Nicotine Dependence
Conditions
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.
Interventions
DRUGNicotine
Participants will receive 5% nicotine in two flavor exposures via e-cigarettes. Each exposure will be 10 3-sec puffs
Sponsors
Yale University
National Institute on Drug Abuse (NIDA)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Plasma Nicotine Levels | Lab 1 (day 1) and Lab 2 (24 hour minimum / 2 week maximum from Lab 1). During each lab session, plasma levels were collected at baseline, 5, 15, 30, 45 and 60 minutes after e-cigarette exposure. | Mean plasma levels obtained after e-cigarette administration at each lab session (lab 1 and lab 2). |
| Nicotine Metabolic Rate | Lab 1 (day 1) and Lab 2 (24 hour minimum / 2 week maximum from Lab 1). During each lab session, plasma levels were collected at baseline, 5, 15, 30, 45 and 60 minutes after e-cigarette exposure. | Mean Area under the curve (AUC) for plasma nicotine and NMR were computed and then log transformed to reduce skewness of the two measures. |
Countries
United States
Participant flow
Pre-assignment details
All participants will be exposed to the two flavor conditions (tobacco and menthol) in a counterbalanced randomized order. Each lab session exposure will consist of 10 3-sec puffs separated by 30 second intervals and will be separated by a minimum of 24 hours and maximum of 2 weeks.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 14 Participants |
| Age, Continuous | 40.36 years STANDARD_DEVIATION 9.56 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 14 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Region of Enrollment United States | 14 participants |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 14 | 0 / 14 |
| other Total, other adverse events | 2 / 14 | 0 / 14 |
| serious Total, serious adverse events | 0 / 14 | 0 / 14 |
Outcome results
None listed