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NCT05294497
CSD201301: Study to Assess Elements of Abuse Liability for Four P13 Nicotine Pouches
NA trial testing Product A in Smoking in 42 participants. Completed in 27 May 2022.
27 May 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 | 42 |
| Start date | 1 May 2022 |
| Primary completion | 27 May 2022 |
| Estimated completion | 27 May 2022 |
| Sites | 2 locations across United States |
Drugs / interventions tested
Conditions studied
- Smoking — all drugs for Smoking →
- Tobacco Use — all drugs for Tobacco Use →
- Tobacco Smoking — all drugs for Tobacco Smoking →
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 a two-site, open-label, randomized, 6-way cross-over study designed to evaluate elements of abuse liability (AL) including subjective effects and physiological measures (pharmacodynamics \[PD\]) and plasma nicotine uptake (pharmacokinetics \[PK\]) during and following ad libitum use of the study investigational products (IPs) by generally healthy smokers.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Randomized crossover clinical studies to assess abuse liability and nicotine pharmacokinetics of Velo Oral Nicotine pouches.
Kanobe MN, Powell CY, Patrudu M, Baxter SA, et al · · 2025 · cited 2× · PMID 40183092 · DOI 10.3389/fphar.2025.1547073
Verify or expand the search:
- PubMed search for NCT05294497
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Product A
Trials testing the same drug.
- 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
- NCT06777784 — Modern Nicotine Oral Product Abuse Liability · NA · completed
- NCT06356610 — Pharmacokinetic and Subjective Effects of Heated Tobacco Products · NA · completed
Other recruiting trials for Smoking
Currently open trials in the same condition.
- NCT07488741 — Comparison of the Effects of Different Chest Techniques on University Students With Smoking Addiction · NA · recruiting
- NCT07443631 — Assessment of HPHC Exposure in Smokers Switching to THS/TP18 With Different Device Variants · NA · recruiting
- NCT07132814 — Abuse Liability for Five Modern Oral Nicotine Products · NA · recruiting
- NCT06966258 — Inspire HER: Inspiring the Heart and Emotions for Radical Health · NA · recruiting
- NCT06713603 — Technology Assisted Motivational Interviewing · NA · recruiting
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 NCT05294497 (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 RAI Services Company
- Last refreshed: 29 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/NCT05294497.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing