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| ID | Type | Description | Link |
|---|---|---|---|
| R03DA047582 | 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 current study aims to establish proof-of-concept that neural cue-reactivity can serve as an early, objective marker of electronic cigarette (ECIG) addictive potential. Further, this study will examine the effect of flavor and nicotine concentration on the addictive potential of ECIGs to aid research informing U.S. Food and Drug Administration (FDA) flavor regulations and smoking cessation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 18mg/ml Tobacco Flavor ECIG | Experimental | Participants will be provided with an ECIG containing 18mg/ml nicotine concentration and a tobacco flavor. |
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| 0mg/ml Tobacco Flavor ECIG | Placebo Comparator | Participants will be provided with an ECIG containing 0mg/ml nicotine concentration and a tobacco flavor. |
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| 18mg/ml Strawberry Vanilla Flavor ECIG | Experimental | Participants will be provided with an ECIG containing 18mg/ml nicotine concentration and a strawberry vanilla flavor. |
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| 0mg/ml Strawberry Vanilla Flavor ECIG | Placebo Comparator | Participants will be provided with an ECIG containing 0mg/ml nicotine concentration and a strawberry vanilla flavor. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nicotine Containing ECIG with tobacco flavor | Other | Participants will be provided with an EGO style ECIG to be used for 28 days. The EGO style ECIG is a "vape pen-style" device that comprises of a rechargeable battery and a tank containing liquid. Those in this intervention group will receive an ECIG with 18mg/ml nicotine concentration and a tobacco flavor. |
| Measure | Description | Time Frame |
|---|---|---|
| Baseline Neural Flavor Cue-reactivity at Baseline | Functional magnetic resonance imaging (fMRI) will be used to measure blood oxygen-level dependent (BOLD) signal in response to tobacco vs. strawberry-vanilla ECIG flavors at baseline. The means reported are the average percentage of BOLD signal change between the fMRI task odor conditions (tobacco vs. strawberry) identified using a whole-brain one-sample t-test with FSL software. Positive values indicate stronger BOLD signal during tobacco odor cues and negative values indicate stronger BOLD signal during strawberry odor cues. | Baseline |
| Changes in Neural Flavor Cue-reactivity Across Nicotine Groups | Functional magnetic resonance imaging (fMRI) will be used to measure changes in blood oxygen-level dependent (BOLD) signal for the tobacco>strawberry contrast across 18 mg/ml vs. 0 mg/ml nicotine concentration groups from baseline to 4-weeks post-randomization using a whole-brain repeated measures ANOVA with FSL software. The means reported are the difference (4-week post-intervention - baseline) of the average percentage of BOLD signal change between the fMRI task odor conditions (tobacco vs. strawberry). Positive values indicate increases in tobacco>strawberry BOLD signal and negative values indicate decreases in tobacco> strawberry BOLD signal. | Baseline to 4-weeks |
| Changes in Neural Flavor Cue-reactivity Across Flavor Groups | Functional magnetic resonance imaging (fMRI) will be used to measure changes in blood oxygen-level dependent (BOLD) signal for the tobacco > strawberry contrast across flavor groups (tobacco vs. strawberry) from baseline to 4-weeks post-randomization. The means reported are the difference (4-week post-intervention - baseline) of the average percentage of BOLD signal change between the fMRI task odor condition (tobacco vs. strawberry) identified using a whole-brain repeated measures ANOVA with FSL software. Positive values indicate increases in tobacco>strawberry BOLD signal and negative values indicate decreases in tobacco> strawberry BOLD signal. | Baseline to 4-weeks |
| Measure | Description | Time Frame |
|---|---|---|
| ECIG Dependence | Changes in self-reported ECIG dependence will be measured using the Penn State Electronic Cigarette Dependence Index (PSECDI). Total scores on this 10-item measure range from 0 to 20, with higher scores indicating higher levels of e-cigarette dependence. The means reported here are the week 4 - week 2 difference scores of the total dependence score. Positive means indicate increases in e-cigarette dependence, while negative means indicated decreases in e-cigarette dependence. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Penn State Health | Hershey | Pennsylvania | 17033 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 18mg/ml Tobacco Flavor ECIG | Participants will be provided with an ECIG containing 18mg/ml nicotine concentration and a tobacco flavor. |
| FG001 | 0mg/ml Tobacco Flavor ECIG | Participants will be provided with an ECIG containing 0mg/ml nicotine concentration and a tobacco flavor. |
| 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 | Nov 20, 2024 |
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| Nicotine Containing ECIG with Strawberry Vanilla Flavor | Other | Participants will be provided with an EGO style ECIG to be used for 28 days. The EGO style ECIG is a "vape pen-style" device that comprises of a rechargeable battery and a tank containing liquid. Those in this intervention group will receive an ECIG with 18mg/ml nicotine concentration and a strawberry vanilla flavor. |
|
| Placebo ECIG with Tobacco Flavor | Other | Participants will be provided with an EGO style ECIG to be used for 28 days. The EGO style ECIG is a "vape pen-style" device that comprises of a rechargeable battery and a tank containing liquid. Those in this intervention group will receive an ECIG with 0mg/ml nicotine concentration and a tobacco flavor. |
|
| Placebo ECIG with Strawberry Vanilla Flavor | Other | Participants will be provided with an EGO style ECIG to be used for 28 days. The EGO style ECIG is a "vape pen-style" device that comprises of a rechargeable battery and a tank containing liquid. Those in this intervention group will receive an ECIG with 0mg/ml nicotine concentration and a strawberry vanilla flavor. |
|
| 2-weeks post-randomization to 4-weeks post-randomization |
| ECIG Liking and Satisfaction | Changes in subjective experiences of ECIG use related to liking and satisfaction will be collected via a self-report survey. The survey consists of 21-items (7-reversed scored) with response options on a 7-point likert scale and total scores ranging from 0 to 126. Higher scores indicate more ECIG liking and satisfaction. The means reported here are the difference of the total scores at week 4 - week 2, with positive means indicating increases in e-cigarette liking and negative means indicating decreases in liking. Note that standard deviation cannot be reported for groups with only one participant. | 2-weeks to 4-weeks |
| Craving to Smoke/Vape | Changes in self-reported craving to smoke/vape were measured with 3 questions on amount, intensity, and self-control using visual analogue scales ranging from 0 to 10 prior to completing the functional MRI scan. Total scores range from 0 to 30 and higher scores indicate more craving. The means reported here are week 4 post-intervention - baseline difference scores of the total craving score. Positive means indicate increases in craving, while negative means indicate decreases in craving. | Baseline to 4-weeks post-randomization |
| FG002 | 18mg/ml Strawberry Vanilla Flavor ECIG | Participants will be provided with an ECIG containing 18mg/ml nicotine concentration and a strawberry vanilla flavor. |
| FG003 | 0mg/ml Strawberry Vanilla Flavor ECIG | Participants will be provided with an ECIG containing 0mg/ml nicotine concentration and a strawberry vanilla flavor. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 18mg/ml Tobacco Flavor ECIG | Participants will be provided with an ECIG containing 18mg/ml nicotine concentration and a tobacco flavor. |
| BG001 | 0mg/ml Tobacco Flavor ECIG | Participants will be provided with an ECIG containing 0mg/ml nicotine concentration and a tobacco flavor. |
| BG002 | 18mg/ml Strawberry Vanilla Flavor ECIG | Participants will be provided with an ECIG containing 18mg/ml nicotine concentration and a strawberry vanilla flavor. |
| BG003 | 0mg/ml Strawberry Vanilla Flavor ECIG | Participants will be provided with an ECIG containing 0mg/ml nicotine concentration and a strawberry vanilla flavor. |
| BG004 | 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 | No |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
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| Race (NIH/OMB) | Count of Participants | Participants | No |
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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 | Baseline Neural Flavor Cue-reactivity at Baseline | Functional magnetic resonance imaging (fMRI) will be used to measure blood oxygen-level dependent (BOLD) signal in response to tobacco vs. strawberry-vanilla ECIG flavors at baseline. The means reported are the average percentage of BOLD signal change between the fMRI task odor conditions (tobacco vs. strawberry) identified using a whole-brain one-sample t-test with FSL software. Positive values indicate stronger BOLD signal during tobacco odor cues and negative values indicate stronger BOLD signal during strawberry odor cues. | For this within-subjects comparison of laboratory task conditions, we included all 19 participants who completed a functional MRI scan at baseline. All assigned groups were combined since group assignment was not a variable of interest for this aim. | Posted | Mean | Standard Deviation | percentage of BOLD signal change | Baseline |
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| Primary | Changes in Neural Flavor Cue-reactivity Across Nicotine Groups | Functional magnetic resonance imaging (fMRI) will be used to measure changes in blood oxygen-level dependent (BOLD) signal for the tobacco>strawberry contrast across 18 mg/ml vs. 0 mg/ml nicotine concentration groups from baseline to 4-weeks post-randomization using a whole-brain repeated measures ANOVA with FSL software. The means reported are the difference (4-week post-intervention - baseline) of the average percentage of BOLD signal change between the fMRI task odor conditions (tobacco vs. strawberry). Positive values indicate increases in tobacco>strawberry BOLD signal and negative values indicate decreases in tobacco> strawberry BOLD signal. | This analysis includes 15 participants who completed baseline and post-intervention functional MRI scans. Groups assigned to nicotine vs. no nicotine were compared and flavor sub-groups within the nicotine groups (tobacco vs. strawberry) were combined, since flavor was not a variable of interest for this aim. | Posted | Mean | Standard Deviation | % BOLD signal change difference score | Baseline to 4-weeks |
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| Primary | Changes in Neural Flavor Cue-reactivity Across Flavor Groups | Functional magnetic resonance imaging (fMRI) will be used to measure changes in blood oxygen-level dependent (BOLD) signal for the tobacco > strawberry contrast across flavor groups (tobacco vs. strawberry) from baseline to 4-weeks post-randomization. The means reported are the difference (4-week post-intervention - baseline) of the average percentage of BOLD signal change between the fMRI task odor condition (tobacco vs. strawberry) identified using a whole-brain repeated measures ANOVA with FSL software. Positive values indicate increases in tobacco>strawberry BOLD signal and negative values indicate decreases in tobacco> strawberry BOLD signal. | This analysis includes 15 participants who completed baseline and post-intervention functional MRI scans. Groups assigned to tobacco vs. strawberry were compared and nicotine sub-groups within the flavor groups (nicotine vs. no nicotine) were combined, since nicotine was not a variable of interest for this aim. | Posted | Mean | Standard Deviation | % BOLD signal change difference score | Baseline to 4-weeks |
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| Secondary | ECIG Dependence | Changes in self-reported ECIG dependence will be measured using the Penn State Electronic Cigarette Dependence Index (PSECDI). Total scores on this 10-item measure range from 0 to 20, with higher scores indicating higher levels of e-cigarette dependence. The means reported here are the week 4 - week 2 difference scores of the total dependence score. Positive means indicate increases in e-cigarette dependence, while negative means indicated decreases in e-cigarette dependence. | This analysis included 14 participants who completed the 2-week check-in and 4-week post-intervention visits and completed the PSECDI. | Posted | Mean | Standard Deviation | units on a scale | 2-weeks post-randomization to 4-weeks post-randomization |
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| Secondary | ECIG Liking and Satisfaction | Changes in subjective experiences of ECIG use related to liking and satisfaction will be collected via a self-report survey. The survey consists of 21-items (7-reversed scored) with response options on a 7-point likert scale and total scores ranging from 0 to 126. Higher scores indicate more ECIG liking and satisfaction. The means reported here are the difference of the total scores at week 4 - week 2, with positive means indicating increases in e-cigarette liking and negative means indicating decreases in liking. Note that standard deviation cannot be reported for groups with only one participant. | This analysis includes 8 participants who completed the e-cigarette evaluation scale at the 2-week check-in and 4-week post-intervention visit. Only participants who reported using the study e-cigarette since the last study visit completed the evaluation scale. | Posted | Mean | Standard Deviation | units on a scale | 2-weeks to 4-weeks |
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| Secondary | Craving to Smoke/Vape | Changes in self-reported craving to smoke/vape were measured with 3 questions on amount, intensity, and self-control using visual analogue scales ranging from 0 to 10 prior to completing the functional MRI scan. Total scores range from 0 to 30 and higher scores indicate more craving. The means reported here are week 4 post-intervention - baseline difference scores of the total craving score. Positive means indicate increases in craving, while negative means indicate decreases in craving. | This analysis includes 15 participants that completed the craving scales before the functional MRI scans at baseline and at the post-intervention visits. | Posted | Mean | Standard Deviation | units on a scale | Baseline to 4-weeks post-randomization |
|
4 weeks
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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 | 18mg/ml Tobacco Flavor ECIG | Participants will be provided with an ECIG containing 18mg/ml nicotine concentration and a tobacco flavor. | 0 | 6 | 0 | 6 | 0 | 6 |
| EG001 | 0mg/ml Tobacco Flavor ECIG | Participants will be provided with an ECIG containing 0mg/ml nicotine concentration and a tobacco flavor. | 0 | 3 | 0 | 3 | 0 | 3 |
| EG002 | 18mg/ml Strawberry Vanilla Flavor ECIG | Participants will be provided with an ECIG containing 18mg/ml nicotine concentration and a strawberry vanilla flavor. | 0 | 5 | 0 | 5 | 1 | 5 |
| EG003 | 0mg/ml Strawberry Vanilla Flavor ECIG | Participants will be provided with an ECIG containing 0mg/ml nicotine concentration and a strawberry vanilla flavor. | 0 | 5 | 0 | 5 | 2 | 5 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Throat irritation | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment | Participant experienced mild throat irritation during the first few days of using the e-cigarette. |
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| Procedure | Surgical and medical procedures | MedDRA (Unspecified) | Non-systematic Assessment | Participant had fluid drained from knee after experiencing pain. |
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| Flu-like symptoms | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Non-systematic Assessment | Participant experienced flu-like symptoms they reported were related to seasonal allergies. |
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Results of brain activation reported here are average values of the percentage of blood-oxygen level-dependent signal change (tobacco vs. strawberry task odor conditions) extracted after conducting whole-brain, voxel-wise general linear models with FSL software. The sample size was too small to conduct some planned between-group analyses and significance thresholds were increased for some analyses.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Andrea Hobkirk | Pennsylvania State University College of Medicine | 717-531-7279 | alh98@psu.edu |
| Apr 30, 2025 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 20, 2024 | Apr 30, 2025 | ICF_001.pdf |
| ID | Term |
|---|---|
| D014029 | Tobacco Use Disorder |
| D012907 | Smoking |
| D000072137 | Vaping |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D001519 | Behavior |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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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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| More than one race |
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| Unknown or Not Reported |
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| Title | Measurements |
|---|---|
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| Left ventral cerebellum |
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| Right dorsal cerebellum |
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| Left dorsal cerebellum |
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| Medial prefrontal cortex |
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| Left medial pre/postcentral gyri |
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| Left lateral pre/postcentral gyri |
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| Precuneous |
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| Right pre/postcentral gyri |
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| Bilateral superior frontal gyrus |
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| OG003 | 0mg/ml Strawberry Vanilla Flavor ECIG | Participants will be provided with an ECIG containing 0mg/ml nicotine concentration and a strawberry vanilla flavor. |
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Participants will be provided with an ECIG containing 18mg/ml nicotine concentration and a strawberry vanilla flavor. |
| OG003 | 0mg/ml Strawberry Vanilla Flavor ECIG | Participants will be provided with an ECIG containing 0mg/ml nicotine concentration and a strawberry vanilla flavor. |
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| OG003 | 0mg/ml Strawberry Vanilla Flavor ECIG | Participants will be provided with an ECIG containing 0mg/ml nicotine concentration and a strawberry vanilla flavor. |
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