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NCT05239884
CSD201202: A Study to Assess Nicotine Uptake From Electronic Nicotine Delivery System P12
NA trial testing ENDS Product A with 1.5% nicotine in Smoking in 36 participants. Completed in 15 April 2022.
15 April 2022
Quick facts
| Lead sponsor | RAI Services Company |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | other |
| Enrollment | 36 |
| Start date | 14 March 2022 |
| Primary completion | 15 April 2022 |
| Estimated completion | 15 April 2022 |
| Sites | 1 location across United States |
Drugs / interventions tested
- ENDS Product A with 1.5% nicotine
- ENDS Product B with 1.5% nicotine
- ENDS Product C with 1.5% nicotine
- ENDS Product D with 1.5% nicotine
- ENDS Product E with 1.5% nicotine
- ENDS Product F with 1.5% nicotine
- ENDS Product G with 1.5% nicotine
- ENDS Product H with 1.5% nicotine
Conditions studied
- Smoking — all drugs for Smoking →
- Tobacco Use — all drugs for Tobacco Use →
Sponsor
RAI Services Company
Who can join
Adults 21 to 60, any sex, with Smoking or Tobacco Use. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is an open-label, randomized, 8-way crossover study designed to evaluate plasma nicotine pharmacokinetic (PK) parameters following an ad libitum use of Electronic Nicotine Delivery System (ENDS) investigational products (IPs) in a confinement setting by generally healthy combustible cigarette (CC) smokers and dual users of CC and ENDS.
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 NCT05239884
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other RAI Services Company trials
Trials by the same sponsor.
- NCT07323563 — A Study to Assess Nicotine Uptake From Electronic Nicotine Delivery Systems · NA · not yet recruiting
- NCT07323511 — Abuse Liability for Eight Electronic Nicotine Products · NA · not yet recruiting
- NCT07132814 — Abuse Liability for Five Modern Oral Nicotine Products · NA · recruiting
- NCT07172438 — A RCT to Determine the Effect of ENDS Flavor Availability on Abstinence Within Smokers · NA · terminated
- NCT07175987 — A Consumer Use Behavior Study to Evaluate Puffing Topography and Average Daily Consumption of Heated Tobacco Products · 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 NCT05239884 (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 RAI Services Company
- Last refreshed: 24 June 2022
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/NCT05239884.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing