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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2019-07370 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| I 475819 | Other Identifier | Roswell Park Cancer Institute | |
| U54CA228110 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This trial studies activity of time (pharmacokinetics), subjective effects, and abuse liability of nicotine salt-based vaping products with tobacco or e-liquids. This study aims to determine and compare the levels of nicotine delivered to the bloodstream from nicotine salt and free-base nicotine e-liquid solutions.
PRIMARY OBJECTIVES:
I. To determine the effect of nicotine salt (nicotine benzoate) and free-base nicotine in different flavored e-liquid solutions on puffing behaviors and systemic exposure to nicotine from electronic nicotine delivery systems (ENDS) by:
Ia. Assessing short-term effects on nicotine cravings, withdrawal, and satisfaction from single use of ENDS refilled with flavored nicotine salt or flavored free-base nicotine solutions with two different flavors (tobacco or unflavored) in current daily ENDS users following an overnight fast.
Ib. Comparing users' perceptions and preferences towards inhaling vapors containing nicotine salt (nicotine benzoate) or freebase nicotine with two different flavors (tobacco and unflavored) versus their regular brand.
II. This project provides important information on whether the pharmacokinetics of nicotine delivery differ between salt and free-base forms of e-liquid of equivalent nominal concentration using the same device, and whether the previously observed effects of flavors on subjective effects differ between salt and free-base forms.
III. Determine whether maximum concentration of nicotine in plasma (Cmax) or time to maximum concentration (Tmax) differ between free-base and salt-based versions of the same liquid, controlling for flavoring and nominal nicotine concentration [main effect of salt].
IV. Determine whether the effect of flavoring on subjective effects (e.g., harshness, liking) differs between matched free-base and salt-based e-liquids [flavor X salt interaction].
EXPLORATORY OBJECTIVE:
I. Examine effects of salt and flavoring on abuse liability using the Experimental Tobacco Marketplace (ETM).
OUTLINE:
After 8-10 hours after nicotine abstinence, participants attend 4 vaping sessions over 2-2.5 hours, 5-7 days apart. During each session, participants take 20 puffs over 10 minutes (one puff every 30 seconds) of vaporizer filled with freebased nicotine electronic (e)-liquid solution of unflavored, free-based nicotine e-liquid solution of tobacco flavor, salt-based nicotine e-liquid solution of unflavored, or salt-based nicotine e-liquid solution of tobacco flavor assigned in a random order.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Product Sequence D | Experimental | After 8-10 hours after nicotine abstinence, participants attend 4 vaping sessions over 2-2.5 hours , 5-7 days apart. They are randomized to take 20 puffs over 10 minutes (1 puff every 30 seconds) of vaporized filled with freebased nicotine e-liquid solution of unflavored, free-based nicotine e-liquid solution of tobacco flavor, salt-based nicotine e-liquid solution of unflavored or salt based nicotine e-liquid solution of tobacco flavor assigned in a random order. |
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| Product Sequence A then B then C | Experimental | After 8-10 hours after nicotine abstinence, participants attend 4 vaping sessions over 2-2.5 hours , 5-7 days apart. They are randomized to take 20 puffs over 10 minutes (1 puff every 30 seconds) of vaporized filled with freebased nicotine e-liquid solution of unflavored, free-based nicotine e-liquid solution of tobacco flavor, salt-based nicotine e-liquid solution of unflavored or salt based nicotine e-liquid solution of tobacco flavor assigned in a random order. |
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| Product sequence B then C then A then D | Experimental | After 8-10 hours after nicotine abstinence, participants attend 4 vaping sessions over 2-2.5 hours , 5-7 days apart. They are randomized to take 20 puffs over 10 minutes (1 puff every 30 seconds) of vaporized filled with freebased nicotine e-liquid solution of unflavored, free-based nicotine e-liquid solution of tobacco flavor, salt-based nicotine e-liquid solution of unflavored or salt based nicotine e-liquid solution of tobacco flavor assigned in a random order. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nicotine | Drug | Vape Free-Low nicotine unflavored |
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| Measure | Description | Time Frame |
|---|---|---|
| Maximum Concentration of Nicotine in Plasma (Cmax) | The maximum nicotine concentration in blood plasma | Samples were taken at minutes 0, then they started puffing and samples were taken 2, 4, 5, 6, 8, 10 minutes during puffing. Then, samples were taken at times 13, 15, 20, 30, and 120 minutes post puffing. The last dose occurred at week 4. |
| Area Under the Concentration-time Curve (AUC) | Area under the plasma nicotine concentration over time curve | Samples were taken at minutes 0, then they started puffing and samples were taken 2, 4, 5, 6, 8, 10 minutes during puffing. Then, samples were taken at times 13, 15, 20, 30, and 120 minutes post puffing. The last dose occurred at week 4. |
| Time to Maximum Concentration | Time to maximum nicotine concentration in the blood plasma | Samples were taken at minutes 0, then they started puffing and samples were taken 2, 4, 5, 6, 8, 10 minutes during puffing. Then, samples were taken at times 13, 15, 20, 30, and 120 minutes post puffing. The last dose occurred at week 4. |
| Measure | Description | Time Frame |
|---|---|---|
| Perceived Harshness of Experimental Product Sampled | Subjective Measure of Perceived Harshness (Likert, 1-5: 1 = best outcome, 5 = worst outcome). | 1 minute post puffing for 4 weeks |
| Perceived Satisfaction of Experimental Product Sampled |
| Measure | Description | Time Frame |
|---|---|---|
| Intensity of Demand or Estimated Milligrams E-cigarettes Purchased at Free Cost for Each Device Sampled | Demand intensity is a behavioral economic estimated measure of consumption at zero cost in a experimental marketplace focused on purchasing of tobacco and nicotine products over increasing price of one product while others stay the same price. Participants were asked to purchase tobacco products (12 options) for one week's use. At each of the four sessions, participants experienced a marketplace with e-cigarette liquid prices of $1.63, $3.25, $6.50, and $13.00, while the prices of the other 11 tobacco products remained the same. Units purchased are transformed into mg of nicotine and nonlinear regression is used to estimate the purchasing when e-cigarettes are free/demand intensity, which is reported here. Higher scores indicate more mg of nicotine from e-cigarettes were purchased |
Inclusion Criteria:
Willingness to abstain from using ENDS product for 8-10 hours (overnight abstinence) prior to study visits
Current daily ENDS user as determined by
Participant or legal representative must understand the investigational nature of this study and sign and Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Amanda Quisenberry | Roswell Park Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Roswell Park Cancer Institute | Buffalo | New York | 14263 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41863629 | Derived | Block AC, Martin CD, Leigh NJ, Page MK, Kaiser LM, Nardotto GHB, Rosario SR, Felicione NJ, O'Connor RJ, Goniewicz ML, Quisenberry AJ. Effects of nicotine form and tobacco flavor on pharmacokinetics, subjective effects, and behavioral indicators of abuse liability of e-cigarettes. Nicotine Tob Res. 2026 Mar 21:ntag058. doi: 10.1093/ntr/ntag058. Online ahead of print. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Product Sequence D | After 8-10 hours after nicotine abstinence, participants attend 4 vaping sessions over 2-2.5 hours , 5-7 days apart. They are randomized to take 20 puffs over 10 minutes (1 puff every 30 seconds) of vaporized filled with one of the following: freebased nicotine e-liquid solution of unflavored, free-based nicotine e-liquid solution of tobacco flavor, salt-based nicotine e-liquid solution of unflavored or salt-based nicotine e-liquid solution of tobacco flavor assigned in random order. Vaporizer Device: Take puffs from vaporizer filled with different flavors Salt-High Nicotine Tobacco Flavored (Product D): Vape Salt-High Tobacco |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 5, 2023 |
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The participant and researcher will be blinded to solution flavor and nicotine concentrates.
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| Product sequence D then B then A then C | Experimental | After 8-10 hours after nicotine abstinence, participants attend 4 vaping sessions over 2-2.5 hours , 5-7 days apart. They are randomized to take 20 puffs over 10 minutes (1 puff every 30 seconds) of vaporized filled with freebased nicotine e-liquid solution of unflavored, free-based nicotine e-liquid solution of tobacco flavor, salt-based nicotine e-liquid solution of unflavored or salt based nicotine e-liquid solution of tobacco flavor assigned in a random order. |
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| Product sequence C then D then B then A | Experimental | After 8-10 hours after nicotine abstinence, participants attend 4 vaping sessions over 2-2.5 hours , 5-7 days apart. They are randomized to take 20 puffs over 10 minutes (1 puff every 30 seconds) of vaporized filled with freebased nicotine e-liquid solution of unflavored, free-based nicotine e-liquid solution of tobacco flavor, salt-based nicotine e-liquid solution of unflavored or salt based nicotine e-liquid solution of tobacco flavor assigned in a random order. |
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| Product sequence A then C | Experimental | After 8-10 hours after nicotine abstinence, participants attend 4 vaping sessions over 2-2.5 hours , 5-7 days apart. They are randomized to take 20 puffs over 10 minutes (1 puff every 30 seconds) of vaporized filled with freebased nicotine e-liquid solution of unflavored, free-based nicotine e-liquid solution of tobacco flavor, salt-based nicotine e-liquid solution of unflavored or salt based nicotine e-liquid solution of tobacco flavor assigned in a random order. |
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| Product sequence D then C then B then A | Experimental | After 8-10 hours after nicotine abstinence, participants attend 4 vaping sessions over 2-2.5 hours , 5-7 days apart. They are randomized to take 20 puffs over 10 minutes (1 puff every 30 seconds) of vaporized filled with freebased nicotine e-liquid solution of unflavored, free-based nicotine e-liquid solution of tobacco flavor, salt-based nicotine e-liquid solution of unflavored or salt based nicotine e-liquid solution of tobacco flavor assigned in a random order. |
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| Product sequence A then D then B then C | Experimental | After 8-10 hours after nicotine abstinence, participants attend 4 vaping sessions over 2-2.5 hours , 5-7 days apart. They are randomized to take 20 puffs over 10 minutes (1 puff every 30 seconds) of vaporized filled with freebased nicotine e-liquid solution of unflavored, free-based nicotine e-liquid solution of tobacco flavor, salt-based nicotine e-liquid solution of unflavored or salt based nicotine e-liquid solution of tobacco flavor assigned in a random order. |
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| Product sequence D then A then C then B | Experimental | After 8-10 hours after nicotine abstinence, participants attend 4 vaping sessions over 2-2.5 hours , 5-7 days apart. They are randomized to take 20 puffs over 10 minutes (1 puff every 30 seconds) of vaporized filled with freebased nicotine e-liquid solution of unflavored, free-based nicotine e-liquid solution of tobacco flavor, salt-based nicotine e-liquid solution of unflavored or salt based nicotine e-liquid solution of tobacco flavor assigned in a random order. |
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| Product sequence C then D then A then B | Experimental | After 8-10 hours after nicotine abstinence, participants attend 4 vaping sessions over 2-2.5 hours , 5-7 days apart. They are randomized to take 20 puffs over 10 minutes (1 puff every 30 seconds) of vaporized filled with freebased nicotine e-liquid solution of unflavored, free-based nicotine e-liquid solution of tobacco flavor, salt-based nicotine e-liquid solution of unflavored or salt based nicotine e-liquid solution of tobacco flavor assigned in a random order. |
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| Product sequence A then C then D then B | Experimental | After 8-10 hours after nicotine abstinence, participants attend 4 vaping sessions over 2-2.5 hours , 5-7 days apart. They are randomized to take 20 puffs over 10 minutes (1 puff every 30 seconds) of vaporized filled with freebased nicotine e-liquid solution of unflavored, free-based nicotine e-liquid solution of tobacco flavor, salt-based nicotine e-liquid solution of unflavored or salt based nicotine e-liquid solution of tobacco flavor assigned in a random order. |
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| Product Sequence A then B then D then C | Experimental | After 8-10 hours after nicotine abstinence, participants attend 4 vaping sessions over 2-2.5 hours , 5-7 days apart. They are randomized to take 20 puffs over 10 minutes (1 puff every 30 seconds) of vaporized filled with freebased nicotine e-liquid solution of unflavored, free-based nicotine e-liquid solution of tobacco flavor, salt-based nicotine e-liquid solution of unflavored or salt based nicotine e-liquid solution of tobacco flavor assigned in a random order. |
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| Product sequence B then A then D thn C | Experimental | After 8-10 hours after nicotine abstinence, participants attend 4 vaping sessions over 2-2.5 hours , 5-7 days apart. They are randomized to take 20 puffs over 10 minutes (1 puff every 30 seconds) of vaporized filled with freebased nicotine e-liquid solution of unflavored, free-based nicotine e-liquid solution of tobacco flavor, salt-based nicotine e-liquid solution of unflavored or salt based nicotine e-liquid solution of tobacco flavor assigned in a random order. |
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| Product sequence B then D then C then A | Experimental | After 8-10 hours after nicotine abstinence, participants attend 4 vaping sessions over 2-2.5 hours , 5-7 days apart. They are randomized to take 20 puffs over 10 minutes (1 puff every 30 seconds) of vaporized filled with freebased nicotine e-liquid solution of unflavored, free-based nicotine e-liquid solution of tobacco flavor, salt-based nicotine e-liquid solution of unflavored or salt based nicotine e-liquid solution of tobacco flavor assigned in a random order. |
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| Vaporizer Device | Device | Take puffs from vaporizer filled with different flavors |
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| Salt-HIgh Nicotine Unflavored (Product B) | Drug | Vape Salt-High nicotine unflavored |
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| Free-Low Nicotine Tobacco Flavored (Product C) | Drug | Vape Free-Low Nicotine Tobacco |
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| Salt-High Nicotine Tobacco Flavored (Product D) | Drug | Vape Salt-High Tobacco |
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Nicotine Solution Rating Scale that orders each of the four products from 1 to 4, with 1 being least satisfying and 4 being most satisfying. Mean rank is provided with a possible score of 1 through 4.
| 120 minutes after session start on last session (session 4) |
| Perceived Liking of Experimental Product Sampled | Drug Effects Questionnaire Item #1 - perceived liking of the experimental product assessed by the question, "Do you like any of the effects you are feeling right now?" on a Likert scale from 0 (not at all) to 100 (extremely), with lower scores representing less liking of the experimental product. Mean is provided with possible scores between 0 and 100. | 1 minute post puffing for 4 weeks |
| Minnesota Nicotine Withdrawal Scale Change (Change From Pre- to Post-) | Minnesota Nicotine Withdrawal Scale Change Minnesota Nicotine Withdrawal scale measures 8 facets of withdrawal and results in a total score. We use change from 5 minutes Pre-puffing to 3 minutes post puffing session. Individual questions are scored 0 (none/better) to 4 (severe/worse). And then the scores are totaled. Positive change score = more withdrawal symptoms. Change score can range from -32 to 36). Positive change score = worse withdrawal symptoms Individual questions are scored 0 (none/better) to 4 (severe/worse). And then the scores are totaled. | 5 minutes pre puffing and 3 minutes post puffing for 4 weeks |
| 60 minutes post puffing for 4 weeks |
| Elasticity of Demand or Sensitivity to Price for Each Device Sampled | Demand elasticity , or sensitivity to price, is a behavioral economic measure of of the rate of purchasing decline over increasing cost for e-cigarettes. At each of the four sessions, participants experienced a marketplace with e-cigarette liquid prices of $1.63, $3.25, $6.50, and $13.00, while the prices of the other 11 tobacco products remained the same. Units purchased are transformed into mg of nicotine and nonlinear regression is used to estimate the purchasing when e-cigarettes are free/demand intensity, which is reported here. Higher scores indicate more sensitivity to price, also called inelastic demand. | 60 minutes post puffing for 4 weeks |
| Substitution Levels of Alternative Tobacco Products | Substitution is the slope of the line regressing consumption of the substitute product onto the price of cigarettes (cross-price elasticity). A positive coefficient indicates substitution (use of the substitute increases with increasing cigarette price). A negative value indicates complementarity (use of the substitute declines with increasing cigarette price). A value of 0 indicates no relationship. | 120 minutes post puffing for 4 weeks |
| FG001 | Product Sequence A then B then C | After 8-10 hours after nicotine abstinence, participants attend 4 vaping sessions over 2-2.5 hours , 5-7 days apart. They are randomized to take 20 puffs over 10 minutes (1 puff every 30 seconds) of vaporized filled with one of the following: freebased nicotine e-liquid solution of unflavored, free-based nicotine e-liquid solution of tobacco flavor, salt-based nicotine e-liquid solution of unflavored or salt-based nicotine e-liquid solution of tobacco flavor assigned in random order. Nicotine: Vape Free-Low nicotine unflavored Vaporizer Device: Take puffs from vaporizer filled with different flavors Salt-HIgh Nicotine Unflavored (Product B): Vape Salt-High nicotine unflavored Free-Low Nicotine Tobacco Flavored (Product C): Vape Free-Low Nicotine Tobacco |
| FG002 | Product sequence B then C then A then D | After 8-10 hours after nicotine abstinence, participants attend 4 vaping sessions over 2-2.5 hours , 5-7 days apart. They are randomized to take 20 puffs over 10 minutes (1 puff every 30 seconds) of vaporized filled with one of the following: freebased nicotine e-liquid solution of unflavored, free-based nicotine e-liquid solution of tobacco flavor, salt-based nicotine e-liquid solution of unflavored or salt-based nicotine e-liquid solution of tobacco flavor assigned in random order. Nicotine: Vape Free-Low nicotine unflavored Vaporizer Device: Take puffs from vaporizer filled with different flavors Salt-HIgh Nicotine Unflavored (Product B): Vape Salt-High nicotine unflavored Free-Low Nicotine Tobacco Flavored (Product C): Vape Free-Low Nicotine Tobacco Salt-High Nicotine Tobacco Flavored (Product D): Vape Salt-High Tobacco |
| FG003 | Product sequence D then B then A then C | After 8-10 hours after nicotine abstinence, participants attend 4 vaping sessions over 2-2.5 hours , 5-7 days apart. They are randomized to take 20 puffs over 10 minutes (1 puff every 30 seconds) of vaporized filled with one of the following: freebased nicotine e-liquid solution of unflavored, free-based nicotine e-liquid solution of tobacco flavor, salt-based nicotine e-liquid solution of unflavored or salt-based nicotine e-liquid solution of tobacco flavor assigned in random order. Nicotine: Vape Free-Low nicotine unflavored Vaporizer Device: Take puffs from vaporizer filled with different flavors Salt-HIgh Nicotine Unflavored (Product B): Vape Salt-High nicotine unflavored Free-Low Nicotine Tobacco Flavored (Product C): Vape Free-Low Nicotine Tobacco Salt-High Nicotine Tobacco Flavored (Product D): Vape Salt-High Tobacco |
| FG004 | Product sequence C then D then B then A | After 8-10 hours after nicotine abstinence, participants attend 4 vaping sessions over 2-2.5 hours , 5-7 days apart. They are randomized to take 20 puffs over 10 minutes (1 puff every 30 seconds) of vaporized filled with one of the following: freebased nicotine e-liquid solution of unflavored, free-based nicotine e-liquid solution of tobacco flavor, salt-based nicotine e-liquid solution of unflavored or salt-based nicotine e-liquid solution of tobacco flavor assigned in random order. Nicotine: Vape Free-Low nicotine unflavored Vaporizer Device: Take puffs from vaporizer filled with different flavors Salt-HIgh Nicotine Unflavored (Product B): Vape Salt-High nicotine unflavored Free-Low Nicotine Tobacco Flavored (Product C): Vape Free-Low Nicotine Tobacco Salt-High Nicotine Tobacco Flavored (Product D): Vape Salt-High Tobacco |
| FG005 | Product sequence A then C | After 8-10 hours after nicotine abstinence, participants attend 4 vaping sessions over 2-2.5 hours , 5-7 days apart. They are randomized to take 20 puffs over 10 minutes (1 puff every 30 seconds) of vaporized filled with one of the following: freebased nicotine e-liquid solution of unflavored, free-based nicotine e-liquid solution of tobacco flavor, salt-based nicotine e-liquid solution of unflavored or salt-based nicotine e-liquid solution of tobacco flavor assigned in random order. Nicotine: Vape Free-Low nicotine unflavored Vaporizer Device: Take puffs from vaporizer filled with different flavors Free-Low Nicotine Tobacco Flavored (Product C): Vape Free-Low Nicotine Tobacco |
| FG006 | Product sequence D then C then B then A | After 8-10 hours after nicotine abstinence, participants attend 4 vaping sessions over 2-2.5 hours , 5-7 days apart. They are randomized to take 20 puffs over 10 minutes (1 puff every 30 seconds) of vaporized filled with one of the following: freebased nicotine e-liquid solution of unflavored, free-based nicotine e-liquid solution of tobacco flavor, salt-based nicotine e-liquid solution of unflavored or salt-based nicotine e-liquid solution of tobacco flavor assigned in random order. Nicotine: Vape Free-Low nicotine unflavored Vaporizer Device: Take puffs from vaporizer filled with different flavors Salt-HIgh Nicotine Unflavored (Product B): Vape Salt-High nicotine unflavored Free-Low Nicotine Tobacco Flavored (Product C): Vape Free-Low Nicotine Tobacco Salt-High Nicotine Tobacco Flavored (Product D): Vape Salt-High Tobacco |
| FG007 | Product sequence A then D then B then C | After 8-10 hours after nicotine abstinence, participants attend 4 vaping sessions over 2-2.5 hours , 5-7 days apart. They are randomized to take 20 puffs over 10 minutes (1 puff every 30 seconds) of vaporized filled with one of the following: freebased nicotine e-liquid solution of unflavored, free-based nicotine e-liquid solution of tobacco flavor, salt-based nicotine e-liquid solution of unflavored or salt-based nicotine e-liquid solution of tobacco flavor assigned in random order. Nicotine: Vape Free-Low nicotine unflavored Vaporizer Device: Take puffs from vaporizer filled with different flavors Salt-HIgh Nicotine Unflavored (Product B): Vape Salt-High nicotine unflavored Free-Low Nicotine Tobacco Flavored (Product C): Vape Free-Low Nicotine Tobacco Salt-High Nicotine Tobacco Flavored (Product D): Vape Salt-High Tobacco |
| FG008 | Product sequence D then A then C then B | After 8-10 hours after nicotine abstinence, participants attend 4 vaping sessions over 2-2.5 hours , 5-7 days apart. They are randomized to take 20 puffs over 10 minutes (1 puff every 30 seconds) of vaporized filled with one of the following: freebased nicotine e-liquid solution of unflavored, free-based nicotine e-liquid solution of tobacco flavor, salt-based nicotine e-liquid solution of unflavored or salt-based nicotine e-liquid solution of tobacco flavor assigned in random order. Nicotine: Vape Free-Low nicotine unflavored Vaporizer Device: Take puffs from vaporizer filled with different flavors Salt-HIgh Nicotine Unflavored (Product B): Vape Salt-High nicotine unflavored Free-Low Nicotine Tobacco Flavored (Product C): Vape Free-Low Nicotine Tobacco Salt-High Nicotine Tobacco Flavored (Product D): Vape Salt-High Tobacco |
| FG009 | Product sequence C then D then A then B | After 8-10 hours after nicotine abstinence, participants attend 4 vaping sessions over 2-2.5 hours , 5-7 days apart. They are randomized to take 20 puffs over 10 minutes (1 puff every 30 seconds) of vaporized filled with one of the following: freebased nicotine e-liquid solution of unflavored, free-based nicotine e-liquid solution of tobacco flavor, salt-based nicotine e-liquid solution of unflavored or salt-based nicotine e-liquid solution of tobacco flavor assigned in random order. Nicotine: Vape Free-Low nicotine unflavored Vaporizer Device: Take puffs from vaporizer filled with different flavors Salt-HIgh Nicotine Unflavored (Product B): Vape Salt-High nicotine unflavored Free-Low Nicotine Tobacco Flavored (Product C): Vape Free-Low Nicotine Tobacco Salt-High Nicotine Tobacco Flavored (Product D): Vape Salt-High Tobacco |
| FG010 | Product sequence A then C then D then B | After 8-10 hours after nicotine abstinence, participants attend 4 vaping sessions over 2-2.5 hours , 5-7 days apart. They are randomized to take 20 puffs over 10 minutes (1 puff every 30 seconds) of vaporized filled with one of the following: freebased nicotine e-liquid solution of unflavored, free-based nicotine e-liquid solution of tobacco flavor, salt-based nicotine e-liquid solution of unflavored or salt-based nicotine e-liquid solution of tobacco flavor assigned in random order. Nicotine: Vape Free-Low nicotine unflavored Vaporizer Device: Take puffs from vaporizer filled with different flavors Salt-HIgh Nicotine Unflavored (Product B): Vape Salt-High nicotine unflavored Free-Low Nicotine Tobacco Flavored (Product C): Vape Free-Low Nicotine Tobacco Salt-High Nicotine Tobacco Flavored (Product D): Vape Salt-High Tobacco |
| FG011 | Product Sequence A then B then D then C | After 8-10 hours after nicotine abstinence, participants attend 4 vaping sessions over 2-2.5 hours , 5-7 days apart. They are randomized to take 20 puffs over 10 minutes (1 puff every 30 seconds) of vaporized filled with one of the following: freebased nicotine e-liquid solution of unflavored, free-based nicotine e-liquid solution of tobacco flavor, salt-based nicotine e-liquid solution of unflavored or salt-based nicotine e-liquid solution of tobacco flavor assigned in random order. Nicotine: Vape Free-Low nicotine unflavored Vaporizer Device: Take puffs from vaporizer filled with different flavors Salt-HIgh Nicotine Unflavored (Product B): Vape Salt-High nicotine unflavored Free-Low Nicotine Tobacco Flavored (Product C): Vape Free-Low Nicotine Tobacco Salt-High Nicotine Tobacco Flavored (Product D): Vape Salt-High Tobacco |
| FG012 | Product sequence B then A then D thn C | After 8-10 hours after nicotine abstinence, participants attend 4 vaping sessions over 2-2.5 hours , 5-7 days apart. They are randomized to take 20 puffs over 10 minutes (1 puff every 30 seconds) of vaporized filled with one of the following: freebased nicotine e-liquid solution of unflavored, free-based nicotine e-liquid solution of tobacco flavor, salt-based nicotine e-liquid solution of unflavored or salt-based nicotine e-liquid solution of tobacco flavor assigned in random order. Nicotine: Vape Free-Low nicotine unflavored Vaporizer Device: Take puffs from vaporizer filled with different flavors Salt-HIgh Nicotine Unflavored (Product B): Vape Salt-High nicotine unflavored Free-Low Nicotine Tobacco Flavored (Product C): Vape Free-Low Nicotine Tobacco Salt-High Nicotine Tobacco Flavored (Product D): Vape Salt-High Tobacco |
| FG013 | Product sequence B then D then C then A | After 8-10 hours after nicotine abstinence, participants attend 4 vaping sessions over 2-2.5 hours , 5-7 days apart. They are randomized to take 20 puffs over 10 minutes (1 puff every 30 seconds) of vaporized filled with one of the following: freebased nicotine e-liquid solution of unflavored, free-based nicotine e-liquid solution of tobacco flavor, salt-based nicotine e-liquid solution of unflavored or salt-based nicotine e-liquid solution of tobacco flavor assigned in random order. Nicotine: Vape Free-Low nicotine unflavored Vaporizer Device: Take puffs from vaporizer filled with different flavors Salt-HIgh Nicotine Unflavored (Product B): Vape Salt-High nicotine unflavored Free-Low Nicotine Tobacco Flavored (Product C): Vape Free-Low Nicotine Tobacco Salt-High Nicotine Tobacco Flavored (Product D): Vape Salt-High Tobacco |
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| NOT COMPLETED |
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All treated and eligible patients
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| ID | Title | Description |
|---|---|---|
| BG000 | Product Sequence D | After 8-10 hours after nicotine abstinence, participants attend 4 vaping sessions over 2-2.5 hours , 5-7 days apart. They are randomized to take 20 puffs over 10 minutes (1 puff every 30 seconds) of vaporized filled with one of the following: freebased nicotine e-liquid solution of unflavored, free-based nicotine e-liquid solution of tobacco flavor, salt-based nicotine e-liquid solution of unflavored or salt-based nicotine e-liquid solution of tobacco flavor assigned in random order. Vaporizer Device: Take puffs from vaporizer filled with different flavors Salt-High Nicotine Tobacco Flavored (Product D): Vape Salt-High Tobacco |
| BG001 | Product Sequence A Then B Then C | After 8-10 hours after nicotine abstinence, participants attend 4 vaping sessions over 2-2.5 hours , 5-7 days apart. They are randomized to take 20 puffs over 10 minutes (1 puff every 30 seconds) of vaporized filled with one of the following: freebased nicotine e-liquid solution of unflavored, free-based nicotine e-liquid solution of tobacco flavor, salt-based nicotine e-liquid solution of unflavored or salt-based nicotine e-liquid solution of tobacco flavor assigned in random order. Nicotine: Vape Free-Low nicotine unflavored Vaporizer Device: Take puffs from vaporizer filled with different flavors Salt-HIgh Nicotine Unflavored (Product B): Vape Salt-High nicotine unflavored Free-Low Nicotine Tobacco Flavored (Product C): Vape Free-Low Nicotine Tobacco |
| BG002 | Product Sequence B Then C Then A Then D | After 8-10 hours after nicotine abstinence, participants attend 4 vaping sessions over 2-2.5 hours , 5-7 days apart. They are randomized to take 20 puffs over 10 minutes (1 puff every 30 seconds) of vaporized filled with one of the following: freebased nicotine e-liquid solution of unflavored, free-based nicotine e-liquid solution of tobacco flavor, salt-based nicotine e-liquid solution of unflavored or salt-based nicotine e-liquid solution of tobacco flavor assigned in random order. Vaporizer Device: Take puffs from vaporizer filled with different flavors Salt-HIgh Nicotine Unflavored (Product B): Vape Salt-High nicotine unflavored Free-Low Nicotine Tobacco Flavored (Product C): Vape Free-Low Nicotine Tobacco Salt-High Nicotine Tobacco Flavored (Product D): Vape Salt-High Tobacco |
| BG003 | Product Sequence D Then B Then A Then C | After 8-10 hours after nicotine abstinence, participants attend 4 vaping sessions over 2-2.5 hours , 5-7 days apart. They are randomized to take 20 puffs over 10 minutes (1 puff every 30 seconds) of vaporized filled with one of the following: freebased nicotine e-liquid solution of unflavored, free-based nicotine e-liquid solution of tobacco flavor, salt-based nicotine e-liquid solution of unflavored or salt-based nicotine e-liquid solution of tobacco flavor assigned in random order. Nicotine: Vape Free-Low nicotine unflavored Vaporizer Device: Take puffs from vaporizer filled with different flavors Salt-HIgh Nicotine Unflavored (Product B): Vape Salt-High nicotine unflavored Free-Low Nicotine Tobacco Flavored (Product C): Vape Free-Low Nicotine Tobacco Salt-High Nicotine Tobacco Flavored (Product D): Vape Salt-High Tobacco |
| BG004 | Product Sequence C Then D Then B Then A | After 8-10 hours after nicotine abstinence, participants attend 4 vaping sessions over 2-2.5 hours , 5-7 days apart. They are randomized to take 20 puffs over 10 minutes (1 puff every 30 seconds) of vaporized filled with one of the following: freebased nicotine e-liquid solution of unflavored, free-based nicotine e-liquid solution of tobacco flavor, salt-based nicotine e-liquid solution of unflavored or salt-based nicotine e-liquid solution of tobacco flavor assigned in random order. Nicotine: Vape Free-Low nicotine unflavored Vaporizer Device: Take puffs from vaporizer filled with different flavors Salt-HIgh Nicotine Unflavored (Product B): Vape Salt-High nicotine unflavored Free-Low Nicotine Tobacco Flavored (Product C): Vape Free-Low Nicotine Tobacco Salt-High Nicotine Tobacco Flavored (Product D): Vape Salt-High Tobacco |
| BG005 | Product Sequence A Then C | After 8-10 hours after nicotine abstinence, participants attend 4 vaping sessions over 2-2.5 hours , 5-7 days apart. They are randomized to take 20 puffs over 10 minutes (1 puff every 30 seconds) of vaporized filled with one of the following: freebased nicotine e-liquid solution of unflavored, free-based nicotine e-liquid solution of tobacco flavor, salt-based nicotine e-liquid solution of unflavored or salt-based nicotine e-liquid solution of tobacco flavor assigned in random order. Nicotine: Vape Free-Low nicotine unflavored Vaporizer Device: Take puffs from vaporizer filled with different flavors Free-Low Nicotine Tobacco Flavored (Product C): Vape Free-Low Nicotine Tobacco |
| BG006 | Product Sequence D Then C Then B Then A | After 8-10 hours after nicotine abstinence, participants attend 4 vaping sessions over 2-2.5 hours , 5-7 days apart. They are randomized to take 20 puffs over 10 minutes (1 puff every 30 seconds) of vaporized filled with one of the following: freebased nicotine e-liquid solution of unflavored, free-based nicotine e-liquid solution of tobacco flavor, salt-based nicotine e-liquid solution of unflavored or salt-based nicotine e-liquid solution of tobacco flavor assigned in random order. Nicotine: Vape Free-Low nicotine unflavored Vaporizer Device: Take puffs from vaporizer filled with different flavors Salt-HIgh Nicotine Unflavored (Product B): Vape Salt-High nicotine unflavored Free-Low Nicotine Tobacco Flavored (Product C): Vape Free-Low Nicotine Tobacco Salt-High Nicotine Tobacco Flavored (Product D): Vape Salt-High Tobacco |
| BG007 | Product Sequence A Then D Then B Then C | After 8-10 hours after nicotine abstinence, participants attend 4 vaping sessions over 2-2.5 hours , 5-7 days apart. They are randomized to take 20 puffs over 10 minutes (1 puff every 30 seconds) of vaporized filled with one of the following: freebased nicotine e-liquid solution of unflavored, free-based nicotine e-liquid solution of tobacco flavor, salt-based nicotine e-liquid solution of unflavored or salt-based nicotine e-liquid solution of tobacco flavor assigned in random order. Nicotine: Vape Free-Low nicotine unflavored Vaporizer Device: Take puffs from vaporizer filled with different flavors Salt-HIgh Nicotine Unflavored (Product B): Vape Salt-High nicotine unflavored Free-Low Nicotine Tobacco Flavored (Product C): Vape Free-Low Nicotine Tobacco Salt-High Nicotine Tobacco Flavored (Product D): Vape Salt-High Tobacco |
| BG008 | Product Sequence D Then A Then C Then B | After 8-10 hours after nicotine abstinence, participants attend 4 vaping sessions over 2-2.5 hours , 5-7 days apart. They are randomized to take 20 puffs over 10 minutes (1 puff every 30 seconds) of vaporized filled with one of the following: freebased nicotine e-liquid solution of unflavored, free-based nicotine e-liquid solution of tobacco flavor, salt-based nicotine e-liquid solution of unflavored or salt-based nicotine e-liquid solution of tobacco flavor assigned in random order. Nicotine: Vape Free-Low nicotine unflavored Vaporizer Device: Take puffs from vaporizer filled with different flavors Salt-HIgh Nicotine Unflavored (Product B): Vape Salt-High nicotine unflavored Free-Low Nicotine Tobacco Flavored (Product C): Vape Free-Low Nicotine Tobacco Salt-High Nicotine Tobacco Flavored (Product D): Vape Salt-High Tobacco |
| BG009 | Product Sequence C Then D Then A Then B | After 8-10 hours after nicotine abstinence, participants attend 4 vaping sessions over 2-2.5 hours , 5-7 days apart. They are randomized to take 20 puffs over 10 minutes (1 puff every 30 seconds) of vaporized filled with one of the following: freebased nicotine e-liquid solution of unflavored, free-based nicotine e-liquid solution of tobacco flavor, salt-based nicotine e-liquid solution of unflavored or salt-based nicotine e-liquid solution of tobacco flavor assigned in random order. Nicotine: Vape Free-Low nicotine unflavored Vaporizer Device: Take puffs from vaporizer filled with different flavors Salt-HIgh Nicotine Unflavored (Product B): Vape Salt-High nicotine unflavored Free-Low Nicotine Tobacco Flavored (Product C): Vape Free-Low Nicotine Tobacco Salt-High Nicotine Tobacco Flavored (Product D): Vape Salt-High Tobacco |
| BG010 | Product Sequence A Then C Then D Then B | After 8-10 hours after nicotine abstinence, participants attend 4 vaping sessions over 2-2.5 hours , 5-7 days apart. They are randomized to take 20 puffs over 10 minutes (1 puff every 30 seconds) of vaporized filled with one of the following: freebased nicotine e-liquid solution of unflavored, free-based nicotine e-liquid solution of tobacco flavor, salt-based nicotine e-liquid solution of unflavored or salt-based nicotine e-liquid solution of tobacco flavor assigned in random order. Nicotine: Vape Free-Low nicotine unflavored Vaporizer Device: Take puffs from vaporizer filled with different flavors Salt-HIgh Nicotine Unflavored (Product B): Vape Salt-High nicotine unflavored Free-Low Nicotine Tobacco Flavored (Product C): Vape Free-Low Nicotine Tobacco Salt-High Nicotine Tobacco Flavored (Product D): Vape Salt-High Tobacco |
| BG011 | Product Sequence A Then B Then D Then C | After 8-10 hours after nicotine abstinence, participants attend 4 vaping sessions over 2-2.5 hours , 5-7 days apart. They are randomized to take 20 puffs over 10 minutes (1 puff every 30 seconds) of vaporized filled with one of the following: freebased nicotine e-liquid solution of unflavored, free-based nicotine e-liquid solution of tobacco flavor, salt-based nicotine e-liquid solution of unflavored or salt-based nicotine e-liquid solution of tobacco flavor assigned in random order. Nicotine: Vape Free-Low nicotine unflavored Vaporizer Device: Take puffs from vaporizer filled with different flavors Salt-HIgh Nicotine Unflavored (Product B): Vape Salt-High nicotine unflavored Free-Low Nicotine Tobacco Flavored (Product C): Vape Free-Low Nicotine Tobacco Salt-High Nicotine Tobacco Flavored (Product D): Vape Salt-High Tobacco |
| BG012 | Product Sequence B Then A Then D Thn C | After 8-10 hours after nicotine abstinence, participants attend 4 vaping sessions over 2-2.5 hours , 5-7 days apart. They are randomized to take 20 puffs over 10 minutes (1 puff every 30 seconds) of vaporized filled with one of the following: freebased nicotine e-liquid solution of unflavored, free-based nicotine e-liquid solution of tobacco flavor, salt-based nicotine e-liquid solution of unflavored or salt-based nicotine e-liquid solution of tobacco flavor assigned in random order. Nicotine: Vape Free-Low nicotine unflavored Vaporizer Device: Take puffs from vaporizer filled with different flavors Salt-HIgh Nicotine Unflavored (Product B): Vape Salt-High nicotine unflavored Free-Low Nicotine Tobacco Flavored (Product C): Vape Free-Low Nicotine Tobacco Salt-High Nicotine Tobacco Flavored (Product D): Vape Salt-High Tobacco |
| BG013 | Product Sequence B Then D Then C Then A | After 8-10 hours after nicotine abstinence, participants attend 4 vaping sessions over 2-2.5 hours , 5-7 days apart. They are randomized to take 20 puffs over 10 minutes (1 puff every 30 seconds) of vaporized filled with one of the following: freebased nicotine e-liquid solution of unflavored, free-based nicotine e-liquid solution of tobacco flavor, salt-based nicotine e-liquid solution of unflavored or salt-based nicotine e-liquid solution of tobacco flavor assigned in random order. Nicotine: Vape Free-Low nicotine unflavored Vaporizer Device: Take puffs from vaporizer filled with different flavors Salt-HIgh Nicotine Unflavored (Product B): Vape Salt-High nicotine unflavored Free-Low Nicotine Tobacco Flavored (Product C): Vape Free-Low Nicotine Tobacco Salt-High Nicotine Tobacco Flavored (Product D): Vape Salt-High Tobacco |
| BG014 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Maximum Concentration of Nicotine in Plasma (Cmax) | The maximum nicotine concentration in blood plasma | All treated and eligible patients | Posted | Mean | Standard Error | ng/mL | Samples were taken at minutes 0, then they started puffing and samples were taken 2, 4, 5, 6, 8, 10 minutes during puffing. Then, samples were taken at times 13, 15, 20, 30, and 120 minutes post puffing. The last dose occurred at week 4. |
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| Primary | Area Under the Concentration-time Curve (AUC) | Area under the plasma nicotine concentration over time curve | All treated and eligible patients | Posted | Mean | Standard Error | ng*min/mL | Samples were taken at minutes 0, then they started puffing and samples were taken 2, 4, 5, 6, 8, 10 minutes during puffing. Then, samples were taken at times 13, 15, 20, 30, and 120 minutes post puffing. The last dose occurred at week 4. |
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| Primary | Time to Maximum Concentration | Time to maximum nicotine concentration in the blood plasma | All treated and eligible patients | Posted | Mean | Standard Error | minutes | Samples were taken at minutes 0, then they started puffing and samples were taken 2, 4, 5, 6, 8, 10 minutes during puffing. Then, samples were taken at times 13, 15, 20, 30, and 120 minutes post puffing. The last dose occurred at week 4. |
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| Secondary | Perceived Harshness of Experimental Product Sampled | Subjective Measure of Perceived Harshness (Likert, 1-5: 1 = best outcome, 5 = worst outcome). | All treated and eligible patients | Posted | Mean | Standard Error | score on a scale | 1 minute post puffing for 4 weeks |
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| Secondary | Perceived Satisfaction of Experimental Product Sampled | Nicotine Solution Rating Scale that orders each of the four products from 1 to 4, with 1 being least satisfying and 4 being most satisfying. Mean rank is provided with a possible score of 1 through 4. | All treated and eligible patients | Posted | Mean | Standard Error | score on a scale | 120 minutes after session start on last session (session 4) |
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| Secondary | Perceived Liking of Experimental Product Sampled | Drug Effects Questionnaire Item #1 - perceived liking of the experimental product assessed by the question, "Do you like any of the effects you are feeling right now?" on a Likert scale from 0 (not at all) to 100 (extremely), with lower scores representing less liking of the experimental product. Mean is provided with possible scores between 0 and 100. | All treated and eligible patients | Posted | Mean | Standard Error | score on a scale | 1 minute post puffing for 4 weeks |
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| Secondary | Minnesota Nicotine Withdrawal Scale Change (Change From Pre- to Post-) | Minnesota Nicotine Withdrawal Scale Change Minnesota Nicotine Withdrawal scale measures 8 facets of withdrawal and results in a total score. We use change from 5 minutes Pre-puffing to 3 minutes post puffing session. Individual questions are scored 0 (none/better) to 4 (severe/worse). And then the scores are totaled. Positive change score = more withdrawal symptoms. Change score can range from -32 to 36). Positive change score = worse withdrawal symptoms Individual questions are scored 0 (none/better) to 4 (severe/worse). And then the scores are totaled. | All treated and eligible patients | Posted | Mean | Standard Error | score on a scale | 5 minutes pre puffing and 3 minutes post puffing for 4 weeks |
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| Other Pre-specified | Intensity of Demand or Estimated Milligrams E-cigarettes Purchased at Free Cost for Each Device Sampled | Demand intensity is a behavioral economic estimated measure of consumption at zero cost in a experimental marketplace focused on purchasing of tobacco and nicotine products over increasing price of one product while others stay the same price. Participants were asked to purchase tobacco products (12 options) for one week's use. At each of the four sessions, participants experienced a marketplace with e-cigarette liquid prices of $1.63, $3.25, $6.50, and $13.00, while the prices of the other 11 tobacco products remained the same. Units purchased are transformed into mg of nicotine and nonlinear regression is used to estimate the purchasing when e-cigarettes are free/demand intensity, which is reported here. Higher scores indicate more mg of nicotine from e-cigarettes were purchased | All treated and eligible patients | Posted | Mean | 95% Confidence Interval | mg of nicotine | 60 minutes post puffing for 4 weeks |
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| Other Pre-specified | Elasticity of Demand or Sensitivity to Price for Each Device Sampled | Demand elasticity , or sensitivity to price, is a behavioral economic measure of of the rate of purchasing decline over increasing cost for e-cigarettes. At each of the four sessions, participants experienced a marketplace with e-cigarette liquid prices of $1.63, $3.25, $6.50, and $13.00, while the prices of the other 11 tobacco products remained the same. Units purchased are transformed into mg of nicotine and nonlinear regression is used to estimate the purchasing when e-cigarettes are free/demand intensity, which is reported here. Higher scores indicate more sensitivity to price, also called inelastic demand. | All treated and eligible patients | Posted | Mean | 95% Confidence Interval | mg nicotine per dollar | 60 minutes post puffing for 4 weeks |
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| Other Pre-specified | Substitution Levels of Alternative Tobacco Products | Substitution is the slope of the line regressing consumption of the substitute product onto the price of cigarettes (cross-price elasticity). A positive coefficient indicates substitution (use of the substitute increases with increasing cigarette price). A negative value indicates complementarity (use of the substitute declines with increasing cigarette price). A value of 0 indicates no relationship. | All treated and eligible patients | Posted | Mean | 95% Confidence Interval | mg nicotine per dollar | 120 minutes post puffing for 4 weeks |
|
2 year and 2 months
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | A: Unflavored Free-based Nicotine Form | Participants will sample a standardized e-cigarette with a formulation that contains free-based nicotine that is unflavored. | 0 | 12 | 0 | 12 | 0 | 12 |
| EG001 | B: Unflavored Salt-based Nicotine Form | Participants will sample a standardized e-cigarette with a formulation that contains salt-based nicotine that is unflavored. | 0 | 12 | 0 | 12 | 0 | 12 |
| EG002 | C: Tobacco Flavor Free-based Nicotine Form | Participants will sample a standardized e-cigarette with a formulation that contains free-based nicotine that is tobacco flavored. | 0 | 12 | 0 | 12 | 0 | 12 |
| EG003 | D: Tobacco Flavor Salt-based Nicotine Form | Participants will sample a standardized e-cigarette with a formulation that contains salt-based nicotine that is tobacco flavored. | 0 | 13 | 0 | 13 | 0 | 13 |
Not provided
Not provided
Not provided
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Administrator, Compliance - Clinical Research Services | Roswell Park Comprehensive Cancer Center | 716-845-2300 | Adrienne.Groman@RoswellPark.org |
| Aug 7, 2024 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 7, 2023 | Aug 6, 2024 | ICF_001.pdf |
| ID | Term |
|---|---|
| D014029 | Tobacco Use Disorder |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D009538 | Nicotine |
| D009330 | Nebulizers and Vaporizers |
| ID | Term |
|---|---|
| D012991 | Solanaceous Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D004864 | Equipment and Supplies |
Not provided
Not provided
| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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Participants will sample a standardized e-cigarette with a formulation that contains salt-based nicotine that is tobacco flavored. |
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Participants will sample a standardized e-cigarette with a formulation that contains salt-based nicotine that is tobacco flavored.
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Participants will sample a standardized e-cigarette with a formulation that contains salt-based nicotine that is tobacco flavored. |
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| D: Tobacco Flavor Salt-based Nicotine Form |
Participants will sample a standardized e-cigarette with a formulation that contains salt-based nicotine that is tobacco flavored. |
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| OG003 | D: Tobacco Flavor Salt-based Nicotine Form | Participants will sample a standardized e-cigarette with a formulation that contains salt-based nicotine that is tobacco flavored. |
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| OG002 | C: Tobacco Flavor Free-based Nicotine Form | Participants will sample a standardized e-cigarette with a formulation that contains free-based nicotine that is tobacco flavored. |
| OG003 | D: Tobacco Flavor Salt-based Nicotine Form | Participants will sample a standardized e-cigarette with a formulation that contains salt-based nicotine that is tobacco flavored. |
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|
Participants will sample a standardized e-cigarette with a formulation that contains free-based nicotine that is tobacco flavored.
| OG003 | D: Tobacco Flavor Salt-based Nicotine Form | Participants will sample a standardized e-cigarette with a formulation that contains salt-based nicotine that is tobacco flavored. |
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| OG003 | D: Tobacco Flavor Salt-based Nicotine Form | Participants will sample a standardized e-cigarette with a formulation that contains salt-based nicotine that is tobacco flavored. |
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