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The study is a randomized crossover trial. Current smokers will complete a session with each product: usual brand cigarette, e-cigarette, and heat-not-burn. The objective of this survey is to assess for ongoing use of study products and is part of safety monitoring.
The study is a randomized crossover trial. Current smokers will be randomized to session order and complete a standardized 10-puff bout (5 minutes) followed by a 60-minute ad libitum session with each product (usual brand cigarette, e-cigarette, heat-not-burn). Throughout each visit, blood will be collected for nicotine analysis via an IV catheter placed in the patient's arm. Blood samples will be aliquoted into two separate vials. One will be analyzed for the current study and one will be placed in a biospecimen repository if participant provides consent for biorepository. Puff topography will be collected passively throughout the session to measure puffing patterns. Participants will complete self-report measures of nicotine withdrawal and craving. Finally, breath samples will be collected to measure changes in exhaled carbon monoxide, a potent lung toxicant, pre- and post-product use. At the final visit, participants will complete a behavioral economics concurrent choice task (see below for description) to behaviorally measure their decisions regarding use of e-cigarettes or heat not burn products in place of cigarettes. Finally, participants will be contacted by phone 6 months following the conclusion of visit 3 (or study discontinuation) to complete a phone survey. The objective of this survey is to assess for ongoing use of study products and is part of safety monitoring. We have no hypotheses related to the follow-up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| E-Cigarette then Heat not burn. | Active Comparator | We will use a 1:1 fashion randomization to product order (combustible cigarette, e-cigarette, heat-not-burn device. |
|
| Heat not burn then E-Cigarette | Active Comparator | We will use a 1:1 fashion randomization to product order combustible cigarette, heat-not-burn device, e-cigarette. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| E-cigarette and Heat not burn | Combination Product | Current smokers will be randomized to session order and complete a standardized 10-puff bout (5 minutes) followed by a 60-minute ad libitum session with each product (usual brand cigarette, e-cigarette, heat-not-burn). |
| Measure | Description | Time Frame |
|---|---|---|
| Nicotine Delivery | Blood plasma nicotine concentration after 10 puff bout of product at 5 minutes | Baseline, after 10 puff bout of product at 5 minutes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eleanor Leavens, PhD | University of Kansas Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kansas Medical Center | Kansas City | Missouri | 66160 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37042345 | Derived | Funk OL, Nollen NL, Wagener TL, Ahluwalia JS, Mayo MS, Mahmud KMF, Lambart L, Leavens ELS. Concurrent Choice Assessment of Preference and Substitutability of E-cigarettes and Heated Tobacco Products for Combustible Cigarettes Among African American and White Smokers. Nicotine Tob Res. 2023 Jul 14;25(8):1505-1508. doi: 10.1093/ntr/ntad052. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Cigarette, E-Cigarette Then Heat Not Burn. | At lab visit 1 participants receive their usual brand cigarette during the 10-puff standardized puff bout and 60-minute ad libitum session. Following at least a 48-hour washout period, at lab visit 2, participants receive electronic cigarette during the 10-puff standardized puff bout and 60-minute ad libitum session. Following at least a 48-hour washout period, at lab visit 3, participants receive Heat Not Burn during the 10-puff standardized puff bout and 60-minute ad libitum session. |
| FG001 | Cigarette, Heat Not Burn Then E-Cigarette | At lab visit 1 participants receive their usual brand cigarette during the 10-puff standardized puff bout and 60-minute ad libitum session. Following at least a 48-hour washout period, at lab visit 2, participants receive Heat Not Burn during the 10-puff standardized puff bout and 60-minute ad libitum session. Following at least a 48-hour washout period, at lab visit 3, participants receive electronic cigarette during the 10-puff standardized puff bout and 60-minute ad libitum session. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Baseline blood plasma nicotine concentration
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| ID | Title | Description |
|---|---|---|
| BG000 | Cigarette, E-Cigarette Then Heat Not Burn. | At lab visit 1 participants receive their usual brand cigarette during the 10-puff standardized puff bout and 60-minute ad libitum session. Following at least a 48-hour washout period, at lab visit 2, participants receive electronic cigarette during the 10-puff standardized puff bout and 60-minute ad libitum session. Following at least a 48-hour washout period, at lab visit 3, participants receive Heat Not Burn during the 10-puff standardized puff bout and 60-minute ad libitum session. |
| Units | Counts |
|---|---|
| Participants |
|
| 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 | Nicotine Delivery | Blood plasma nicotine concentration after 10 puff bout of product at 5 minutes | Blood plasma nicotine concentration 5 minutes after start | Posted | Mean | Full Range | ng/mL | Baseline, after 10 puff bout of product at 5 minutes |
|
6 months
No differences in definitions.
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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 | Cigarette | At the first visit, all participants used their usual brand of cigarette. Participants completed a standardized 10-puff bout (5 minutes) followed by a 60-minute ad libitum session with cigarettes. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Leah Lambart Graduate Research Assistant | University of Kansas Medical Center | 9139457862 | llambart@kumc.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 | May 11, 2021 | Mar 30, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D014029 | Tobacco Use Disorder |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D066300 | Electronic Nicotine Delivery Systems |
| ID | Term |
|---|---|
| D000074602 | Smoking Devices |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
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| BG001 | Cigarette, Heat Not Burn Then E-Cigarette | At lab visit 1 participants receive their usual brand cigarette during the 10-puff standardized puff bout and 60-minute ad libitum session. Following at least a 48-hour washout period, at lab visit 2, participants receive Heat Not Burn during the 10-puff standardized puff bout and 60-minute ad libitum session. Following at least a 48-hour washout period, at lab visit 3, participants receive electronic cigarette during the 10-puff standardized puff bout and 60-minute ad libitum session. |
| BG002 | Total | Total of all reporting groups |
| 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 |
|
Participants who used the heat not burn product during either the second or third study visit. |
|
|
|
| 0 |
| 22 |
| 0 |
| 22 |
| 0 |
| 22 |
| EG001 | E-Cigarette | At the second and third visits, participants were randomly assigned either e-cigarette or heat not burn. All participants completed a visit for each product but the order was random. Participants completed a standardized 10-puff bout (5 minutes) followed by a 60-minute ad libitum session with the e-cigarette. | 0 | 22 | 0 | 22 | 0 | 22 |
| EG002 | Heat Not Burn | At the second and third visits, participants were randomly assigned either e-cigarette or heat not burn. All participants completed a visit for each product but the order was random. Participants completed a standardized 10-puff bout (5 minutes) followed by a 60-minute ad libitum session with heat-not-burn. | 0 | 22 | 0 | 22 | 0 | 22 |
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