Brief Summary

The goal of this clinical trial is to discover if an overdose prevention app (UnityPhilly) can encourage citizen responders to respond and prevent opioid overdoses using the UnityPhilly app. The main hypotheses to answer are: Hypothesis 1: UnityPhilly signal rates relative to EMS calls will increase over time. The primary outcome will be assessed as the total number of overdoses signaled by participants relative to all overdose-related EMS calls, per year. Hypothesis 2: The number of cases where a nearby UnityPhilly participant successfully reverses an overdose with naloxone will increase over time. The primary outcome will be assessed as the number of successful reversals relative to the total number of responder arrivals, per year. Participants will be supplied with the UnityPhilly app, training on how to use the app and respond to an opioid overdose using naloxone, and respond to follow up surveys about their experiences.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

450

participants targeted

Target at P75+ for all trials

Timeline

25mo left

Started Sep 2025

Typical duration for all trials

Geographic Reach

1 country

1 active site

Status

recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2.8 years study duration

Study Progress27%

Sep 2025Jul 2028

First Submitted

Initial submission to the registry

June 14, 2024

Completed

6 days until next milestone

First Posted

Study publicly available on registry

June 20, 2024

Completed

1.2 years until next milestone

Study Start

First participant enrolled

September 16, 2025

Completed

2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected

7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2028

Last Updated

May 12, 2026

Status Verified

May 1, 2026

Enrollment Period

2.2 years

First QC Date

June 14, 2024

Last Update Submit

May 7, 2026

Conditions

Opioid Overdose

Keywords

overdose preventionPhiladelphiaUnityPhilly

Outcome Measures

Primary Outcomes (2)

Rate of Overdoses Signaled
\# events signaled by participants vs. # all overdose-related EMS calls, per year
2 year period
Rate of Overdoses Reversed
\# successful opioid reversals vs. # all arrivals, per year
2 year period

Study Arms (5)

Active non-medical opioid user

Person who has used an opioid, e.g., heroin, fentanyl, non-medically in the past 30 days.

Other: UnityPhilly app

Active prescription medical opioid user

Person who has used an opioid, e.g., hydrocodone, with a medical prescription in the past 30 days.

Other: UnityPhilly app

Person in recovery from opioid misuse

Person who formerly used opioids non-medically and/or is on opioid replacement therapy.

Other: UnityPhilly app

Caregiver/family members of groups 1, 2, 3

Person who is caring for or a family member of active non-medical user, medical user, or person in recovery.

Other: UnityPhilly app

Concerned community member

Person in the community who is concerned about the opioid overdose crisis and is interested addressing the problem.

Other: UnityPhilly app

Interventions

UnityPhilly appOTHER

UnityPhilly automatically connects bystanders and victims of opioid overdose with nearby community members who can respond immediately with naloxone.

Active non-medical opioid userActive prescription medical opioid userCaregiver/family members of groups 1, 2, 3Concerned community memberPerson in recovery from opioid misuse

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

Key study enrollment criteria will include: owning a smartphone with a data package; living or working in one of three identified Philadelphia neighborhoods, i.e., Kensington, South Philadelphia, West Philadelphia; aged 18 or older. Furthermore, participants will be placed into one of the five subgroups based upon 30-day self-report of non-medical opioid use, medical opioid use, abstinence or recovery from any opioid use, family member or community self-affiliation (see subgroups 1-5 above). The study will enroll 450 participants and all will be assigned the intervention, i.e., UnityPhilly app.

You may qualify if:

owning a smartphone with a data package;
living or working in one of three identified Philadelphia neighborhoods;
aged 18 or older.

You may not qualify if:

persons aged under 18 years of age

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Drexel Universitylead
University of Michigancollaborator

Study Sites (1)

Drexel University

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Related Publications (5)

Khalemsky M, Khalemsky A, Lankenau S, Ataiants J, Roth A, Marcu G, Schwartz DG. Predictive Dispatch of Volunteer First Responders: Algorithm Development and Validation. JMIR Mhealth Uhealth. 2023 Nov 28;11:e41551. doi: 10.2196/41551.
PMID: 38015602BACKGROUND
Ataiants J, Reed MK, Schwartz DG, Roth A, Marcu G, Lankenau SE. Decision-making by laypersons equipped with an emergency response smartphone app for opioid overdose. Int J Drug Policy. 2021 Sep;95:103250. doi: 10.1016/j.drugpo.2021.103250. Epub 2021 Apr 20.
PMID: 33887699BACKGROUND
Marcu G, Schwartz DG, Ataiants J, Roth A, Yahav I, Cocchiaro B, Khalemsky M, Lankenau S. Empowering communities with a smartphone-based response network for opioid overdoses. IEEE Pervasive Comput. 2020 Oct-Dec;19(4):42-47. doi: 10.1109/mprv.2020.3019947. Epub 2020 Nov 17.
PMID: 33568966BACKGROUND
Schwartz DG, Ataiants J, Roth A, Marcu G, Yahav I, Cocchiaro B, Khalemsky M, Lankenau S. Layperson reversal of opioid overdose supported by smartphone alert: A prospective observational cohort study. EClinicalMedicine. 2020 Aug 3;25:100474. doi: 10.1016/j.eclinm.2020.100474. eCollection 2020 Aug.
PMID: 32954238BACKGROUND
Marcu G, Aizen R, Roth AM, Lankenau S, Schwartz DG. Acceptability of smartphone applications for facilitating layperson naloxone administration during opioid overdoses. JAMIA Open. 2019 Dec 4;3(1):44-52. doi: 10.1093/jamiaopen/ooz068. eCollection 2020 Apr.
PMID: 32607487BACKGROUND

MeSH Terms

Conditions

Opiate Overdose

Condition Hierarchy (Ancestors)

Drug OverdosePrescription Drug MisuseDrug MisuseSubstance-Related DisordersChemically-Induced DisordersOpioid-Related DisordersNarcotic-Related DisordersMental Disorders

Study Officials

Stephen Lankenau, PhD
Drexel University
PRINCIPAL INVESTIGATOR

Central Study Contacts

Stephen Lankenau, PhD

CONTACT

323-326-6438 sel59@drexel.edu

Kushal Naik, MPH

CONTACT

kun24@drexel.edu

Study Design

Study Type: observational
Observational Model: ECOLOGIC OR COMMUNITY
Time Perspective: PROSPECTIVE
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Professor

Study Record Dates

First Submitted

June 14, 2024

First Posted

June 20, 2024

Study Start

September 16, 2025

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

July 1, 2028

Last Updated

May 12, 2026

Record last verified: 2026-05

Locations

US(1)

UnityPhilly Response App for Overdose Reversal

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Study Arms (5)

Active non-medical opioid user

Active prescription medical opioid user

Person in recovery from opioid misuse

Caregiver/family members of groups 1, 2, 3

Concerned community member

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (5)

Related Links

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

Locations

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Study Arms (5)

Active non-medical opioid user

Active prescription medical opioid user

Person in recovery from opioid misuse

Caregiver/family members of groups 1, 2, 3

Concerned community member

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (5)

Related Links

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

Locations