N/A
N=38
Clinical Pharmacology of Electronic Cigarettes
Nicotine Dependence
Bottom Line
View on ClinicalTrials.gov: NCT02470754 ↗Enrolled (actual)
38
Serious AEs
0.0%
Results posted
Nov 2019
Primary outcome: Primary: Standardized Session: Mean CMax — 6.1; 20.2 ng/mL
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Tobacco Cigarette (Device); Electronic Cigarette (Device)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- University of California, San Francisco
- Primary completion
- Feb 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Standardized Session: Mean CMax |
6.1; 20.2 | — |
| PRIMARY Standardized Session: Mean TMax |
6.5; 2.7 | — |
| PRIMARY Standardized Session: AUC 0-240 |
550; 1368 | — |
| PRIMARY PK-estimated Nicotine Dose |
0.9; 2.2 | — |
| SECONDARY Standardized Session: QSU Factor 1 (Vaping) |
23.9; 20.7 | — |
| SECONDARY Standardized Session: Positive and Negative Affect Score (Negative Affect) |
14.3; 14.0 | — |
| SECONDARY Standardized Session: Minnesota Nicotine Withdrawal Scale |
10.8; 9.6 | — |
| SECONDARY Standardized Session: QSU Factor 2 (Vaping) |
14.9; 13.0 | — |
| SECONDARY Standardized Session: QSU Factor 1 (Smoking) |
22.9; 24.2 | — |
| SECONDARY Standardized Session: QSU Factor 2 (Smoking) |
14.4; 14.1 | — |
Summary
The purpose of this study is to learn more about nicotine exposure and the safety of electronic cigarettes (EC). It will focus on the areas that are thought to most closely relate to the addictive potential of EC, namely: (1) EC as nicotine delivery devices, covering issues of nicotine intake and pharmacokinetics, temporal patterns of use and titration of nicotine; and (2) subjective effects of EC use, including relationship of use to reward, withdrawal and craving.
Eligibility Criteria
Inclusion Criteria
- Healthy on the basis of medical history and limited physical examination as described below:
- Heart rate 90*
- Diastolic Blood Pressure 50*
- Body Mass Index ≤ 38.0 *Considered out of range if both machine and manual readings are above/below these thresholds.
- Current regular "dual" user of both EC and conventional TC
- EC device is one of the most popular 1st, 2nd or 3rd generation brands (with the exception of rebuildable atomizers) as determined at time of study commencement
- Carbon monoxide ≥ 5 ppm or per discretion of Principal Investigator
- Saliva cotinine ≥50 ng/ml or urine cotinine
- Age: ≥ 21 years
Exclusion Criteria
- Current regular use of selected psychiatric medications
- Current regular use of cardiovascular medications for cardiovascular conditions including hypertension (Example: beta and alpha-blockers)
- Current regular use of medications inducers of nicotine metabolizing enzymes CYP2A6 (Example: rifampicin, dexamethasone, phenobarbital, and other anticonvulsant drugs).
- Use of other tobacco products
- Pregnancy or breastfeeding (by history and pregnancy test)
- Concurrent use of nicotine-containing medications
- Drug/Alcohol Dependence
- Positive toxicology test at the screening visit (THC okay)
- Concurrent participation in another clinical trial
- Inability to communicate in English
- Planning to quit smoking within the next 60 days
Data sourced from ClinicalTrials.gov (NCT02470754). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.