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| ID | Type | Description | Link |
|---|---|---|---|
| 2U54DA036105 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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The purpose of this study is to determine if abuse liability indices will be impacted by varying flavors and e-cigarette (ECIG) nicotine delivery capability (i.e., nicotine flux) among current combustible cigarette users.
The investigators will compare abuse liability indices between three FDA-authorized ECIG products that vary in nicotine flux (but are all tobacco flavor) and own brand cigarettes. The investigators will also test the influence of ECIG flavor availability (tobacco vs. menthol) within three ECIG product classes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All Participants | Experimental | All participants will receive the same interventions in the same order. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tobacco product administration and assessment | Other | Subjective measures 1 is followed by product sampling that includes 5 self-directed ECIG/own brand cigarette puffs over 10 minutes. After sampling is complete participants complete subjective measures 2. Ten minutes after their sampling has been completed, they complete subjective measures 3 and the behavioral economic task(s). These activities are preceded and followed by cardiovascular response assessment. |
| Measure | Description | Time Frame |
|---|---|---|
| Intensity of Drug Purchase Task (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. Order effects are not assessed in this study design. Intensity, as measured by DPT, is a self-report measure used to assess the reinforcing efficacy or motivational value of a substance. It is a specific quantitative index that refers to the maximum amount of a drug a person would consume if it were available at zero or minimal cost. For this assessment, intensity is measured in puffs (e.g., 0-100 puffs if each puff were free). | There are 4 Sessions: Day 1: own brand (1 condition), Day 3: 2.4% (2 conditions), Day 5: 5% (2 conditions), and Day 7: 6% (2 conditions). The sessions were separated by 48 hours. |
| Price Sensitivity of Drug Purchase Task (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. Order effects are not assessed in this study design. Price sensitivity (α; change in amount purchased as price increases) as measured by DPT. By analyzing these metrics, researchers can quantify and compare the motivational strength and reinforcing value of different substances or different doses, providing insight into the overvaluation of drugs that contributes to addiction. (e.g., 0% to 1% range) DPT outcomes included: breakpoint (highest price participants were willing to pay), intensity (consumption at zero cost), and price sensitivity (α; change in amount purchased as price increases | There are 4 Sessions: Day 1: own brand (1 condition), Day 3: 2.4% (2 conditions), Day 5: 5% (2 conditions), and Day 7: 6% (2 conditions). The sessions were separated by 48 hours. |
| Breakpoint of Drug Purchase Task (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. Order effects are not assessed in this study design. Breakpoint, as measured by DPT, is defined as the first price at which a participant's consumption of a hypothetical drug product is suppressed to zero. The DPT is a behavioral economics assessment tool used to measure the reinforcing value (or abuse liability) of substances. Participants are asked to report how much of a drug they would consume at a series of escalating prices, assuming no access to other similar products and that all consumption would occur within a specified time period (e.g., one day). (e.g. $0.00 to $10.00 range) |
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Inclusion Criteria:
Exclusion Criteria:
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| 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 |
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Thirty-two subjects were eligible and consented. Thirty participants started and completed the study procedures. Study data were collected only from the 30 subjects who actually participated in the study interventions (Demographic and outcome). Order effects are not assessed in this study design. There were four sessions, for the seven conditions: 1.) own brand (1 condition), 2.) 2.4% (2 conditions), 3.) 5% (2 conditions), and 4.) 6% (2 conditions)
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| ID | Title | Description |
|---|---|---|
| FG000 | All Participants | Thirty-two subjects were eligible and consented. Thirty participated in the study procedures. Study data were collected only from the 30 subjects who actually participated in the study interventions (Demographic and outcome). Order effects are not assessed in this study design. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Thirty-two subjects were eligible and consented. Thirty participated in the study procedures. Study data were collected only from the 30 subjects who actually participated in the study interventions (Demographic and outcome). Order effects are not assessed in this study design.
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | Thirty-two subjects were eligible and consented. Thirty participants started and completed the study procedures. Study data were collected only from the 30 subjects who actually participated in the study interventions (Demographic and outcome). Order effects are not assessed in this study design. There were four sessions, for the seven conditions: 1.) own brand (1 condition), 2.) 2.4% (2 conditions), 3.) 5% (2 conditions), and 4.) 6% (2 conditions) . |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Intensity of Drug Purchase Task (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. Order effects are not assessed in this study design. Intensity, as measured by DPT, is a self-report measure used to assess the reinforcing efficacy or motivational value of a substance. It is a specific quantitative index that refers to the maximum amount of a drug a person would consume if it were available at zero or minimal cost. For this assessment, intensity is measured in puffs (e.g., 0-100 puffs if each puff were free). | Thirty-two subjects were eligible and consented. Thirty participants started and completed the study procedures. Study data were collected only from the 30 subjects who actually participated in the study interventions (Demographic and outcome). Order effects are not assessed in this study design. There were four sessions, for the seven conditions: 1.) own brand (1 condition), 2.) 2.4% (2 conditions), 3.) 5% (2 conditions), and 4.) 6% (2 conditions) . | Posted | Mean | Standard Deviation | number of puffs | There are 4 Sessions: Day 1: own brand (1 condition), Day 3: 2.4% (2 conditions), Day 5: 5% (2 conditions), and Day 7: 6% (2 conditions). The sessions were separated by 48 hours. |
At baseline and through to the completion of all of the protocol procedures. There are 4 Sessions: Day 1: own brand (1 condition), Day 3: 2.4% (2 conditions), Day 5: 5% (2 conditions), and Day 7: 6% (2 conditions). The sessions were separated by 48 hours.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | All Participants | Thirty-two subjects were eligible and consented. Thirty participants started and completed the study procedures. Study data were collected only from the 30 subjects who actually participated in the study interventions (Demographic and outcome). Order effects are not assessed in this study design. There were four sessions, for the seven conditions: 1.) own brand (1 condition), 2.) 2.4% (2 conditions), 3.) 5% (2 conditions), and 4.) 6% (2 conditions) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Caroline Cobb | Virginia Commonwealth University | (804) 827-3562 | cobbco@vcu.edu |
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| 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 | Dec 17, 2024 | Sep 2, 2025 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 20, 2024 | Sep 30, 2024 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D000072137 | Vaping |
| D064424 | Tobacco Use |
| ID | Term |
|---|---|
| D012907 | Smoking |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D012149 | Restraint, Physical |
| ID | Term |
|---|---|
| D032763 | Behavior Control |
| D013812 | Therapeutics |
| D007103 | Immobilization |
| D008919 | Investigative Techniques |
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This is a single-arm study. All of the participants will receive the same interventions in the same order.
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| There are 4 Sessions: Day 1: own brand (1 condition), Day 3: 2.4% (2 conditions), Day 5: 5% (2 conditions), and Day 7: 6% (2 conditions). The sessions were separated by 48 hours. |
| Cross-price Elasticity of the Cross Product-DPT | The Cross Product (CP)-DPTs assess cross-product purchasing behaviors between various tobacco products offered at a fixed amount and own brand cigarettes offered at varying prices. Order effects are not assessed in this study design. CP-DPT involves participants making two hypothetical choices at once, for a series of price scenarios. For example, participants are asked how many puffs of their Own Brand Cigarette AND how many puffs of a menthol-flavored NJOY Ace 2.4% Nicotine ECIG they would purchase if each Own Brand Cigarette puff cost $0.00 (i.e., free) and each menthol-flavored NJOY Ace 2.4% Nicotine ECIG puff cost $0.10.The outcome of the task is cross-price elasticity. | There are 4 Sessions: Day 1: own brand (1 condition), Day 3: 2.4% (2 conditions), Day 5: 5% (2 conditions), and Day 7: 6% (2 conditions). The sessions were separated by 48 hours. |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| ID | Title | Description |
|---|---|---|
| OG000 | All Participants | Thirty-two subjects were eligible and consented. Thirty participated in the study procedures. Study data were collected only from the 30 subjects who actually participated in the study interventions (Demographic and outcome). Order effects are not assessed in this study design. . |
|
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| Primary | Price Sensitivity of Drug Purchase Task (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. Order effects are not assessed in this study design. Price sensitivity (α; change in amount purchased as price increases) as measured by DPT. By analyzing these metrics, researchers can quantify and compare the motivational strength and reinforcing value of different substances or different doses, providing insight into the overvaluation of drugs that contributes to addiction. (e.g., 0% to 1% range) DPT outcomes included: breakpoint (highest price participants were willing to pay), intensity (consumption at zero cost), and price sensitivity (α; change in amount purchased as price increases | Thirty-two subjects were eligible and consented. Thirty participants started and completed the study procedures. Study data were collected only from the 30 subjects who participated in the interventions (Demographic and outcome). Order effects are not assessed in this study design. There were four sessions, for the seven conditions: 1.) own brand (1 condition), 2.) 2.4% (2 conditions), 3.) 5% (2 conditions), and 4.) 6% (2 conditions). 13 subjects completed this intervention. | Posted | Mean | Standard Deviation | dollars per e-cig puff | There are 4 Sessions: Day 1: own brand (1 condition), Day 3: 2.4% (2 conditions), Day 5: 5% (2 conditions), and Day 7: 6% (2 conditions). The sessions were separated by 48 hours. |
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| Primary | Breakpoint of Drug Purchase Task (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. Order effects are not assessed in this study design. Breakpoint, as measured by DPT, is defined as the first price at which a participant's consumption of a hypothetical drug product is suppressed to zero. The DPT is a behavioral economics assessment tool used to measure the reinforcing value (or abuse liability) of substances. Participants are asked to report how much of a drug they would consume at a series of escalating prices, assuming no access to other similar products and that all consumption would occur within a specified time period (e.g., one day). (e.g. $0.00 to $10.00 range) | Thirty-two subjects were eligible and consented. Thirty participants started and completed the study procedures. Study data were collected only from the 30 subjects who actually participated in the study interventions (Demographic and outcome). Order effects are not assessed in this study design. There were four sessions, for the seven conditions: 1.) own brand (1 condition), 2.) 2.4% (2 conditions), 3.) 5% (2 conditions), and 4.) 6% (2 conditions) | Posted | Mean | Standard Deviation | US dollars ($) | There are 4 Sessions: Day 1: own brand (1 condition), Day 3: 2.4% (2 conditions), Day 5: 5% (2 conditions), and Day 7: 6% (2 conditions). The sessions were separated by 48 hours. |
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| Primary | Cross-price Elasticity of the Cross Product-DPT | The Cross Product (CP)-DPTs assess cross-product purchasing behaviors between various tobacco products offered at a fixed amount and own brand cigarettes offered at varying prices. Order effects are not assessed in this study design. CP-DPT involves participants making two hypothetical choices at once, for a series of price scenarios. For example, participants are asked how many puffs of their Own Brand Cigarette AND how many puffs of a menthol-flavored NJOY Ace 2.4% Nicotine ECIG they would purchase if each Own Brand Cigarette puff cost $0.00 (i.e., free) and each menthol-flavored NJOY Ace 2.4% Nicotine ECIG puff cost $0.10.The outcome of the task is cross-price elasticity. | 32 subjects were eligible and consented. Thirty participants started and completed the study procedures. Study data were collected only from the 30 subjects who actually participated in the study interventions (Demographic and outcome). Order effects are not assessed. 4 Sessions/ 7 Conditions: Session 1.) own brand (1 cond), Session 2.) 2.4% (2 condit, Session 3.) 5% (2 condit), and Session 4.) 6% (2 condit). The session timing was not standardized, this is a difficult population to schedule. | Posted | Mean | Standard Deviation | dollars per e-cigarette puffs | There are 4 Sessions: Day 1: own brand (1 condition), Day 3: 2.4% (2 conditions), Day 5: 5% (2 conditions), and Day 7: 6% (2 conditions). The sessions were separated by 48 hours. |
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| 0 |
| 30 |
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| 30 |
| 0 |
| 30 |
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| NJOY Ace 5.0% Nicotine ECIG - Menthol Flavor |
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| NJOY Ace 5.0% Nicotine ECIG - Classic Tobacco Flavor |
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| NJOY Daily 6.0% Nicotine ECIG - Menthol Flavor |
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| NJOY Daily 6.0% Nicotine ECIG - Extra Rich Tobacco Flavor |
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| NJOY Ace 5.0% Nicotine ECIG - Menthol Flavor |
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| NJOY Ace 5.0% Nicotine ECIG - Classic Tobacco Flavor |
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| NJOY Daily 6.0% Nicotine ECIG - Menthol Flavor |
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| NJOY Daily 6.0% Nicotine ECIG - Extra Rich Tobacco Flavor |
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| NJOY Ace 5.0% Nicotine ECIG - Classic Tobacco Flavor |
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| NJOY Ace 6.0% Nicotine ECIG - Menthol Flavor |
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| NJOY Ace 6.0% Nicotine ECIG - Extra Rich Tobacco Flavor |
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