Youth use of e-cigarettes: Does dependence vary by device type?
Alayna P Tackett, Emily T Hébert, Caitlin E Smith...
https://pubmed.ncbi.nlm.nih.gov/33798918/Actively Recruiting
Led by University of Southern California · Updated on 2026-07-09
320
Participants Needed
2
Research Sites
N/A
Total Duration
Researchers are studying the appeal and abuse potential of new oral nicotine products ONPs, such as nicotine gum and pouches, among young adult exclusive e-cigarette EC users aged 21 to 25. These products come in various flavors and nicotine strengths, and their use may lead to dual use with ECs, which could increase nicotine dependence. The study focuses on how flavor mint vs. fruit and nicotine concentration 2mg vs. 6mg affect the products appeal and abuse liability, especially in sexual and gender minority SGM groups. Participants will be randomized to use either gum or pouch ONPs with either low 2mg or high 6mg nicotine strength. The study involves three virtual sessions conducted remotely a sensory appeal session testing mint and fruit flavors, followed by two abuse liability sessions where participants use their preferred flavors after 18 hours of nicotine abstinence. Participants will receive the study products by mail, including devices for verifying smoking abstinence and supplies for sample collection. During the study, participants will rate the appeal and sensory qualities of the products, and researchers will measure withdrawal relief, craving suppression, subjective effects, and economic demand for the ONPs. After each abuse liability session, participants will report their naturalistic use of the products daily for seven days. The study will gather detailed data on dual use patterns and abuse liability to inform regulations aimed at reducing nicotine dependence in young adults.
CONDITIONS
Abuse Liability and Appeal of Oral Nicotine Products
J
John R Monterosso, PhD
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University of Southern California
Lead Sponsor
National Cancer Institute (NCI)
Collaborating Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | Low‑nicotine gum | High‑nicotine gum | Low‑nicotine pouch | High‑nicotine pouch |
|---|---|---|---|---|
| What it is | Investigational low‑nicotine oral nicotine gum variant tested in the study | Investigational high‑nicotine oral nicotine gum variant tested in the study | Investigational low‑nicotine oral nicotine pouch variant tested in the study | Investigational high‑nicotine oral nicotine pouch variant tested in the study |
| Role in trial | Randomized investigational arm | Randomized investigational arm | Randomized investigational arm | Randomized investigational arm |
| Primary use | Evaluated for abuse liability and appeal based on flavor and nicotine concentration | Evaluated for abuse liability and appeal based on flavor and nicotine concentration | Evaluated for abuse liability and appeal based on flavor and nicotine concentration | Evaluated for abuse liability and appeal based on flavor and nicotine concentration |
| How it is given or performed | Oral nicotine gum with low nicotine strength and a specified flavor | Oral nicotine gum with high nicotine strength and a specified flavor | Oral nicotine pouch with low nicotine strength and a specified flavor | Oral nicotine pouch with high nicotine strength and a specified flavor |
| Evidence context | Nicotine gum is an FDA‑approved first‑line smoking cessation aid and common form of nicotine replacement therapy | Nicotine gum is an FDA‑approved first‑line smoking cessation aid as above | Oral nicotine pouches are not an established treatment; evidence for appeal and abuse liability is emerging | As above, oral nicotine pouches are still under study and not yet standard therapy |
| Important limitations | Trial does not compare against standard-of-care nicotine replacement regimens like patch or lozenge | No standard NRT comparator arm limits clinical interpretability relative to current treatments | Same as above—no comparison to established oral NRT products or dosing regimens | Same limitation—no standard nicotine patch, gum, or lozenge comparator is included |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 1 week
Participants complete orientation via Zoom, provide informed consent, confirm nicotine use by urine test, and receive study materials by mail.
1 virtual session
Duration - 1 visit
Participants self-administer and rate the appeal and sensory attributes of mint and fruit flavored oral nicotine products during a virtual session.
1 virtual session
Duration - 2 visits and 7-day monitoring periods
Participants complete two separate sessions using their preferred mint and fruit flavored products after 18-hour nicotine abstinence, followed by daily reports of product use for 7 days.
2 virtual sessions plus daily surveys
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
4
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Lead Sponsor
National Cancer Institute (NCI)
Collaborating Sponsor