Abuse Liability and Appeal of Oral Nicotine Products
The Effect of Flavor and Nicotine Strength on the Abuse Liability and Appeal of Oral Nicotine Products
2 other identifiers
interventional
320
1 country
2
Brief Summary
There has been a recent proliferation of novel oral nicotine products (ONPs) brought to market, including new nicotine gums and pouches. Unlike electronic cigarettes (ECs) ONPs have no impending regulatory barriers with regard to flavoring or nicotine dose, and manufacturers have capitalized on this by introducing an extensive slate of characterizing flavors and nicotine concentrations. Both sales trajectory and the surge in marketing suggest ONP use is likely to increase in the coming years. Work by the investigators and others indicates that interest in these products is high among current EC users, and among specific demographic groups including those who identify as sexual and gender minority (SGM). ONP use is discrete and so can function as a secondary source of nicotine, encouraging dual use patterns and more severe nicotine dependence. Depending on the use patterns of ONPs that emerge, regulation of ONPs may serve the public health interest. However, very little is known about factors relevant to the actual appeal and abuse liability of these products. The investigators propose to address this important gap by assessing the appeal and abuse liability of gum and pouch ONPs as a function of flavor (mint vs fruit) and nicotine concentration (2mg vs. 4mg). Flavor and nicotine strength, along with product type, are regulatable attributes, and so it is essential to understand their impact on appeal and abuse liability. Evidence from EC use suggests a potential interaction between flavor and nicotine strength, with flavorants in the "mint" category desensitizing receptors integral to the aversive sensory experience of nicotine, leading to greater tolerability of high nicotine concentration. Because of current ONP marketing emphasis on youth, the investigators will recruit young adult exclusive EC users (N = 320; ages 21 - 25). The investigators will target recruitment of a sufficient number of SGM participants (N = 64, 20% of sample) to allow assessment of potential differentiation of this group. Participants will complete one virtual session focused on assessment of the sensory appeal of ONPs. Based on individual participant ratings, the preferred fruit and the preferred mint ONP will be selected (from their randomized product type and nicotine strength) to each be assessed in a single-product session examining factors known to predict abuse liability (relief of withdrawal, liking, behavioral economic indices of demand, and follow-up naturalistic product use). The investigators will pay particular attention to evidence suggesting dual use potential of ONPs, given its association with greater severity of nicotine dependence. The proposed work will inform efforts to mitigate ONPs potential to promote dual-use and more severe nicotine dependence among young adult EC users, by isolating the impact of potential regulatory targets.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2024
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 9, 2024
CompletedFirst Submitted
Initial submission to the registry
July 3, 2024
CompletedFirst Posted
Study publicly available on registry
July 17, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 14, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 14, 2028
July 17, 2024
July 1, 2024
4 years
July 3, 2024
July 10, 2024
Conditions
Outcome Measures
Primary Outcomes (2)
Product appeal ratings
Participants will rate the sensory appeal of products and their motivation to use the products
immediately after the intervention
Product consumption
Participants will have periods in which ad lib use of the product ("use as much or as little as you like") and the total used will be recorded
immediately after the intervention
Secondary Outcomes (2)
Behavioral economic measures related to abuse liability
immediately after the intervention
ad lib use at home
7 days after each abuse liability session
Study Arms (4)
Low Nicotine Gum
ACTIVE COMPARATORParticipants in this arm will only use Lucy brand 2mg nicotine gum
High Nicotine Gum
ACTIVE COMPARATORParticipants in this arm will only use Lucy brand 6mg nicotine gum
Low Nicotine Pouch
ACTIVE COMPARATORParticipants in this arm will only use ON! brand 2mg nicotine pouches
High Nicotine Pouch
ACTIVE COMPARATORParticipants in this arm will only use ON! brand 6mg nicotine pouches
Interventions
The study will compare sweet vs. cool flavors
The study will compare low vs. high strength Oral Nicotine Products
Eligibility Criteria
You may qualify if:
- aged 21-25 years
- current exclusive EC user (defined as at least weekly use over the past 3 months) and recent nicotine use confirmed by positive urine test (\>1 semiquantitative Total Nicotine Equivalent; see below)
- not currently using another tobacco/nicotine product (defined as no use in the past 6 months)
- have never used any ONP (medicinal or nonmedicinal)
- willing to try study provided ONPs.
You may not qualify if:
- recent COVID-19+ (positive test in the past 30 days)
- a recent COVID-19 hospitalization (past 3 months)
- unstable or significant psychiatric conditions (past and stable conditions allowed)
- history of cardiac event or distress within the past 3 months
- currently pregnant (based on urine pregnancy test), planning to become pregnant, or breastfeeding.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Southern Californialead
- National Cancer Institute (NCI)collaborator
- Food and Drug Administration (FDA)collaborator
Study Sites (2)
University of Southern California
Los Angeles, California, 90089, United States
University of Southern California
Los Angeles, California, 90089, United States
Related Publications (16)
Ali FRM, Vallone D, Seaman EL, Cordova J, Diaz MC, Tynan MA, Trivers KF, King BA. Evaluation of Statewide Restrictions on Flavored e-Cigarette Sales in the US From 2014 to 2020. JAMA Netw Open. 2022 Feb 1;5(2):e2147813. doi: 10.1001/jamanetworkopen.2021.47813.
PMID: 35142832BACKGROUNDBuchting FO, Emory KT, Scout, Kim Y, Fagan P, Vera LE, Emery S. Transgender Use of Cigarettes, Cigars, and E-Cigarettes in a National Study. Am J Prev Med. 2017 Jul;53(1):e1-e7. doi: 10.1016/j.amepre.2016.11.022. Epub 2017 Jan 13.
PMID: 28094133BACKGROUNDWheldon CW, Wiseman KP. Tobacco Use Among Transgender and Gender Non-conforming Adults in the United States. Tob Use Insights. 2019 May 23;12:1179173X19849419. doi: 10.1177/1179173X19849419. eCollection 2019.
PMID: 31205426BACKGROUNDLunell E, Fagerstrom K, Hughes J, Pendrill R. Pharmacokinetic Comparison of a Novel Non-tobacco-Based Nicotine Pouch (ZYN) With Conventional, Tobacco-Based Swedish Snus and American Moist Snuff. Nicotine Tob Res. 2020 Oct 8;22(10):1757-1763. doi: 10.1093/ntr/ntaa068.
PMID: 32319528BACKGROUNDLeventhal AM, Goldenson NI, Barrington-Trimis JL, Pang RD, Kirkpatrick MG. Effects of non-tobacco flavors and nicotine on e-cigarette product appeal among young adult never, former, and current smokers. Drug Alcohol Depend. 2019 Oct 1;203:99-106. doi: 10.1016/j.drugalcdep.2019.05.020. Epub 2019 Aug 1.
PMID: 31434028BACKGROUNDGoldenson NI, Leventhal AM, Simpson KA, Barrington-Trimis JL. A Review of the Use and Appeal of Flavored Electronic Cigarettes. Curr Addict Rep. 2019 Jun;6(2):98-113. doi: 10.1007/s40429-019-00244-4. Epub 2019 May 17.
PMID: 31453046BACKGROUNDLeventhal A, Cho J, Barrington-Trimis J, Pang R, Schiff S, Kirkpatrick M. Sensory attributes of e-cigarette flavours and nicotine as mediators of interproduct differences in appeal among young adults. Tob Control. 2020 Nov;29(6):679-686. doi: 10.1136/tobaccocontrol-2019-055172. Epub 2019 Dec 18.
PMID: 31852818BACKGROUNDHoutsmuller EJ, Fant RV, Eissenberg TE, Henningfield JE, Stitzer ML. Flavor improvement does not increase abuse liability of nicotine chewing gum. Pharmacol Biochem Behav. 2002 Jun;72(3):559-68. doi: 10.1016/s0091-3057(02)00723-2.
