Effects of Menthol in E-cigarettes on Smoking Behaviors

NCT ID: NCT04521647

Last Updated: 2024-09-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-10
• Study Completion Date: 2023-07-25

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

menthol flavor

Participants will receive 5% nicotine in an e-cigarette

Group Type: EXPERIMENTAL

Nicotine

Intervention Type: DRUG

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

tobacco flavor

Participants will receive 5% nicotine in an e-cigarette

Group Type: EXPERIMENTAL

Nicotine

Intervention Type: DRUG

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

Interventions

Nicotine

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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Connecticut Mental Health Center

New Haven, Connecticut, United States

Countries

United States

Other Identifiers

2U54DA036151-06

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2000028570

Identifier Type: -

Identifier Source: org_study_id