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| ID | Type | Description | Link |
|---|---|---|---|
| U54DA036105 | U.S. NIH Grant/Contract | View source | |
| F31DA047018 | 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 differences in nicotine delivery, user behaviors, subjective effects, and physiological effects, when cigarette smokers use an electronic cigarette with different nicotine (and sweetener) concentrations relative to using their own brand of cigarettes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cigarette smokers | Experimental | Each participant will participate in 5 sessions. During each session, participants will complete a 10-puff, directed product use bout, and then have the option later to puff as little or as much as they like during a 30-minute self administration task. Session 1: Own brand cigarette use Session 2: ECIG 15 mg nicotine, sweetened Session 3: ECIG Lab Session ECIG 15 mg nicotine, unsweetened Session 4: ECIG Lab Session ECIG 0 mg nicotine, sweetened Session 5: ECIG Lab Session ECIG 0 mg nicotine, unsweetened |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Own Brand Cigarette | Other | Effects of own brand cigarette use. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma Nicotine Concentration | Change in plasma nicotine concentration. Changes in plasm nicotine concentration during puff bout are considered to be the more relevant and accurate values so analysis and results reporting will focus on change from baseline to immediately following 10-puff bout. | Blood will be taken 4 times in each session to examine changes from baseline (approx 70 minutes) to immediately following a ten-puff bout (approx 80 minutes), and immediately before (approx 140 minutes) and after the PRT (approx 180 minutes). |
| Progressive Ratio Task - Breakpoint | The progressive ratio task (PRT) is a self-administration task that will take 30-minutes to complete. It will begin by requiring ten computer key presses to earn the first puff of the session product, and this requirement will increase by 30% (i.e., 10, 13, 17, etc.) after each reinforcer (puff) is earned and consumed. The PRT will have three outcome measures (1) breakpoint (maximum number of key presses completed to earn a puff), (2) number of puffs, and (3) latency (sec) to initiate key pressing. Breakpoint is reported here. | This task will begin approximately an hour and ten minutes after the 10-puff directed product use bout. |
| Progressive Ratio Task - Number of Puffs | The progressive ratio task (PRT) is a self-administration task that will take 30-minutes to complete. It will begin by requiring ten computer key presses to earn the first puff of the session product, and this requirement will increase by 30% (i.e., 10, 13, 17, etc.) after each reinforcer (puff) is earned and consumed. The PRT will have three outcome measures (1) breakpoint (maximum number of key presses completed to earn a puff), (2) number of puffs, and (3) latency (sec) to initiate key pressing. Number of puffs is reported here. | This task will begin approximately an hour and ten minutes after the 10-puff directed product use bout. |
| Progressive Ratio Task - Latency | The progressive ratio task (PRT) is a self-administration task that will take 30-minutes to complete. It will begin by requiring ten computer key presses to earn the first puff of the session product, and this requirement will increase by 30% (i.e., 10, 13, 17, etc.) after each reinforcer (puff) is earned and consumed. The PRT will have three outcome measures (1) breakpoint (maximum number of key presses completed to earn a puff), (2) number of puffs, and (3) latency (milliseconds) to initiate key pressing. Latency is reported here. |
| Measure | Description | Time Frame |
|---|---|---|
| Puff Volume | The volume of each puff, in ml, averaged over the 10-puff use bout | Puff volume will be measured during the approximately 5-minute, 10-puff use bout. |
| Puff Duration | The duration of each puff, in seconds, averaged over the 10-puff use bout |
| Measure | Description | Time Frame |
|---|---|---|
| Hughes-Hatsukami Questionnaire | This scale will be used to assess the extent to which product use reduces tobacco abstinence symptoms, and consists of 11 items scored 0-100, with lower scores indicating less severe symptoms. There are no sub-scales. Items are analyzed separately. | This questionnaire will be administered 4 times in each session to examine changes from baseline (70 minutes) to immediately following a ten-puff bout (80 minutes), and immediately before (140 minutes) and after the PRT (180 minutes) |
Inclusion Criteria-- Participants must be:
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 |
|---|---|---|
| Alison Breland, PhD | Virginia Commonwealth University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Behavioral Pharmacology Laboratory | Richmond | Virginia | 23298 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38815111 | Derived | Maloney SF, Hoetger C, Bono RS, Lester Scholtes R, Combs M, Karaoghlanian N, Lipato T, Breland A, Eissenberg T. Assessment of human abuse potential of an unflavored, sucralose-sweetened electronic cigarette in combustible cigarette smokers. Exp Clin Psychopharmacol. 2024 Oct;32(5):588-603. doi: 10.1037/pha0000720. Epub 2024 May 30. |
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Each participant will participate in 5 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 | Cigarette Smokers | Each participant will participate in 5 sessions. During each session, participants will complete a 10-puff, directed product use bout, and then have the option later to puff as little or as much as they like during a 30-minute self administration task. Session 1: Own brand cigarette use Session 2: ECIG 15 mg nicotine, sweetened Session 3: ECIG Lab Session ECIG 15 mg nicotine, unsweetened Session 4: ECIG Lab Session ECIG 0 mg nicotine, sweetened Session 5: ECIG Lab Session ECIG 0 mg nicotine, unsweetened Own Brand Cigarette: Effects of own brand cigarette use. ECIG 15 mg nicotine, sweetened: Effects of using a 30 Watt ECIG filled with 15 mg nicotine, sweetened liquid ECIG 15 mg nicotine, unsweet: Effects of using a 30 Watt ECIG filled with 15 mg nicotine, unsweet liquid ECIG 0 mg nicotine, sweetened: Effects of using a 30 Watt ECIG filled with 0 mg nicotine, sweetened liquid ECIG 0 mg nicotine, unsweet: Effects of using a 30 Watt ECIG filled with 0 mg nicotine, unsweet liquid |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Cigarette Smokers | Each participant will participate in 5 sessions. During each session, participants will complete a 10-puff, directed product use bout, and then have the option later to puff as little or as much as they like during a 30-minute self administration task. Session 1: Own brand cigarette use Session 2: ECIG 15 mg nicotine, sweetened Session 3: ECIG Lab Session ECIG 15 mg nicotine, unsweetened Session 4: ECIG Lab Session ECIG 0 mg nicotine, sweetened Session 5: ECIG Lab Session ECIG 0 mg nicotine, unsweetened Own Brand Cigarette: Effects of own brand cigarette use. ECIG 15 mg nicotine, sweetened: Effects of using a 30 Watt ECIG filled with 15 mg nicotine, sweetened liquid ECIG 15 mg nicotine, unsweet: Effects of using a 30 Watt ECIG filled with 15 mg nicotine, unsweet liquid ECIG 0 mg nicotine, sweetened: Effects of using a 30 Watt ECIG filled with 0 mg nicotine, sweetened liquid ECIG 0 mg nicotine, unsweet: Effects of using a 30 Watt ECIG filled with 0 mg nicotine, unsweet liquid |
| 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 | Plasma Nicotine Concentration | Change in plasma nicotine concentration. Changes in plasm nicotine concentration during puff bout are considered to be the more relevant and accurate values so analysis and results reporting will focus on change from baseline to immediately following 10-puff bout. | One participant had incomplete blood data and was excluded from the analysis. | Posted | Mean | Standard Deviation | ng/ml | Blood will be taken 4 times in each session to examine changes from baseline (approx 70 minutes) to immediately following a ten-puff bout (approx 80 minutes), and immediately before (approx 140 minutes) and after the PRT (approx 180 minutes). |
|
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This protocol was minimal risk and All-Cause Mortality, Serious, and Other [Not Including Serious] Adverse Events were not monitored/assessed.
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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 Smokers | Own Brand Cigarette: Effects of own brand cigarette use. | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alison Breland | Virginia Commonwealth University | 804 628 2300 | abbrelan@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 | Aug 10, 2021 | Oct 7, 2022 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 10, 2021 | Dec 14, 2021 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D000072137 | Vaping |
| ID | Term |
|---|---|
| D012907 | Smoking |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D009538 | Nicotine |
| ID | Term |
|---|---|
| D012991 | Solanaceous Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D011725 | Pyridines |
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| ECIG 15 mg nicotine, sweetened |
| Other |
Effects of using a 30 Watt ECIG filled with 15 mg nicotine, sweetened liquid |
|
| ECIG 15 mg nicotine, unsweet | Other | Effects of using a 30 Watt ECIG filled with 15 mg nicotine, unsweet liquid |
|
| ECIG 0 mg nicotine, sweetened | Other | Effects of using a 30 Watt ECIG filled with 0 mg nicotine, sweetened liquid |
|
| ECIG 0 mg nicotine, unsweet | Other | Effects of using a 30 Watt ECIG filled with 0 mg nicotine, unsweet liquid |
|
| This task will begin approximately an hour and ten minutes after the 10-puff directed product use bout. |
| The duration of each puff will be measured during the approximately 5-minute, 10-puff use bout. |
| Positive and Negative Affect Schedule | This scale will be used to measure positive and negative affect and consists of 20-items that are scored on a 5-point likert scale ranging from "very slightly or not at all" to "extremely". The items from this scale are scored into two dimensions: Positive Affect and Negative Affect. | This questionnaire will be administered 4 times in each session to examine changes from baseline (70 minutes) to immediately following a ten-puff bout (80 minutes), and immediately before (140 minutes) and after the PRT (180 minutes) |
| Drug Effects Questionnaire | This questionnaire assess a respondent's feelings after recently using tobacco or nicotine products. It has a total of five items that participants rate from not at all to extremely scored 0-100. Each item is scored and analyzed separately (there are no sub-scales). | This questionnaire will be administered 4 times in each session to examine changes from baseline (70 minutes) to immediately following a ten-puff bout (80 minutes), and immediately before (140 minutes) and after the PRT (180 minutes) |
| Heart Rate | Change in heart rate, measure in beats per minute. | Heart rate will be measured continuously throughout the session, and will be used to examine changes in HR from baseline (70 minutes) to during (75 minutes) and immediately following a ten-puff bout (80 minutes) |
| Inter Puff Interval | The time between each puff, in seconds. | Inter puff interval will be measured during the approximately 5-minute, 10-puff use bout. |
| Flow Rate | The rate of air flow during each puff, in ml/second. | Flow rate will be measured during the approximately 5-minute, 10-puff use bout. |
| lack of venous access |
|
| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Cigarettes per day | Mean | Standard Deviation | Cigarettes per day |
|
|
|
| Primary | Progressive Ratio Task - Breakpoint | The progressive ratio task (PRT) is a self-administration task that will take 30-minutes to complete. It will begin by requiring ten computer key presses to earn the first puff of the session product, and this requirement will increase by 30% (i.e., 10, 13, 17, etc.) after each reinforcer (puff) is earned and consumed. The PRT will have three outcome measures (1) breakpoint (maximum number of key presses completed to earn a puff), (2) number of puffs, and (3) latency (sec) to initiate key pressing. Breakpoint is reported here. | Cigarette smokers | Posted | Mean | Standard Deviation | Key presses | This task will begin approximately an hour and ten minutes after the 10-puff directed product use bout. |
|
|
|
| Secondary | Puff Volume | The volume of each puff, in ml, averaged over the 10-puff use bout | Cigarette smokers | Posted | Mean | Standard Deviation | ml | Puff volume will be measured during the approximately 5-minute, 10-puff use bout. |
|
|
|
| Secondary | Puff Duration | The duration of each puff, in seconds, averaged over the 10-puff use bout | Cigarette smokers | Posted | Mean | Standard Deviation | seconds | The duration of each puff will be measured during the approximately 5-minute, 10-puff use bout. |
|
|
|
| Other Pre-specified | Hughes-Hatsukami Questionnaire | This scale will be used to assess the extent to which product use reduces tobacco abstinence symptoms, and consists of 11 items scored 0-100, with lower scores indicating less severe symptoms. There are no sub-scales. Items are analyzed separately. | Not Posted | This questionnaire will be administered 4 times in each session to examine changes from baseline (70 minutes) to immediately following a ten-puff bout (80 minutes), and immediately before (140 minutes) and after the PRT (180 minutes) | Participants |
| Other Pre-specified | Positive and Negative Affect Schedule | This scale will be used to measure positive and negative affect and consists of 20-items that are scored on a 5-point likert scale ranging from "very slightly or not at all" to "extremely". The items from this scale are scored into two dimensions: Positive Affect and Negative Affect. | Not Posted | This questionnaire will be administered 4 times in each session to examine changes from baseline (70 minutes) to immediately following a ten-puff bout (80 minutes), and immediately before (140 minutes) and after the PRT (180 minutes) | Participants |
| Other Pre-specified | Drug Effects Questionnaire | This questionnaire assess a respondent's feelings after recently using tobacco or nicotine products. It has a total of five items that participants rate from not at all to extremely scored 0-100. Each item is scored and analyzed separately (there are no sub-scales). | Not Posted | This questionnaire will be administered 4 times in each session to examine changes from baseline (70 minutes) to immediately following a ten-puff bout (80 minutes), and immediately before (140 minutes) and after the PRT (180 minutes) | Participants |
| Other Pre-specified | Heart Rate | Change in heart rate, measure in beats per minute. | Not Posted | Heart rate will be measured continuously throughout the session, and will be used to examine changes in HR from baseline (70 minutes) to during (75 minutes) and immediately following a ten-puff bout (80 minutes) | Participants |
| Other Pre-specified | Inter Puff Interval | The time between each puff, in seconds. | Not Posted | Inter puff interval will be measured during the approximately 5-minute, 10-puff use bout. | Participants |
| Other Pre-specified | Flow Rate | The rate of air flow during each puff, in ml/second. | Not Posted | Flow rate will be measured during the approximately 5-minute, 10-puff use bout. | Participants |
| Primary | Progressive Ratio Task - Number of Puffs | The progressive ratio task (PRT) is a self-administration task that will take 30-minutes to complete. It will begin by requiring ten computer key presses to earn the first puff of the session product, and this requirement will increase by 30% (i.e., 10, 13, 17, etc.) after each reinforcer (puff) is earned and consumed. The PRT will have three outcome measures (1) breakpoint (maximum number of key presses completed to earn a puff), (2) number of puffs, and (3) latency (sec) to initiate key pressing. Number of puffs is reported here. | Cigarette smokers | Posted | Mean | Standard Deviation | Number of puffs | This task will begin approximately an hour and ten minutes after the 10-puff directed product use bout. |
|
|
|
| Primary | Progressive Ratio Task - Latency | The progressive ratio task (PRT) is a self-administration task that will take 30-minutes to complete. It will begin by requiring ten computer key presses to earn the first puff of the session product, and this requirement will increase by 30% (i.e., 10, 13, 17, etc.) after each reinforcer (puff) is earned and consumed. The PRT will have three outcome measures (1) breakpoint (maximum number of key presses completed to earn a puff), (2) number of puffs, and (3) latency (milliseconds) to initiate key pressing. Latency is reported here. | Cigarette smokers | Posted | Mean | Standard Deviation | milliseconds | This task will begin approximately an hour and ten minutes after the 10-puff directed product use bout. |
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| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | ECIG 15 mg Nicotine, Sweetened | ECIG 15 mg nicotine, sweetened: Effects of using a 30 Watt ECIG filled with 15 mg nicotine, sweetened liquid | 0 | 0 | 0 | 0 | 0 | 0 |
| EG002 | ECIG 15 mg Nicotine, Unsweet | ECIG 15 mg nicotine, unsweet: Effects of using a 30 Watt ECIG filled with 15 mg nicotine, unsweet liquid | 0 | 0 | 0 | 0 | 0 | 0 |
| EG003 | ECIG 0 mg Nicotine, Sweetened | ECIG 0 mg nicotine, sweetened: Effects of using a 30 Watt ECIG filled with 0 mg nicotine, sweetened liquid | 0 | 0 | 0 | 0 | 0 | 0 |
| EG004 | ECIG 0 mg Nicotine, Unsweet | ECIG 0 mg nicotine, unsweet: Effects of using a 30 Watt ECIG filled with 0 mg nicotine, unsweet liquid | 0 | 0 | 0 | 0 | 0 | 0 |
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| D006573 |
| Heterocyclic Compounds, 1-Ring |
|
| Sweetened, 15 mg/ml nicotine |
|
| Own brand cigarette |
|
|
| Sweetened, 15 mg/ml nicotine |
|
| Own brand cigarette |
|
| Title | Measurements |
|---|---|
|
| Sweetened, 15 mg/ml nicotine |
|
| Own brand cigarette |
|
| Title | Measurements |
|---|---|
|
| Sweetened, 15 mg/ml nicotine |
|
| Own brand cigarette |
|
|
| Sweetened, 15 mg/ml nicotine |
|
| Own brand cigarette |
|