PMID: 12175452BACKGROUNDKing JL, Reboussin D, Cornacchione Ross J, Wiseman KD, Wagoner KG, Sutfin EL. Polytobacco Use Among a Nationally Representative Sample of Adolescent and Young Adult E-Cigarette Users. J Adolesc Health. 2018 Oct;63(4):407-412. doi: 10.1016/j.jadohealth.2018.04.010. Epub 2018 Aug 13.
PMID: 30115508BACKGROUNDTackett AP, Hebert ET, Smith CE, Wallace SW, Barrington-Trimis JL, Norris JE, Lechner WV, Stevens EM, Wagener TL. Youth use of e-cigarettes: Does dependence vary by device type? Addict Behav. 2021 Aug;119:106918. doi: 10.1016/j.addbeh.2021.106918. Epub 2021 Mar 23.
PMID: 33798918BACKGROUNDMorean ME, Krishnan-Sarin S, Sussman S, Foulds J, Fishbein H, Grana R, Halpern-Felsher B, Kim H, Weaver SR, O'Malley SS. Development and psychometric validation of a novel measure of sensory expectancies associated with E-cigarette use. Addict Behav. 2019 Apr;91:208-215. doi: 10.1016/j.addbeh.2018.08.031. Epub 2018 Aug 31.
PMID: 30197032BACKGROUNDCox LS, Tiffany ST, Christen AG. Evaluation of the brief questionnaire of smoking urges (QSU-brief) in laboratory and clinical settings. Nicotine Tob Res. 2001 Feb;3(1):7-16. doi: 10.1080/14622200020032051.
PMID: 11260806BACKGROUNDCassidy RN, Long V, Tidey JW, Colby SM. Validation of an E-cigarette Purchase Task in Advanced Generation Device Users. Nicotine Tob Res. 2020 Oct 8;22(10):1851-1859. doi: 10.1093/ntr/ntaa060.
PMID: 32267947BACKGROUNDMackillop J, Murphy JG, Tidey JW, Kahler CW, Ray LA, Bickel WK. Latent structure of facets of alcohol reinforcement from a behavioral economic demand curve. Psychopharmacology (Berl). 2009 Mar;203(1):33-40. doi: 10.1007/s00213-008-1367-5. Epub 2008 Oct 17.
PMID: 18925387BACKGROUNDHursh SR, Silberberg A. Economic demand and essential value. Psychol Rev. 2008 Jan;115(1):186-98. doi: 10.1037/0033-295X.115.1.186.
PMID: 18211190BACKGROUNDGonzalez-Roz A, Jackson J, Murphy C, Rohsenow DJ, MacKillop J. Behavioral economic tobacco demand in relation to cigarette consumption and nicotine dependence: a meta-analysis of cross-sectional relationships. Addiction. 2019 Nov;114(11):1926-1940. doi: 10.1111/add.14736. Epub 2019 Aug 18.
PMID: 31313403BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
John R Monterosso, PhD
University of Southern California
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assoc Prof Psychology
Study Record Dates
First Submitted
July 3, 2024
First Posted
July 17, 2024
Study Start
February 9, 2024
Primary Completion (Estimated)
February 14, 2028
Study Completion (Estimated)
February 14, 2028
Last Updated
July 17, 2024
Record last verified: 2024-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
- Time Frame
- Data will be made available within a target of 1 year after study completion
- Access Criteria
- To be determined
This study is part of the USC Tobacco Center of Regulatory Science (TCORS). We will approach data sharing in two ways: 1) USC TCORS website will include a listing of all data sets and associated data dictionaries; and 2) a formal policy will be developed for collaborative data sharing with investigators from other TCORS or other research entities. USC TCORS will provide ongoing documentation of data sets so that potential collaborators can identify opportunities to engage with the USC team and it will describe NIH policies related to collaboration and data sharing with other academics and the community. After projects have been completed and data analyzed and reported, targeting one year after completion of data collection, we will make de-identified data available generally. We will incorporate appropriate language about provision of data access into our consent processes. We will make available data codebooks, survey platforms and experimental protocols.