Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 5U54DA031659-09 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
| National Institutes of Health (NIH) | NIH |
Not provided
Not provided
Not provided
Not provided
This study is proposing a four condition Electronic Tobacco Marketplace (ETM) study to determine if banning normal nicotine content (NNC) is sufficient for encouraging smokers to switch to potentially less harmful products or if the availability of higher nicotine and/or flavored alternative products (specifically e-cigarettes) are needed to achieve maximal reductions in smoking.
The Family Smoking Prevention and Tobacco Control Act (FSPTCA) passed in 2009 provides the FDA with the authority to regulate tobacco products. One provision in this legislative act empowers the FDA to set limits on constituents in tobacco products, including nicotine. Such a measure has the potential to reduce the chance of individuals experimenting with smoking from becoming dependent and enable current smokers to quit when they are motivated to do so. Although the proposal to reduce nicotine in cigarettes has been met with skepticism by some because of concerns over compensatory smoking behavior and the potential emergence of a black market, this policy measure was considered to be technically feasible by the American Medical Association and the British Medical, by tobacco control researchers, policymakers and governmental officials who were convened in a meeting on nicotine regulation8, and by the World Health Organization Study Group on Tobacco Product Regulation. Most importantly, in July 2017, FDA Commissioner Gottlieb announced he was "directing our Center for Tobacco Products to develop a comprehensive nicotine regulatory plan premised on the need to confront and alter cigarette addiction." This announcement was followed on March 16, 2018 by the release of the Advance Notice of Proposed Rulemaking entitled "Tobacco Product Standard for Nicotine Level of Combusted Cigarettes" (ID: FDA-2017-N-6189-0001) "to obtain information for consideration in developing a tobacco product standard to set the maximum nicotine level for cigarettes."
This study proposes to conduct a within-subjects, multi-session virtual lab study and validation field assessment to determine how the availability of flavored e-liquids affects product purchasing among cigarette smokers. Adult daily cigarette smokers (N=64) will be recruited for this study. After initial eligibility is assessed, participants will complete six virtual sessions (1 baseline, 4 experimental, and 1 follow-up) and one field assessment to evaluate their tobacco use.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Normal Nicotine Content Vape with all flavor e-liquids | Experimental | Normal Nicotine Content Vape with all flavor e-liquids |
|
| Normal nicotine content vape with tobacco e-liquids | Experimental | Normal nicotine content vape with tobacco e-liquids |
|
| Low nicotine content vape with all flavor e-liquids | Experimental | Low nicotine content vape with all flavor e-liquids |
|
| Low nicotine content vape with tobacco e-liquids | Experimental | Low nicotine content vape with tobacco e-liquids |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Normal Nicotine Content Vape with all flavor e-liquids | Other | Participants are randomly assigned to the order of each marketplace Group |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Cigarettes Purchased | Average number of cigarettes purchased (analyzed as raw data and using derived behavioral economic measures) | Visit 6 approximately 4 weeks after baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Number of E-liquid Milliliters Purchased | Average number of e-liquid milliliters purchased (analyzed as raw data and using derived behavioral economic measures) | Visit 6 approximately 4 weeks after baseline |
| Proportion of Participants Completing Flavor and Nicotine Content Discrete Choice Projections |
| Measure | Description | Time Frame |
|---|---|---|
| Product Use Themes Emerging From the Qualitative Interviews | Participants are asked about their opinions and experiences using tobacco products other than their usual brand during the field assessment. | Screening visit through end of study (up to week eight) |
| Tobacco Product Use During Field Assessment |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Eric M Donny, PhD | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest University Health Sciences | Winston-Salem | North Carolina | 27157 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 10465828 | Background | Jarvis MJ, Bates C. Eliminating nicotine in cigarettes. Tob Control. 1999 Spring;8(1):106-7; author reply 107-9. No abstract available. | |
| 25795345 | Background | Kozlowski LT. Prospects for a nicotine-reduction strategy in the cigarette endgame: Alternative tobacco harm reduction scenarios. Int J Drug Policy. 2015 Jun;26(6):543-7. doi: 10.1016/j.drugpo.2015.02.001. Epub 2015 Feb 23. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Out of the initial 69 participants enrolled, 5 people were lost to follow up or withdrew between screening eligible and getting randomized to a group leaving 64 participants randomized. Staff instructed participants that one iteration of the task would be randomly selected and would determine which products (flavor e-liquids or tobacco e-liquids) they would use during the assessment. In reality, participants were only randomly assigned to tobacco e-liquid and never assigned to flavor e-liquid.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Normal Nicotine Content Vape With All Flavor E-liquids | Normal Nicotine Content Vape with all flavor e-liquids Normal Nicotine Content Vape with all flavor e-liquids: Participants are randomly assigned to the order of each marketplace Group |
| FG001 | Normal Nicotine Content Vape With Tobacco E-liquids |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| 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 | Sep 16, 2022 |
Not provided
Participants are randomly assigned to either low nicotine or normal nicotine content vaping devices with tobacco flavors only available
Not provided
Not provided
Participants are told their shopping trips are randomly selected, when they are actually being randomly selected between the two marketplace groups where only one flavor of e-liquid is available.
