Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06597435
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-29
Brief Title:
Effects of Nicotine Pouch Characteristics on Perceptions and Behavior
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Effect of Product Characteristics on the Appeal and Sensory Attributes of Nicotine Pouches
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
There is a growing sector of modern tobacco-free oral nicotine pouches that are federally regulated as non-medicinal nicotinetobacco products While nicotine pouches employ marketing approaches that may attract current tobacco users such as marketing themes connoting minimal harm information on the long-term health effects of nicotine pouches is lacking nicotine pouches may appeal to younger adults because they are available in similar product characteristics eg nicotine concentration protonated nicotine that many younger people prefer to use in e-cigarettes In addition nicotine pouches may be of particular interest to younger adult e-cigarette users because these products can be used discreetly where vaping is not allowed which may translate into an increased likelihood of becoming dual users of e-cigarettes and nicotine pouches Indeed approximately 15 young adults who used e-cigarettes in the past 30 days were past 30-day nicotine pouch users Manufacturers of modern nicotine pouches use acid additives to lower pH which changes nicotine from a free-base to a protonated nicotine resulting in improved appeal and sensory experience and higher abuse liability Thus nicotine concentration and pH in modern nicotine pouches should be focal targets for regulatory policies Evidence is also lacking on mechanisms mediating differences in product appeal and abuse liability of nicotine pouches across products varying in nicotine concentration and pH level The scientific objective of this research is to assess the effect of variation in nicotine concentration in nicotine pouches and its interaction effect with pH level on the proximal outcomes of relevance to the US Food and Drug Administration regulation sensory attributes and product appeal among younger adults who use nicotine pouches in the past 30 days current dual users of nicotine pouches and e-cigarettes andor combustible cigarettes will be eligible and are unmotivated to quit nicotine use This innovative project proposes to conduct a double-blind within-subject randomized study in which participants N 72 will administer nicotine pouches varied by nicotine concentration eg 3 vs 6 mg and pH eg 85 or greater vs less than 85 to achieve the project aim to evaluate the effects of nicotine concentration and pH on subjective product appeal and sensory attributes of nicotine pouches The findings of this proposed research will provide the US Food and Drug Administration with new evidence necessary to inform regulatory restrictions on product characteristics and constituents of nicotine pouches which may put young adults at risk of using a novel class of oral nicotine products
Detailed Description:
The project will assess the effect of variation in nicotine concentration in nicotine pouches and its interaction effect with pH level on two proximal outcomes of relevance to regulation 1 sensory attributes and 2 product appeal in an experimental study of young adult 21-35 years nicotine pouch users who are unmotivated to quit nicotine use Before the experimental session the investigators will conduct orientation sessions where participants will confirm age provide informed consent and complete verification of nicotine use status by cotinine test strip Eligible participants will be scheduled for their experimental visits and instructed to abstain from nicotine use for 8 hours overnight prior to the experimental session During the experimental session participants N72 will self-administer 4 different nicotine pouches varied by nicotine concentration eg 3mg vs 6mg and pH eg 85 or greater vs less than 85 equated on other product characteristics eg pouch size and weight moisture content in a single-visit 4-hour within-subject double-blind randomized clinical trial Participants will rate the appeal eg liking disliking willingness to use again and sensory attributes eg smoothness harshness sweetness bitterness irritation of each nicotine pouch and select their favorite nicotine pouch product alternative appeal measure at the end of the study During the experimental sessions questionnaires will also assess participants nicotine product use characteristics and sociodemographic characteristics After the experimental session participants will be remunerated Study materials will be selected among commercially available products manufactured by leading providers eg ZYN Lucy VELO Rogue on and product constituents will be analyzed and reported This project will identify two product characteristics low pH and high nicotine that may perpetuate nicotine pouch use and nicotine dependence risk by increasing their appeal and potential abuse liability in young adults and therefore merit targeting in the US Food and Drug Administration regulation
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None