Effects of E-cigarette Flavors on Youth TCORS 2.0

Nicotine Use Disorder Clinical Trial

Official title:

Effects of E-cigarette Flavors on Youth

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03634839
• Other study ID #: 2000023077-1
• Secondary ID: 2U54DA036151-06
• Status: Completed
• Phase: Phase 1
• Start date: November 7, 2022
• Est. completion date: July 20, 2023

Study information

• Verified date: February 2024
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is an examination of the influence of sweet and cooling flavors on the appeal and abuse potential of nicotine-containing e-cigarettes among susceptible youth.

Description:

Researchers will examine the influence of sweet and cooling flavors on the appeal and abuse potential of nicotine-containing e-cigarettes among susceptible youth. Participants will rate the flavor intensity, coolness, sweetness, and irritation experienced using validated rating scales. Forty youth (18-20 years of age) who have experience with e-cigarettes and will participate in 1 laboratory session. They will receive 1 nicotine concentrations (36mg/ml nicotine salt) during the session; during the session they will be exposed, in random order, to sweet (watermelon) and sweet-cooling (watermelon-menthol) flavors combined with the assigned session nicotine concentration.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: July 20, 2023
• Est. primary completion date: June 16, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 20 Years

Eligibility

Inclusion Criteria:

• Ages 18-20 years

• Able to read and write

• Used e-cigs at least 10 times in lifetime

• Used e-cigs in past 30 days

Exclusion Criteria:

• Current use of non-prescription substances besides nicotine, marijuana, alcohol

• Any significant current medical or psychiatric condition

• Known hypersensitivity to propylene glycol

• Pregnant or lactating females

• Uncontrolled asthma

• Nut/e-liquid flavorant allergy

• current marijuana (tetrahydrocannabinol) vaping + E-cigarette or vaping use Associated Lung Injury (EVALI) symptoms

Related Conditions & MeSH terms

• Nicotine Use Disorder
• Tobacco Use Disorder

Intervention

Drug:
• Flavoring Agents
Flavor of e-liquid - sweet or tobacco
• Nicotine
Nicotine level (0, 3, or 12 mg)

Locations

Country	Name	City	State
United States	CMHC, Substance Abuse Center	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Lim J, Wood A, Green BG. Derivation and evaluation of a labeled hedonic scale. Chem Senses. 2009 Nov;34(9):739-51. doi: 10.1093/chemse/bjp054. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Exploratory Aim: Change in e-cigarette use 1 month after study procedures	Difference in e-cigarette use (number of days/month) after e-cigarette procedures	+1 month after lab session completion
Primary	Liking: Difference score in liking/wanting of each e-cigarette condition	The Labeled Hedonic Scale will be used to ask about liking and wanting of the e-cigarette (one item Visual Analog Scale with ratings ranging from "most disliked sensation imaginable" to "most liked sensation imaginable" with higher values indicating greater liking).	Following administration of e-cigarette condition 1 (+10 minutes), following administration of e-cigarette condition 2 (+40)
Primary	Reinforcing Efficacy: Difference score in drug effects of each e-cigarette condition	Difference between e-cigarette effects for each e-cigarette condition as measured by the computerized version of the Drug Effects Questionnaire (DEQ). Participants will self-report their responses using a computer mouse to indicate where on the scale response falls. A modified version of the Drug Effects Questionnaire (DEQ) will be used in which participants rate acute responses to the e-cigarette on a 0-100mm scale from "not at all" (0mm) to "extremely" (100mm).	Following administration of e-cigarette condition 1 (+10 minutes), following administration of e-cigarette condition 2 (+40)
Primary	Craving: change in craving score for e-cigarette	Difference from baseline in craving for each e-cigarette condition will be measured by the Generalized Labeled Magnitude Scale (gLMS). Participants will self-report their craving for e-cigarettes using a computer mouse to indicate where on the scale response falls. The Generalized Labeled Magnitude Scales (gLMS) are category ratio scales with seven semantic labels: "no sensation", "barely detectable", "weak", "moderate", "strong", "very strong", and "strongest imaginable", positioned quasi-logarithmically as per empirically determined semantic magnitudes on a 0-100 scale (strongest imaginable at the 100 end).	At baseline (+0 minutes), Following administration of e-cigarette condition 1 (+10 minutes), following administration of e-cigarette condition 2 (+40)
Primary	Irritation/Harshness: Difference score in irritation of harshness of each e-cigarette condition	Difference in irritation at each e-cigarette condition as measured by the computerized Generalized Labeled Magnitude Scale (gLMS). Participants will self-report their responses using a computer mouse to indicate where on the scale response falls. The Generalized Labeled Magnitude Scales (gLMS) are category ratio scales with seven semantic labels: "no sensation", "barely detectable", "weak", "moderate", "strong", "very strong", and "strongest imaginable", positioned quasi-logarithmically as per empirically determined semantic magnitudes on a 0-100 scale (strongest imaginable at the 100 end).	Following administration of e-cigarette condition 1 (+10 minutes), following administration of e-cigarette condition 2 (+40)