Electronic Cigarette Use
Conditions
Brief summary
This grant compares the effects of cigarette smoking, protonated nicotine (salt) aerosol through an Electronic Nicotine Delivery System (ENDS), and unprotonated nicotine aerosol through an ENDS on nicotine delivery, nicotine craving, and other outcomes in cigarette smokers.
Detailed description
The purpose of this study is to determine differences in nicotine delivery, user behavior, subjective effects, and physiological effects, when cigarette smokers use a nicotine salt (protonated) aerosol, relative to an unprotonated aerosol or their own brand of cigarettes.
Interventions
OTHERSubox Mini C with Avail 18 mg nicotine salt (protonated)
Participants will be instructed to take one puff of the Subox Mini C with Avail 18 mg nicotine salt (protonated) liquid every 30 seconds for 5 minutes followed by a 2nd blood draw. Next, participants will be given 90 minutes to use the product ad lib, i.e., as much as desired.
OTHERSubox Mini C with Avail 18 mg nicotine (unprotonated)
Participants will be instructed to take one puff of the Subox Mini C with Avail 18 mg nicotine (unprotonated) liquid every 30 seconds for 5 minutes followed by a 2nd blood draw. Next, participants will be given 90 minutes to use the product ad lib, i.e., as much as desired.
OTHEROwn brand cigarette
Participants will be instructed to take one puff of a cigarette matching their typical brand every 30 seconds for 5 minutes followed by a 2nd blood draw. Next, participants will be given 90 minutes to use the product ad lib, i.e., as much as desired.
Sponsors
National Institute on Drug Abuse (NIDA)
Eastern Virginia Medical School
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
Participants must be: * healthy (determined by self-report) * between 21-55 years old * wiling to provide informed consent * able to attend lab and abstain from tobacco/nicotine as required and agree to use designated products according to study protocol * cigarette smokers
Exclusion criteria
• Women if breast-feeding or test positive for pregnancy (by urinalysis) at screening Some study details about 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 | Blood will be taken 4 times in each session: baseline, 5 minutes after the start of a 10-puff product use, and then before and after an approximately 1-hour ad lib use period. | Change in plasma nicotine level |
Countries
United States
Participant flow
Pre-assignment details
This is a within-subjects design study with 3 conditions on 3 separate follow-ups after an initial screening visit. Enrolled participants were sometimes excluded from the study, primarily due to loss to follow-up.
Participants by arm
| Arm | Count |
|---|---|
| Own Brand Cigarette First, Then ENDS With Protonated Nicotine, Then ENDS With Unprotonated Nicotine In each of the 3 sessions, participants will be instructed to take one puff of the tobacco product (cigarette or Subox Mini C ENDS with 18 mg nicotine) every 30 seconds for 5 minutes followed by a 2nd blood draw (if staffing allows). Next, participants will be given 90 minutes to use ad lib, i.e., as much as desired | 1 |
| ENDS With Unprotonated Nicotine First, Then ENDS With Protonated Nicotine, Then Own Brand Cigarette In each of the 3 sessions, participants will be instructed to take one puff of the tobacco product (cigarette or Subox Mini C ENDS with 18 mg nicotine) every 30 seconds for 5 minutes followed by a 2nd blood draw (if staffing allows). Next, participants will be given 90 minutes to use ad lib, i.e., as much as desired | 3 |
| ENDS With Protonated Nicotine First, Then Own Brand Cigarette, Then ENDS With Unprotonated Nicotine In each of the 3 sessions, participants will be instructed to take one puff of the tobacco product (cigarette or Subox Mini C ENDS with 18 mg nicotine) every 30 seconds for 5 minutes followed by a 2nd blood draw (if staffing allows). Next, participants will be given 90 minutes to use ad lib, i.e., as much as desired | 1 |
| ENDS With Protonated Nicotine First, Then ENDS With Unprotonated Nicotine, Then Own Brand Cigarette In each of the 3 sessions, participants will be instructed to take one puff of the tobacco product (cigarette or Subox Mini C ENDS with 18 mg nicotine) every 30 seconds for 5 minutes followed by a 2nd blood draw (if staffing allows). Next, participants will be given 90 minutes to use ad lib, i.e., as much as desired | 1 |
| Own Brand Cigarette First, Then ENDS With Unprotonated Nicotine, Then ENDS With Protonated Nicotine In each of the 3 sessions, participants will be instructed to take one puff of the tobacco product (cigarette or Subox Mini C ENDS with 18 mg nicotine) every 30 seconds for 5 minutes followed by a 2nd blood draw (if staffing allows). Next, participants will be given 90 minutes to use ad lib, i.e., as much as desired | 1 |
| ENDS With Unprotonated Nicotine First, Then Own Brand Cigarette, Then ENDS With Protonated Nicotine In each of the 3 sessions, participants will be instructed to take one puff of the tobacco product (cigarette or Subox Mini C ENDS with 18 mg nicotine) every 30 seconds for 5 minutes followed by a 2nd blood draw (if staffing allows). Next, participants will be given 90 minutes to use ad lib, i.e., as much as desired | 4 |
| Total | 11 |
Baseline characteristics
| Characteristic | ENDS With Unprotonated Nicotine First, Then ENDS With Protonated Nicotine, Then Own Brand Cigarette | ENDS With Protonated Nicotine First, Then Own Brand Cigarette, Then ENDS With Unprotonated Nicotine | ENDS With Protonated Nicotine First, Then ENDS With Unprotonated Nicotine, Then Own Brand Cigarette | Own Brand Cigarette First, Then ENDS With Unprotonated Nicotine, Then ENDS With Protonated Nicotine | ENDS With Unprotonated Nicotine First, Then Own Brand Cigarette, Then ENDS With Protonated Nicotine | Own Brand Cigarette First, Then ENDS With Protonated Nicotine, Then ENDS With Unprotonated Nicotine | Total |
|---|---|---|---|---|---|---|---|
| Age, Continuous | 34.7 years STANDARD_DEVIATION 8.5 | 38 years STANDARD_DEVIATION 0 | 30 years STANDARD_DEVIATION 0 | 41 years STANDARD_DEVIATION 0 | 40.8 years STANDARD_DEVIATION 10.9 | 28 years STANDARD_DEVIATION 0 | 34.3 years STANDARD_DEVIATION 7.2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 3 Participants | 1 Participants | 1 Participants | 1 Participants | 4 Participants | 1 Participants | 11 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 1 Participants | 6 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 2 Participants | 0 Participants | 3 Participants |
| Region of Enrollment United States | 2 participants | 1 participants | 1 participants | 1 participants | 4 participants | 1 participants | 11 participants |
| Sex: Female, Male Female | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 4 Participants | 1 Participants | 7 Participants |
| Sex: Female, Male Male | 2 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 5 | 0 / 5 | 0 / 6 |
| other Total, other adverse events | 0 / 5 | 0 / 5 | 0 / 6 |
| serious Total, serious adverse events | 0 / 5 | 0 / 5 | 0 / 6 |
Outcome results
Primary
Plasma Nicotine
Change in plasma nicotine level
Time frame: Blood will be taken 4 times in each session: baseline, 5 minutes after the start of a 10-puff product use, and then before and after an approximately 1-hour ad lib use period.
Population: We were unable to collect this outcome measure (plasma nicotine) due to staffing issues and difficulties with blood draws.