Examining the effects of a standardized electronic cigarette on nicotine delivery and health risks
Comparative Pharmacokinetics and Pharmacodynamics of Nicotine With Use of NIDA Standardized Research Electronic Cigarette (SREC) vs Usual Brand E-cigarette
This study tests how a new type of electronic cigarette compares to regular ones in delivering nicotine and its potential health risks for regular users.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 21 Years to 70 Years |
| Sex | All |
| Sponsor | University of California, San Francisco Academic / other |
| Locations | 1 site (San Francisco, California) |
| Trial ID | NCT05658471 on ClinicalTrials.gov |
What this trial studies
This crossover study investigates the pharmacokinetics and pharmacodynamics of a Standardized Research Electronic Cigarette (SREC) compared to usual brand e-cigarettes among regular users. Participants will undergo assessments in a hospital setting, where they will be assigned to either SREC or usual brand e-cigarettes for the initial evaluation, followed by a switch to the other condition within two weeks. The study aims to characterize nicotine delivery and systemic exposure, as well as evaluate potential harm associated with SREC use.
Who should consider this trial
Good fit: Ideal candidates are healthy adults aged 21 to 70 who are regular users of electronic cigarettes and meet specific health criteria.
Not a fit: Patients with unstable medical conditions such as heart disease, cancer, or diabetes may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into safer nicotine delivery methods and inform public health strategies regarding electronic cigarette use.
How similar studies have performed: While there have been studies on electronic cigarettes, this specific approach using a standardized device is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Healthy on the basis of medical history and limited physical examination- * 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. * Body Mass Index \<= 38.0. * Current regular user of electronic cigarettes (EC) * EC device use at least 15 or more days in the past 30 days (with e- liquid \>= 3mg/ml) * No restriction on flavor or type of e-cigarette used * Saliva cotinine \>= 50 ng/ml and/or NicAlert = 6 * Age \>= 21 years old \<= 70 years old * Willingness to abstain from drug use for the duration of the study Exclusion Criteria: * The following unstable medical conditions: * 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) * 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 (Example: nicotine patch, lozenge, gum). * Any stimulant medications (example: Adderall) generally given for attention deficit hyperactivity disorder (ADHD) treatment. * Other/Misc. Health Conditions * Oral thrush * Fainting (within the last 30 days) * Other "life threatening illnesses" as per principal investigator and/or study physician's discretion * Pregnancy * Pregnancy (self-reported and urine pregnancy test) * Breastfeeding (determined by self-report) * Women of childbearing potential must be using an acceptable method of contraception * Concurrent participation in another clinical trial. * Inability to read and write in English * Planning to quit smoking or vaping within the next 60 days * A known propylene glycol/vegetable glycerin allergy * Uncomfortable with getting blood drawn * Recent onset or change (worsening) in cough, fever and/or abdominal symptoms (vomiting or pain) in the past two weeks
Where this trial is running
San Francisco, California
- University of California, San Francisco - Tobacco Research Center — San Francisco, California, United States (Recruiting)
Study contacts
- Principal investigator: Neal Benowitz, MD — University of California, San Francisco
- Study coordinator: Lisa Lawrence
- Email: Lisa.Lawerence@ucsf.edu
- Phone: 415-608-4864
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.