Electronic Cigarettes
Conditions
Brief summary
The purpose of this study is to determine differences in nicotine delivery, user behaviors, subjective effects, and physiological effects, when cigarette smokers use an electronic cigarette with different nicotine (and sweetener) concentrations relative to using their own brand of cigarettes.
Interventions
OTHEROwn Brand Cigarette
Effects of own brand cigarette use.
OTHERECIG 15 mg nicotine, sweetened
Effects of using a 30 Watt ECIG filled with 15 mg nicotine, sweetened liquid
OTHERECIG 15 mg nicotine, unsweet
Effects of using a 30 Watt ECIG filled with 15 mg nicotine, unsweet liquid
OTHERECIG 0 mg nicotine, sweetened
Effects of using a 30 Watt ECIG filled with 0 mg nicotine, sweetened liquid
OTHERECIG 0 mg nicotine, unsweet
Effects of using a 30 Watt ECIG filled with 0 mg nicotine, unsweet liquid
Sponsors
National Institute on Drug Abuse (NIDA)
Virginia Commonwealth University
Study design
Allocation
NA
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 the ages of 21-55 years old * Current cigarette smokers * Wiling to provide informed consent * Able to attend the lab session and abstain from tobacco/nicotine products as required * Agree to use designated products according to the study protocol
Exclusion criteria
* Women if they are breast-feeding or test positive for pregnancy (by urinalysis) at screening. * Individuals who weigh less than 110 pounds. 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 | Blood will be taken 4 times in each session to examine changes from baseline (approx 70 minutes) to immediately following a ten-puff bout (approx 80 minutes), and immediately before (approx 140 minutes) and after the PRT (approx 180 minutes). | Change in plasma nicotine concentration. Changes in plasm nicotine concentration during puff bout are considered to be the more relevant and accurate values so analysis and results reporting will focus on change from baseline to immediately following 10-puff bout. |
| Progressive Ratio Task - Latency | This task will begin approximately an hour and ten minutes after the 10-puff directed product use bout. | The progressive ratio task (PRT) is a self-administration task that will take 30-minutes to complete. It will begin by requiring ten computer key presses to earn the first puff of the session product, and this requirement will increase by 30% (i.e., 10, 13, 17, etc.) after each reinforcer (puff) is earned and consumed. The PRT will have three outcome measures (1) breakpoint (maximum number of key presses completed to earn a puff), (2) number of puffs, and (3) latency (milliseconds) to initiate key pressing. Latency is reported here. |
| Progressive Ratio Task - Number of Puffs | This task will begin approximately an hour and ten minutes after the 10-puff directed product use bout. | The progressive ratio task (PRT) is a self-administration task that will take 30-minutes to complete. It will begin by requiring ten computer key presses to earn the first puff of the session product, and this requirement will increase by 30% (i.e., 10, 13, 17, etc.) after each reinforcer (puff) is earned and consumed. The PRT will have three outcome measures (1) breakpoint (maximum number of key presses completed to earn a puff), (2) number of puffs, and (3) latency (sec) to initiate key pressing. Number of puffs is reported here. |
| Progressive Ratio Task - Breakpoint | This task will begin approximately an hour and ten minutes after the 10-puff directed product use bout. | The progressive ratio task (PRT) is a self-administration task that will take 30-minutes to complete. It will begin by requiring ten computer key presses to earn the first puff of the session product, and this requirement will increase by 30% (i.e., 10, 13, 17, etc.) after each reinforcer (puff) is earned and consumed. The PRT will have three outcome measures (1) breakpoint (maximum number of key presses completed to earn a puff), (2) number of puffs, and (3) latency (sec) to initiate key pressing. Breakpoint is reported here. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Puff Volume | Puff volume will be measured during the approximately 5-minute, 10-puff use bout. | The volume of each puff, in ml, averaged over the 10-puff use bout |
| Puff Duration | The duration of each puff will be measured during the approximately 5-minute, 10-puff use bout. | The duration of each puff, in seconds, averaged over the 10-puff use bout |
Other
| Measure | Time frame | Description |
|---|---|---|
| Hughes-Hatsukami Questionnaire | This questionnaire will be administered 4 times in each session to examine changes from baseline (70 minutes) to immediately following a ten-puff bout (80 minutes), and immediately before (140 minutes) and after the PRT (180 minutes) | This scale will be used to assess the extent to which product use reduces tobacco abstinence symptoms, and consists of 11 items scored 0-100, with lower scores indicating less severe symptoms. There are no sub-scales. Items are analyzed separately. |
| Positive and Negative Affect Schedule | This questionnaire will be administered 4 times in each session to examine changes from baseline (70 minutes) to immediately following a ten-puff bout (80 minutes), and immediately before (140 minutes) and after the PRT (180 minutes) | This scale will be used to measure positive and negative affect and consists of 20-items that are scored on a 5-point likert scale ranging from very slightly or not at all to extremely. The items from this scale are scored into two dimensions: Positive Affect and Negative Affect. |
| Inter Puff Interval | Inter puff interval will be measured during the approximately 5-minute, 10-puff use bout. | The time between each puff, in seconds. |
| Heart Rate | Heart rate will be measured continuously throughout the session, and will be used to examine changes in HR from baseline (70 minutes) to during (75 minutes) and immediately following a ten-puff bout (80 minutes) | Change in heart rate, measure in beats per minute. |
| Drug Effects Questionnaire | This questionnaire will be administered 4 times in each session to examine changes from baseline (70 minutes) to immediately following a ten-puff bout (80 minutes), and immediately before (140 minutes) and after the PRT (180 minutes) | This questionnaire assess a respondent's feelings after recently using tobacco or nicotine products. It has a total of five items that participants rate from not at all to extremely scored 0-100. Each item is scored and analyzed separately (there are no sub-scales). |
| Flow Rate | Flow rate will be measured during the approximately 5-minute, 10-puff use bout. | The rate of air flow during each puff, in ml/second. |
Countries
United States
Participant flow
Pre-assignment details
Each participant will participate in 5 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 |
|---|---|
| Cigarette Smokers Each participant will participate in 5 sessions. During each session, participants will complete a 10-puff, directed product use bout, and then have the option later to puff as little or as much as they like during a 30-minute self administration task.
Session 1: Own brand cigarette use Session 2: ECIG 15 mg nicotine, sweetened Session 3: ECIG Lab Session ECIG 15 mg nicotine, unsweetened Session 4: ECIG Lab Session ECIG 0 mg nicotine, sweetened Session 5: ECIG Lab Session ECIG 0 mg nicotine, unsweetened
Own Brand Cigarette: Effects of own brand cigarette use.
ECIG 15 mg nicotine, sweetened: Effects of using a 30 Watt ECIG filled with 15 mg nicotine, sweetened liquid
ECIG 15 mg nicotine, unsweet: Effects of using a 30 Watt ECIG filled with 15 mg nicotine, unsweet liquid
ECIG 0 mg nicotine, sweetened: Effects of using a 30 Watt ECIG filled with 0 mg nicotine, sweetened liquid
ECIG 0 mg nicotine, unsweet: Effects of using a 30 Watt ECIG filled with 0 mg nicotine, unsweet liquid | 14 |
| Total | 14 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | COVID-19 shut down | 4 |
| Overall Study | lack of venous access | 1 |
| Overall Study | Lost to Follow-up | 1 |
| Overall Study | Protocol Violation | 2 |
Baseline characteristics
| Characteristic | Cigarette Smokers |
|---|---|
| Age, Continuous | 37.07 years STANDARD_DEVIATION 10.5 |
| Cigarettes per day | 14.21 Cigarettes per day STANDARD_DEVIATION 4.4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 13 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 7 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 6 Participants |
| Region of Enrollment United States | 14 Participants |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
Outcome results
Primary
Plasma Nicotine Concentration
Change in plasma nicotine concentration. Changes in plasm nicotine concentration during puff bout are considered to be the more relevant and accurate values so analysis and results reporting will focus on change from baseline to immediately following 10-puff bout.
Time frame: Blood will be taken 4 times in each session to examine changes from baseline (approx 70 minutes) to immediately following a ten-puff bout (approx 80 minutes), and immediately before (approx 140 minutes) and after the PRT (approx 180 minutes).
Population: One participant had incomplete blood data and was excluded from the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cigarette Smokers | Plasma Nicotine Concentration | Own Brand | 12.32 ng/ml | Standard Deviation 8.3 |
| Cigarette Smokers | Plasma Nicotine Concentration | Unsweetened, 0 mg/ml nicotine | -0.22 ng/ml | Standard Deviation 1 |
| Cigarette Smokers | Plasma Nicotine Concentration | Unsweetened, 15 mg/ml nicotine | 7.09 ng/ml | Standard Deviation 8.6 |
| Cigarette Smokers | Plasma Nicotine Concentration | Sweetened, 15 mg/ml nicotine | 5.85 ng/ml | Standard Deviation 7 |
| Cigarette Smokers | Plasma Nicotine Concentration | Sweetened, 0 mg/ml nicotine | -0.29 ng/ml | Standard Deviation 1.1 |
Primary
Progressive Ratio Task - Breakpoint
The progressive ratio task (PRT) is a self-administration task that will take 30-minutes to complete. It will begin by requiring ten computer key presses to earn the first puff of the session product, and this requirement will increase by 30% (i.e., 10, 13, 17, etc.) after each reinforcer (puff) is earned and consumed. The PRT will have three outcome measures (1) breakpoint (maximum number of key presses completed to earn a puff), (2) number of puffs, and (3) latency (sec) to initiate key pressing. Breakpoint is reported here.
Time frame: This task will begin approximately an hour and ten minutes after the 10-puff directed product use bout.
Population: Cigarette smokers
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cigarette Smokers | Progressive Ratio Task - Breakpoint | Unsweetened, 0 mg/ml nicotine | 416.07 Key presses | Standard Deviation 502 |
| Cigarette Smokers | Progressive Ratio Task - Breakpoint | Sweetened, 0 mg/ml nicotine | 307.29 Key presses | Standard Deviation 415.3 |
| Cigarette Smokers | Progressive Ratio Task - Breakpoint | Unsweetened, 15 mg/ml nicotine | 336.43 Key presses | Standard Deviation 687.3 |
| Cigarette Smokers | Progressive Ratio Task - Breakpoint | Sweetened, 15 mg/ml nicotine | 492.86 Key presses | Standard Deviation 811 |
| Cigarette Smokers | Progressive Ratio Task - Breakpoint | Own brand cigarette | 812.86 Key presses | Standard Deviation 1132.3 |
Primary
Progressive Ratio Task - Latency
The progressive ratio task (PRT) is a self-administration task that will take 30-minutes to complete. It will begin by requiring ten computer key presses to earn the first puff of the session product, and this requirement will increase by 30% (i.e., 10, 13, 17, etc.) after each reinforcer (puff) is earned and consumed. The PRT will have three outcome measures (1) breakpoint (maximum number of key presses completed to earn a puff), (2) number of puffs, and (3) latency (milliseconds) to initiate key pressing. Latency is reported here.
Time frame: This task will begin approximately an hour and ten minutes after the 10-puff directed product use bout.
Population: Cigarette smokers
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cigarette Smokers | Progressive Ratio Task - Latency | Unsweetened, 0 mg/ml nicotine | 161176.93 milliseconds | Standard Deviation 473649.1 |
| Cigarette Smokers | Progressive Ratio Task - Latency | Sweetened, 0 mg/ml nicotine | 390300.43 milliseconds | Standard Deviation 764004.4 |
| Cigarette Smokers | Progressive Ratio Task - Latency | Unsweetened, 15 mg/ml nicotine | 315803.79 milliseconds | Standard Deviation 636134.5 |
| Cigarette Smokers | Progressive Ratio Task - Latency | Sweetened, 15 mg/ml nicotine | 263130.86 milliseconds | Standard Deviation 651141 |
| Cigarette Smokers | Progressive Ratio Task - Latency | Own brand cigarette | 6500.64 milliseconds | Standard Deviation 6972.8 |
Primary
Progressive Ratio Task - Number of Puffs
The progressive ratio task (PRT) is a self-administration task that will take 30-minutes to complete. It will begin by requiring ten computer key presses to earn the first puff of the session product, and this requirement will increase by 30% (i.e., 10, 13, 17, etc.) after each reinforcer (puff) is earned and consumed. The PRT will have three outcome measures (1) breakpoint (maximum number of key presses completed to earn a puff), (2) number of puffs, and (3) latency (sec) to initiate key pressing. Number of puffs is reported here.
Time frame: This task will begin approximately an hour and ten minutes after the 10-puff directed product use bout.
Population: Cigarette smokers
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cigarette Smokers | Progressive Ratio Task - Number of Puffs | Unsweetened, 0 mg/ml nicotine | 7.64 Number of puffs | Standard Deviation 4.2 |
| Cigarette Smokers | Progressive Ratio Task - Number of Puffs | Sweetened, 0 mg/ml nicotine | 6.21 Number of puffs | Standard Deviation 4.7 |
| Cigarette Smokers | Progressive Ratio Task - Number of Puffs | Unsweetened, 15 mg/ml nicotine | 5.07 Number of puffs | Standard Deviation 5.1 |
| Cigarette Smokers | Progressive Ratio Task - Number of Puffs | Sweetened, 15 mg/ml nicotine | 7.21 Number of puffs | Standard Deviation 5 |
| Cigarette Smokers | Progressive Ratio Task - Number of Puffs | Own brand cigarette | 9.93 Number of puffs | Standard Deviation 4.1 |
Secondary
Puff Duration
The duration of each puff, in seconds, averaged over the 10-puff use bout
Time frame: The duration of each puff will be measured during the approximately 5-minute, 10-puff use bout.
Population: Cigarette smokers
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cigarette Smokers | Puff Duration | Sweetened, 15 mg/ml nicotine | 1.94 seconds | Standard Deviation 1.4 |
| Cigarette Smokers | Puff Duration | Own brand cigarette | 2.06 seconds | Standard Deviation 1.3 |
| Cigarette Smokers | Puff Duration | Unsweetened, 0 mg/ml nicotine | 2.54 seconds | Standard Deviation 1.8 |
| Cigarette Smokers | Puff Duration | Sweetened, 0 mg/ml nicotine | 2.74 seconds | Standard Deviation 1.5 |
| Cigarette Smokers | Puff Duration | Unsweetened, 15 mg/ml nicotine | 1.60 seconds | Standard Deviation 0.7 |
Secondary
Puff Volume
The volume of each puff, in ml, averaged over the 10-puff use bout
Time frame: Puff volume will be measured during the approximately 5-minute, 10-puff use bout.
Population: Cigarette smokers
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cigarette Smokers | Puff Volume | Unsweetened, 0 mg/ml nicotine | 207.17 ml | Standard Deviation 124.5 |
| Cigarette Smokers | Puff Volume | Sweetened, 0 mg/ml nicotine | 233.47 ml | Standard Deviation 157.7 |
| Cigarette Smokers | Puff Volume | Unsweetened, 15 mg/ml nicotine | 130.57 ml | Standard Deviation 110.4 |
| Cigarette Smokers | Puff Volume | Sweetened, 15 mg/ml nicotine | 166.51 ml | Standard Deviation 141 |
| Cigarette Smokers | Puff Volume | Own brand cigarette | 65.12 ml | Standard Deviation 48.3 |
Other Pre-specified
Drug Effects Questionnaire
This questionnaire assess a respondent's feelings after recently using tobacco or nicotine products. It has a total of five items that participants rate from not at all to extremely scored 0-100. Each item is scored and analyzed separately (there are no sub-scales).
Time frame: This questionnaire will be administered 4 times in each session to examine changes from baseline (70 minutes) to immediately following a ten-puff bout (80 minutes), and immediately before (140 minutes) and after the PRT (180 minutes)
Other Pre-specified
Flow Rate
The rate of air flow during each puff, in ml/second.
Time frame: Flow rate will be measured during the approximately 5-minute, 10-puff use bout.
Other Pre-specified
Heart Rate
Change in heart rate, measure in beats per minute.
Time frame: Heart rate will be measured continuously throughout the session, and will be used to examine changes in HR from baseline (70 minutes) to during (75 minutes) and immediately following a ten-puff bout (80 minutes)
Other Pre-specified
Hughes-Hatsukami Questionnaire
This scale will be used to assess the extent to which product use reduces tobacco abstinence symptoms, and consists of 11 items scored 0-100, with lower scores indicating less severe symptoms. There are no sub-scales. Items are analyzed separately.
Time frame: This questionnaire will be administered 4 times in each session to examine changes from baseline (70 minutes) to immediately following a ten-puff bout (80 minutes), and immediately before (140 minutes) and after the PRT (180 minutes)
Other Pre-specified
Inter Puff Interval
The time between each puff, in seconds.
Time frame: Inter puff interval will be measured during the approximately 5-minute, 10-puff use bout.
Other Pre-specified
Positive and Negative Affect Schedule
This scale will be used to measure positive and negative affect and consists of 20-items that are scored on a 5-point likert scale ranging from very slightly or not at all to extremely. The items from this scale are scored into two dimensions: Positive Affect and Negative Affect.
Time frame: This questionnaire will be administered 4 times in each session to examine changes from baseline (70 minutes) to immediately following a ten-puff bout (80 minutes), and immediately before (140 minutes) and after the PRT (180 minutes)