Electronic Cigarettes
Conditions
Brief summary
This study aims to understand the effects of device power and nicotine concentration on the likelihood that someone would use or abuse e-cigarettes.
Interventions
OTHERE-cigarette Lab Session 15 watts, 10 mg nicotine
E-cigarette paired with low nicotine, low device power
OTHERE-cigarette Lab Session 15 watts, 30 mg nicotine
E-cigarette paired with low nicotine, low device power
OTHERE-cigarette Lab Session 30 watts, 10 mg nicotine
E-cigarette paired with low nicotine, low device power
OTHERE-cigarette Lab Session 30 watts, 30 mg nicotine
E-cigarette paired with low nicotine, low device power
OTHEROwn Brand Session - E-cigarette
E-cigarette paired with own brand liquid and preferred power
OTHEROwn Brand Session - E-cigarette/Cigarette
Own brand cigarette OR E-cigarette paired with own brand liquid and preferred power
Sponsors
National Institute on Drug Abuse (NIDA)
Virginia Commonwealth University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)
Masking description
Participants will be blinded to their condition (power level and nicotine concentration) used in each session, except during their 'own brand' session.
Intervention model description
We will recruit two populations of e-cigarette users: exclusive e-cigarette users and dual users of e-cigarettes and tobacco cigarettes. All participants complete 5 within-subject laboratory conditions that each last 4 hours. Conditions (sessions) differ by the tobacco product used: 1) e-cigarette with low device power, low nicotine mg/ml; 2) e-cigarette with low device power, high nicotine mg/ml; 3) e-cigarette with high device power, low nicotine mg/ml; 4) e-cigarette with high device power, high nicotine mg/ml; and 5) own brand e-cigarette/cigarette. The first four sessions are latin-square-ordered and the last session for all participants will be their own brand cigarette/e-cigarette depending on the population. For dual users, we will counter-balance own brand condition product assignment (cigarette vs. e-cigarette). Conditions will differ in the presentation of primary outcomes (task order) which will be counterbalanced.
Eligibility
Sex/Gender
ALL
Age
21 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* healthy (determined by self-report) * between the ages of 21-55 * 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 |
|---|---|---|
| Breakpoint of Drug Purchase Tasks (DPT) | Up to 180 minutes | The DPTs will yield measures of willingness to pay and measures of price sensitivity for session-specific tobacco products. Choices made during this task are not reinforced during the session. Each DPT will be completed once per study session (either 90 minutes or approximately 180 minutes into the session, timing varies based on task order presentation and potentially choices made in tasks presented prior to this task). |
| Breakpoint of Multiple Choice Procedure (MCP) | Up to 180 minutes. | The MCP will yield of measure of willingness to pay for session-specific tobacco products. One choice made during this task is reinforced (i.e., money or tobacco product is distributed). Completed once per study session (either 90 minutes or approximately 180 minutes into the session, timing varies based on task order presentation and potentially choices made in tasks presented prior to this task). |
| Effort for Product Puffs With the Progressive Ratio Task (PRT) | Up to 180 minutes. | The PRT will yield a measure of willingness to work for session-specific tobacco products (via number of times a space bar is pressed to earn puffs) by measuring the number of puffs self-administrated. Completed once per study session (either 90 minutes or approximately 180 minutes into the session, timing varies based on task order presentation and potentially choices made in tasks presented prior to this task). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Subjective Measures of Nicotine Abstinence Symptoms | First measure given, regardless of task order, 90 minutes into each session | Measures of related to nicotine abstinence symptoms and nicotine side effects will be measured during each study session. |
| Change in Diastolic Blood Pressure | Recorded throughout each 4 hour study session using automated software every 5 minutes. | and blood pressure (measured in hg) |
| Change in Heart Rate | Recorded throughout each 4 hour study session using automated software every 10 seconds. | Heart rate (measured in bpm) |
| Change in Systolic Blood Pressure | Recorded throughout each 4 hour study session using automated software every 5 minutes. | Blood pressure (measured in mm) |
Countries
United States
Participant flow
Pre-assignment details
Each participant will participate in 6 sessions. Sessions differ by the tobacco product used (see study arms). The sessions are ordered by latin-square; however, session order was NOT expected to change any outcomes and order effects are not relevant to the study. Therefore all outcome data was merged and analyzed only by arm and session without regard to order.
Participants by arm
| Arm | Count |
|---|---|
| E-cigarette User (Exclusive) Other: E-cigarette Lab Session 15 watts, 10 mg nicotine Other: E-cigarette Lab Session 15 watts, 30 mg nicotine Other: E-cigarette Lab Session 30 watts, 10 mg nicotine Other: E-cigarette Lab Session 30 watts, 30 mg nicotine Other: Own Brand Session - E-cigarette
E-cigarette Lab Session 15 watts, 10 mg nicotine: E-cigarette paired with low nicotine, low device power
E-cigarette Lab Session 15 watts, 30 mg nicotine: E-cigarette paired with low nicotine, low device power
E-cigarette Lab Session 30 watts, 10 mg nicotine: E-cigarette paired with low nicotine, low device power
E-cigarette Lab Session 30 watts, 30 mg nicotine: E-cigarette paired with low nicotine, low device power
Own Brand Session - E-cigarette: E-cigarette paired with own brand liquid and preferred power | 19 |
| Dual User Other: E-cigarette Lab Session 15 watts, 10 mg nicotine Other: E-cigarette Lab Session 15 watts, 30 mg nicotine Other: E-cigarette Lab Session 30 watts, 10 mg nicotine Other: E-cigarette Lab Session 30 watts, 30 mg nicotine Other: Own Brand Session - E-cigarette/Cigarette
E-cigarette Lab Session 15 watts, 10 mg nicotine: E-cigarette paired with low nicotine, low device power
E-cigarette Lab Session 15 watts, 30 mg nicotine: E-cigarette paired with low nicotine, low device power
E-cigarette Lab Session 30 watts, 10 mg nicotine: E-cigarette paired with low nicotine, low device power
E-cigarette Lab Session 30 watts, 30 mg nicotine: E-cigarette paired with low nicotine, low device power
Own Brand Session - E-cigarette: E-cigarette paired with own brand liquid and preferred power
Own Brand Session - E-cigarette/Cigarette: Own brand cigarette OR E-cigarette paired with own brand liquid and preferred power | 13 |
| Total | 32 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Physician Decision | 2 | 3 |
| Overall Study | Protocol Violation | 0 | 1 |
| Overall Study | Study terminated due to COVID | 4 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 2 |
Baseline characteristics
| Characteristic | E-cigarette User (Exclusive) | Dual User | Total |
|---|---|---|---|
| Age, Continuous | 27.53 years STANDARD_DEVIATION 7.53 | 29 years STANDARD_DEVIATION 6.84 | 28.13 years STANDARD_DEVIATION 7.18 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 1 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 18 Participants | 12 Participants | 30 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian | 1 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized Black or African American | 3 Participants | 3 Participants | 6 Participants |
| Race/Ethnicity, Customized Middle Eastern | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized More than one race | 2 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized White | 13 Participants | 8 Participants | 21 Participants |
| Region of Enrollment United States | 19 participants | 13 participants | 32 participants |
| Sex: Female, Male Female | 6 Participants | 6 Participants | 12 Participants |
| Sex: Female, Male Male | 13 Participants | 7 Participants | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 19 | 0 / 13 |
| other Total, other adverse events | 3 / 19 | 7 / 13 |
| serious Total, serious adverse events | 1 / 19 | 0 / 13 |
Outcome results
Primary
Breakpoint of Drug Purchase Tasks (DPT)
The DPTs will yield measures of willingness to pay and measures of price sensitivity for session-specific tobacco products. Choices made during this task are not reinforced during the session. Each DPT will be completed once per study session (either 90 minutes or approximately 180 minutes into the session, timing varies based on task order presentation and potentially choices made in tasks presented prior to this task).
Time frame: Up to 180 minutes
Population: Protocol was changed after study completion by 4 Dual Users so results are not being reported on those participants.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| E-cigarette User (Exclusive) | Breakpoint of Drug Purchase Tasks (DPT) | 30 watts, 30 mg/ml nicotine | 3.29 US Dollars | Standard Deviation 3.73 |
| E-cigarette User (Exclusive) | Breakpoint of Drug Purchase Tasks (DPT) | 30 watts, 10 mg/ml nicotine | 3.37 US Dollars | Standard Deviation 3.43 |
| E-cigarette User (Exclusive) | Breakpoint of Drug Purchase Tasks (DPT) | 15 watts, 30 mg/ml nicotine | 3.51 US Dollars | Standard Deviation 3.41 |
| E-cigarette User (Exclusive) | Breakpoint of Drug Purchase Tasks (DPT) | 15 watts, 10 mg/ml nicotine | 3.74 US Dollars | Standard Deviation 3.5 |
| E-cigarette User (Exclusive) | Breakpoint of Drug Purchase Tasks (DPT) | own brand e-cigarette | 3.95 US Dollars | Standard Deviation 3.59 |
| Dual User | Breakpoint of Drug Purchase Tasks (DPT) | 15 watts, 10 mg/ml nicotine | 4.80 US Dollars | Standard Deviation 3.86 |
| Dual User | Breakpoint of Drug Purchase Tasks (DPT) | own brand e-cigarette | 3.79 US Dollars | Standard Deviation 3.09 |
| Dual User | Breakpoint of Drug Purchase Tasks (DPT) | 30 watts, 30 mg/ml nicotine | 4.43 US Dollars | Standard Deviation 3.74 |
| Dual User | Breakpoint of Drug Purchase Tasks (DPT) | 15 watts, 30 mg/ml nicotine | 4.26 US Dollars | Standard Deviation 3.63 |
| Dual User | Breakpoint of Drug Purchase Tasks (DPT) | 30 watts, 10 mg/ml nicotine | 4.23 US Dollars | Standard Deviation 3.77 |
Primary
Breakpoint of Multiple Choice Procedure (MCP)
The MCP will yield of measure of willingness to pay for session-specific tobacco products. One choice made during this task is reinforced (i.e., money or tobacco product is distributed). Completed once per study session (either 90 minutes or approximately 180 minutes into the session, timing varies based on task order presentation and potentially choices made in tasks presented prior to this task).
Time frame: Up to 180 minutes.
Population: Protocol was changed after study completion by 4 Dual Users so results are not being reported on those participants.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| E-cigarette User (Exclusive) | Breakpoint of Multiple Choice Procedure (MCP) | 30 watts, 30 mg/ml nicotine | 2.51 US Dollars | Standard Deviation 3.18 |
| E-cigarette User (Exclusive) | Breakpoint of Multiple Choice Procedure (MCP) | 30 watts, 10 mg/ml nicotine | 2.63 US Dollars | Standard Deviation 2.98 |
| E-cigarette User (Exclusive) | Breakpoint of Multiple Choice Procedure (MCP) | 15 watts, 30 mg/ml nicotine | 2.56 US Dollars | Standard Deviation 2.93 |
| E-cigarette User (Exclusive) | Breakpoint of Multiple Choice Procedure (MCP) | 15 watts, 10 mg/ml nicotine | 2.35 US Dollars | Standard Deviation 2.13 |
| E-cigarette User (Exclusive) | Breakpoint of Multiple Choice Procedure (MCP) | Own brand e-cigarette | 3.05 US Dollars | Standard Deviation 2.92 |
| Dual User | Breakpoint of Multiple Choice Procedure (MCP) | 15 watts, 10 mg/ml nicotine | 2.23 US Dollars | Standard Deviation 2.34 |
| Dual User | Breakpoint of Multiple Choice Procedure (MCP) | Own brand e-cigarette | 2.90 US Dollars | Standard Deviation 2.99 |
| Dual User | Breakpoint of Multiple Choice Procedure (MCP) | 30 watts, 30 mg/ml nicotine | 2.36 US Dollars | Standard Deviation 2.41 |
| Dual User | Breakpoint of Multiple Choice Procedure (MCP) | 15 watts, 30 mg/ml nicotine | 2.51 US Dollars | Standard Deviation 1.98 |
| Dual User | Breakpoint of Multiple Choice Procedure (MCP) | 30 watts, 10 mg/ml nicotine | 2.10 US Dollars | Standard Deviation 2.06 |
Primary
Effort for Product Puffs With the Progressive Ratio Task (PRT)
The PRT will yield a measure of willingness to work for session-specific tobacco products (via number of times a space bar is pressed to earn puffs) by measuring the number of puffs self-administrated. Completed once per study session (either 90 minutes or approximately 180 minutes into the session, timing varies based on task order presentation and potentially choices made in tasks presented prior to this task).
Time frame: Up to 180 minutes.
Population: Protocol was changed after study completion by 4 Dual Users so results are not being reported on those participants.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| E-cigarette User (Exclusive) | Effort for Product Puffs With the Progressive Ratio Task (PRT) | 30 watts, 30 mg/ml nicotine | 4.74 e-cigarette puffs | Standard Deviation 1.88 |
| E-cigarette User (Exclusive) | Effort for Product Puffs With the Progressive Ratio Task (PRT) | 30 watts, 10 mg/ml nicotine | 5.58 e-cigarette puffs | Standard Deviation 1.68 |
| E-cigarette User (Exclusive) | Effort for Product Puffs With the Progressive Ratio Task (PRT) | 15 watts, 30 mg/ml nicotine | 4.58 e-cigarette puffs | Standard Deviation 1.77 |
| E-cigarette User (Exclusive) | Effort for Product Puffs With the Progressive Ratio Task (PRT) | 15 watts, 10 mg/ml nicotine | 4.89 e-cigarette puffs | Standard Deviation 1.59 |
| E-cigarette User (Exclusive) | Effort for Product Puffs With the Progressive Ratio Task (PRT) | own brand e-cigarette | 4.95 e-cigarette puffs | Standard Deviation 1.54 |
| Dual User | Effort for Product Puffs With the Progressive Ratio Task (PRT) | 15 watts, 10 mg/ml nicotine | 4.77 e-cigarette puffs | Standard Deviation 1.92 |
| Dual User | Effort for Product Puffs With the Progressive Ratio Task (PRT) | own brand e-cigarette | 4.54 e-cigarette puffs | Standard Deviation 1.56 |
| Dual User | Effort for Product Puffs With the Progressive Ratio Task (PRT) | 30 watts, 30 mg/ml nicotine | 4.54 e-cigarette puffs | Standard Deviation 1.76 |
| Dual User | Effort for Product Puffs With the Progressive Ratio Task (PRT) | 15 watts, 30 mg/ml nicotine | 4.38 e-cigarette puffs | Standard Deviation 2.06 |
| Dual User | Effort for Product Puffs With the Progressive Ratio Task (PRT) | 30 watts, 10 mg/ml nicotine | 5.38 e-cigarette puffs | Standard Deviation 1.56 |
Other Pre-specified
Change in Diastolic Blood Pressure
and blood pressure (measured in hg)
Time frame: Recorded throughout each 4 hour study session using automated software every 5 minutes.
Other Pre-specified
Change in Heart Rate
Heart rate (measured in bpm)
Time frame: Recorded throughout each 4 hour study session using automated software every 10 seconds.
Other Pre-specified
Change in Systolic Blood Pressure
Blood pressure (measured in mm)
Time frame: Recorded throughout each 4 hour study session using automated software every 5 minutes.
Other Pre-specified
Subjective Measures of Nicotine Abstinence Symptoms
Measures of related to nicotine abstinence symptoms and nicotine side effects will be measured during each study session.
Time frame: Third measure given during each session, approximately 120 minutes into each session (timing dependent on choices made in tasks presented prior to this measure).
Other Pre-specified
Subjective Measures of Nicotine Abstinence Symptoms
Measures of related to nicotine abstinence symptoms and nicotine side effects will be measured during each study session.
Time frame: Fifth measure given during each session, approximately 180 minutes into each session (timing dependent on choices made in tasks presented prior to this measure).
Other Pre-specified
Subjective Measures of Nicotine Abstinence Symptoms
Measures of related to nicotine abstinence symptoms and nicotine side effects will be measured during each study session.
Time frame: Last measure given during each session, approximately 240 minutes into each session (timing dependent on choices made in tasks presented prior to this measure).
Other Pre-specified
Subjective Measures of Nicotine Abstinence Symptoms
Measures of related to nicotine abstinence symptoms and nicotine side effects will be measured during each study session.
Time frame: First measure given, regardless of task order, 90 minutes into each session