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Effects of Menthol in E-cigarettes on Smoking Behaviors | Clinical Trials | Clareo Health

COMPLETEDPHASE1

Effects of Menthol in E-cigarettes on Smoking Behaviors

NCT04521647•Yale University

Summary

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.

Eligibility

Age

21 - 65 years

Sex

ALL

Healthy Volunteers

Yes

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.
+1 more criteria

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)
+3 more criteria

Locations (1)

Connecticut Mental Health Center

New Haven, Connecticut, United States

Key Dates

Start Date

May 10, 2022

Primary Completion Date

July 25, 2023

Completion Date

July 25, 2023

Last Updated

September 5, 2024

Enrollment

ACTUAL participants

Conditions

Nicotine Dependence

Interventions

Nicotine

DRUG

Advanced Functional and Structural MRI Techniques for Neuropharmacological Imaging

NCT01036581

Drug AbuseNicotine Dependence

View study

RECRUITINGNA

Behavioral Intervention for Youth to Promote Vaping Cessation

NCT06765291

VapingVaping Teens+1 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 5, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Effects of Menthol in E-cigarettes on Smoking Behaviors

Inclusion Criteria

Exclusion Criteria

Advanced Functional and Structural MRI Techniques for Neuropharmacological Imaging

Behavioral Intervention for Youth to Promote Vaping Cessation

tDCS Plus Varenicline for Smoking Cessation

Neurobehavioral Mechanisms Linking Childhood Adversity to Increased Risk for Smoking

Beta-Adrenergic Modulation of Drug Cue Reactivity

NeuroControl of Nicotine Dependence