| Normal nicotine content vape with tobacco e-liquids | Other | Participants are randomly assigned to the order of each marketplace Group |
|
| Low nicotine content vape with all flavor e-liquids | Other | Participants are randomly assigned to the order of each marketplace Group |
|
| Low nicotine content vape with tobacco e-liquids | Other | Participants are randomly assigned to the order of each marketplace Group |
|
The proportion of participants projected to choose a cigarette over an e-cigarette under different potential regulatory scenarios, as determined by regression analysis. |
| Month 1 after baseline |
| Lung Cancer Perceived Risk Scores for VLNC Cigarettes | The response options rely on a 10-point Likert-like scale: 1 = very low risk of disease; 2, 3, 4, 5, 6, 7, 8, 9, 10 = very high risk of disease. Minimum possible response 1. Maximum possible response 10. The higher the score, the greater perceived risk of VLNC cigarettes for lung cancer. | Baseline |
| Product Evaluation Scale Scores | Product evaluation scale scores for VLNC cigarettes among participants who received VLNC cigarettes will be determined by a product evaluation questionnaire. The questionnaire measures the strength of self-reported positive subjective effects (e.g., reward, satisfaction) following product use. The response options rely on a 7-point Likert-like scale: 1=not at all; 2= very little; 3= a little; 4= moderately; 5= a lot; 6= quite a lot; 7= extremely. The summed score adds responses to 13 separate items. Minimum possible response: 13. Maximum possible response: 91. Higher scores denote more favorable product effects. Note: This was only administered (at Virtual Visit 6) to participants who received each product type in the field (dependent on their baseline ETM shopping trip purchases). | Visit 6 approximately 4 weeks after baseline |
| Minnesota Nicotine Withdrawal Scale Scores | Minnesota Nicotine Withdrawal Scale measures the severity of nicotine withdrawal symptoms. The response options rely on a 5-point Likert-like scale; 0=None; 1= Slight; 2=Mild; 3=Moderate; 4=Severe. There are 7 items total, that are summed. Minimum possible response: 0. Maximum possible response: 28. Higher scores denote greater severity of withdrawal symptoms. | Visit 6 approximately 4 weeks after baseline |
| Questionnaire on Smoking Urges Score | Questionnaire on Smoking Urges measures the strength of urges to smoke. The response options rely on a 7-point Likert-like scale: 1=Strongly Disagree; 2; 3; 4; 5; 6; 7= Strongly Agree. The questionnaire has 10 total items; scores sum responses to each item. Minimum possible response: 10. Maximum possible response: 70. Higher scores denote greater urges to smoke. | Visit 6 approximately 4 weeks after baseline |
| Tobacco Product Interest Scores | Tobacco Product Interest of different products; Slider scale ranging from 0=No Interest to 100=Very Interested | 1 month after baseline |
| Tobacco Policy Questionnaire Scores | Tobacco Policy Questionnaire scored from Support, Oppose, and Don't know for personal opinions on Making Cigarettes Less Addictive | 1 month after baseline |
Participants are asked what products they had used and quantity every day during the field assessment. |
| Screening visit through end of study (up to week eight) |
| Biomarkers of Exposure During Field Assessment - Carbon Monoxide | Product use and biomarkers of exposure during the field assessment will be analyzed using linear regression or other appropriate regression models. The model for primary analysis of these data will include main effects for each of the two factors (for the ETM condition carried into the field assessment), and the corresponding baseline measure to improve precision. Carbon Monoxide (CO) is collected in ppm. | Screening visit through end of study (up to week eight) |
| Biomarkers of Exposure During Field Assessment - Cotinine | Product use and biomarkers of exposure during the field assessment will be analyzed using linear regression or other appropriate regression models. The model for primary analysis of these data will include main effects for each of the two factors (for the ETM condition carried into the field assessment), and the corresponding baseline measure to improve precision. Cotinine is collected in ng/ml. | Screening visit through end of study (up to week eight) |
| 27357937 | Background | Kozlowski LT. Cigarette prohibition and the need for more prior testing of the WHO TobReg's global nicotine-reduction strategy. Tob Control. 2017 Mar;26(e1):e31-e34. doi: 10.1136/tobaccocontrol-2016-052995. Epub 2016 Jun 29. No abstract available. |
| 27554993 | Background | Kozlowski LT. Let actual markets help assess the worth of optional very-low-nicotine cigarettes before deciding on mandatory regulations. Addiction. 2017 Jan;112(1):3-5. doi: 10.1111/add.13515. Epub 2016 Aug 23. No abstract available. |
| 10465827 | Background | Shatenstein S. Eliminating nicotine in cigarettes. Tob Control. 1999 Spring;8(1):106; author reply 107-9. No abstract available. |
| 9825424 | Background | Henningfield JE, Benowitz NL, Slade J, Houston TP, Davis RM, Deitchman SD. Reducing the addictiveness of cigarettes. Council on Scientific Affairs, American Medical Association. Tob Control. 1998 Autumn;7(3):281-93. doi: 10.1136/tc.7.3.281. |
| 20876072 | Background | Hatsukami DK, Perkins KA, Lesage MG, Ashley DL, Henningfield JE, Benowitz NL, Backinger CL, Zeller M. Nicotine reduction revisited: science and future directions. Tob Control. 2010 Oct;19(5):e1-10. doi: 10.1136/tc.2009.035584. |
| 26353746 | Background | World Health Organization. WHO STUDY GROUP ON TOBACCO PRODUCT REGULATION. Report on the Scientific Basis of Tobacco Product Regulations: Fifth Report of a WHO Study Group. World Health Organ Tech Rep Ser. 2015;(989):1-234, back cover. |
Normal nicotine content vape with tobacco e-liquids Normal nicotine content vape with tobacco e-liquids: Participants are randomly assigned to the order of each marketplace Group |
| FG002 | Low Nicotine Content Vape With All Flavor E-liquids | Low nicotine content vape with all flavor e-liquids Low nicotine content vape with all flavor e-liquids: Participants are randomly assigned to the order of each marketplace Group |
| FG003 | Low Nicotine Content Vape With Tobacco E-liquids | Low nicotine content vape with tobacco e-liquids Low nicotine content vape with tobacco e-liquids: Participants are randomly assigned to the order of each marketplace Group |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Participants that completed all virtual shopping trips before randomization of take-home products. Participants were told they may have a chance of taking home "all flavor e-liquids" to prevent purchasing bias, but they were only able to take home tobacco e-liquids.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Normal Nicotine Content Vape With All Flavor E-liquids | Normal Nicotine Content Vape with all flavor e-liquids Normal Nicotine Content Vape with all flavor e-liquids: Participants are randomly assigned to the order of each marketplace Group |
| BG001 | Normal Nicotine Content Vape With Tobacco E-liquids | Normal nicotine content vape with tobacco e-liquids Normal nicotine content vape with tobacco e-liquids: Participants are randomly assigned to the order of each marketplace Group |
| BG002 | Low Nicotine Content Vape With All Flavor E-liquids | Low nicotine content vape with all flavor e-liquids Low nicotine content vape with all flavor e-liquids: Participants are randomly assigned to the order of each marketplace Group |
| BG003 | Low Nicotine Content Vape With Tobacco E-liquids | Low nicotine content vape with tobacco e-liquids Low nicotine content vape with tobacco e-liquids: Participants are randomly assigned to the order of each marketplace Group |
| BG004 | 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, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | 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 |
|
| 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 | Number of Cigarettes Purchased | Average number of cigarettes purchased (analyzed as raw data and using derived behavioral economic measures) | Among those participants who purchased cigarettes in Shopping Trip 7 at Virtual Visit 6, the average number of cigarettes purchased (in an experimental tobacco marketplace where packs of very low nicotine content (VLNC) cigarettes, bottles of e-liquid matched to their randomization condition, boxes of nicotine gum were available). | Posted | Mean | Standard Deviation | average number of cigarettes | Visit 6 approximately 4 weeks after baseline |
|
|
| ||||||||||||||||||||||||||||||||||
