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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2021-05882 | Registry Identifier | CTRP (Clinical Trial Reporting Program) |
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This clinical trial studies the effect of free-base compared with nicotine salt based e-liquids on electronic cigarette (EC) puffing behavior, abuse liability, and deposition and absorption of nicotine in the respiratory tract and rate of uptake in the brain in current EC smokers. The results from this study may provide much needed scientific information to public health officials and regulators.
PRIMARY OBJECTIVES:
I. To examine the influence of nicotine form on puffing behavior and abuse liability.
II. To evaluate the influence of nicotine form and concentration on nicotine distribution in the brain and respiratory tract.
OUTLINE:
VISIT 1: Patients sample 4-liquids to determine whether they can vape the unflavored e-liquid without coughing
Patients are randomized to 1 of 2 arms.
ARM I:
VISIT 2: Patients receive 1 puff of tobacco flavored or unflavored protonated e-liquid and undergo 0-15 minutes (min) head and 5 min chest positron emission tomography (PET)/computed tomography (CT) and then 0-15 min chest and 5 min head PET/CT. About 2 hours post initial PET/CT, patients receive a second puff of tobacco flavored or unflavored protonated e-liquid and undergo 0-15 min chest and 5 min head PET/CT and then 0-15 min head and 5 min chest PET/CT.
VISIT 3: Patients receive 1 puff of tobacco flavored or unflavored unprotonated e-liquid and undergo 0-15 min head and 5 min chest PET/CT and then 0-15 min chest and 5 min head PET/CT. About 2 hours post initial PET/CT, patients receive a second puff of tobacco flavored or unflavored unprotonated e-liquid and undergo 0-15 min chest and 5 min head PET/CT and then 0-15 min head and 5 min chest
ARM II:
VISIT 2: Patients receive 1 puff of tobacco flavored or unflavored unprotonated e-liquid and undergo 0-15 min head and 5 min chest PET/CT and then 0-15 min chest and 5 min head PET/CT. About 2 hours post initial PET/CT, patients receive a second puff of tobacco flavored or unflavored unprotonated e-liquid and undergo 0-15 min chest and 5 min head PET/CT and then 0-15 min head and 5 min chest.
VISIT 3: Patients receive 1 puff of tobacco flavored or unflavored protonated e-liquid and undergo 0-15 min head and 5 min chest PET/CT and then 0-15 min chest and 5 min head PET/CT. About 2 hours post initial PET/CT, patients receive a second puff of tobacco flavored or unflavored protonated e-liquid and undergo 0-15 min chest and 5 min head PET/CT and then 0-15 min head and 5 min chest PET/CT.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I (pronated e-liquid, unprotonated e-liquid | Experimental | VISIT 2: Patients receive 1 puff of tobacco flavored or unflavored protonated e-liquid and undergo 0-15 min head and 5 min chest PET?CT and then 0-15 min chest and 5 min head PET/CT. About 2 hours post initial PET/CT, patients receive a second puff of tobacco flavored or unflavored protonated e-liquid and undergo 0-15 min chest and 5 min head PET/CT and then 0-15 min head and 5 min chest PET/CT. VISIT 3: Patients receive 1 puff of tobacco flavored or unflavored unprotonated e-liquid and undergo 0-15 min head and 5 min chest PET/CT and then 0-15 min chest and 5 min head PET/CT. About 2 hours post initial PET/CT, patients receive a second puff of tobacco flavored or unflavored protonated e-liquid and undergo 0-15 min chest and 5 min head PET/CT and then 0-15 min head and 5 min chest |
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| Arm II (unprotonated e-liquid, protonated e-liquid | Active Comparator | VISIT 2: Patients receive 1 puff of tobacco flavored or unflavored unprotonated e-liquid and undergo 0-15 min head and 5 min chest PET/CT and then 0-15 min chest and 5 min head PET/CT. About 2 hours post initial PET/CT, patients receive a second puff of tobacco flavored or unflavored unprotonated e-liquid and undergo 0-15 min chest and 5 min head PET/CT and then 0-15 min head and 5 min chest. VISIT 3: Patients receive 1 puff of tobacco flavored or unflavored protonated e-liquid and undergo 0-15 min head and 5 min chest PET/CT and then 0-15 min chest and 5 min head PET/CT. About 2 hours post initial PET/CT, patients receive a second puff of tobacco flavored or unflavored protonated e-liquid and undergo 0-15 min chest and 5 min head PET/CT and then 0-15 min head and 5 min chest PET/CT. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cigarette Smoking | Behavioral | Receive 1 puff of tobacco flavored protonated e-liquid |
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| Measure | Description | Time Frame |
|---|---|---|
| PET/CT Imaging of the Head | Evaluate effect of nicotine form (free-base vs nicotine salt base) on nicotine absorption and distribution in the brain with total absorbed dose (TAD) of [11C]nicotine. | 1.5 hours |
| PET/CT Imaging of the Chest | Evaluate effect of nicotine form (free-base vs nicotine salt base) on nicotine absorption and distribution in the respiratory tract with total absorbed dose (TAD) of [11C]nicotine. | 1.5 hours |
| Puff Volume (mL) | Puffing topography data was captured by the study e-cigarette to determine the puff volume. | approx. 30 minutes |
| Puff Duration (s) | Puffing topography data was captured by the study e-cigarette to determine the puff duration. | approx. 30 minutes |
| Age of First Tobacco Use | Age of first use will be assessed using the tobacco use history questionnaire. | approx. 5 minutes |
| Years of Tobacco Use | Years of tobacco use will be assessed using the tobacco use history questionnaire. | approx. 5 minutes |
| Years of Regular Use of Nicotine/Tobacco Products | Years of regular use of nicotine/tobacco products will be assessed using the tobacco history questionnaire | approx. 5 minutes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Theodore L Wagener, PhD | Ohio State University Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ohio State University Comprehensive Cancer Center | Columbus | Ohio | 43210 | United States |
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| Label | URL |
|---|---|
| The Jamesline | View source |
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1 participant was consented and enrolled in the study but found to be ineligible during visit 1, prior to randomization.
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm I (Protonated E-liquid, Unprotonated E-liquid) | Visit 2: Patients sample protonated e-liquid Visit 3: Patients sample unprotonated e-liquid |
| FG001 | Arm II (Unprotonated E-liquid, Protonated E-liquid) |
| 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_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 26, 2023 |
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| Cigarette Smoking | Behavioral | Receive 1 puff of unflavored protonated e-liquid |
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| Cigarette Smoking | Behavioral | Receive 1 puff of tobacco flavored unprotonated cigarette |
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| Cigarette Smoking | Behavioral | Receive 1 puff of unfavored unprotonated cigarette |
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| Computed Tomography | Procedure | Undergo PET/CT |
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| Positron Emission Tomography | Procedure | Undergo PET/CT |
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| Questionnaire Administration | Other | Ancillary studies |
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| Past 30 Day Use of Nicotine/Tobacco Products | Days used in the past 30 days of nicotine/tobacco products including cigars, cigarillos, little cigars, pipe tobacco, chewing tobacco, snuff, snus, EC/vape/mod/APV/e-hookah, and hookah tobacco. | approx. 5 minutes |
| Modified Cigarette Evaluation Questionnaire (mCEQ) | 12-item modified Cigarette Evaluation Questionnaire (mCEQ) completed following e-cigarette self-administration to assess subjective responses. The 12-item mCEQ includes five subscales: Smoking Satisfaction, Psychological Reward, Aversion, Enjoyment of Respiratory Tract Sensations, and Craving Reduction, with items rated from 0 (not at all) to 6 (extremely likely). Scores for each subscale are calculated as the mean of the individual item responses or the single item. Higher scores indicate greater intensity on that scale. | approx. 5 minutes |
| Drug Effects Liking Questionnaire (DEQ) | An adapted version of the Drug Effects/Liking Questionnaire will assess the desire and liking of the study products. Five visual analog scale items ranging from 0 (not at all) to 100 (extremely) assessed wanting to vape the product again, liking the product, enjoying the product, finding the product pleasurable and satisfying. Higher scores indicate greater liking. | approx. 5 minutes |
| Modified Tiffany-Drobes Questionnaire of Smoking Urges: Brief Form (QSU) | Urges/craving will be measured using a modified version of the Tiffany-Drobes Questionnaire of Smoking Urges: Brief Form. This is a 10-item measure where participants rate e-cigarette smoking-related items (All I want right now is an e-cigarette) on a 7-point Likert scale ranging from 1 (strongly disagree) to 7 (strongly agree). Similar to previous studies, we will collapse the items into two previously identified factors (Factor 1: strong desire and intention to smoke an e-cigarette; Factor 2: anticipation of relief from withdrawal symptoms). Scores are calculated by summing the items and range from 5 to 35 with higher scores indicating greater craving to vape. | aprox. 5 minutes |
