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| ID | Type | Description | Link |
|---|---|---|---|
| 1P50DA036151-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| APT Foundation, Inc. | OTHER |
| National Institute on Drug Abuse (NIDA) | NIH |
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This one-year pilot study of 30 non-treatment seeking young adult e-cigarette/combustible tobacco product dual users (15 males/15 females) will use smartphone-based ecological momentary assessment (EMA) to gather real-time data of e-cigarette and combustible tobacco product behaviors during a 1-week cigarette/e-cigarette dual use period .(1) Participants will respond to daily random prompts assessing in-the-moment use of e-cigarettes/cigarettes and the subjective factors (ratings of satisfaction and withdrawal) and contextual factors (location, activity, social cues) associated with each episode of use. Participants will also complete daily electronic diaries to document e-cigarette use episodes/day, and satisfaction with the e-cigarette experience during the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Survey Arm | Experimental | Will receive incentives for completing surveys and evidence of tobacco use status daily for 1 week |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Survey Arm | Behavioral | Contingency Management for completion of surveys and evidence of tobacco use status |
|
| Measure | Description | Time Frame |
|---|---|---|
| Contextual Factors Associated With Tobacco Use Episode Reported Via Ecological Momentary Assessment | Participant responses to prompt during ecological momentary assessment about their activity, location, and companionship during a tobacco use episode that occurred within the past 15 minutes. | week 1 |
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Inclusion Criteria:
Exclusion Criteria.
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| Name | Affiliation | Role |
|---|---|---|
| Deepa R Camenga, MD | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale University | New Haven | Connecticut | 06511 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34769525 | Result | Camenga DR, Haeny AM, Krishnan-Sarin S, O'Malley SS, Bold KW. Pilot Ecological Momentary Assessment Study of Subjective and Contextual Factors Surrounding E-Cigarette and Combustible Tobacco Product Use among Young Adults. Int J Environ Res Public Health. 2021 Oct 20;18(21):11005. doi: 10.3390/ijerph182111005. |
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Participants were recruited through flyers, targeted advertisements on Facebook, Instagram, Craigslist, public boards in local colleges, and through the university research volunteer database.
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| ID | Title | Description |
|---|---|---|
| FG000 | Survey Arm | Will receive incentives for completing surveys and evidence of tobacco use status daily for 1 week Survey Arm: Contingency Management for completion of surveys and evidence of tobacco use status |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Survey Arm | Will receive incentives for completing surveys and evidence of tobacco use status daily for 1 week Survey Arm: Contingency Management for completion of surveys and evidence of tobacco use status |
| 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 |
| 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 | Contextual Factors Associated With Tobacco Use Episode Reported Via Ecological Momentary Assessment | Participant responses to prompt during ecological momentary assessment about their activity, location, and companionship during a tobacco use episode that occurred within the past 15 minutes. | non-treatment seeking young adults who use both e-cigarettes and combustible tobacco products | Posted | Number | tobacco use episodes | week 1 | tobacco use episodes | tobacco use episodes |
|
1 week
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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 | Survey Arm | Will receive incentives for completing surveys and evidence of tobacco use status daily for 1 week Survey Arm: Contingency Management for completion of surveys and evidence of tobacco use status |
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Small sample
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Deepa Camenga, Principal Investigator | Yale School of Medicine | 12037378310 | deepa.camenga@yale.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 | Oct 18, 2017 | Nov 22, 2022 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 7, 2018 | Nov 22, 2022 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D000073865 | Cigarette Smoking |
| D064424 | Tobacco Use |
| ID | Term |
|---|---|
| D000073869 | Tobacco Smoking |
| D012907 | Smoking |
| D001519 | Behavior |
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30 non-treatment seeking young adult e-cigarette/cigarette dual users (15 males/15 females) will participate in a contingency-management reinforced 1 week observation period
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Highest Level of Education Completed | Count of Participants | Participants |
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| Baseline FTCD Score | The Fagerström Test for Nicotine Dependence is a standard instrument for assessing the intensity of physical addiction to nicotine. The six-item instrument provides ordinal measure of nicotine dependence related to cigarette smoking. In scoring the FTND, yes/no items are scored from 0 to 1 and multiple-choice items are scored from 0 to 3. The items are summed to yield a total score of 0-10. The higher the total Fag xscore, the more intense is the patient's physical dependence on nicotine. | Mean | Standard Deviation | units on a scale |
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| E-cigarette Device Type Used | Count of Participants | Participants |
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| Cigarettes Smoked/Day | Count of Participants | Participants |
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| Type of Combustible Tobacco Product Used in Past Week | Count of Participants | Participants |
|
Episode of Combustible Tobacco Product Use reported via ecological momentary assessment.
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| 0 |
| 29 |
| 0 |
| 29 |
| 0 |
| 29 |
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