Electronic Cigarette Use
Conditions
Brief summary
The purpose of this study is to determine differences in nicotine delivery, use behavior, carbon monoxide delivery, subjective effects, and physiological effects, when cigarette smokers use an electronic cigarette with constant device settings and different e-liquid concentrations.
Detailed description
Only one arm enrolled.
Interventions
OTHERCigarette Smoker/ECIG users: 0 mg/ml nicotine concentration
ECIG LAB SESSION: 30 watts, 0 mg/ml nicotine concentration. During each session, participants will first complete a 10-puff product use bout, and then a 90-minute ad lib product use bout.
OTHERCigarette Smokers/ECIG users: 6 mg/ml nicotine concentration
ECIG Lab Session, 30 watts, 6 mg/ml nicotine concentration. During each session, participants will first complete a 10-puff product use bout, and then a 90-minute ad lib product use bout.
OTHERCigarette Smokers/ECIG users: 15 mg/ml nicotine concentration
ECIG Lab Session, 30 watts, 15 mg/ml nicotine concentration. During each session, participants will first complete a 10-puff product use bout, and then a 90-minute ad lib product use bout.
OTHERCigarette Smokers/ECIG users: 30 mg/ml nicotine concentration
ECIG Lab Session, 30 watts, 30 mg/ml nicotine concentration During each session, participants will first complete a 10-puff product use bout, and then a 90-minute ad lib product use bout.
Sponsors
Virginia Commonwealth University
National Institute on Drug Abuse (NIDA)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Intervention model description
The purpose of this study is to determine differences in nicotine delivery, use behavior, (puff topography), and carbon monoxide delivery, subjective effects, and physiological effects, when cigarette smokers use an electronic cigarette with constant device settings and different e-liquid concentrations. Only one arm enrolled.
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* healthy (determined by self-report) * between the ages of 18-55 * willing to provide informed consent * able to attend the lab and abstain from tobacco/nicotine as required and must agree to use designated products according to study protocol
Exclusion criteria
• Women if they are breast-feeding or test positive for pregnancy (by urinalysis) at screening. Some study details about the eligibility criteria are purposely omitted at this time to preserve scientific integrity. Full details will be posted at the conclusion of the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Plasma Nicotine Concentration | Before directed bout, after directed bout, prior to ad lib use, after ad lib use, and immediately after own brand use. | Blood will be taken during each session (5) to examine changes from baseline to immediately follow a ten-puff bout. There is one arm, but 4 different conditions per outcome. One subject with/ missing plasma samples was removed from analysis. |
| Cigarette/ECIG Challenge Paradigm | Completion of ad lib bout to use of own brand cigarette | Subjects, following a period of abstinence, they are given a limited time to use either their own brand of cigarette or an e-cigarette. One arm enrolled and the subjects received each of the 4 conditions per outcome. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Puff Volume | During directed bout, during ad lib bout | Puff volume. |
| Puff Duration | During directed bout, during ad lib bout | Puff duration measured in seconds. |
Countries
United States
Contacts
STUDY_DIRECTORAlison Breland, PhD
Virginia Commonwealth University
Participant flow
Recruitment details
In this single-arm study, 33 were enrolled. Participants completed four, approximately 3-hr sessions.
Pre-assignment details
33 were enrolled
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 29.41 years STANDARD_DEVIATION 10.18 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 31 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 5 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants |
| Race (NIH/OMB) More than one race | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants |
| Race (NIH/OMB) White | 17 Participants |
| Region of Enrollment United States | 32 Participants |
| Sex: Female, Male Female | 11 Participants |
| Sex: Female, Male Male | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 32 |
| other Total, other adverse events | 0 / 32 |
| serious Total, serious adverse events | 0 / 32 |
Outcome results
None listed