| Secondary | Number of E-liquid Milliliters Purchased | Average number of e-liquid milliliters purchased (analyzed as raw data and using derived behavioral economic measures) | Among those participants who purchased e-liquid in Shopping Trip 7 at Virtual Visit 6, the average number of mls purchased (in an experimental tobacco marketplace where packs of VLNC cigarettes, bottles of e-liquid matched to their randomization condition, boxes of nicotine gum were available). | Posted | Mean | Standard Deviation | average number of milliliters | Visit 6 approximately 4 weeks after baseline |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Proportion of Participants Completing Flavor and Nicotine Content Discrete Choice Projections | The proportion of participants projected to choose a cigarette over an e-cigarette under different potential regulatory scenarios, as determined by regression analysis. | Scores reveal how important each product characteristic is to a participant when indicating their preference for one product over another (0 to 100, summing to 100). In our study, product type (2 levels: cigarette or e-cigarette), cigarette nicotine content (2 levels: normal or very low), e-liquid nicotine content (2 levels: 25mg/ml or 50mg/g) and available e-liquid flavor (2 levels: mint, fruit, sweet, tobacco or only tobacco) were manipulated in the discrete choice experiment. | Posted | Number | Proportion of participants | Month 1 after baseline |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Lung Cancer Perceived Risk Scores for VLNC Cigarettes | The response options rely on a 10-point Likert-like scale: 1 = very low risk of disease; 2, 3, 4, 5, 6, 7, 8, 9, 10 = very high risk of disease. Minimum possible response 1. Maximum possible response 10. The higher the score, the greater perceived risk of VLNC cigarettes for lung cancer. | Group average for responses using a 10-point Likert-like scale: 1 = very low risk of disease; 2, 3, 4, 5, 6, 7, 8, 9, 10 = very high risk of disease. Minimum possible response 1. Maximum possible response 10. The higher the score, the greater perceived risk of VLNC cigarettes for lung cancer. | Posted | Mean | Standard Deviation | score on a scale | Baseline |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Product Evaluation Scale Scores | Product evaluation scale scores for VLNC cigarettes among participants who received VLNC cigarettes will be determined by a product evaluation questionnaire. The questionnaire measures the strength of self-reported positive subjective effects (e.g., reward, satisfaction) following product use. The response options rely on a 7-point Likert-like scale: 1=not at all; 2= very little; 3= a little; 4= moderately; 5= a lot; 6= quite a lot; 7= extremely. The summed score adds responses to 13 separate items. Minimum possible response: 13. Maximum possible response: 91. Higher scores denote more favorable product effects. Note: This was only administered (at Virtual Visit 6) to participants who received each product type in the field (dependent on their baseline ETM shopping trip purchases). | Group Averages, summed score of 13 items The product evaluation questionnaire measures the strength of self-reported positive effects (e.g., reward, satisfaction) following product use. The response options rely on a 7-point Likert-like scale: 1=not at all; 2= very little; 3= a little; 4= moderately; 5= a lot; 6= quite a lot; 7= extremely. Only administered to participants who received each product type in the field. | Posted | Mean | Standard Deviation | score on a scale | Visit 6 approximately 4 weeks after baseline |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Minnesota Nicotine Withdrawal Scale Scores | Minnesota Nicotine Withdrawal Scale measures the severity of nicotine withdrawal symptoms. The response options rely on a 5-point Likert-like scale; 0=None; 1= Slight; 2=Mild; 3=Moderate; 4=Severe. There are 7 items total, that are summed. Minimum possible response: 0. Maximum possible response: 28. Higher scores denote greater severity of withdrawal symptoms. | Group averages, summed score of 7 items Minnesota Nicotine Withdrawal Scale measures the severity of nicotine withdrawal symptoms. The response options rely on a 5-point Likert-like scale; 0=None; 1= Slight; 2=Mild; 3=Moderate; 4=Severe. Minimum possible response: 0. Maximum possible response: 28. Higher scores denote greater severity of withdrawal symptoms. | Posted | Mean | Standard Deviation | score on a scale | Visit 6 approximately 4 weeks after baseline |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Questionnaire on Smoking Urges Score | Questionnaire on Smoking Urges measures the strength of urges to smoke. The response options rely on a 7-point Likert-like scale: 1=Strongly Disagree; 2; 3; 4; 5; 6; 7= Strongly Agree. The questionnaire has 10 total items; scores sum responses to each item. Minimum possible response: 10. Maximum possible response: 70. Higher scores denote greater urges to smoke. | Group averages, summed score of 10 items Questionnaire on Smoking Urges measures the strength of urges to smoke. The response options rely on a 7-point Likert-like scale: 1=Strongly Disagree; 2; 3; 4; 5; 6; 7= Strongly Agree. The questionnaire has 10 total items; scores sum responses to each item. Minimum possible response: 10. Maximum possible response: 70. Higher scores denote greater urges to smoke. | Posted | Mean | Standard Deviation | score on a scale | Visit 6 approximately 4 weeks after baseline |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Tobacco Product Interest Scores | Tobacco Product Interest of different products; Slider scale ranging from 0=No Interest to 100=Very Interested | Product interest toward different cigarettes and e-cigarettes; Slider scale ranging from 0 = No Interest to 100 = Very Interested Ppts were not actually randomized to "all flavor e-liquids" | Posted | Mean | Full Range | score on a scale | 1 month after baseline |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Tobacco Policy Questionnaire Scores | Tobacco Policy Questionnaire scored from Support, Oppose, and Don't know for personal opinions on Making Cigarettes Less Addictive | Ppts were not actually randomized to "all flavor" e-liquid groups. | Posted | Count of Participants | Participants | 1 month after baseline |
| |||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Product Use Themes Emerging From the Qualitative Interviews | Participants are asked about their opinions and experiences using tobacco products other than their usual brand during the field assessment. | Not Posted | Screening visit through end of study (up to week eight) | Participants | ||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Tobacco Product Use During Field Assessment | Participants are asked what products they had used and quantity every day during the field assessment. | Not Posted | Screening visit through end of study (up to week eight) | Participants | ||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Biomarkers of Exposure During Field Assessment - Carbon Monoxide | Product use and biomarkers of exposure during the field assessment will be analyzed using linear regression or other appropriate regression models. The model for primary analysis of these data will include main effects for each of the two factors (for the ETM condition carried into the field assessment), and the corresponding baseline measure to improve precision. Carbon Monoxide (CO) is collected in ppm. | Not Posted | Screening visit through end of study (up to week eight) | Participants | ||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Biomarkers of Exposure During Field Assessment - Cotinine | Product use and biomarkers of exposure during the field assessment will be analyzed using linear regression or other appropriate regression models. The model for primary analysis of these data will include main effects for each of the two factors (for the ETM condition carried into the field assessment), and the corresponding baseline measure to improve precision. Cotinine is collected in ng/ml. | Not Posted | Screening visit through end of study (up to week eight) | Participants |
Screening visit through end of study (up to week eight)
Number of participants at risk is zero for two of the groups because no participants were assigned to those groups.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Normal Nicotine Content Vape With All Flavor E-liquids | Normal Nicotine Content Vape with all flavor e-liquids Normal Nicotine Content Vape with all flavor e-liquids: Participants are randomly assigned to the order of each marketplace Group | 0 | 0 | 0 | 0 | 0 | 0 |
| EG001 | Normal Nicotine Content Vape With Tobacco E-liquids | Normal nicotine content vape with tobacco e-liquids Normal nicotine content vape with tobacco e-liquids: Participants are randomly assigned to the order of each marketplace Group | 0 | 29 | 0 | 29 | 1 | 29 |
| EG002 | Low Nicotine Content Vape With All Flavor E-liquids | Low nicotine content vape with all flavor e-liquids Low nicotine content vape with all flavor e-liquids: Participants are randomly assigned to the order of each marketplace Group | 0 | 0 | 0 | 0 | 0 | 0 |
| EG003 | Low Nicotine Content Vape With Tobacco E-liquids | Low nicotine content vape with tobacco e-liquids Low nicotine content vape with tobacco e-liquids: Participants are randomly assigned to the order of each marketplace Group | 0 | 32 | 0 | 32 | 2 | 32 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Stress/Irritability | Psychiatric disorders | Non-systematic Assessment | Two Participants experienced an increase in stress; due to the lower nicotine amount in cigs they reported. |
| |
| COVID | Infections and infestations | Non-systematic Assessment | Tested positive for COVID during trial |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Darcy Lockhart, Project Manager I | Wake Forest School of Medicine | 3367166182 | alaverdi@wakehealth.edu |
| Aug 2, 2024 |
| Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 8, 2023 | Oct 5, 2023 | ICF_000.pdf |
| ID | Term |
|---|---|
| D064424 | Tobacco Use |
| D000073865 | Cigarette Smoking |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D000073869 | Tobacco Smoking |
| D012907 | Smoking |
Not provided
Not provided
| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| OG003 | Low Nicotine Content Vape With Tobacco E-liquids | Low nicotine content vape with tobacco e-liquids Low nicotine content vape with tobacco e-liquids: Participants are randomly assigned to the order of each marketplace Group |
|
|
| Low Nicotine Content Vape With All Flavor E-liquids |
Low nicotine content vape with all flavor e-liquids Low nicotine content vape with all flavor e-liquids: Participants are randomly assigned to the order of each marketplace Group |
| OG003 | Low Nicotine Content Vape With Tobacco E-liquids | Low nicotine content vape with tobacco e-liquids Low nicotine content vape with tobacco e-liquids: Participants are randomly assigned to the order of each marketplace Group |
|
|
Low nicotine content vape with all flavor e-liquids Low nicotine content vape with all flavor e-liquids: Participants are randomly assigned to the order of each marketplace Group |
| OG003 | Low Nicotine Content Vape With Tobacco E-liquids | Low nicotine content vape with tobacco e-liquids Low nicotine content vape with tobacco e-liquids: Participants are randomly assigned to the order of each marketplace Group |
|
|
| Normal Nicotine Content Vape With Tobacco E-liquids |
Normal nicotine content vape with tobacco e-liquids Normal nicotine content vape with tobacco e-liquids: Participants are randomly assigned to the order of each marketplace Group |
| OG002 | Low Nicotine Content Vape With All Flavor E-liquids | Low nicotine content vape with all flavor e-liquids Low nicotine content vape with all flavor e-liquids: Participants are randomly assigned to the order of each marketplace Group |
| OG003 | Low Nicotine Content Vape With Tobacco E-liquids | Low nicotine content vape with tobacco e-liquids Low nicotine content vape with tobacco e-liquids: Participants are randomly assigned to the order of each marketplace Group |
|
|
| OG002 |
| Low Nicotine Content Vape With All Flavor E-liquids |
Low nicotine content vape with all flavor e-liquids Low nicotine content vape with all flavor e-liquids: Participants are randomly assigned to the order of each marketplace Group |
| OG003 | Low Nicotine Content Vape With Tobacco E-liquids | Low nicotine content vape with tobacco e-liquids Low nicotine content vape with tobacco e-liquids: Participants are randomly assigned to the order of each marketplace Group |
|
|
| OG002 | Low Nicotine Content Vape With All Flavor E-liquids | Low nicotine content vape with all flavor e-liquids Low nicotine content vape with all flavor e-liquids: Participants are randomly assigned to the order of each marketplace Group |
| OG003 | Low Nicotine Content Vape With Tobacco E-liquids | Low nicotine content vape with tobacco e-liquids Low nicotine content vape with tobacco e-liquids: Participants are randomly assigned to the order of each marketplace Group |
|
|
| OG003 | Low Nicotine Content Vape With Tobacco E-liquids | Low nicotine content vape with tobacco e-liquids Low nicotine content vape with tobacco e-liquids: Participants are randomly assigned to the order of each marketplace Group |
|
|
| Low Nicotine Content Vape With Tobacco E-liquids |
Low nicotine content vape with tobacco e-liquids Low nicotine content vape with tobacco e-liquids: Participants are randomly assigned to the order of each marketplace Group |
|
|