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NCT05294497

CSD201301: Study to Assess Elements of Abuse Liability for Four P13 Nicotine Pouches

Completed NA Last updated 29 June 2022
What this trial tests

NA trial testing Product A in Smoking in 42 participants. Completed in 27 May 2022.

Timeline
1 May 2022
Primary endpoint
27 May 2022
27 May 2022

Quick facts

Lead sponsorRAI Services Company
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designcrossover
Maskingnone
Primary purposeother
Enrollment42
Start date1 May 2022
Primary completion27 May 2022
Estimated completion27 May 2022
Sites2 locations across United States

Drugs / interventions tested

Conditions studied

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):

  1. 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:

Other trials of Product A

Trials testing the same drug.

Other recruiting trials for Smoking

Currently open trials in the same condition.

Other RAI Services Company trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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