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The proposed project will test three commercial cellphone breathalyzers against a police grade breathalyzer device.The study will test the accuracy of these smartphone breathalyzers at assessing Breath Alcohol Content (BrAC) against a standard police grade breathalyzer. This study aims to fill the knowledge gap by determining the validity of smartphone paired breathalyzer devices to accurately assess BrAC. Data collection includes collection of BrAC measurements, as well as survey data.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Commercial Smartphone-paired breathalyzers-Set 1 | Experimental | All subjects will first be given a priming dose of alcohol containing vodka designed to raise the blood alcohol content based on weight and gender. Blood alcohol content will first be measured with three commercial smartphone-paired breathalyzers: Drivesafe Evoc, Alcohoot, and BacTrack Pro which will be tested in a randomized order and recorded. Participants blood alcohol content will also be measured using the Intoxilyzer 240, a police grade breathalyzer device After the tertiary dose of alcohol, a nurse will perform a blood draw on the participants, which will be used to determine blood alcohol content. |
|
| Commercial Smartphone-paired breathalyzers-Set 2 | Experimental | All subjects will first be given a priming dose of alcohol containing vodka designed to raise the blood alcohol content based on weight and gender. Blood alcohol content will first be measured with three commercial smartphone-paired breathalyzers: BACtrack Vio, Drinkmate, and Floome which will be tested in a randomized order and recorded. Participants blood alcohol content will also be measured using the Intoxilyzer 240, a police grade breathalyzer device After the tertiary dose of alcohol, a nurse will perform a blood draw on the participants, which will be used to determine blood alcohol content. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alcohoot | Device | Alcohoot branded smartphone-paired breathalyzer |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage Alcohol in Breath Variability | Difference in Breath Alcohol Concentration (BrAC) from police-grade (Intoxilyzer 240) and consumer smartphone-paired breath testing devices relative to Blood Alcohol Concentration (BAC) measured from blood draw after tertiary dose of alcohol. | 8 Hours |
| Measure | Description | Time Frame |
|---|---|---|
| Differences in Readings on Devices for Percentage of Alcohol in Breath | Mean difference in percent of blood in breath (BrAC) between the police-grade and personal, commercial breath testing devices | 8 Hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| M. Kit Delgado, MD, MS | University of Pennsylvania | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23279560 | Background | Alessi SM, Petry NM. A randomized study of cellphone technology to reinforce alcohol abstinence in the natural environment. Addiction. 2013 May;108(5):900-9. doi: 10.1111/add.12093. Epub 2013 Jan 30. | |
| 10636603 | Background | Easton CJ, Swan S, Sinha R. Prevalence of family violence in clients entering substance abuse treatment. J Subst Abuse Treat. 2000 Jan;18(1):23-8. doi: 10.1016/s0740-5472(99)00019-7. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Commercial Smartphone-paired Breathalyzers-Set 1 | Smartphone-paired mobile breathalyzer-Set 1: All subjects will first be given a priming dose of alcohol containing vodka designed to raise the blood alcohol content based on weight and gender. Blood alcohol content will first be measured with three commercial smartphone-paired breathalyzers: Drivesafe Evoc, Alcohoot, and BacTrack Pro which will be tested in a randomized order and recorded. Participants' blood alcohol content will also be measured using the Intoxilyzer 240, a police grade breathalyzer device. After the tertiary dose of alcohol, a nurse will perform a blood draw on the participants, which will be used to determine blood alcohol content. |
| FG001 | Commercial Smartphone-paired Breathalyzers-Set 2 | Smartphone-paired mobile breathalyzer-Set 2: All subjects will first be given a priming dose of alcohol containing vodka designed to raise the blood alcohol content based on weight and gender. Blood alcohol content will first be measured with three commercial smartphone-paired breathalyzers: BACtrack Vio, Drinkmate, and Floome which will be tested in a randomized order and recorded. Participants' blood alcohol content will also be measured using the Intoxilyzer 240, a police grade breathalyzer device. After the tertiary dose of alcohol, a nurse will perform a blood draw on the participants, which will be used to determine blood alcohol content. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Commercial Smartphone-paired Breathalyzers-Set 1 | Smartphone-paired mobile breathalyzer-Set 1: All subjects will first be given a priming dose of alcohol containing vodka designed to raise the blood alcohol content based on weight and gender. Blood alcohol content will first be measured with three commercial smartphone-paired breathalyzers: Drivesafe Evoc, Alcohoot, and BacTrack Pro which will be tested in a randomized order and recorded. Participants' blood alcohol content will also be measured using the Intoxilyzer 240, a police grade breathalyzer device. After the tertiary dose of alcohol, a nurse will perform a blood draw on the participants, which will be used to determine blood alcohol content. |
| 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 | Percentage Alcohol in Breath Variability | Difference in Breath Alcohol Concentration (BrAC) from police-grade (Intoxilyzer 240) and consumer smartphone-paired breath testing devices relative to Blood Alcohol Concentration (BAC) measured from blood draw after tertiary dose of alcohol. | Group 1: Alcohoot, Evoc, BACtrack Mobile Pro, Intoxilyzer 240 (A). Group 2: BACtrack Vio, Drinkmate, Floome, Intoxilyzer 240 (B). Percent of Alcohol in Blood - grouped. | Posted | Mean | Standard Deviation | percentage of alcohol | 8 Hours |
|
8 hours
Screening for eligibility reduced risk of all risk mortality
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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 | Commercial Smartphone-paired Breathalyzers-Set 1 | All subjects will first be given a priming dose of alcohol containing vodka designed to raise the blood alcohol content based on weight and gender. Blood alcohol content will first be measured with three commercial smartphone-paired breathalyzers: Drivesafe Evoc, Alcohoot, and BacTrack Pro which will be tested in a randomized order and recorded. Participants blood alcohol content will also be measured using the Intoxilyzer 240, a police grade breathalyzer device After the tertiary dose of alcohol, a nurse will perform a blood draw on the participants, which will be used to determine blood alcohol content. Alcohoot: Alcohoot branded smartphone-paired breathalyzer BACtrack Mobile Pro: BACtrack Mobile Pro branded smartphone-paired breathalyzer DRIVESAFE Evoc: DRIVESAFE Evoc branded smartphone-paired breathalyzer Intoxilyzer 240: Intoxilyzer 240 police grade breathalyzer |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jessie Hemmons | University of Pennsylvania | 215-746-8255 | jhemmons@pennmedicine.upenn.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 | Mar 21, 2017 | Feb 20, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000428 | Alcohol Drinking |
| D000435 | Alcoholic Intoxication |
| ID | Term |
|---|---|
| D004327 | Drinking Behavior |
| D001519 | Behavior |
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
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| BACtrack Mobile Pro | Device | BACtrack Mobile Pro branded smartphone-paired breathalyzer |
|
| DRIVESAFE Evoc | Device | DRIVESAFE Evoc branded smartphone-paired breathalyzer |
|
| BACtrack Vio | Device | BACtrack Vio branded smartphone-paired breathalyzer |
|
| Drinkmate | Device | Drinkmate branded smartphone-paired breathalyzer |
|
| Floome | Device | Floome branded smartphone-paired breathalyzer |
|
| Intoxilyzer 240 | Device | Intoxilyzer 240 police grade breathalyzer |
|
| 15907777 | Background | Harrison EL, Fillmore MT. Are bad drivers more impaired by alcohol? Sober driving precision predicts impairment from alcohol in a simulated driving task. Accid Anal Prev. 2005 Sep;37(5):882-9. doi: 10.1016/j.aap.2005.04.005. |
| 18179312 | Background | Harrison EL, Marczinski CA, Fillmore MT. Driver training conditions affect sensitivity to the impairing effects of alcohol on a simulated driving test [corrected]. Exp Clin Psychopharmacol. 2007 Dec;15(6):588-98. doi: 10.1037/1064-1297.15.6.588. |
| 12724485 | Background | Kosten TR, O'Connor PG. Management of drug and alcohol withdrawal. N Engl J Med. 2003 May 1;348(18):1786-95. doi: 10.1056/NEJMra020617. No abstract available. |
| 18042920 | Background | Loewenstein G, Brennan T, Volpp KG. Asymmetric paternalism to improve health behaviors. JAMA. 2007 Nov 28;298(20):2415-7. doi: 10.1001/jama.298.20.2415. No abstract available. |
| 21373791 | Background | MacKillop J, Amlung MT, Few LR, Ray LA, Sweet LH, Munafo MR. Delayed reward discounting and addictive behavior: a meta-analysis. Psychopharmacology (Berl). 2011 Aug;216(3):305-21. doi: 10.1007/s00213-011-2229-0. Epub 2011 Mar 4. |
| 23216417 | Background | Marczinski CA, Stamates AL. Artificial sweeteners versus regular mixers increase breath alcohol concentrations in male and female social drinkers. Alcohol Clin Exp Res. 2013 Apr;37(4):696-702. doi: 10.1111/acer.12039. Epub 2012 Dec 6. |