| Minnesota Nicotine Withdrawal Scale | Nicotine withdrawal will be assessed using the empirically validated 15-item version of the Minnesota Nicotine Withdrawal Scale (MNWS). Items were rated on a 5-point scale from 0 (none) to 4 (severe). This measure assesses smoking craving, anger/irritability, anxiety, depressed mood, restlessness/difficulty concentrating, increased appetite, sleep problems, and somatic symptoms (nausea, constipation, sore throat, dizziness, coughing). MNWS is the sum of 8 items with scores ranging from 0 to 32 and MNWS Craving is a single item with scores ranging from 0 to 4, higher scores indicate a greater craving. | approx. 5 minutes |
| Exhaled Breath Carbon Monoxide (CO) | Exhaled breath carbon monoxide was collected before each scan with a handheld electrochemical device. | approx. 5 minutes |
Visit 2: Patients sample unprotonated e-liquid
Visit 3: Patients sample protonated e-liquid
| Sample Protonated E-liquid |
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| Sample Unprotonated E-liquid |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm I (Protonated E-liquid, Unprotonated E-liquid) | Visit 2: Patients sample protonated e-liquid Visit 3: Patients sample unprotonated e-liquid |
| BG001 | Arm II (Unprotonated E-liquid, Protonated E-liquid) | Visit 2: Patients sample unprotonated e-liquid Visit 3: Patients sample protonated e-liquid |
| BG002 | Total | Total of all reporting groups |
| 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 | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Years of regular e-cigarette use | Mean | Standard Deviation | years |
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| 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 | PET/CT Imaging of the Head | Evaluate effect of nicotine form (free-base vs nicotine salt base) on nicotine absorption and distribution in the brain with total absorbed dose (TAD) of [11C]nicotine. | Scan data from 3 participants was insufficient for calculating TAD and are not included in the statistics presented here, these participants were used for protocol optimizations. | Posted | Mean | Standard Deviation | %TAD/kg | 1.5 hours | PET Scans | PET Scans |
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| Primary | PET/CT Imaging of the Chest | Evaluate effect of nicotine form (free-base vs nicotine salt base) on nicotine absorption and distribution in the respiratory tract with total absorbed dose (TAD) of [11C]nicotine. | Scan data from 3 participants was insufficient for calculating TAD and are not included in the statistics presented here, these participants were used for protocol optimizations. | Posted | Mean | Standard Deviation | %TAD/kg | 1.5 hours | PET Scans | PET Scans |
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| Primary | Puff Volume (mL) | Puffing topography data was captured by the study e-cigarette to determine the puff volume. | Puffing topography was not able to be recorded for 2 participants while sampling the Protonated e-liquid and 1 participant while sampling the Unprotonated e-liquid. | Posted | Mean | Standard Deviation | mL | approx. 30 minutes | Puffs | Puffs |
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| Primary | Puff Duration (s) | Puffing topography data was captured by the study e-cigarette to determine the puff duration. | Puffing topography was not able to be recorded for 2 participants while sampling the Protonated e-liquid and 1 participant while sampling the Unprotonated e-liquid. | Posted | Mean | Standard Deviation | seconds | approx. 30 minutes | Puffs | Puffs |
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| Primary | Age of First Tobacco Use | Age of first use will be assessed using the tobacco use history questionnaire. | Posted | Mean | Standard Deviation | years | approx. 5 minutes |
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| Primary | Years of Tobacco Use | Years of tobacco use will be assessed using the tobacco use history questionnaire. | Posted | Mean | Standard Deviation | years | approx. 5 minutes |
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| Primary | Years of Regular Use of Nicotine/Tobacco Products | Years of regular use of nicotine/tobacco products will be assessed using the tobacco history questionnaire | Posted | Mean | Standard Deviation | years | approx. 5 minutes |
