Designing Studies to Inform Tobacco Harm Reduction: Learnings From an Oral Nicotine Pouch Actual Use Pilot Study.

ABSTRACT:

Background

Introduction of new tobacco products in the United States, including those that may be lower on the risk continuum than traditional combustible cigarettes, requires premarket authorization by the US Food and Drug Administration and information on the potential impact of the products on consumer behaviors. Efficient recruitment and data capture processes are needed to collect relevant information in a near-to-real-world environment.

Objective

The aim of this pilot study was to develop and test a protocol for an actual use study of a new tobacco product. The product included in this study was a commercially available oral nicotine pouch. Through the process of study design and execution, learnings were garnered to inform the design, execution, analysis, and report w

SUBMITTER: Campbell C 

PROVIDER: S-EPMC9440415 | biostudies-literature | 2022 Aug

REPOSITORIES: biostudies-literature