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NCT06303115
CSD231005 Nicotine Pouch Biomarkers of Exposure
NA trial testing Nicotine Pouch P1312914, 4 mg nicotine in Tobacco Use in 200 participants. Completed in 15 January 2025.
15 January 2025
Quick facts
| Lead sponsor | RAI Services Company |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | other |
| Enrollment | 200 |
| Start date | 22 August 2024 |
| Primary completion | 15 January 2025 |
| Estimated completion | 15 January 2025 |
| Sites | 5 locations across United States |
Drugs / interventions tested
- Nicotine Pouch P1312914, 4 mg nicotine
- Nicotine Pouch P1312915, 8 mg nicotine
- Nicotine Pouch P1013215, 8 mg nicotine
- Nicotine Pouch P1013218, 10 mg nicotine
- Nicotine Pouch P1012919, 12 mg nicotine
- Smoking Abstinence
- Continued UB cigarette smoking
Conditions studied
- Tobacco Use — all drugs for Tobacco Use →
- Smoking — all drugs for Smoking →
Sponsor
RAI Services Company
Who can join
Adults 21 to 60, any sex, with Tobacco Use or Smoking. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This will be a multi center open label, randomized, controlled, switching parallel-group study designed to assess changes in select biomarkers of exposure (BoE) in generally healthy smokers following a 5 day in-clinic switch to use of nicotine Pouch investigational products (IPs) compared to continued usual brand (UB) cigarette smoking or smoking abstinence.
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 NCT06303115
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Tobacco Use
Currently open trials in the same condition.
- NCT07162935 — Cigar Legislation and Regulation in Tobacco for the Young (Project CLARITY) · NA · recruiting
- NCT07132814 — Abuse Liability for Five Modern Oral Nicotine Products · NA · recruiting
- NCT07148232 — Extended Intervention for Tobacco Use (EXIT) for People Experiencing Homelessness · Phase 4 · recruiting
- NCT06983678 — Neural Correlates and Behavioral Impact of Withdrawal-induced Hyperalgesia Among People Who Smoke With and Without Chron · NA · recruiting
- NCT06922617 — STEPS: Substance Use Trial of E-cigarettes or Pharmacotherapy for Smoking · 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 NCT06303115 (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: 11 April 2025
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/NCT06303115.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing