Trial Outcomes & Findings for Comparison of the Substitution Between Different Tobacco/Nicotine Products as a Function of Tobacco-user Type (NCT NCT05177848)
NCT ID: NCT05177848
Last Updated: 2025-01-30
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
60 participants
Primary outcome timeframe
1 day
Results posted on
2025-01-30
Participant Flow
Participants are assigned to exclusive smokers or dual cigarette/nicotine vaping product users groups based on the screening form.
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
29
|
31
|
|
Overall Study
COMPLETED
|
26
|
26
|
|
Overall Study
NOT COMPLETED
|
3
|
5
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
4
|
|
Overall Study
Discontinued
|
2
|
1
|
Baseline Characteristics
Comparison of the Substitution Between Different Tobacco/Nicotine Products as a Function of Tobacco-user Type
Baseline characteristics by cohort
| Measure |
Exclusive Cigarette Smokers
n=26 Participants
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.
|
Dual Cigarette/ Nicotine Vaping Product Users
n=26 Participants
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.
|
Total
n=52 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
35.19 years
STANDARD_DEVIATION 10.63 • n=5 Participants
|
37.00 years
STANDARD_DEVIATION 9.98 • n=7 Participants
|
36.10 years
STANDARD_DEVIATION 10.30 • n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
24 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
22 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Number of cigarettes smoked per day
|
18.22 cigarettes smoked per day
STANDARD_DEVIATION 7.31 • n=5 Participants
|
19.74 cigarettes smoked per day
STANDARD_DEVIATION 8.97 • n=7 Participants
|
18.97 cigarettes smoked per day
STANDARD_DEVIATION 8.14 • n=5 Participants
|
PRIMARY outcome
Timeframe: 1 dayParticipants 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.
Outcome measures
| Measure |
Exclusive Cigarette Smokers
n=26 Participants
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.
|
Dual Cigarette/ Nicotine Vaping Product Users
n=26 Participants
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.
|
|---|---|---|
|
Nicotine/Tobacco Products Substitution
NPP 2
|
16.36 mg of nicotine purchased
Standard Deviation 50.81
|
-1.09 mg of nicotine purchased
Standard Deviation 27.51
|
|
Nicotine/Tobacco Products Substitution
HTP 1/2
|
25.28 mg of nicotine purchased
Standard Deviation 45.78
|
17.08 mg of nicotine purchased
Standard Deviation 22.07
|
|
Nicotine/Tobacco Products Substitution
HTP 2
|
19.70 mg of nicotine purchased
Standard Deviation 43.92
|
10.73 mg of nicotine purchased
Standard Deviation 24.88
|
|
Nicotine/Tobacco Products Substitution
NPP 1/2
|
20.77 mg of nicotine purchased
Standard Deviation 52.88
|
11.06 mg of nicotine purchased
Standard Deviation 28.00
|
|
Nicotine/Tobacco Products Substitution
NVP 1/2
|
11.62 mg of nicotine purchased
Standard Deviation 118.50
|
-0.68 mg of nicotine purchased
Standard Deviation 81.91
|
|
Nicotine/Tobacco Products Substitution
Control
|
12.11 mg of nicotine purchased
Standard Deviation 51.66
|
4.82 mg of nicotine purchased
Standard Deviation 25.93
|
|
Nicotine/Tobacco Products Substitution
NVP 2
|
24.56 mg of nicotine purchased
Standard Deviation 39.38
|
11.58 mg of nicotine purchased
Standard Deviation 26.46
|
PRIMARY outcome
Timeframe: 1 dayParticipants 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.
Outcome measures
| Measure |
Exclusive Cigarette Smokers
n=26 Participants
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.
|
Dual Cigarette/ Nicotine Vaping Product Users
n=26 Participants
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.
|
|---|---|---|
|
Cigarette Demand
NVP 2
|
198.93 mg of nicotine purchased
Standard Deviation 197.99
|
237.64 mg of nicotine purchased
Standard Deviation 309.73
|
|
Cigarette Demand
Control
|
212.39 mg of nicotine purchased
Standard Deviation 206.92
|
193.58 mg of nicotine purchased
Standard Deviation 258.37
|
|
Cigarette Demand
HTP 1/2
|
221.66 mg of nicotine purchased
Standard Deviation 235.08
|
163.28 mg of nicotine purchased
Standard Deviation 170.31
|
|
Cigarette Demand
HTP 2
|
186.03 mg of nicotine purchased
Standard Deviation 206.94
|
231.96 mg of nicotine purchased
Standard Deviation 391.03
|
|
Cigarette Demand
NPP 1/2
|
229.45 mg of nicotine purchased
Standard Deviation 225.12
|
186.18 mg of nicotine purchased
Standard Deviation 200.50
|
|
Cigarette Demand
NPP 2
|
225.77 mg of nicotine purchased
Standard Deviation 217.11
|
163.71 mg of nicotine purchased
Standard Deviation 225.14
|
|
Cigarette Demand
NVP 1/2
|
187.58 mg of nicotine purchased
Standard Deviation 205.34
|
184.45 mg of nicotine purchased
Standard Deviation 229.39
|
Adverse Events
Exclusive Cigarette Smokers
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Dual Cigarette/ Nicotine Vaping Product Users
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Roberta Freitas-Lemos
Fralin Biomedical Research Institute at VTC
Phone: (540)526-2106
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place