Opioid OverdoseNCT06466005
UnityPhilly Response App for Overdose Reversal
A study testing UnityPhilly app in people with Opioid Overdose, run by Drexel University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Opioid Overdose
- What is being tested?
- UnityPhilly app
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 450 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Sep 2025to Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- owning a smartphone with a data package;
- living or working in one of three identified Philadelphia neighborhoods;
- aged 18 or older.
Who cannot join
- persons aged under 18 years of age
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Kushal Naik, MPH contact
United States1 site, 1 recruiting
- Recruiting
Drexel University
Philadelphia, Pennsylvania, 19104
Stephen Lankenau, PhD, 323-326-6438, sel59@drexel.edu
Kushal Naik, MPH, kun24@drexel.edu
About this study
Official title: UnityPhilly Response App for Overdose Reversal: Assessing Citywide Effectiveness and Sustainability
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.
Read more
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.
Read the detailed description
This is a behavioral clinical trial, which is has been developed to evaluate and compare ways that people respond to a drug overdose using the UnityPhilly overdose response app. The UnityPhilly app, along with training participants how to use the app, the provision of naloxone, and overdose prevention training, is the intervention in this study. All individuals enrolled in this study are prospectively assigned to use the UnityPhilly app so that there is no control or placebo group - all receive the intervention. By enrolling five different types of individuals into the study, e.g., person who uses opioids, person in recovery, we will be evaluate the effectiveness of the UnityPhilly app in these different groups in responding to and reducing opioid overdose in Philadelphia. Aim 1 of the study will redevelop the UnityPhilly app previously tested in an earlier R34 study so that the app is easy to use among different groups of users in different overdose environments. Aim 2 of the study will enroll 450 study participants from 3 different neighborhoods in Philadelphia over a period of 9 months and who will be studied for an additional 12 month period to assess the effectiveness of the app. Participants will self-identify into the following 5 subgroups: (1) Active non-medical opioid user; (2) Active prescription medical opioid user; (3) Person in recovery from opioid misuse; (4) Caregiver/family member of (1), (2), or (3); or (5) Concerned community member. All 450 persons will be prospectively assigned to use of the UnityPhilly app into this longitudinal study. Effectiveness of the app, including such outcomes as overdoses signaled, willingness to respond to an app signal, and first to scene of an overdose, will be assessed among the five groups overtime using a mix of quantitative assessments (baseline, follow up, incident, log data) and qualitative interviews. Multivariate and qualitative analyses will assess a series of five hypotheses linked to key effectiveness outcomes. Aim 3 of the study will enroll an additional 3,000 resident volunteers to determine the sustainability of UnityPhilly using the Reach, Effectiveness, Adoption, Implementation and Maintenance (RE-AIM) Model. These 3,000 individuals, who will be exposed to the UnityPhilly app by the 450 study participants and/or other social media/community outreach during the study, will download/use the UnityPhilly app and will be assessed over a two-year period. Sustainability of the app, including reasons to join UnityPhilly, equity in diffusion of the app, network density of the app, will be assessed using a mix of quantitative assessments (baseline, log) and quantitative interviews from both the study participants (n=450) and resident volunteers (n=3,000). Multivariate and qualitative analyses (n=60) will assess a series of six research questions linked to key sustainability outcomes.
- Conditions
- Opioid Overdose
- Being tested
- UnityPhilly app
- Keywords
- overdose prevention, Philadelphia, UnityPhilly
- Medical subject headings
- Opiate Overdose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UnityPhilly appOther
UnityPhilly automatically connects bystanders and victims of opioid overdose with nearby community members who can respond immediately with naloxone.
| Study group | Role | What they receive |
|---|---|---|
| Active non-medical opioid user | Other | Person who has used an opioid, e.g., heroin, fentanyl, non-medically in the past 30 days. Receives: Other: UnityPhilly app |
| Active prescription medical opioid user | Other | Person who has used an opioid, e.g., hydrocodone, with a medical prescription in the past 30 days. Receives: Other: UnityPhilly app |
| Person in recovery from opioid misuse | Other | Person who formerly used opioids non-medically and/or is on opioid replacement therapy. Receives: Other: UnityPhilly app |
| Caregiver/family members of groups 1, 2, 3 | Other | Person who is caring for or a family member of active non-medical user, medical user, or person in recovery. Receives: Other: UnityPhilly app |
| Concerned community member | Other | Person in the community who is concerned about the opioid overdose crisis and is interested addressing the problem. Receives: Other: UnityPhilly app |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Overdoses Signaled
# events signaled by participants vs. # all overdose-related EMS calls, per year
Measured: 2 year period
Rate of Overdoses Reversed
# successful opioid reversals vs. # all arrivals, per year
Measured: 2 year period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2024
- Study start16 Sep 2025
- Primary completionDec 2027 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Opioid OverdoseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- 5 different subgroups recruited
- Masking
- None (open label)
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Drexel University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Michigan
- Responsible party
- Principal investigator, Stephen Lankenau, Drexel University
- Investigators
- Stephen Lankenau, PhD, Principal investigator, Drexel University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06466005
- Sponsor's protocol ID
- 2401010340
- Other IDs
- DA055851
- Status last verified
- May 2026
- First submitted
- 14 Jun 2024
- Last updated
- 20 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Even though the final datasets will be stripped of identifiers prior to release for sharing, we believe that there remains the possibility of deductive disclosure of subjects based on advanced location analytics. Thus, we will make the data and associated documentation available to users only under a data-sharing agreement that provides for: (1) a commitment to using the data only for research purposes and not to identify any individual participant; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying or returning the data after analyses are completed.
Publications
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.
PubMed 38015602Ataiants 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.