| 22690907 | Background | McCarthy DM, Niculete ME, Treloar HR, Morris DH, Bartholow BD. Acute alcohol effects on impulsivity: associations with drinking and driving behavior. Addiction. 2012 Dec;107(12):2109-14. doi: 10.1111/j.1360-0443.2012.03974.x. Epub 2012 Aug 10. |
| 9707655 | Background | McNeill JA, Sherwood GD, Starck PL, Thompson CJ. Assessing clinical outcomes: patient satisfaction with pain management. J Pain Symptom Manage. 1998 Jul;16(1):29-40. doi: 10.1016/s0885-3924(98)00034-7. |
| 25569175 | Background | Patel MS, Asch DA, Volpp KG. Wearable devices as facilitators, not drivers, of health behavior change. JAMA. 2015 Feb 3;313(5):459-60. doi: 10.1001/jama.2014.14781. No abstract available. |
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| 10669051 | Background | Petry NM. A comprehensive guide to the application of contingency management procedures in clinical settings. Drug Alcohol Depend. 2000 Feb 1;58(1-2):9-25. doi: 10.1016/s0376-8716(99)00071-x. |
| 10780125 | Background | Petry NM, Martin B, Cooney JL, Kranzler HR. Give them prizes, and they will come: contingency management for treatment of alcohol dependence. J Consult Clin Psychol. 2000 Apr;68(2):250-7. doi: 10.1037//0022-006x.68.2.250. |
| 17034434 | Background | Prendergast M, Podus D, Finney J, Greenwell L, Roll J. Contingency management for treatment of substance use disorders: a meta-analysis. Addiction. 2006 Nov;101(11):1546-60. doi: 10.1111/j.1360-0443.2006.01581.x. |
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| 24603444 | Background | Sloan FA, Eldred LM, Xu Y. The behavioral economics of drunk driving. J Health Econ. 2014 May;35:64-81. doi: 10.1016/j.jhealeco.2014.01.005. Epub 2014 Feb 11. |
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| 7289599 | Background | Watson PE, Watson ID, Batt RD. Prediction of blood alcohol concentrations in human subjects. Updating the Widmark Equation. J Stud Alcohol. 1981 Jul;42(7):547-56. doi: 10.15288/jsa.1981.42.547. No abstract available. |
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| BG001 | Commercial Smartphone-paired Breathalyzers-Set 2 | Smartphone-paired mobile breathalyzer-Set 2: All subjects will first be given a priming dose of alcohol containing vodka designed to raise the blood alcohol content based on weight and gender. Blood alcohol content will first be measured with three commercial smartphone-paired breathalyzers: BACtrack Vio, Drinkmate, and Floome which will be tested in a randomized order and recorded. Participants' blood alcohol content will also be measured using the Intoxilyzer 240, a police grade breathalyzer device. After the tertiary dose of alcohol, a nurse will perform a blood draw on the participants, which will be used to determine blood alcohol content. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| BMI (mean ± SD) | Mean | Standard Deviation | kg/m^2 |
|
| OG002 | DRIVESAFE Evoc | DRIVESAFE Evoc branded smartphone-paired breathalyzer |
| OG003 | Intoxilyzer 240 (A) | Intoxilyzer 240 police grade breathalyzer |
| OG004 | BACtrack Vio | BACtrack Vio branded smartphone-paired breathalyzer |
| OG005 | Drinkmate | Drinkmate branded smartphone-paired breathlyzer |
| OG006 | Floome | Floome branded smartphone-paired breathalyzer |
| OG007 | Intoxilyzer 240 (B) | Intoxilyzer 240 police grade breathalyzer |
| OG008 | Percent of Alcohol in Blood | Percentage of Alcohol in Blood measured from blood draw |
|
|
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| Secondary | Differences in Readings on Devices for Percentage of Alcohol in Breath | Mean difference in percent of blood in breath (BrAC) between the police-grade and personal, commercial breath testing devices | Posted | Mean | 95% Confidence Interval | percentage of alcohol in breath | 8 Hours |
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| 0 |
| 20 |
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| 20 |
| 0 |
| 20 |
| EG001 | Commercial Smartphone-paired Breathalyzers-Set 2 | All subjects will first be given a priming dose of alcohol containing vodka designed to raise the blood alcohol content based on weight and gender. Blood alcohol content will first be measured with three commercial smartphone-paired breathalyzers: BACtrack Vio, Drinkmate, and Floome which will be tested in a randomized order and recorded. Participants blood alcohol content will also be measured using the Intoxilyzer 240, a police grade breathalyzer device After the tertiary dose of alcohol, a nurse will perform a blood draw on the participants, which will be used to determine blood alcohol content. BACtrack Vio: BACtrack Vio branded smartphone-paired breathalyzer Drinkmate: Drinkmate branded smartphone-paired breathalyzer Floome: Floome branded smartphone-paired breathalyzer Intoxilyzer 240: Intoxilyzer 240 police grade breathalyzer | 0 | 20 | 0 | 20 | 0 | 20 |
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| D064419 |
| Chemically-Induced Disorders |
| D001523 | Mental Disorders |