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OpenTrials
Completed

NCT Number: NCT04521647

Effects of Menthol in E-cigarettes on Smoking Behaviors

The overall goal of this proposal is to understand the relationship between nicotine metabolism and menthol flavor in e-cigarettes on smoking behavior in smokers.

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Key information

Age range

21 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Connecticut Mental Health Center

New Haven, Connecticut, 06519, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • At least 21 years of age
  • Able to read and write English.
  • Smoking at least 1 menthol cigarettes/cigars/little cigars per day
  • Report regular menthol cigarette use
  • Have at least 200ng/ml urine cotinine
  • Willing to abstain from combustible tobacco products 12 hrs prior to each experimental session.
  • not planning a smoking quit attempt.
  • Have not stopped use due to COVID.
  • used e-cigarettes at least 10 times in the past six months.
  • Fully vaccinated against COVID-19.
  • must report history of JUUL and other nicotine salt/pod devices (i.e., JUUL-like)

Exclusion criteria

  • Use of psychoactive drugs including anxiolytics, antidepressants, and other psychostimulants unless prescribed and stable for two months.
  • Current diagnosis of any severe psychiatric disorder
  • Any significant current medical condition such as neurological, cardiovascular, endocrine, renal, pulmonary or hepatic pathology that would increase risk or would interfere with/mimic tobacco abstinence.
  • Known hypersensitivity to propylene glycol and nut allergies.
  • Pregnant or lactating females.
  • current criteria for moderate or severe cannabis and alcohol use disorder per DSM-5 criteria.
  • current criteria for other substance use disorders per DSM-5 criteria.
  • Seeking treatment to stop smoking.
  • individuals who do not want to use e-cigarettes.
  • Uncontrolled asthma (defined as <20 on Asthma Control Test) AND/OR endorsement of "yes" to environmentally induced bronchospasm that requires prescription Epipen)
  • blood pressure >170/>100 and heart rate >100
  • vaping of CBD/THC or marijuana related products in the past 3 months
  • For current THC vapers: Any report of mild or great EVALI-related symptoms (i.e. cough, shortness of breath, chest pain, nausea, vomiting, stomach pain, diarrhea, fever, chills, or weight loss) without non-EVALI reasonable and proximal cause

Treatment and study plan

nicotine

Drug

Participants will receive 5% nicotine in two flavor exposures via e-cigarettes. Each exposure will be 10 3-sec puffs

Primary outcomes

  1. Plasma Nicotine Levels

    Time frame: Lab 1 (day 1) and Lab 2 (24 hour minimum / 2 week maximum from Lab 1). During each lab session, plasma levels were collected at baseline, 5, 15, 30, 45 and 60 minutes after e-cigarette exposure.

    Mean plasma levels obtained after e-cigarette administration at each lab session (lab 1 and lab 2).

  2. Nicotine Metabolic Rate

    Time frame: Lab 1 (day 1) and Lab 2 (24 hour minimum / 2 week maximum from Lab 1). During each lab session, plasma levels were collected at baseline, 5, 15, 30, 45 and 60 minutes after e-cigarette exposure.

    Mean Area under the curve (AUC) for plasma nicotine and NMR were computed and then log transformed to reduce skewness of the two measures.

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Aug 20, 2020
Registry last updated
Jun 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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