Finding studies
Finding studies
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Saves the questions and what to expect into your notes, next to the visit they belong to.
Dae Hee Han, PhD
CONTACT
Adam Leventhal, PhD
CONTACT
Lead
University of Southern California
With
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 (N=72) will self-administer 4 different nicotine pouches varied by nicotine concentration (e.g., 3mg vs. 6mg) and pH (e.g., 8.5 or greater vs. less than 8.5) equated on other product characteristics (e.g., pouch size and weight, moisture content) in a single-visit 4-hour within-subject double-blind randomized clinical trial. Participants will rate the appeal (e.g., liking, disliking, willingness to use again) and sensory attributes (e.g., 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 (e.g., 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 U.S. Food and Drug Administration regulation.
Age
21–35
Sex
ALL
Healthy volunteers
Accepted
