Last reviewed · How we verify
Evaluating the Comparative Pharmacokinetics of Nicotine After Administration Via JUUL or Tobacco Cigarettes
NA trial testing JUUL in Nicotine Administration & Dosage in 17 participants. Completed in 31 March 2022.
| Lead sponsor | University of California, San Francisco |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | basic science |
| Enrollment | 17 |
| Start date | 9 December 2019 |
| Primary completion | 31 March 2022 |
| Estimated completion | 31 March 2022 |
| Sites | 2 locations across United States |
University of California, San Francisco
Adults 21 to 70, any sex, with Nicotine Administration & Dosage or E-cigarettes. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Plasma nicotine area under the concentrated time curve (AUC) (ng/ml\*h)
| Group | Value | 95% CI |
|---|---|---|
| E-cigarette (JUUL) | 4.6 | ± 2.2 |
| Tobacco Cigarette | 9.2 | ± 5.8 |
Participant heart rate will be measured in beats per minute (bpm) at baseline (before any use of products) and at 2, 5, 7, 10, 15, 30, 45, 60, 75, 90, 100,and 118 minutes after the standardized sessions of e-cigarette and tobacco cigarette use. The mean of each time point will be averaged over time.
| Group | Value | 95% CI |
|---|---|---|
| E-cigarette (JUUL) | 69.4 | ± 11.6 |
| Tobacco Cigarette | 73.4 | ± 13.1 |
Participant systolic blood pressure will be taken at Baseline (prior to use of any product) and at 5, 10, 15, 30, 45, 60, 75, 90, 100, and 118 minutes after the standardized sessions of e-cigarette and/or tobacco cigarette use on each arm. The mean of each time point will be averaged over time.
| Group | Value | 95% CI |
|---|---|---|
| E-cigarette (JUUL) | 123 | ± 12.3 |
| Tobacco Cigarette | 122 | ± 11.8 |
Participant diastolic blood pressure will be taken at Baseline (prior to use of any product) and at 5, 10, 15, 30, 45, 60, 75, 90, 100, and 118 minutes after the standardized session during e-cigarette and/or tobacco cigarette use on each arm. The mean of each time point will be averaged over time.
| Group | Value | 95% CI |
|---|---|---|
| E-cigarette (JUUL) | 75.6 | ± 12 |
| Tobacco Cigarette | 76.9 | ± 10.6 |
The QSU (Questionnaire of Smoking Urges) is a self-report survey, modified to replace "cigarette" with "e-cigarette" and "smoking" with "vaping" for use during both the tobacco cigarette and the E-cigarette Arm. This instrument is composed of 10 items; 5 items measuring desire/intention to smoke/vape with smoking/vaping perceived as rewarding (Factor 1), and 5 items measuring anticipation of relief from negative affect with an urgent desire to smoke/vape (Factor 2). Scores for each factor (1 and 2) range from 5-35 with higher scores indicating more severe craving. The mean and standard deviati
| Group | Value | 95% CI |
|---|---|---|
| E-cigarette (JUUL) | 20.9 | ± 9.62 |
| Tobacco Cigarette | 19.0 | ± 9.96 |
| Group | Value | 95% CI |
|---|---|---|
| E-cigarette (JUUL) | 13.5 | ± 8.72 |
| Tobacco Cigarette | 11.3 | ± 8.28 |
The Minnesota Nicotine Withdrawal Scale is an 15-item self -report scale designed to measure the severity of craving and withdrawal symptoms experienced during smoking cessation. Each item is on a scale of 0 to 4 with 0=none to 4=Severe. The responses to each item are summed to produce a total withdrawal summary score with a possible range between 0 and 60, with higher scores indicating greater withdrawal symptom severity with greater scores indicating a higher level of severity in nicotine withdrawal symptoms overall. The mean and standard deviation will be reported.
| Group | Value | 95% CI |
|---|---|---|
| E-cigarette (JUUL) | 12 | ± 8.75 |
| Tobacco Cigarette | 11 | ± 8.03 |
The CES is a self-report survey measuring smoking/vaping satisfaction, psychological reward, aversion, sensations, and craving reduction. This 12-item instrument has a total score range from 12 to 84, with higher scores indicating higher perception of the above factors. The mean and standard deviation will be reported.
| Group | Value | 95% CI |
|---|---|---|
| E-cigarette (JUUL) | 49.5 | ± 12.87 |
| Tobacco Cigarette | 47.7 | ± 14.18 |
Time frame: Up to 1 month.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Electronic Cigarette | Tobacco Cigarette |
|---|---|---|---|
| cough | Respiratory, thoracic and mediastinal disorders | — | — |
| vertigo | Ear and labyrinth disorders | — | — |
Data from ClinicalTrials.gov NCT04053868 adverse events section.
This is an observational, crossover design that will examine the pharmacokinetics and pharmacodynamics of impact of smoking tobacco cigarettes or vaping the JUUL electronic cigarette.
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
Trials testing the same drug.
Trials by the same sponsor.
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/NCT04053868.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing