Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2U54DA036105 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
Not provided
Not provided
Not provided
Not provided
This study aims to better understand how e-cigarettes (ECIG) nicotine flux impacts several behavioral economic measures of abuse liability.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tobacco product administration and assessment, own brand cigarettes | Other | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. |
| 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. | Each DPT will be completed once per study session, about 75 minutes into the session. The results will reported in US dollars ($). |
| 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. | The PRT is completed once per study session, at 85 minutes into the session. |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Caroline O Cobb, PhD | Virginia Commonwealth University | Principal Investigator |
| Andrew Barnes, PhD | Virginia Commonwealth University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for the Study of Tobacco Products | Richmond | Virginia | 23220 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Overall Enrollment | When I try to add the individual numbers for the different procedures, it confuses the system since it looks like each procedure is a seperate arm. For feasibility issues the study design was altered from a crossover study to a single-arm parallel one. So for this arm, 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 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 21, 2024 |
Not provided
Not provided
Not provided
Not provided
Participants will be blinded to their condition (nicotine level) used in each session, except during their 'own brand' session.
Not provided
|
| Tobacco product administration and assessment, ECIG 30 Watts, 0 mg/ml nicotine | Other | 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 |
|
| Tobacco product administration and assessment, ECIG 30 Watts, 8 mg/ml nicotine | Other | 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 |
|
| Tobacco product administration and assessment, ECIG 30 Watts, 15 mg/ml nicotine | Other | 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 |
|
| Tobacco product administration and assessment, ECIG 30 Watts, 30 mg/ml nicotine | Other | 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 |
|
| Active Comparator: Own Brand Cig |
|
| Experimental: ECIG 30 W, 0 mg/ml Nic |
|
| Experimental: ECIG 30 W, 8 mg/ml Nic |
|
| Experimental: ECIG 30 W, 15 mg/ml Nic |
|
| Experimental: ECIG 30 W, 30 mg/ml Nic |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Mean | Standard Deviation | Breakpoint (highest trial completed) | 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. |
|
|
| ||||||||||||||||||||||||||||||||||
| 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. | 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. | Posted | Mean | Standard Deviation | US dollars ($) | Each DPT will be completed once per study session, about 75 minutes into the session. The results will reported in US dollars ($). |
| ||||||||||||||||||||||||||||||||||||
| 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. | 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. | Posted | Mean | Standard Deviation | Number of puffs | The PRT is completed once per study session, at 85 minutes into the session. |
|
|
Data were collected during laboratory visits, approximately over 3 weeks; no follow up adverse event data collection occurred.
Non-systematic. Questionnaire assessed at the beginning of each laboratory session, participant self-report. For adverse events that happened outside of the laboratory, no experimental condition is applicable. For adverse events that happened within the laboratory (e.g., during an experimental session), events are reported separately for each relevant experimental condition.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Experimental | The study was originally organized as a cross-over study but due to feasibility circumstances, the study team determined that it was more important to preserve the subject enrollment numbers and complete the study in the most efficient manner for the enrolled subjects. So this became a single-arm parallel study. The study involved Tobacco product administration and assessment: 1) Effort for Product Puffs With Cross Product Progressive Ratio Task (CP-PRT), 2) Breakpoint of Drug Purchase Task (DPT), and 3) Effort for Product Puffs With Progressive Ratio Task (PRT) The individual interventions are listed in the milestones section. | 0 | 44 | 1 | 44 | 3 | 44 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Surgical and medical procedures: unrelated hysterectomy | Surgical and medical procedures | Non-systematic Assessment | Surgical and medical procedures: unrelated hysterectomy. (Note: adverse event occurred outside of the laboratory; therefore, reporting by experimental condition is not applicable.) |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Elevated Blood Pressure, ECIG 30 W, 30 mg/ml nicotine condition | Blood and lymphatic system disorders | Non-systematic Assessment | Blood pressure was elevated in the ECIG 30 W, 30 mg/ml nicotine condition |
|
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Caroline Cobb, PhD, PI | Virginia Commonwealth University | 804-828-8687 | cobbco@vcu.edu |
| Dec 12, 2024 |
| Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 27, 2023 | Dec 12, 2024 | ICF_002.pdf |
| ID | Term |
|---|---|
| D000072137 | Vaping |
| ID | Term |
|---|---|
| D012907 | Smoking |
| D001519 | Behavior |
Not provided
Not provided
| ID | Term |
|---|---|
| D012149 | Restraint, Physical |
| D009538 | Nicotine |
| ID | Term |
|---|---|
| D032763 | Behavior Control |
| D013812 | Therapeutics |
| D007103 | Immobilization |
| D008919 | Investigative Techniques |
| D012991 | Solanaceous Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
Not provided
Not provided
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
| ECIG 30 Watts, 30 mg/ml nicotine |
|
| Units | Counts |
|---|
| Participants |
|
|
|