Clinical Trials Logo

Clinical Trial 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.


Clinical Trial Description

The AUS is a multi-site, open-label, 8-week, prospective observational study, conducted at multiple sites geographically dispersed within the U.S. Adult smokers will be recruited, and candidate subjects who meet study inclusion criteria and none of the exclusion criteria will give verbal consent for further screening. Candidate subjects will be scheduled to attend an in-person Site Enrollment Visit (SEV). At the SEV, site staff will confirm eligibility, including age verification with a government-issued photo identification. Candidate subjects will review product information and will be shown physical examples of the Study IP, but will not sample the products. Those who indicate an "intention to use" the Study IP will undergo a second consent process, will be enrolled in the study, and will install and be trained on an eDiary application on their personal smartphones or site provisioned devices. During a 1-week Baseline Assessment Period (BAP, Week 0), enrolled subjects will record all CC and any other TNP use in the eDiary. At the end of the BAP, subjects will return to the study site for Site Visit 1 (SV1). At this visit, subjects will be able to select up to five different Study IPs for the first two weeks of the AUP from the Study IPs available. During the subsequent 6-week observational AUP, subjects can choose to use the Study IP (or not). Subjects will be instructed to record all daily Study IP, TNP and CC use in the eDiary. They will return to the site every two weeks during the AUP for an in-person interview to answer questionnaires and for product accountability and resupply. As with SV1, at Site Visit 2 (SV2) and Site Visit 3 (SV3), subjects will be able to select up to five IP varieties (if desired) for use during the subsequent 2-week AUP. After Week 6 of the AUP, there will be a final site visit (SV4) and week-long Close Out Period (COP). In addition to collecting information on daily ad libitum use of Study IP, TNP and CC use, the study will assess subjective measures (i.e., product assessment) for each Study IP, including product use behaviors and intent to use again (at close of study). Information on intention to quit CC will be collected at enrollment and at study conclusion. A passive surveillance mechanism will be used to collect information on adverse health experiences. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05184920
Study type Observational
Source RAI Services Company
Contact Erin Evans, MSHS
Phone 336-741-3521
Email [email protected]
Status Recruiting
Phase
Start date January 19, 2022
Completion date April 30, 2022

See also
  Status Clinical Trial Phase
Completed NCT03999411 - Smartphone Intervention for Smoking Cessation and Adherence to Anti- Retroviral Therapy (ART) Among People Living With Human Immunodeficiency Virus (HIV) Phase 4
Active, not recruiting NCT03931772 - Online Automated Self-Hypnosis Program N/A
Completed NCT02649556 - A 26-week Extension of the ZRHR-ERS-09-US Study Evaluating Biological and Functional Changes in Healthy Smokers After Switching to THS 2.2 N/A
Completed NCT03901066 - Smoking Dependence and Periodontitis
Completed NCT04808609 - Smoking Cessation Pilot for People Living With HIV (PLWH) N/A
Completed NCT03170752 - Implementing and Testing a Cardiovascular Assessment Screening Program (CASP) N/A
Completed NCT03305978 - Pulmonary Nodule Detection: Comparison of an Ultra Low Dose vs Standard Scan. N/A
Completed NCT00000437 - Tobacco Dependence in Alcoholism Treatment (Nicotine Patch/Naltrexone) Phase 4
Active, not recruiting NCT02752022 - Monitoring the Transition From Smoking to E-cigarettes
Completed NCT04340830 - The Effect of Smoking on Dimensional Changes of Free Gingival Graft Around Dental Implants N/A
Completed NCT03206619 - A Health Recommeder System to Tailor Message Preferences in a Smoking Cessation Programme
Completed NCT02912000 - TEACH: Technology Evaluation to Address Child Health N/A
Completed NCT02901171 - The Contribution of a Smartphone Application to Acceptance and Commitment Therapy Group Treatment for Smoking Cessation N/A
Completed NCT02949648 - Electronic Cigarette Use and Quitting in Youth N/A
Completed NCT02945371 - Tailored Inhibitory Control Training to Reverse EA-linked Deficits in Mid-life N/A
Completed NCT02246114 - Self-Monitoring of Carbon Monoxide to Enhance Reproductive Outcomes in Women N/A
Recruiting NCT02008292 - Acetylcholine, Tobacco Smoking, Genes and Nicotinic Receptors N/A
Completed NCT01898507 - Nicotine Metabolism and Low Nicotine Cigarettes N/A
Completed NCT03448900 - Intervention Study for Smoking Cessation in Spanish College Students N/A
Completed NCT01954407 - Young Adults' Responses to Anti-smoking Messages N/A