NCT04378907

Assessing Electronic Cigarette Nicotine Flux

Completed NA Results posted Last updated 4 February 2026

What this trial tests

NA trial testing Cigarette Smoker/ECIG users: 0 mg/ml nicotine concentration in Electronic Cigarette Use in 33 participants. Completed in 1 February 2023.

Timeline

5 January 2021

Primary endpoint
1 February 2023

1 February 2023

Quick facts

Lead sponsor	Virginia Commonwealth University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	basic science
Enrollment	33
Start date	5 January 2021
Primary completion	1 February 2023
Estimated completion	1 February 2023
Sites	1 location across United States

Drugs / interventions tested

• Cigarette Smoker/ECIG users: 0 mg/ml nicotine concentration
• Cigarette Smokers/ECIG users: 6 mg/ml nicotine concentration
• Cigarette Smokers/ECIG users: 15 mg/ml nicotine concentration
• Cigarette Smokers/ECIG users: 30 mg/ml nicotine concentration

Conditions studied

• Electronic Cigarette Use — all drugs for Electronic Cigarette Use →

Sponsor

Virginia Commonwealth University

Who can join

Adults 18 to 55, any sex, with Electronic Cigarette Use. 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.

Plasma Nicotine Concentration Primary · Before directed bout, after directed bout, prior to ad lib use, after ad lib use, and immediately after own brand use.

Blood will be taken during each session (5) to examine changes from baseline to immediately follow a ten-puff bout. There is one arm, but 4 different conditions per outcome. One subject with/ missing plasma samples was removed from analysis.

Before directed bout

Group	Value	95% CI
Experimental Arm/ 0mg Condition	2.00	± 2.86
Experimental Arm/ 6mg Condition	1.92	± 2.59
Experimental Arm/ 15 mg Condition	1.64	± 2.34
Experimental Arm/ 30mg Condition	1.62	± 2.53

After directed bout

Group	Value	95% CI
Experimental Arm/ 0mg Condition	1.93	± 2.80
Experimental Arm/ 6mg Condition	4.75	± 3.44
Experimental Arm/ 15 mg Condition	8.80	± 7.41
Experimental Arm/ 30mg Condition	12.42	± 12.21

Before ad lib use

Group	Value	95% CI
Experimental Arm/ 0mg Condition	1.74	± 2.36
Experimental Arm/ 6mg Condition	3.29	± 2.29
Experimental Arm/ 15 mg Condition	5.28	± 3.79
Experimental Arm/ 30mg Condition	7.62	± 5.75

After ad lib use

Group	Value	95% CI
Experimental Arm/ 0mg Condition	1.62	± 2.15
Experimental Arm/ 6mg Condition	5.39	± 3.32
Experimental Arm/ 15 mg Condition	8.61	± 7.47
Experimental Arm/ 30mg Condition	11.05	± 8.71

After own brand use

Group	Value	95% CI
Experimental Arm/ 0mg Condition	10.93	± 9.67
Experimental Arm/ 6mg Condition	15.05	± 10.04
Experimental Arm/ 15 mg Condition	16.55	± 10.40
Experimental Arm/ 30mg Condition	17.01	± 9.70

Cigarette/ECIG Challenge Paradigm Primary · Completion of ad lib bout to use of own brand cigarette

Subjects, following a period of abstinence, they are given a limited time to use either their own brand of cigarette or an e-cigarette. One arm enrolled and the subjects received each of the 4 conditions per outcome.

Group	Value	95% CI
Experimental Arm/0 mg Condition	7.74	± 4.59
Experimental Arm/6 mg Condition	10.18	± 12.27
Experimental Arm/ 15 mg Condition	10.51	± 9.57
Experimental Arm/ 30 mg Condition	11.64	± 12.10

Puff Volume Secondary · During directed bout, during ad lib bout

Puff volume.

Directed bout

Group	Value	95% CI
Experimental Arm/ 0 mg Condition	424.46	± 235.73
Experimental/ 6 mg Condition	425.48	± 248.99
Experimental Arm/ 15 mg Condition	363.21	± 184.21
Experimental Arm/ 30 mg Condition	328.52	± 181.95

Ad lib bout

Group	Value	95% CI
Experimental Arm/ 0 mg Condition	400.87	± 220.94
Experimental/ 6 mg Condition	372.31	± 232.72
Experimental Arm/ 15 mg Condition	340.99	± 194.09
Experimental Arm/ 30 mg Condition	298.76	± 185.46

Puff Duration Secondary · During directed bout, during ad lib bout

Puff duration measured in seconds.

Directed bout

Group	Value	95% CI
Experimental Arm/ 0mg Condition	2.31	± 0.46
Experimental Arm/ 6 mg Condition	2.32	± 0.51
Experimental Arm/ 15 mg Condition	2.16	± 0.41
Experimental Arm/ 30 mg Condition	2.01	± 0.52

Ad lib bout

Group	Value	95% CI
Experimental Arm/ 0mg Condition	2.26	± 0.66
Experimental Arm/ 6 mg Condition	2.08	± 0.68
Experimental Arm/ 15 mg Condition	2.08	± 0.57
Experimental Arm/ 30 mg Condition	1.91	± 0.59

Sponsor's own description

The purpose of this study is to determine differences in nicotine delivery, use behavior, carbon monoxide delivery, subjective effects, and physiological effects, when cigarette smokers use an electronic cigarette with constant device settings and different e-liquid concentrations.

Publications & conference data

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

1. Constraining electronic nicotine delivery systems (ENDS) nicotine dose by controlling nicotine flux at a limited puff duration.
   Patev AJ, Combs M, Gaitan N, Karaoghlanian N, et al · · 2024 · cited 2× · PMID 38815113 · DOI 10.1037/pha0000719