the function in logarithmic units, and α is the demand elasticity.
Time frame: 1 day
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Exclusive Cigarette Smokers | Cigarette Demand | HTP 2 | 186.03 mg of nicotine purchased | Standard Deviation 206.94 |
| Exclusive Cigarette Smokers | Cigarette Demand | NPP 2 | 225.77 mg of nicotine purchased | Standard Deviation 217.11 |
| Exclusive Cigarette Smokers | Cigarette Demand | HTP 1/2 | 221.66 mg of nicotine purchased | Standard Deviation 235.08 |
| Exclusive Cigarette Smokers | Cigarette Demand | NVP 1/2 | 187.58 mg of nicotine purchased | Standard Deviation 205.34 |
| Exclusive Cigarette Smokers | Cigarette Demand | NPP 1/2 | 229.45 mg of nicotine purchased | Standard Deviation 225.12 |
| Exclusive Cigarette Smokers | Cigarette Demand | NVP 2 | 198.93 mg of nicotine purchased | Standard Deviation 197.99 |
| Exclusive Cigarette Smokers | Cigarette Demand | Control | 212.39 mg of nicotine purchased | Standard Deviation 206.92 |
| Dual Cigarette/ Nicotine Vaping Product Users | Cigarette Demand | NVP 2 | 237.64 mg of nicotine purchased | Standard Deviation 309.73 |
| Dual Cigarette/ Nicotine Vaping Product Users | Cigarette Demand | Control | 193.58 mg of nicotine purchased | Standard Deviation 258.37 |
| Dual Cigarette/ Nicotine Vaping Product Users | Cigarette Demand | HTP 1/2 | 163.28 mg of nicotine purchased | Standard Deviation 170.31 |
| Dual Cigarette/ Nicotine Vaping Product Users | Cigarette Demand | HTP 2 | 231.96 mg of nicotine purchased | Standard Deviation 391.03 |
| Dual Cigarette/ Nicotine Vaping Product Users | Cigarette Demand | NPP 1/2 | 186.18 mg of nicotine purchased | Standard Deviation 200.5 |
| Dual Cigarette/ Nicotine Vaping Product Users | Cigarette Demand | NPP 2 | 163.71 mg of nicotine purchased | Standard Deviation 225.14 |
| Dual Cigarette/ Nicotine Vaping Product Users | Cigarette Demand | NVP 1/2 | 184.45 mg of nicotine purchased | Standard Deviation 229.39 |
p-value: 0.29Mixed Models Analysis
p-value: 0.46Mixed Models Analysis
Primary
Nicotine/Tobacco Products Substitution
Participants will complete purchasing trials in an Experimental Tobacco Marketplace (ETM) with cigarettes increasing in price. Other product prices in the ETM will depend on the experimental condition. The degree to which other nicotine/tobacco products substitute for conventional cigarettes as a function of novel product (e.g. nicotine vaping products, heated tobacco products, nicotine pouch products) prices will be assessed. To obtain estimates of substitution of price-constant products in the different ETM conditions, the investigators will use ordinary least squares regression to model the relationship of the price-manipulated product to predict total quantity purchased of the price-constant product.
Time frame: 1 day
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Exclusive Cigarette Smokers | Nicotine/Tobacco Products Substitution | Control | 12.11 mg of nicotine purchased | Standard Deviation 51.66 |
| Exclusive Cigarette Smokers | Nicotine/Tobacco Products Substitution | HTP 1/2 | 25.28 mg of nicotine purchased | Standard Deviation 45.78 |
| Exclusive Cigarette Smokers | Nicotine/Tobacco Products Substitution | HTP 2 | 19.70 mg of nicotine purchased | Standard Deviation 43.92 |
| Exclusive Cigarette Smokers | Nicotine/Tobacco Products Substitution | NPP 1/2 | 20.77 mg of nicotine purchased | Standard Deviation 52.88 |
| Exclusive Cigarette Smokers | Nicotine/Tobacco Products Substitution | NPP 2 | 16.36 mg of nicotine purchased | Standard Deviation 50.81 |
| Exclusive Cigarette Smokers | Nicotine/Tobacco Products Substitution | NVP 1/2 | 11.62 mg of nicotine purchased | Standard Deviation 118.5 |
| Exclusive Cigarette Smokers | Nicotine/Tobacco Products Substitution | NVP 2 | 24.56 mg of nicotine purchased | Standard Deviation 39.38 |
| Dual Cigarette/ Nicotine Vaping Product Users | Nicotine/Tobacco Products Substitution | NPP 1/2 | 11.06 mg of nicotine purchased | Standard Deviation 28 |
| Dual Cigarette/ Nicotine Vaping Product Users | Nicotine/Tobacco Products Substitution | Control | 4.82 mg of nicotine purchased | Standard Deviation 25.93 |
| Dual Cigarette/ Nicotine Vaping Product Users | Nicotine/Tobacco Products Substitution | NVP 1/2 | -0.68 mg of nicotine purchased | Standard Deviation 81.91 |
| Dual Cigarette/ Nicotine Vaping Product Users | Nicotine/Tobacco Products Substitution | HTP 1/2 | 17.08 mg of nicotine purchased | Standard Deviation 22.07 |
| Dual Cigarette/ Nicotine Vaping Product Users | Nicotine/Tobacco Products Substitution | NPP 2 | -1.09 mg of nicotine purchased | Standard Deviation 27.51 |
| Dual Cigarette/ Nicotine Vaping Product Users | Nicotine/Tobacco Products Substitution | HTP 2 | 10.73 mg of nicotine purchased | Standard Deviation 24.88 |
| Dual Cigarette/ Nicotine Vaping Product Users | Nicotine/Tobacco Products Substitution | NVP 2 | 11.58 mg of nicotine purchased | Standard Deviation 26.46 |
p-value: 0.9793Mixed Models Analysis