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| ID | Type | Description | Link |
|---|---|---|---|
| 2U54DA036105 | U.S. NIH Grant/Contract | View source |
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Study terminated due to COVID
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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This study aims to understand the effects of device power and nicotine concentration on the likelihood that someone would use or abuse e-cigarettes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| E-cigarette User (Exclusive) | Active Comparator | 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 |
|
| Dual User | Active Comparator | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| E-cigarette Lab Session 15 watts, 10 mg nicotine | Other | E-cigarette paired with low nicotine, low device power |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Up to 180 minutes |
| 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). | Up to 180 minutes. |
| 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). | Up to 180 minutes. |
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| Measure | Description | Time Frame |
|---|---|---|
| Subjective Measures of Nicotine Abstinence Symptoms | Measures of related to nicotine abstinence symptoms and nicotine side effects will be measured during each study session. | First measure given, regardless of task order, 90 minutes into each session |
| Subjective Measures of Nicotine Abstinence Symptoms |
Inclusion Criteria:
Exclusion Criteria:
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.
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| Name | Affiliation | Role |
|---|---|---|
| Caroline Cobb (Amey), 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 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37988256 | Derived | Bono RS, White AM, Hoetger C, Lipato T, Bickel WK, Cobb CO, Barnes AJ. Expanding on cross-price elasticity: Understanding tobacco product demand and substitution from the cross-price purchase task. J Exp Anal Behav. 2024 Mar;121(2):175-188. doi: 10.1002/jeab.890. Epub 2023 Nov 21. | |
| 36480388 | Derived | White AM, Bono RS, Lester RC, Underwood M, Hoetger C, Lipato T, Bickel WK, Cobb CO, Barnes AJ. The electronic nicotine delivery system (ENDS) purchase task: Are results sensitive to price framing? Exp Clin Psychopharmacol. 2023 Oct;31(5):895-901. doi: 10.1037/pha0000631. Epub 2022 Dec 8. |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 16, 2020 | Mar 16, 2021 |
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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.
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Participants will be blinded to their condition (power level and nicotine concentration) used in each session, except during their 'own brand' session.
| E-cigarette Lab Session 15 watts, 30 mg nicotine | Other | E-cigarette paired with low nicotine, low device power |
|
| E-cigarette Lab Session 30 watts, 10 mg nicotine | Other | E-cigarette paired with low nicotine, low device power |
|
| E-cigarette Lab Session 30 watts, 30 mg nicotine | Other | E-cigarette paired with low nicotine, low device power |
|
| Own Brand Session - E-cigarette | Other | E-cigarette paired with own brand liquid and preferred power |
|
| Own Brand Session - E-cigarette/Cigarette | Other | Own brand cigarette OR E-cigarette paired with own brand liquid and preferred power |
|
Measures of related to nicotine abstinence symptoms and nicotine side effects will be measured during each study session. |
| Third measure given during each session, approximately 120 minutes into each session (timing dependent on choices made in tasks presented prior to this measure). |
| Subjective Measures of Nicotine Abstinence Symptoms | Measures of related to nicotine abstinence symptoms and nicotine side effects will be measured during each study session. | Fifth measure given during each session, approximately 180 minutes into each session (timing dependent on choices made in tasks presented prior to this measure). |
| Subjective Measures of Nicotine Abstinence Symptoms | Measures of related to nicotine abstinence symptoms and nicotine side effects will be measured during each study session. | Last measure given during each session, approximately 240 minutes into each session (timing dependent on choices made in tasks presented prior to this measure). |
| Change in Heart Rate | Heart rate (measured in bpm) | Recorded throughout each 4 hour study session using automated software every 10 seconds. |
| Change in Systolic Blood Pressure | Blood pressure (measured in mm) | Recorded throughout each 4 hour study session using automated software every 5 minutes. |
| Change in Diastolic Blood Pressure | and blood pressure (measured in hg) | Recorded throughout each 4 hour study session using automated software every 5 minutes. |
| 34647773 | Derived | Hoetger C, Bono RS, White AM, Barnes AJ, Cobb CO. The interaction of nicotine concentration and device power on electronic nicotine delivery system (ENDS) abuse liability among exclusive ENDS users and dual users of ENDS and combustible cigarettes. Exp Clin Psychopharmacol. 2022 Dec;30(6):973-982. doi: 10.1037/pha0000523. Epub 2021 Oct 14. |
| FG001 | 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 |
| 15 Watts, 10 mg Nicotine |
|
| 15 Watts, 30 mg Nicotine |
|
| 30 Watts, 10 mg Nicotine |
|
| 30 Watts, 30 mg Nicotine |
|
| Own Brand | Exclusive e-cigarette users only used e-cigarettes during own brand session, dual users used either their cigarettes and e-cigarettes. Completion of either one considered a milestone depending on study arm |
|
| COMPLETED |
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| NOT COMPLETED |
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|
Protocol was changed after study completion by 4 Dual Users so results are not being reported on those participants due to the protocol changes.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | 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 |
| BG002 | Total | Total of all reporting groups |
| 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/Ethnicity, Customized | 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 | 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). | Protocol was changed after study completion by 4 Dual Users so results are not being reported on those participants. | Posted | Mean | Standard Deviation | US Dollars | Up to 180 minutes |
|
|
| |||||||||||||||||||||||||||||||||||
| 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). | Protocol was changed after study completion by 4 Dual Users so results are not being reported on those participants. | Posted | Mean | Standard Deviation | US Dollars | Up to 180 minutes. |
| |||||||||||||||||||||||||||||||||||||
| 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). | Protocol was changed after study completion by 4 Dual Users so results are not being reported on those participants. | Posted | Mean | Standard Deviation | e-cigarette puffs | Up to 180 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. | Not Posted | First measure given, regardless of task order, 90 minutes into each session | Participants | |||||||||||||||||||||||||||||||||||||||||
| 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. | Not Posted | Third measure given during each session, approximately 120 minutes into each session (timing dependent on choices made in tasks presented prior to this measure). | Participants | |||||||||||||||||||||||||||||||||||||||||
| 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. | Not Posted | Fifth measure given during each session, approximately 180 minutes into each session (timing dependent on choices made in tasks presented prior to this measure). | Participants | |||||||||||||||||||||||||||||||||||||||||
| 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. | Not Posted | Last measure given during each session, approximately 240 minutes into each session (timing dependent on choices made in tasks presented prior to this measure). | Participants | |||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Change in Heart Rate | Heart rate (measured in bpm) | Not Posted | Recorded throughout each 4 hour study session using automated software every 10 seconds. | Participants | |||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Change in Systolic Blood Pressure | Blood pressure (measured in mm) | Not Posted | Recorded throughout each 4 hour study session using automated software every 5 minutes. | Participants | |||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Change in Diastolic Blood Pressure | and blood pressure (measured in hg) | Not Posted | Recorded throughout each 4 hour study session using automated software every 5 minutes. | Participants |
Data were collected during laboratory visits, approximately over 3 weeks; no follow up data collection occurred.
Protocol was changed after study completion by 4 Dual Users so results are not being reported on those participants.
All adverse events occurred in between study sessions (i.e., while participants were not receiving the intervention). Because effects of interventions end as soon as the intervention ends, adverse events occurring in between sessions are not related to the intervention and data about prior nor current session details was not stored with adverse events data.
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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 | 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 | 0 | 19 | 1 | 19 | 3 | 19 |
| EG001 | 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 | 0 | 13 | 0 | 13 | 7 | 13 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalization | Surgical and medical procedures | Non-systematic Assessment | Unrelated hospitalization |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Worsening cough | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Shortness of breath | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Fatigue | General disorders | Non-systematic Assessment |
| ||
| Abdominal pain | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Injury | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Andrew J. Barnes | Virginia Commonwealth University | 804-827-4361 | abarnes3@vcu.edu |
| Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 21, 2020 | Mar 16, 2021 | SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 21, 2020 | Dec 3, 2020 | ICF_000.pdf |
| ID | Term |
|---|---|
| D000072137 | Vaping |
| ID | Term |
|---|---|
| D012907 | Smoking |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D009538 | Nicotine |
| D062789 | Tobacco Products |
| ID | Term |
|---|---|
| D012991 | Solanaceous Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D000074602 | Smoking Devices |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
Not provided
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| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Middle Eastern |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| 15 watts, 30 mg/ml nicotine |
|
| 30 watts, 10 mg/ml nicotine |
|
| 15 watts, 10 mg/ml nicotine |
|
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
|
|
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 |
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