NCT02179034

Brief Summary

This study is to examine if inhaled doses of menthol that produce low and high cooling effects change the appeal of e-cigarettes containing low and high doses of nicotine in adolescent smokers. The hypothesis is that the combination of nicotine and menthol, when compared with menthol or nicotine alone, will result in greater increase in liking of an e-cigarette and greater reduction in nicotine withdrawal.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
59

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Oct 2014

Typical duration for phase_1

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 24, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 1, 2014

Completed
4 months until next milestone

Study Start

First participant enrolled

October 23, 2014

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 18, 2016

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 12, 2017

Completed
Last Updated

May 4, 2020

Status Verified

April 1, 2020

Enrollment Period

1.7 years

First QC Date

June 24, 2014

Last Update Submit

April 30, 2020

Conditions

Nicotine Dependence, Other Tobacco Product

Keywords

tobaccoelectronic cigarettesmentholflavors

Outcome Measures

Primary Outcomes (1)

  • Liking/effect score of the e-cigarette

    The Drug Effects Questionnaire (Soria et al) will be used to ask about participants' liking/effect of the e-cigarettes smoked during the 4 bouts of e-cigarette puffing during the lab session to determine which menthol dose is most preferred. A linear mixed-effects regression model wil be used with nicotine group (none, low, high) as between-subject factor, and menthol dose (none, low dose, high dose) as within-subject factor.

    Every 30 min for 120 min during lab session

Secondary Outcomes (3)

  • Maximum value of money at which the e-cigarette is chosen over money

    Every 30 min for 120 min during lab session

  • Change scores from baseline in Nicotine Withdrawal

    Every 30 min for 120 min during lab session

  • Change scores from baseline in Tobacco Craving

    Every 30 min for 120 min during lab session

Study Arms (3)

Tobacco Flavor

PLACEBO COMPARATOR

In this arm, subjects will receive tobacco flavor- without nicotine (placebo). Participants will then be exposed to 3 levels of a menthol additive in random order: no dose, low dose and high dose.

Other: Low Dose MentholOther: High Dose Menthol

Low Dose Nicotine

ACTIVE COMPARATOR

In this arm, subjects will receive a low dose of nicotine (6 mg/ml) added to the tobacco flavor. Participants will then be exposed to 3 levels of a menthol additive in random order: no dose, low dose and high dose.

Drug: NicotineOther: Low Dose MentholOther: High Dose Menthol

High Dose Nicotine

ACTIVE COMPARATOR

In this arm, subjects will receive a high dose of nicotine (12 mg/ml) added to the tobacco flavor. Participants will then be exposed to 3 levels of a menthol additive in random order: no dose, low dose and high dose.

Drug: NicotineOther: Low Dose MentholOther: High Dose Menthol

Interventions

NicotineDRUG

Participants will receive no nicotine, low dose nicotine (6 mg/ml) or high dose nicotine (12 mg/ml)

High Dose NicotineLow Dose Nicotine
Low Dose MentholOTHER

A low dose of menthol will be added to the tobacco flavor.

High Dose NicotineLow Dose NicotineTobacco Flavor
High Dose MentholOTHER

A high dose of menthol will be added to the tobacco flavor.

High Dose NicotineLow Dose NicotineTobacco 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
  • Cigarette smoker
  • Use of e-cigarettes in the past 30 days

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

New Haven, Connecticut, 06519, United States

Location

MeSH Terms

Conditions

Tobacco Use DisorderVaping

Interventions

NicotineMenthol

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental DisordersSmokingBehavior

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Dana Cavallo, PhD

    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

June 24, 2014

First Posted

July 1, 2014

Study Start

October 23, 2014

Primary Completion

July 18, 2016

Study Completion

June 12, 2017

Last Updated

May 4, 2020

Record last verified: 2020-04

Locations

US(1)