Status:
COMPLETED
Effects of Menthol in E-cigarettes on Smoking Behaviors
Lead Sponsor:
Yale University
Collaborating Sponsors:
National Institute on Drug Abuse (NIDA)
Conditions:
Nicotine Dependence
Eligibility:
All Genders
21-65 years
Phase:
PHASE1
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 10 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 25 2023
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT04521647
Start Date
May 10 2022
End Date
July 25 2023
Last Update
September 5 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Connecticut Mental Health Center
New Haven, Connecticut, United States, 06519