Evaluation of Statewide Restrictions on Flavored e-Cigarette Sales in the US From 2014 to 2020.
Fatma Romeh M Ali, Donna Vallone, Elizabeth L Seaman...
https://pubmed.ncbi.nlm.nih.gov/35142832Actively Recruiting
Led by University of Southern California · Updated on 2024-07-17
320
Participants Needed
2
Research Sites
N/A
Total Duration
U
University of Southern California
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
Researchers are investigating the appeal and potential for abuse of new oral nicotine products (ONPs), such as gums and pouches, among young adults who currently use e-cigarettes (ECs). This study focuses on how flavor (mint vs. fruit) and nicotine strength (2mg vs. 6mg) influence the attractiveness and abuse risk of these products. Special attention is given to sexual and gender minority (SGM) individuals, as they show higher interest in ONPs. Understanding these factors will help guide regulations to prevent harmful dual use of ECs and ONPs that may increase nicotine dependence. Participants will be randomly assigned to use either nicotine gum or pouches with a low (2mg) or high (6mg) nicotine dose. The study involves three virtual sessions conducted remotely, where participants self-administer different flavored ONPs and provide ratings on appeal and sensory experiences. Following initial sensory testing, participants complete two abuse liability sessions with their preferred mint and fruit flavors, including controlled use and a seven-day period of naturalistic product use at home. Throughout the study, participants will complete surveys on nicotine withdrawal, cravings, and subjective effects. Behavioral economic measures will assess the demand for ONPs under different conditions. Researchers will monitor natural use patterns, including use in places where vaping is usually restricted. The primary outcomes are product appeal and consumption immediately after use, with additional measures taken during and after the abuse liability sessions. Participants will be closely monitored for nicotine abstinence and adherence during each phase of the study.
CONDITIONS
Abuse Liability and Appeal of Oral Nicotine Products
You may qualify if you...
You will not qualify if you...
Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Initial phone screen and online screener; orientation session conducted over Zoom for informed consent and baseline assessments.
Duration - 1 day
Participants complete baseline assessments including a urine nicotine test and demographic surveys; then they are randomized to one of four groups based on oral nicotine product type and nicotine concentration.
1 online orientation session (remote, via Zoom)
Duration - 1 day
Participants self-administer four flavored oral nicotine products (two mint and two fruit) in a single visit to rate product appeal and sensory attributes.
1 online experimental session with controlled product use
Duration - 2 weeks
Participants complete two separate sessions testing abuse liability for their top-rated fruit and mint flavored oral nicotine products, each followed by a 7-day period of naturalistic product use and daily reporting.
2 online experimental sessions plus daily electronic surveys for 7 days after each session
Total: 2 locations
1
University of Southern California
Los Angeles, California, United States, 90089
Actively Recruiting
2
University of Southern California
Los Angeles, California, United States, 90089
Actively Recruiting
J
John R Monterosso, PhD
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
4
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