Cardiovascular Risk Factor, Nicotine Dependence
Conditions
Keywords
E-Cigarettes, Vaping, E-Cig Mods, E-Liquid
Brief summary
This study will examine the effects of electronic cigarette e-liquid nicotine content in a randomized, crossover clinical and behavioral pharmacology study of experienced adult e-cigarette users (N=36). The specific aim is to determine the impact of nicotine content of e-liquid on nicotine pharmacology, systemic exposure to toxic volatile organic compounds, and short-term cardiovascular effects.
Detailed description
This is a within-subjects, crossover design of advanced electronic cigarette users in which we will examine nicotine pharmacokinetics, subjective effects, daily nicotine intake and nicotine titration, short-term cardiovascular effects, and toxicant exposure when participants are using low vs. high nicotine e-liquids. Hypothesis 1: E-cigarette users will titrate their intake of nicotine such that they will inhale fewer aerosol toxicants and suffer less harm to health when using higher vs. lower nicotine content e-liquids. Hypothesis 2: Compared to low nicotine, high nicotine e-liquid use will have similar cardiovascular effects throughout the day (due to compensatory behavioral changes), with similar effects on heart rate, blood pressure, and catecholamine release. Hypothesis 3: Exposure to volatile organic compounds (VOCs) will be lower when vaping high nicotine e-liquids compared to low nicotine e-liquids.
Interventions
OTHERLow Nicotine E-Liquid
Participants will vape e-liquid with nicotine concentration of 3 mg/ml.
OTHERMedium or High Nicotine E-Liquid
Participants will vape either e-liquid with nicotine concentration of 18 mg/ml or a JUUL device with JUUL pod of 59 mg/ml nicotine e-liquid.
Sponsors
National Institute on Drug Abuse (NIDA)
University of California, San Francisco
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Intervention model description
Crossover Assignment
Eligibility
Sex/Gender
ALL
Age
21 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy on the basis of medical history and limited physical examination, as described below: * Heart rate \< 105 beats per minute (BPM)\* * Systolic Blood Pressure \< 160 and \> 90\* * Diastolic Blood Pressure \< 100 and \> 50\* \*Considered out of range if both machine and manual readings are above/below these thresholds. * Age: \>= 21 years * Age: \<= 70 years * Current regular user of open tank electronic cigarette (EC) (at least 20 times in the past 30 days) with e-liquid nicotine of 3-6 mg/mL. * Non-smoker or non-daily cigarette smokers agreeing to abstain from cigarettes for the duration of the study. * Saliva cotinine \>50 ng/mL and/or NicAlert=6 * Carbon monoxide \>= 5 ppm or per discretion of Principal Investigator
Exclusion criteria
* Medical * Heart disease * Seizures * Cancer * Thyroid disease (okay if controlled with medication) * Diabetes * Hepatitis B or C or Liver disease * Glaucoma * Kidney disease or urinary retention * History of stroke * An ulcer in the past year * Active use of an inhaler for Asthma or Chronic obstructive pulmonary disease (COPD) * Psychiatric conditions * Current or past schizophrenia, and/or current or past bipolar disorder * Major depression, current or within the past year * Major personality disorder * Participants with current or past minor or moderate depression and/or anxiety disorders will be reviewed by the PI and considered for inclusion * History of psychiatric hospitalizations is not exclusionary, but study participation will be determined as per PI's approval * Drug/Alcohol Dependence * Alcohol or illicit drug dependence within the past 12 months with the exception of those who have recently completed an alcohol/drug treatment program * Positive toxicology test for illicit drugs at the screening visit (THC & prescribed medications okay) * Opioid replacement therapy (including methadone, buprenorphine, or other) * Psychiatric medications * Current regular use of any psychiatric medications with the exception of Selective Serotonin Reuptake Inhibitors (SSRIs) and serotonin-norepinephrine reuptake Inhibitors (SNRIs) and current evaluation by the PI that the participant is otherwise healthy, stable, and able to participate. * Medications * Use of medications that are inducers of nicotine metabolizing enzyme CYP2A6 (Example: rifampicin, carbamazepine, phenobarbital, and other anticonvulsant drugs). * Use of sympatholytic medications for cardiovascular conditions including hypertension (Example: beta and alpha-blockers) * Concurrent use of nicotine-containing medications * Any stimulant medications (example: Adderall) generally given for attention deficit hyperactivity disorder (ADHD) treatment * Other/Misc. Chronic Health Conditions * Oral thrush * Fainting (within the last 30 days) * Other life threatening illnesses as per PI's discretion * Pregnancy * Pregnancy (self-reported and urine pregnancy test) * Breastfeeding (determined by self-report) * Concurrent participation in another clinical trial * Inability to read and write in English * Planning to quit vaping within the next 60 days * Concurrent regular use of marijuana (occasional users of these products may be enrolled if they agree to abstain from their use during the period of the study) * Use of other tobacco products, smokeless tobacco, pipes, cigars/cigarillos, blunts/spliffs (no more than 10 times in the past month and must agree to abstain from their use during the period of the study)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Nicotine Exposure | Day 1 of each Arm | Plasma nicotine area under curve (AUC) (ng/ml\*h) |
| Cardiovascular Effects: Heart Rate | Days 1-3 of each Arm | Participant heart rate will be measured in beats per minute throughout the inpatient stay. |
| Cardiovascular Effects: Systolic Blood Pressure | Day 2 of each Arm | Participant systolic blood pressure will be taken for 24 hours during ad-lib e-cigarette use. |
| Cardiovascular Effects: Diastolic Blood Pressure | Day 2 of each Arm | Participant diastolic blood pressure will be taken for 24 hours during ad-lib e-cigarette use. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Vaping Topography: Puff Duration | Days 1-3 of each Arm | Vaping topography measures will be obtained from self-reported participant vaping log during the ad libitum sessions and measured as seconds per puff. |
| Vaping Topography: Inter-Puff Interval | Days 1-3 of each Arm | Vaping topography measures will be obtained from self-reported participant vaping log during the ad libitum sessions and measured as seconds/minutes between puffs. |
| Vaping Topography: Puff Number | Days 1-3 of each Arm | Vaping topography measures will be obtained from self-reported participant vaping log during the ad libitum sessions and measured as puffs per minute. |
Countries
United States
Outcome results
None listed