NCT07476144

Nordic Spirit Pouch Nicotine Pharmacokinetics Abuse Liability

Nicotine Pharmacokinetics and Subjective Effects of 9 Nordic Spirit Nicotine Pouch Products in Adult Cigarette Smokers: A Controlled, Randomized, Cross-over Study With a Balanced Incomplete Block Design.

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 55 (estimated)
• Sponsor: JT International SA · Industry
• Sex: All
• Age: 22 Years – 65 Years
• Healthy volunteers: Accepted

Summary

Nicotine pharmacokinetics and subjective effects of 9 Nordic Spirit Nicotine Pouch Products in adult cigarette smokers: A controlled, randomized, cross-over study with a balanced incomplete block design.

Detailed description

To characterize nicotine pharmacokinetic (PK) parameters following a single ad libitum administration of 9 Nordic Spirit nicotine pouches (NPs) relative to usual brand combustible cigarette (UBCC), Nicorette (NRT) gum, and a comparator NP product.

Conditions

• Smoking Behaviors

Interventions

Type	Name	Description
DRUG	Participants will place the pouch between their top lip and their gum for 30 minutes as per use instructions.	Participants will place the pouch between their top lip and their gum for 30 minutes as per use instructions. The pouch is not to be swallowed, chewed or broken. At the end of the 30-minute period, participants will remove the pouch and the study staff will collect and dispose of it accordingly. Nicotine pouches deliver nicotine through the mucous membranes of the mouth.

Timeline

• Start date: 2026-01-08
• Primary completion: 2026-04-01
• Completion: 2026-10-01
• First posted: 2026-03-17
• Last updated: 2026-03-17

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study