NCT04231539 is a NA clinical trial of Nicotine in Nicotine Dependence, sponsored by Roswell Park Cancer Institute.

Who is sponsoring NCT04231539?

NCT04231539 is sponsored by Roswell Park Cancer Institute.

What drugs are being tested in NCT04231539?

Interventions in NCT04231539: Nicotine, Vaporizer Device, Salt-HIgh Nicotine Unflavored (Product B), Free-Low Nicotine Tobacco Flavored (Product C), Salt-High Nicotine Tobacco Flavored (Product D).

What condition does NCT04231539 study?

NCT04231539 studies Nicotine Dependence.

Is NCT04231539 still recruiting?

NCT04231539 is currently completed. Last updated 31 October 2025.

Are results published for NCT04231539?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2025-10-31 · How we verify

NCT04231539

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Pharmacokinetics, Subjective Effects, and Abuse Liability of Nicotine Salt-Based Vaping Products With Tobacco or Unflavored E-liquids, SALTVAPE Study

Completed NA Results posted Last updated 31 October 2025

What this trial tests

NA trial testing Nicotine in Nicotine Dependence in 15 participants. Completed in 10 July 2024.

Timeline

18 February 2020

Primary endpoint
10 July 2024

10 July 2024

Quick facts

Lead sponsor	Roswell Park Cancer Institute
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	factorial
Masking	double
Primary purpose	prevention
Enrollment	15
Start date	18 February 2020
Primary completion	10 July 2024
Estimated completion	10 July 2024
Sites	1 location across United States

Drugs / interventions tested

Nicotine (NICOTINE) — full drug profile →
Vaporizer Device
Salt-HIgh Nicotine Unflavored (Product B) — full drug profile →
Free-Low Nicotine Tobacco Flavored (Product C) — full drug profile →
Salt-High Nicotine Tobacco Flavored (Product D) — full drug profile →

Conditions studied

Nicotine Dependence — all drugs for Nicotine Dependence →

Sponsor

Roswell Park Cancer Institute

Who can join

Adults 21 to 55, any sex, with Nicotine Dependence. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Maximum Concentration of Nicotine in Plasma (Cmax) Primary · 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.

The maximum nicotine concentration in blood plasma

Group	Value	95% CI
A: Unflavored Free-based Nicotine Form	5.7	± 0.8
B: Unflavored Salt-based Nicotine Form	11.8	± 3.3
C: Tobacco Flavor Free-based Nicotine Form	6.7	± 1.3
D: Tobacco Flavor Salt-based Nicotine Form	8.1	± 1.7

Area Under the Concentration-time Curve (AUC) Primary · 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 plasma nicotine concentration over time curve

Group	Value	95% CI
A: Unflavored Free-based Nicotine Form	128.8	± 40.8
B: Unflavored Salt-based Nicotine Form	295.6	± 126.7
C: Tobacco Flavor Free-based Nicotine Form	177.3	± 51.7
D: Tobacco Flavor Salt-based Nicotine Form	199.7	± 71.7

Time to Maximum Concentration Primary · 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 nicotine concentration in the blood plasma

Group	Value	95% CI
A: Unflavored Free-based Nicotine Form	11.5	± 1.6
B: Unflavored Salt-based Nicotine Form	9.8	± 1.5
C: Tobacco Flavor Free-based Nicotine Form	11.7	± 1.5
D: Tobacco Flavor Salt-based Nicotine Form	8.6	± 1.3

Perceived Harshness of Experimental Product Sampled Secondary · 1 minute post puffing for 4 weeks

Subjective Measure of Perceived Harshness (Likert, 1-5: 1 = best outcome, 5 = worst outcome).

Group	Value	95% CI
A: Unflavored Free-based Nicotine Form	4.85	± 0.1
B: Unflavored Salt-based Nicotine Form	2.92	± 0.4
C: Tobacco Flavor Free-based Nicotine Form	4.62	± 0.1
D: Tobacco Flavor Salt-based Nicotine Form	3.08	± 0.4

Perceived Satisfaction of Experimental Product Sampled Secondary · 120 minutes after session start on last session (session 4)

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.

Group	Value	95% CI
A: Unflavored Free-based Nicotine Form	3.08	± 0.3
B: Unflavored Salt-based Nicotine Form	3.75	± 0.4
C: Tobacco Flavor Free-based Nicotine Form	3.77	± 0.4
D: Tobacco Flavor Salt-based Nicotine Form	4.23	± 0.3

Perceived Liking of Experimental Product Sampled Secondary · 1 minute post puffing for 4 weeks

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.

Group	Value	95% CI
A: Unflavored Free-based Nicotine Form	45.9	± 5.2
B: Unflavored Salt-based Nicotine Form	55.2	± 4.0
C: Tobacco Flavor Free-based Nicotine Form	46.5	± 6.0
D: Tobacco Flavor Salt-based Nicotine Form	52.5	± 5.4

Minnesota Nicotine Withdrawal Scale Change (Change From Pre- to Post-) Secondary · 5 minutes pre puffing and 3 minutes post puffing for 4 weeks

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.

Group	Value	95% CI
A: Unflavored Free-based Nicotine Form	0.5	± 0.7
B: Unflavored Salt-based Nicotine Form	0.7	± 0.7
C: Tobacco Flavor Free-based Nicotine Form	1.5	± 0.5
D: Tobacco Flavor Salt-based Nicotine Form	-0.5	± 0.7

Intensity of Demand or Estimated Milligrams E-cigarettes Purchased at Free Cost for Each Device Sampled Secondary · 60 minutes post puffing for 4 weeks

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

Group	Value	95% CI
A: Unflavored Free-based Nicotine Form	908.3	425.1 – 2022
B: Unflavored Salt-based Nicotine Form	1142	539.2 – 2926
C: Tobacco Flavor Free-based Nicotine Form	785.5	416.1 – 1521
D: Tobacco Flavor Salt-based Nicotine Form	985.8	475.7 – 2416

Elasticity of Demand or Sensitivity to Price for Each Device Sampled Secondary · 60 minutes post puffing for 4 weeks

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 calle

Group	Value	95% CI
A: Unflavored Free-based Nicotine Form	0.0005	.0002 – .0007
B: Unflavored Salt-based Nicotine Form	0.0004	.0002 – .0006
C: Tobacco Flavor Free-based Nicotine Form	0.0004	.0002 – .0006
D: Tobacco Flavor Salt-based Nicotine Form	0.0005	.0003 – .0007

Substitution Levels of Alternative Tobacco Products Secondary · 120 minutes post puffing for 4 weeks

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.

JUUL Virginia Tobacco

Group	Value	95% CI
A: Unflavored Free-based Nicotine Form	0	0 – 0
B: Unflavored Salt-based Nicotine Form	0	0 – 0
C: Tobacco Flavor Free-based Nicotine Form	0	0 – 0
D: Tobacco Flavor Salt-based Nicotine Form	7.377	-0.5177 – 15.27

JUUL Classic Tobacco

Group	Value	95% CI
A: Unflavored Free-based Nicotine Form	-0.000000000000	-87.64 – 87.64
B: Unflavored Salt-based Nicotine Form	8.167	-69.45 – 85.78
C: Tobacco Flavor Free-based Nicotine Form	2.554	-81.9 – 87.01
D: Tobacco Flavor Salt-based Nicotine Form	-4.175	-95.61 – 87.26

JUUL Menthol

Group	Value	95% CI
A: Unflavored Free-based Nicotine Form	15.54	-38.02 – 69.11
B: Unflavored Salt-based Nicotine Form	17.31	-36.31 – 70.93
C: Tobacco Flavor Free-based Nicotine Form	14.75	-32.1 – 61.61
D: Tobacco Flavor Salt-based Nicotine Form	18.28	-26.91 – 63.47

Revel Dark Mint

Group	Value	95% CI
A: Unflavored Free-based Nicotine Form	0	0 – 0
B: Unflavored Salt-based Nicotine Form	0	0 – 0
C: Tobacco Flavor Free-based Nicotine Form	0	0 – 0
D: Tobacco Flavor Salt-based Nicotine Form	0	0 – 0

Revel Mint

Group	Value	95% CI
A: Unflavored Free-based Nicotine Form	4.232	-1.547 – 10.01
B: Unflavored Salt-based Nicotine Form	0.2371	-2.216 – 2.69
C: Tobacco Flavor Free-based Nicotine Form	4.663	-0.6079 – 9.935
D: Tobacco Flavor Salt-based Nicotine Form	0.2371	-2.216 – 2.69

Marlboro Reds

Group	Value	95% CI
A: Unflavored Free-based Nicotine Form	0	0 – 0
B: Unflavored Salt-based Nicotine Form	0	0 – 0
C: Tobacco Flavor Free-based Nicotine Form	0	0 – 0
D: Tobacco Flavor Salt-based Nicotine Form	0	0 – 0

Marlboro Menthols

Group	Value	95% CI
A: Unflavored Free-based Nicotine Form	0	0 – 0
B: Unflavored Salt-based Nicotine Form	0	0 – 0
C: Tobacco Flavor Free-based Nicotine Form	0	0 – 0
D: Tobacco Flavor Salt-based Nicotine Form	0	0 – 0

Camel Snus Mellow

Group	Value	95% CI
A: Unflavored Free-based Nicotine Form	0	0 – 0
B: Unflavored Salt-based Nicotine Form	0	0 – 0
C: Tobacco Flavor Free-based Nicotine Form	0	0 – 0
D: Tobacco Flavor Salt-based Nicotine Form	0	0 – 0

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Effects of nicotine form and tobacco flavor on pharmacokinetics, subjective effects, and behavioral indicators of abuse liability of e-cigarettes.
Block AC, Martin CD, Leigh NJ, Page MK, et al · · 2026 · PMID 41863629 · DOI 10.1093/ntr/ntag058

Verify or expand the search:

Other trials of Nicotine

Trials testing the same drug.

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Other recruiting trials for Nicotine Dependence

Currently open trials in the same condition.

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Other Roswell Park Cancer Institute trials

Trials by the same sponsor.

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NCT06334016 — Evaluating the Delivery and Effects of THC Vaping Liquids in the Bloodstream · EARLY_PHASE1 · not yet recruiting
NCT06670976 — Propranolol Plus Standard Radiation Therapy Before Surgery for the Treatment of Patients With Soft Tissue Sarcoma · Phase 1 · withdrawn

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04231539 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Roswell Park Cancer Institute
Last refreshed: 31 October 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04231539.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing