Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
20 participants
INTERVENTIONAL
2016-12-13
2017-04-17
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Evaluating Perceived Fitness to Drive While Intoxicated
NCT05028413
Smartphone-paired Breathalyzers and Loss- and Gain-framed Texts for Reducing Drinking and Driving
NCT03335735
Multi-Component Breath Alcohol Intervention Phase 3
NCT06994962
Multi-Component Breath Alcohol Intervention
NCT06124898
Smartphone Technology: Young Adult Drinking
NCT02963818
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
SINGLE_GROUP
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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
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
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Alcohoot
Alcohoot branded smartphone-paired breathalyzer
BACtrack Mobile Pro
BACtrack Mobile Pro branded smartphone-paired breathalyzer
DRIVESAFE Evoc
DRIVESAFE Evoc branded smartphone-paired breathalyzer
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
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Less than 4 drinking days and less than 12 drinks per week on average in the past 2 months
* Have previously consumed four (women) or five (men) or more standard drinks without problems
* A valid photo ID
* Willing to take public transportation home, via septa or an uber rideshare credit.
Exclusion Criteria
* Alcohol dependence with withdrawal per DSM-V criteria
* Non-English-speaking
* Individuals who have a medical condition or who are taking medication which limits or prevents the consumption of alcohol.
21 Years
39 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Pennsylvania
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
M. Kit Delgado, MD, MS
Role: PRINCIPAL_INVESTIGATOR
University of Pennsylvania
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Naimi TS, Brewer RD, Mokdad A, Denny C, Serdula MK, Marks JS. Binge drinking among US adults. JAMA. 2003 Jan 1;289(1):70-5. doi: 10.1001/jama.289.1.70.
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.
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.
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.
Roll JM, Petry NM, Stitzer ML, Brecht ML, Peirce JM, McCann MJ, Blaine J, MacDonald M, DiMaria J, Lucero L, Kellogg S. Contingency management for the treatment of methamphetamine use disorders. Am J Psychiatry. 2006 Nov;163(11):1993-9. doi: 10.1176/ajp.2006.163.11.1993.
Senecal N, Wang T, Thompson E, Kable JW. Normative arguments from experts and peers reduce delay discounting. Judgm Decis Mak. 2012 Sep 1;7(5):568-589.
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.
Van Dyke N, Fillmore MT. Acute effects of alcohol on inhibitory control and simulated driving in DUI offenders. J Safety Res. 2014 Jun;49:5-11. doi: 10.1016/j.jsr.2014.02.004. Epub 2014 Mar 22.
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.
White A, Hingson R. The burden of alcohol use: excessive alcohol consumption and related consequences among college students. Alcohol Res. 2013;35(2):201-18.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
825273
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.