CSD201004: An Actual Use Study of P10 and P13 Nicotine Pouches Among U.S. Adult Smokers

Summary

The purpose of this Actual Use Study (AUS) is to investigate how U.S. adult tobacco consumers 21-60 years of age) who are regular smokers (≥5 cigarettes/day) on at least 20 days out of the past 30 days will use P10 and P13 nicotine pouches (Study Investigational Product \[IP\]) over a 6-week Actual Use Period (AUP) in their real-life/naturalistic environment and in the context of typical consumer marketing materials. Subjects will self-report their ad libitum use of the Study IP as well as use of combustible cigarette (CC) and any other tobacco- or nicotine-containing product (TNP) on a daily basis using an electronic diary (eDiary). The study design is planned to address topics that FDA's Center for Tobacco Products (CTP) has identified as useful in evaluating new tobacco products.

Conditions

• Smoking
• Tobacco Use
• Tobacco Smoking

Interventions

OTHER

P1012919 nicotine pouch

P1012919, a nicotine pouch with 12 mg of nicotine

OTHER

P1012915 nicotine pouch

P1012915, a nicotine pouch with 8 mg of nicotine

OTHER

P1012914 nicotine pouch

P1012914, a nicotine pouch with 4 mg of nicotine

OTHER

P1013315 nicotine pouch

P1013315, a nicotine pouch with 8 mg of nicotine

OTHER

P1013119 nicotine pouch

P1013119, a nicotine pouch with 12 mg of nicotine

OTHER

P1013218 nicotine pouch

P1013218, a nicotine pouch with 10 mg of nicotine

OTHER

P1012818 nicotine pouch

P1012818, a nicotine pouch with 10 mg of nicotine

OTHER

P1312915 nicotine pouch

P1312915, a nicotine pouch with 8 mg of nicotine

OTHER

P1312914 nicotine pouch

P1312914, a nicotine pouch with 4 mg of nicotine

OTHER

P1313015 nicotine pouch

P1313015, a nicotine pouch with 8 mg of nicotine

OTHER

P1313314 nicotine pouch

P1313314, a nicotine pouch with 4 mg of nicotine

OTHER

P1312815 nicotine pouch

P1312815, a nicotine pouch with 8 mg of nicotine

Sponsors & Collaborators

• RAI Services Company

  lead INDUSTRY

Principal Investigators

• Patrudu Makena, PhD · RAIS

Eligibility

Min Age

21 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2022-01-19

Primary Completion

2022-04-29

Completion

2022-04-29

Countries

• United States

Study Locations