Effects of Menthol in E-cigarettes on Smoking Behaviors

NCT04521647 | Completed Phase 1

• 2 other identifiers: 20000285702U54DA036151-06
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Nicotine Dependence

Outcome Measures

Primary Outcomes (2)

• Plasma nicotine levels

  blood samples obtained at baseline and 2, 5, 15, 30, 45, 60, 90, 120, and 180 minutes after nicotine exposure

  up to 3 weeks

• Nicotine Metabolic Rate

  blood samples obtained at baseline and 2, 5, 15, 30, 45, 60, 90, 120, and 180 minutes after nicotine exposure

  up to 3 weeks

Study Arms (2)

menthol flavor

EXPERIMENTAL

Participants will receive 5% nicotine in an e-cigarette

Drug: Nicotine

tobacco flavor

EXPERIMENTAL

Participants will receive 5% nicotine in an e-cigarette

Drug: Nicotine

Interventions

Nicotine DRUG

Participants will receive two nicotine concentrations via e-cigarettes. Each exposure will be 10 3-sec puffs and ad libitum use

menthol flavor; tobacco flavor

Eligibility Criteria

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

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Yale University: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Connecticut Mental Health Center

New Haven, Connecticut, 06519, United States

Location

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 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: August 1, 2020
• First Posted: August 20, 2020
• Study Start: May 10, 2022
• Primary Completion: July 25, 2023
• Study Completion: July 25, 2023
• Last Updated: September 5, 2024

Record last verified: 2024-08

Locations

US (1)