Smoking Clinical Trial - CSD190203: A Study to Determine Subject Puffing

Status Completed

Clinical Trial Summary

This study will be a single-center, randomized, controlled, open-label, parallel 2-cohort study to evaluate the puffing patterns of individuals switching from a similar usual brand (UB) Electronic Nicotine Delivery System (ENDS) product to either a 2.4% or 5% nicotine level ENDS product in healthy adult ENDS users. This study will be conducted for potential submission to the US Food and Drug Administration (FDA) Center for Tobacco Products (CTP) as part of a Premarket Tobacco Product Application (PMTA) for an Electronic Nicotine Delivery System (ENDS), comprised of an electrical power unit and four flavor variants each with two different levels of nicotine (2.4% and 5.0%).

Clinical Trial Description

Potential subjects will complete a pre-screening interview and a Screening Visit to assess their eligibility and, based on meeting eligibility requirements, will be enrolled into the study on the same day of the Screening Visit. Once enrolled, the subjects will be randomized to either the 5.0% nicotine ENDS products or the 2.4% nicotine ENDS products. Once randomized to the nicotine level, subjects will be assigned to one of the four flavor variants based on alignment with their preferred UB flavor. Subjects will be provided an orientation to the product and the Product Use and Behavior (PUB) instrument and provided with enough cartridges (sufficient for three weeks of product use [125% their reported weekly use of their UB]) to last the 3-week period of the study. The subjects will take the products home and use them ad libitum for a 1-week acclimation period followed by a 2-week product use period. During this time product use will be captured by the PUB instrument and their data uploaded to the cloud regularly. At the conclusion of the 3-week ambulatory period, the subject will return to the clinic, return the ENDS power unit, used and unused ENDS cartridges, and the PUB instrument (and all cables/charger), have his/her health status reevaluated, complete the Product Evaluation Scale (PES) questionnaire and will then be discharged from the study. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04104152
Study type	Interventional
Source	RAI Services Company
Contact
Status	Completed
Phase	N/A
Start date	October 7, 2019
Completion date	March 6, 2020

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT03999411` - Smartphone Intervention for Smoking Cessation and Improving Adherence to Treatment Among HIV Patients	Phase 4
Completed	`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
Recruiting	`NCT05846841` - Personalized Tobacco Treatment in Primary Care (MOTIVATE)	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
Completed	`NCT06105424` - BRP1602: Evaluation of Technical and Logistical Feasibility to Measure Lung Permeability	N/A
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	`NCT02901171` - The Contribution of a Smartphone Application to Acceptance and Commitment Therapy Group Treatment for Smoking Cessation	N/A
Completed	`NCT02912000` - TEACH: Technology Evaluation to Address Child Health	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
Completed	`NCT01954407` - Young Adults' Responses to Anti-smoking Messages	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

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

CSD190203: A Study to Determine Subject Puffing Patterns of an Electronic Nicotine Delivery System in an Ambulatory Setting

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms