NCT03168191

Brief Summary

This study is to examine if inhaled doses of an e-cigarette flavor, alone and in combination with menthol, changes the appeal of e-cigarettes containing low and high doses of nicotine. The hypothesis is that menthol and the other experimental flavor will interact with nicotine dose to improve taste and liking for e-cigarettes.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started May 2017

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

April 27, 2017

Completed
5 days until next milestone

Study Start

First participant enrolled

May 2, 2017

Completed
28 days until next milestone

First Posted

Study publicly available on registry

May 30, 2017

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 22, 2018

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 25, 2019

Completed
Last Updated

May 4, 2020

Status Verified

April 1, 2020

Enrollment Period

1.3 years

First QC Date

April 27, 2017

Last Update Submit

April 30, 2020

Conditions

Nicotine Dependence

Outcome Measures

Primary Outcomes (1)

  • Change score in Liking/wanting of the e-cigarette

    The Drug Effects Questionnaire (Soria et al) will be used to ask about liking and wanting during the lab session

    Baseline (+10 minutes) to end of lab session (+40 minutes)

Secondary Outcomes (9)

  • Change score in rating of coolness

    Baseline (+10 minutes) to end of lab session (+40 minutes)

  • Change score in rating of harshness/irritation

    Baseline (+10 minutes) to end of lab session (+40 minutes)

  • Change score in rating of sweetness

    Baseline (+10 minutes) to end of lab session (+40 minutes)

  • Change score in rating of sourness

    End of lab session (+40 minutes)

  • Change score in rating of fruitiness

    Baseline (+10 minutes) to end of lab session (+40 minutes)

  • +4 more secondary outcomes

Study Arms (3)

E-cigarette flavor

EXPERIMENTAL

In this arm, subjects will receive an experimental flavor. Participants will be randomly assigned to low or high dose of nicotine.

Drug: NicotineOther: Experimental Flavor

Menthol Flavor

EXPERIMENTAL

In this arm, subjects will receive a menthol flavor. Participants will be randomly assigned to low or high dose of nicotine.

Drug: NicotineOther: Menthol Flavor

No Flavor

PLACEBO COMPARATOR

In this arm, subjects will receive no flavor. Participants will be randomly assigned to low or high dose of nicotine.

Drug: Nicotine

Interventions

NicotineDRUG

Participants will receive low dose nicotine (6 mg/ml) or high dose nicotine (12 mg/ml)

E-cigarette flavorMenthol FlavorNo Flavor
Experimental FlavorOTHER

Experimental fruit flavored e-cigarette for lab session

E-cigarette flavor
Menthol FlavorOTHER

Menthol flavored e-cigarette for lab session

Menthol Flavor

Eligibility Criteria

Age18 Years - 20 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Ages 18-20 years
  • Able to read and write
  • Urine cotinine levels of \>250 ng/ml at screening appointment
  • Use of e-cigarettes in the past month
  • May or may not currently smoke traditional cigarettes

You may not qualify if:

  • Seeking smoking cessation treatment
  • Current/lifetime criteria for dependence on another psychoactive substance -Daily use of alcohol or marijuana or use of any other drugs including cocaine, opiates, stimulants
  • Regular use of psychoactive drugs including anxiolytics, antidepressants and other psychostimulants
  • Current or past history of psychosis or other psychiatric diagnosis such as major depression
  • Any significant current medical condition

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CMHC, Substance Abuse Center

New Haven, Connecticut, 06519, United States

Location

Related Publications (1)

  • Jackson A, Green B, Erythropel HC, Kong G, Cavallo DA, Eid T, Gueorguieva R, Buta E, O'Malley SS, Krishnan-Sarin S. Influence of menthol and green apple e-liquids containing different nicotine concentrations among youth e-cigarette users. Exp Clin Psychopharmacol. 2021 Aug;29(4):355-365. doi: 10.1037/pha0000368. Epub 2020 Apr 16.

    PMID: 32297782DERIVED

MeSH Terms

Conditions

Tobacco Use Disorder

Interventions

NicotineMenthol

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Solanaceous AlkaloidsAlkaloidsHeterocyclic CompoundsPyridinesHeterocyclic Compounds, 1-RingCyclohexanolsHexanolsFatty AlcoholsAlcoholsOrganic ChemicalsCyclohexane MonoterpenesCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsMonoterpenesTerpenesLipids

Study Officials

  • Dana Cavallo, Ph.D.

    Yale University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 27, 2017

First Posted

May 30, 2017

Study Start

May 2, 2017

Primary Completion

August 22, 2018

Study Completion

February 25, 2019

Last Updated

May 4, 2020

Record last verified: 2020-04

Locations

US(1)