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| Primary | Past 30 Day Use of Nicotine/Tobacco Products | Days used in the past 30 days of nicotine/tobacco products including cigars, cigarillos, little cigars, pipe tobacco, chewing tobacco, snuff, snus, EC/vape/mod/APV/e-hookah, and hookah tobacco. | 2 participants in Arm I declined to provide a response for the number of days they have used cigarettes in the past 30 days. | Posted | Mean | Standard Deviation | days | approx. 5 minutes |
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| Primary | Modified Cigarette Evaluation Questionnaire (mCEQ) | 12-item modified Cigarette Evaluation Questionnaire (mCEQ) completed following e-cigarette self-administration to assess subjective responses. The 12-item mCEQ includes five subscales: Smoking Satisfaction, Psychological Reward, Aversion, Enjoyment of Respiratory Tract Sensations, and Craving Reduction, with items rated from 0 (not at all) to 6 (extremely likely). Scores for each subscale are calculated as the mean of the individual item responses or the single item. Higher scores indicate greater intensity on that scale. | mCEQ was only evaluated during the second study visit | Posted | Mean | Standard Deviation | Score on a scale | approx. 5 minutes |
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| Primary | Drug Effects Liking Questionnaire (DEQ) | An adapted version of the Drug Effects/Liking Questionnaire will assess the desire and liking of the study products. Five visual analog scale items ranging from 0 (not at all) to 100 (extremely) assessed wanting to vape the product again, liking the product, enjoying the product, finding the product pleasurable and satisfying. Higher scores indicate greater liking. | The drug effects liking questionnaire was only administered during the second study visit | Posted | Mean | Standard Deviation | units on a scale | approx. 5 minutes |
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| Primary | Modified Tiffany-Drobes Questionnaire of Smoking Urges: Brief Form (QSU) | Urges/craving will be measured using a modified version of the Tiffany-Drobes Questionnaire of Smoking Urges: Brief Form. This is a 10-item measure where participants rate e-cigarette smoking-related items (All I want right now is an e-cigarette) on a 7-point Likert scale ranging from 1 (strongly disagree) to 7 (strongly agree). Similar to previous studies, we will collapse the items into two previously identified factors (Factor 1: strong desire and intention to smoke an e-cigarette; Factor 2: anticipation of relief from withdrawal symptoms). Scores are calculated by summing the items and range from 5 to 35 with higher scores indicating greater craving to vape. | Posted | Mean | Standard Deviation | Score on a scale | aprox. 5 minutes |
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| Primary | Minnesota Nicotine Withdrawal Scale | Nicotine withdrawal will be assessed using the empirically validated 15-item version of the Minnesota Nicotine Withdrawal Scale (MNWS). Items were rated on a 5-point scale from 0 (none) to 4 (severe). This measure assesses smoking craving, anger/irritability, anxiety, depressed mood, restlessness/difficulty concentrating, increased appetite, sleep problems, and somatic symptoms (nausea, constipation, sore throat, dizziness, coughing). MNWS is the sum of 8 items with scores ranging from 0 to 32 and MNWS Craving is a single item with scores ranging from 0 to 4, higher scores indicate a greater craving. | Posted | Mean | Standard Deviation | score on a scale | approx. 5 minutes |
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| Primary | Exhaled Breath Carbon Monoxide (CO) | Exhaled breath carbon monoxide was collected before each scan with a handheld electrochemical device. | Posted | Mean | Standard Deviation | ppm | approx. 5 minutes |
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Over 3 study visits, up to 3 months
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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 | Protonated E-liquid | Patients sample protonated e-liquid | 0 | 20 | 0 | 20 | 2 | 20 |
| EG001 | Unprotonated E-liquid | Patients sample unprotonated e-liquid | 0 | 20 | 0 | 20 | 0 | 20 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Theodore L. Wagener | OhioSUCCC | 614-366-4265 | Theodore.Wagener@osumc.edu |
| Nov 1, 2023 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D009682 | Magnetic Resonance Spectroscopy |
| ID | Term |
|---|---|
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| Middle Eastern |
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| More than one race |
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| PET Scans |
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