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Completed
NCT04521647
Effects of Menthol in E-cigarettes on Smoking Behaviors
Conditions: Nicotine Dependence
Sex: All
Ages: 21 Years – 65 Years
Healthy volunteers: Yes
Phase: PHASE1
Enrollment: 14
Sponsor: Yale University
Location: Connecticut Mental Health Center New Haven Connecticut
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 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 \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
Source: ClinicalTrials.gov (NCT04521647). StuddyBuddy aggregates publicly available trial information.