PubMed 33887699Marcu 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.
PubMed 33568966Schwartz 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.
PubMed 32954238Marcu 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.
PubMed 32607487
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- UnityPhilly Response App for Overdose Reversal: Assessing Citywide Effectiveness and Sustainability
- ClinicalTrials.gov ID
- NCT06466005
- Acronym / sponsor ID
- 2401010340
- Conditions
- Opioid Overdose
- Keywords
- overdose prevention, Philadelphia, UnityPhilly
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Drexel UniversityUniversity, hospital or other
- Collaborators
- University of Michigan
- Study start
- 16 Sep 2025 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 20 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a behavioral clinical trial, which is has been developed to evaluate and compare ways that people respond to a drug overdose using the UnityPhilly overdose response app. The UnityPhilly app, along with training participants how to use the app, the provision of naloxone, and overdose prevention training, is the intervention in this study. All individuals enrolled in this study are prospectively assigned to use the UnityPhilly app so that there is no control or placebo group - all receive the intervention. By enrolling five different types of individuals into the study, e.g., person who uses opioids, person in recovery, we will be evaluate the effectiveness of the UnityPhilly app in these different groups in responding to and reducing opioid overdose in Philadelphia. Aim 1 of the study will redevelop the UnityPhilly app previously tested in an earlier R34 study so that the app is easy to use among different groups of users in different overdose environments. Aim 2 of the study will enroll 450 study participants from 3 different neighborhoods in Philadelphia over a period of 9 months and who will be studied for an additional 12 month period to assess the effectiveness of the app. Participants will self-identify into the following 5 subgroups: (1) Active non-medical opioid user; (2) Active prescription medical opioid user; (3) Person in recovery from opioid misuse; (4) Caregiver/family member of (1), (2), or (3); or (5) Concerned community member. All 450 persons will be prospectively assigned to use of the UnityPhilly app into this longitudinal study. Effectiveness of the app, including such outcomes as overdoses signaled, willingness to respond to an app signal, and first to scene of an overdose, will be assessed among the five groups overtime using a mix of quantitative assessments (baseline, follow up, incident, log data) and qualitative interviews. Multivariate and qualitative analyses will assess a series of five hypotheses linked to key effectiveness outcomes. Aim 3 of the study will enroll an additional 3,000 resident volunteers to determine the sustainability of UnityPhilly using the Reach, Effectiveness, Adoption, Implementation and Maintenance (RE-AIM) Model. These 3,000 individuals, who will be exposed to the UnityPhilly app by the 450 study participants and/or other social media/community outreach during the study, will download/use the UnityPhilly app and will be assessed over a two-year period. Sustainability of the app, including reasons to join UnityPhilly, equity in diffusion of the app, network density of the app, will be assessed using a mix of quantitative assessments (baseline, log) and quantitative interviews from both the study participants (n=450) and resident volunteers (n=3,000). Multivariate and qualitative analyses (n=60) will assess a series of six research questions linked to key sustainability outcomes.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 5
- Model description
- 5 different subgroups recruited
| Arm | Type | Receives |
|---|---|---|
| Active non-medical opioid user | Other | Other: UnityPhilly appPerson who has used an opioid, e.g., heroin, fentanyl, non-medically in the past 30 days. |
| Active prescription medical opioid user | Other | Other: UnityPhilly appPerson who has used an opioid, e.g., hydrocodone, with a medical prescription in the past 30 days. |
| Person in recovery from opioid misuse | Other | Other: UnityPhilly appPerson who formerly used opioids non-medically and/or is on opioid replacement therapy. |
| Caregiver/family members of groups 1, 2, 3 | Other | Other: UnityPhilly appPerson who is caring for or a family member of active non-medical user, medical user, or person in recovery. |
| Concerned community member | Other | Other: UnityPhilly appPerson in the community who is concerned about the opioid overdose crisis and is interested addressing the problem. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- owning a smartphone with a data package;
- living or working in one of three identified Philadelphia neighborhoods;
- aged 18 or older.
Key exclusion criteria (1 listed)
- persons aged under 18 years of age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UnityPhilly appUnityPhilly automatically connects bystanders and victims of opioid overdose with nearby community members who can respond immediately with naloxone. | Other | Active non-medical opioid user, Active prescription medical opioid user, Caregiver/family members of groups 1, 2, 3, Concerned community member, Person in recovery from opioid misuse |
Primary outcome
Rate of Overdoses Signaled
Time frame: 2 year period
# events signaled by participants vs. # all overdose-related EMS calls, per year
Rate of Overdoses Reversed
Time frame: 2 year period
# successful opioid reversals vs. # all arrivals, per year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2026.
- Background: PubMed 38015602Khalemsky 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.
- Background: PubMed 33887699Ataiants 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.
- Background: PubMed 33568966Marcu 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.
- Background: PubMed 32954238Schwartz 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.
- Background: PubMed 32607487Marcu 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.
- UnityPhilly websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. Even though the final datasets will be stripped of identifiers prior to release for sharing, we believe that there remains the possibility of deductive disclosure of subjects based on advanced location analytics. Thus, we will make the data and associated documentation available to users only under a data-sharing agreement that provides for: (1) a commitment to using the data only for research purposes and not to identify any individual participant; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying or returning the data after analyses are completed.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kushal Naik, MPH contact
Stephen Lankenau, PhD principal investigator
Drexel University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing UnityPhilly app in people with Opioid Overdose, run by Drexel University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stephen Lankenau, PhD (323-326-6438, sel59@drexel.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Overdoses Signaled (time frame: 2 year period). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06466005, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2026; AzTrials last refreshed its copy on 27 Oct 2026.