Effects of Menthol in E-cigarettes on Smoking Behaviors

Yale University

Status and phase: Completed; Phase 1

Conditions: Nicotine Dependence

Treatments: Drug: Nicotine

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04521647

2U54DA036151-06 (U.S. NIH Grant/Contract)

2000028570

Details and patient eligibility

About

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.

Enrollment: 10 patients

Sex: All

Ages: 21 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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10 participants in 2 patient groups

menthol flavor

Experimental group

Description:

Participants will receive 5% nicotine in an e-cigarette

Treatment:

Drug: Nicotine

tobacco flavor

Experimental group

Description:

Participants will receive 5% nicotine in an e-cigarette

Treatment:

Drug: Nicotine