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NCT04123041
Characterize the Nicotine Uptake and Subjective Effects With Use of JUUL Electronic Nicotine Delivery Systems
NA trial testing JUUL ENDS, Combustible cigarette, comparator e-cigarette, Nicorette gum in Electronic Cigarette Use in 137 participants. Completed in 18 December 2019.
18 December 2019
Quick facts
| Lead sponsor | Juul Labs, Inc. |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | other |
| Enrollment | 137 |
| Start date | 23 September 2019 |
| Primary completion | 18 December 2019 |
| Estimated completion | 18 December 2019 |
| Sites | 2 locations across United States |
Drugs / interventions tested
- JUUL ENDS, Combustible cigarette, comparator e-cigarette, Nicorette gum
Conditions studied
- Electronic Cigarette Use — all drugs for Electronic Cigarette Use →
- Tobacco Smoking — all drugs for Tobacco Smoking →
Sponsor
Juul Labs, Inc.
Who can join
Adults 21 to 65, any sex, with Electronic Cigarette Use or Tobacco Smoking. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The purpose of this study is to estimate nicotine uptake and assess subjective effects during ad libitum use sessions of 4 flavors of JUUL ENDS (also referred to as nicotine salt pod system; NSPS) products (i.e., Virginia Tobacco, Mint, Menthol and Mango) with 2 different nicotine concentrations. Subjective effects will also be assessed to gain an understanding of the user's experience during and after JUUL ENDS product use to evaluate the abuse liability of the products. The subject population will consist of healthy adult, male and female smokers, 21 to 65 years of age.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT04123041
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Electronic Cigarette Use
Currently open trials in the same condition.
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- NCT06610838 — Effects of E-cigarette Use on Health · recruiting
- NCT04907136 — Developing and Testing Health Warning Labels on the ENDS Device · NA · recruiting
- NCT06142877 — Effects of Social Media Use on Young Adults' E-Cigarette Use · NA · recruiting
- NCT05338801 — Effect of Menthol on ENDS Users' Addiction and Exposure · NA · recruiting
Other Juul Labs, Inc. trials
Trials by the same sponsor.
- NCT04088175 — Study to Characterize Puffing Topography With Use of JUUL Electronic Nicotine Delivery Systems (ENDS) in Adult, Closed-S · NA · completed
- NCT04143256 — Evaluating Selected Constituents in the Exhaled Breath Samples · NA · completed
- NCT04107779 — Changes in Biomarkers of Cigarette Smoke Exposure After Switching Either Exclusively or Partly to JUUL ENDS · NA · completed
- NCT03700112 — Clinical Study Comparing 7 ENDS Products and 1 Combustible Cigarette Using 2 Delivery Methods. · NA · completed
- NCT03719391 — United States Pre-Market Tobacco Application Pharmacokinetics · NA · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04123041 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Juul Labs, Inc.
- Last refreshed: 13 February 2020
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/NCT04123041.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing