Do Flavors Increase the Addiction Potential of Nicotine?

NCT04696380 | Completed Phase 2 FDA Drug FDA Device

• 1 other identifier: CHRMS 00000555
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

The FDA has concluded that flavors (e.g. menthol) are associated with greater addiction potential in tobacco cigarettes (Gottlieb March 13, 2019). Whether the same is true for e-cigarettes and non-menthol flavors is unclear and our study should help answer this question. Our major hypothesis is that the pharmacological effect of nicotine to induce addiction will be greater with use of a preferred e-cigarette flavor than with use of a non-preferred flavor. The pharmacological effect will be measured by how much a larger nicotine dose increases addiction potential compared to a smaller dose.

Conditions

Nicotine Dependence

Outcome Measures

Primary Outcomes (6)

• Liking and wanting nicotine

  Average of "I feel good e-cigarette effects", "I want more of that e-cigarette I received", "I feel the e-cigarette strength" and "I like the e-cigarette effect" on a 0-100mm scale from "not at all" (0) to "extremely" (100).

  2 weeks

• E-cigarette purchase task

  This is a modification of the Cigarette Purchase Task that asks how much users would spend to obtain their usual amount of e-liquids to use.

  2 weeks

• E-cigarette and tobacco cigarette craving

  Modified items from the Mood and Physical Symptoms Scale that asks about change/strength of urges for e-cigarettes and tobacco cigarettes (0-4 scale, 0= not at all and 4= extremely) and strength of urges (1-5 scale, 1=slight and 5= extremely strong).

  2 weeks

• Modified Drug Effect Questionnaire

  Modified version of the Drug Effects Questionnaire where participants rate acute responses to the e-cigarette drug effects on a 0-100 mm scale, from "not at all" (0) to "extremely" (100).

  2 weeks

• Modified Labeled Hedonic Scale

  1 item about like/dislike of the e-cigarette taste using a modified version of the Labeled Hedonic Scale, a category ratio scale that ranges from -100 (most disliked) to 100 (most liked).

  2 weeks

• Modified Labeled Magnitude Scale

  1 item about e-cigarette taste intensity using a modified version of the Labeled Magnitude Scale, which is a category ratio scale with 7 semantic labels: "no sensation", "barely detectable", "weak", "moderate", "strong", "very strong", and "strongest imaginable", with responses coded on a 0-100 scale (0= no sensation, 100= strongest imaginable).

  2 weeks

Study Arms (4)

High nicotine, preferred flavor

EXPERIMENTAL

Participants will sample their preferred flavored JUUL e-cigarette at 5% nicotine strength.

Drug: Nicotine; Device: JUUL e-cigarette

High nicotine, non-preferred flavor

EXPERIMENTAL

Participants will sample their non-preferred flavored JUUL e-cigarette at 5% nicotine strength.

Drug: Nicotine; Device: JUUL e-cigarette

Low nicotine, preferred flavor

EXPERIMENTAL

Participants will sample their preferred flavored JUUL e-cigarette at 3% nicotine strength.

Drug: Nicotine; Device: JUUL e-cigarette

Low nicotine, non-preferred flavor

EXPERIMENTAL

Participants will sample their non-preferred flavored JUUL e-cigarette at 3% nicotine strength.

Drug: Nicotine; Device: JUUL e-cigarette

Interventions

Nicotine DRUG

Participants will sample high vs low nicotine.

High nicotine, non-preferred flavor; High nicotine, preferred flavor; Low nicotine, non-preferred flavor; Low nicotine, preferred flavor

JUUL e-cigarette DEVICE

Participants will sample preferred vs non-preferred JUUL flavors.

High nicotine, non-preferred flavor; High nicotine, preferred flavor; Low nicotine, non-preferred flavor; Low nicotine, preferred flavor

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years or older
• comfortable reading and writing English
• own a JUUL brand e-cigarette they have used at least 10 times in the past 30 days
• use JUUL e-cigarettes and JUUL pods with 5% nicotine
• used e-cigarettes on 4+ days a week in the last 30 days
• use or do not use tobacco cigarettes
• do not plan to quit e-cigarettes in the next 30 days
• non-pregnant females verified by pregnancy test
• access to the internet in a location where they could join a videoconference call and legally use their JUUL.
• Reside in VT

Sponsors & Collaborators

• University of Vermont: lead

Study Sites (1)

University of Vermont

Burlington, Vermont, 05401, United States

Location

Related Publications (1)

• Peasley-Miklus C, Klemperer EM, Hughes JR, Villanti AC, Krishnan-Sarin S, DeSarno MJ, Mosca LA, Su A, Cassidy RN, Feinstein MJP. The interactive effects of JUUL flavor and nicotine concentration on addiction potential. Exp Clin Psychopharmacol. 2023 Apr;31(2):336-342. doi: 10.1037/pha0000591. Epub 2022 Sep 1.

  PMID: 36048114 DERIVED

MeSH Terms

Conditions

Tobacco Use Disorder

Interventions

Nicotine

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Study Officials

• John R Hughes, MD

  University of Vermont

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 23, 2020
• First Posted: January 6, 2021
• Study Start: March 1, 2021
• Primary Completion: August 31, 2021
• Study Completion: August 31, 2021
• Last Updated: March 22, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)