Electronic Cigarette Use
Conditions
Keywords
Electronic Cigarette, Nicotine Flux
Brief summary
This study aims to better understand how e-cigarettes (ECIG) nicotine flux impacts several behavioral economic measures of abuse liability.
Interventions
OTHERTobacco product administration and assessment, own brand cigarettes
4 sample puffs, followed by a 60 minute rest period, hypothetical drug purchase tasks, followed by progressive ratio tasks (single product and two products, with 60 minute rest in between) where participants work to earn puffs of tobacco products; preceded and followed by physiological and subjective assessment
OTHERTobacco product administration and assessment, ECIG 30 Watts, 0 mg/ml nicotine
4 sample puffs, followed by a 60 minute rest period, hypothetical drug purchase tasks, followed by progressive ratio tasks (single product and two products, with 60 minute rest in between) where participants work to earn puffs of tobacco products; preceded and followed by physiological and subjective assessment
OTHERTobacco product administration and assessment, ECIG 30 Watts, 8 mg/ml nicotine
4 sample puffs, followed by a 60 minute rest period, hypothetical drug purchase tasks, followed by progressive ratio tasks (single product and two products, with 60 minute rest in between) where participants work to earn puffs of tobacco products; preceded and followed by physiological and subjective assessment
OTHERTobacco product administration and assessment, ECIG 30 Watts, 15 mg/ml nicotine
4 sample puffs, followed by a 60 minute rest period, hypothetical drug purchase tasks, followed by progressive ratio tasks (single product and two products, with 60 minute rest in between) where participants work to earn puffs of tobacco products; preceded and followed by physiological and subjective assessment
OTHERTobacco product administration and assessment, ECIG 30 Watts, 30 mg/ml nicotine
4 sample puffs, followed by a 60 minute rest period, hypothetical drug purchase tasks, followed by progressive ratio tasks (single product and two products, with 60 minute rest in between) where participants work to earn puffs of tobacco products; preceded and followed by physiological and subjective assessment
Sponsors
National Institute on Drug Abuse (NIDA)
Virginia Commonwealth University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Masking description
Participants will be blinded to their condition (nicotine level) used in each session, except during their 'own brand' session.
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 |
|---|---|---|
| Effort for Product Puffs With Cross Product Progressive Ratio Task (CP-PRT) | The CP-PRT is completed once per study session (except it is not completed in the 5th, own brand session), at 185 minutes into the session. | This is now a single-arm parallel study design. The main outcome of interest in the CP-PRT is the relative reinforcing value - defined as how hard a participant is willing to work for the session product compared to their own brand cigarette. The breakpoint, or highest trial number that a participant completed for a puff of the session-specific product will be used as the measure of relative reinforcing value. |
| Breakpoint of Drug Purchase Task (DPT) | Each DPT will be completed once per study session, about 75 minutes into the session. The results will reported in US dollars ($). | The DPTs will yield measures of willingness to pay (demand) for session-specific tobacco products. Choices made during this task are not reinforced during the session. Using the DPT, participants estimate the number of session-specific product puffs they would take across increasing prices per puff. DPT demand will be characterized by the Breakpoint (BP); i.e., the highest price per puff at which participants indicate they would stop using the session-specific product rather than incur the cost. |
| Effort for Product Puffs With Progressive Ratio Task (PRT) | The PRT is completed once per study session, at 85 minutes into the session. | 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) through the outcome measure: mean number of puffs self-administrated. The outcome measure of interest is the total number of puffs self-administered. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Experimental Tobacco product administration and assessment: 4 sample puffs, followed by a 60 minute rest period, hypothetical drug purchase tasks, followed by progressive ratio tasks (single product and two products, with 60 minute rest in between) where participants work to earn puffs of tobacco products; preceded and followed by physiological and subjective assessment | 44 |
| Total | 44 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Physician Decision | 6 |
| Overall Study | Withdrawal by Subject | 6 |
Baseline characteristics
| Characteristic | Experimental |
|---|---|
| Age, Continuous | 37.61 years STANDARD_DEVIATION 9.08 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 41 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 23 Participants |
| Race (NIH/OMB) More than one race | 3 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 | 14 Participants |
| Region of Enrollment United States | 44 participants |
| Sex: Female, Male Female | 13 Participants |
| Sex: Female, Male Male | 31 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 44 |
| other Total, other adverse events | 3 / 44 |
| serious Total, serious adverse events | 1 / 44 |
Outcome results
Primary
Breakpoint of Drug Purchase Task (DPT)
The DPTs will yield measures of willingness to pay (demand) for session-specific tobacco products. Choices made during this task are not reinforced during the session. Using the DPT, participants estimate the number of session-specific product puffs they would take across increasing prices per puff. DPT demand will be characterized by the Breakpoint (BP); i.e., the highest price per puff at which participants indicate they would stop using the session-specific product rather than incur the cost.
Time frame: Each DPT will be completed once per study session, about 75 minutes into the session. The results will reported in US dollars ($).
Population: The study morphed from a cross-over study into a single-arm study due to feasibility issues. Instead of different arms completing the interventions in a different order, all of the subjects were moved into one arm and completed the interventions in the same order.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Experimental | Breakpoint of Drug Purchase Task (DPT) | Own Brand Cigarette | 1.23 US dollars ($) | Standard Deviation 2.1 |
| Experimental | Breakpoint of Drug Purchase Task (DPT) | ECIG 30 Watts, 0 mg/ml nicotine | 0.54 US dollars ($) | Standard Deviation 0.9 |
| Experimental | Breakpoint of Drug Purchase Task (DPT) | ECIG 30 Watts, 8 mg/ml nicotine | 0.96 US dollars ($) | Standard Deviation 1.78 |
| Experimental | Breakpoint of Drug Purchase Task (DPT) | ECIG 30 Watts, 15 mg/ml nicotine | 0.43 US dollars ($) | Standard Deviation 0.77 |
| Experimental | Breakpoint of Drug Purchase Task (DPT) | ECIG 30 Watts, 30 mg/ml nicotine | 0.49 US dollars ($) | Standard Deviation 1.01 |
Primary
Effort for Product Puffs With Cross Product Progressive Ratio Task (CP-PRT)
This is now a single-arm parallel study design. The main outcome of interest in the CP-PRT is the relative reinforcing value - defined as how hard a participant is willing to work for the session product compared to their own brand cigarette. The breakpoint, or highest trial number that a participant completed for a puff of the session-specific product will be used as the measure of relative reinforcing value.
Time frame: The CP-PRT is completed once per study session (except it is not completed in the 5th, own brand session), at 185 minutes into the session.
Population: The study morphed from a cross-over study into a single-arm study due to feasibility issues. Instead of different arms completing the interventions in a different order, all of the subjects were moved into one arm and completed the interventions in the same order.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Experimental | Effort for Product Puffs With Cross Product Progressive Ratio Task (CP-PRT) | ECIG 30 Watts, 0 mg/ml nicotine | 6.30 Breakpoint (highest trial completed) | Standard Deviation 2.83 |
| Experimental | Effort for Product Puffs With Cross Product Progressive Ratio Task (CP-PRT) | ECIG 30 Watts, 8 mg/ml nicotine | 6.38 Breakpoint (highest trial completed) | Standard Deviation 2.94 |
| Experimental | Effort for Product Puffs With Cross Product Progressive Ratio Task (CP-PRT) | ECIG 30 Watts, 15 mg/ml nicotine | 6.34 Breakpoint (highest trial completed) | Standard Deviation 2.7 |
| Experimental | Effort for Product Puffs With Cross Product Progressive Ratio Task (CP-PRT) | ECIG 30 Watts, 30 mg/ml nicotine | 5.94 Breakpoint (highest trial completed) | Standard Deviation 2.93 |
Primary
Effort for Product Puffs With 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) through the outcome measure: mean number of puffs self-administrated. The outcome measure of interest is the total number of puffs self-administered.
Time frame: The PRT is completed once per study session, at 85 minutes into the session.
Population: The study morphed from a cross-over study into a single-arm study due to feasibility issues. Instead of different arms completing the interventions in a different order, all of the subjects were moved into one arm and completed the interventions in the same order.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Experimental | Effort for Product Puffs With Progressive Ratio Task (PRT) | Own Brand Cigarette | 9.06 Number of puffs | Standard Deviation 2.73 |
| Experimental | Effort for Product Puffs With Progressive Ratio Task (PRT) | ECIG 30 Watts, 0 mg/ml nicotine | 7.69 Number of puffs | Standard Deviation 3.51 |
| Experimental | Effort for Product Puffs With Progressive Ratio Task (PRT) | ECIG 30 Watts, 8 mg/ml nicotine | 7.88 Number of puffs | Standard Deviation 3.42 |
| Experimental | Effort for Product Puffs With Progressive Ratio Task (PRT) | ECIG 30 Watts, 15 mg/ml nicotine | 7.31 Number of puffs | Standard Deviation 3.89 |
| Experimental | Effort for Product Puffs With Progressive Ratio Task (PRT) | ECIG 30 Watts, 30 mg/ml nicotine | 6.34 Number of puffs | Standard Deviation 4.37 |