OverdosePOP+NCT07214519
Permanent Supportive Housing Overdose Prevention+ Study
A study testing TA Intervention in people with Overdose and Substance Use, run by NYU Langone Health at 1 site in United States.
Trial summary
This community-partnered study examines a technical assistance intervention designed to help permanent supportive housing agencies implement evidence-based practices to prevent tenant overdose and improve tenant health. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Overdose, Substance Use
- What is being tested?
- TA Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,940 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2027to 31 Mar 2031
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Supportive Housing Agencies/Individuals who Work at Supportive Housing Agencies:
- Serve at least 40 tenants in New York and/or New Jersey
- Have a significant concern for overdose (as demonstrated by past year tenant overdose)
- Be willing to complete all activities required for participation in the trial
- Tenants who Live in Supportive Housing Agencies:
- Must live in an enrolled Supportive Housing Agency
- Must be 18 years and older
Who cannot join
- See inclusion criteria.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Preventing Overdose in Supportive Housing: Stepped Wedge Randomized Controlled Trial of a Multi-Sector, Upstream Intervention
This community-partnered study examines a technical assistance intervention designed to help permanent supportive housing agencies implement evidence-based practices to prevent tenant overdose and improve tenant health.
Read the detailed description
Homelessness and housing instability are strongly linked with overdose risk. Permanent supportive housing (PSH) -subsidized housing paired with supportive services-is a key strategy to end homelessness yet supportive housing tenants face high overdose risk due to a confluence of factors. This multi-sector, community-partnered, stepped wedge randomized controlled trial evaluates the impact of a technical assistance intervention designed to support supportive housing agencies in sustainably implementing evidence-based practices to reduce tenant overdose and improve tenant health more broadly. The technical assistance intervention will be delivered to supportive housing agencies in New Jersey and New York who are enrolled in the trial. Outcomes include PSH agency implementation of overdose prevention practices and downstream tenant overdose, substance use, and other health-related outcomes. Outcomes will be assessed using surveys, administrative data, and agency records. This trial is a part of the HEAL Initiative (https://heal.nih.gov/).
- Conditions
- Overdose, Substance Use
- Being tested
- TA Intervention
- Medical subject headings
- Drug Overdose, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TA InterventionBehavioural
Technical assistance (TA) intervention designed to support PSH agencies in sustainably implementing evidence-based practices to reduce tenant overdose and improve tenant health more broadly.
| Study group | Role | What they receive |
|---|---|---|
| Wave 1: Control, Intervention, Sustainment | Experimental | Participants at agencies assigned to wave 1 will receive the control condition from months 1-6; intervention for months 6-12; and sustainment from months 12-45. Receives: Behavioral: TA Intervention |
| Wave 2: Control, Intervention, Sustainment | Experimental | Participants at agencies assigned to wave 2 will receive the control condition from months 1-13; intervention for months 13-19; and sustainment from months 19-45. Receives: Behavioral: TA Intervention |
| Wave 3: Control, Intervention, Sustainment | Experimental | Participants at agencies assigned to wave 3 will receive the control condition from months 1-20; intervention for months 20-26; and sustainment from months 26-45. Receives: Behavioral: TA Intervention |
| Wave 4: Control, Intervention, Sustainment | Experimental | Participants at agencies assigned to wave 4 will receive the control condition from months 1-27; intervention for months 27-33; and sustainment from months 33-45. Receives: Behavioral: TA Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite Score of Agency-Level Fidelity to Overdose Prevention Evidence-Based Practices
Fidelity will be measured as the extent to which an intervention is implemented as intended by researchers; the specific method of measurement will be determined during the trial's preparatory phase, in consultation with multiple stakeholders. The measurement will comprise a composite score of multiple measures.
Measured: Baseline, Month 12 (End of Wave 1), Month 19 (End of Wave 2), Month 26 (End of Wave 3), Month 33 (End of Wave 4)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2025
- Study start1 Jul 2027 (estimated)
- Primary completion30 Sep 2030 (estimated)
- Study completion31 Mar 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OverdoseStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 2,940 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Kelly Doran, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07214519
- Sponsor's protocol ID
- (Pending) POP+
- Other IDs
- UG3DA063084
- Acronym
- POP+
- Status last verified
- May 2026
- First submitted
- 24 Sep 2025
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data that will be shared / made available to the research community resulting from this project includes: analytic summary matrices for focus groups; analytic summary matrices for one-on-one qualitative interviews; deidentified survey data; summary data for analyses using administrative datasets and accompanying code; and all metadata and other documentation. Study data will be available no later than the time of an associated publication or within 3 months following the end of the study, whichever is first. Deidentified data will be made available after completion of a data use agreement (DUA). Data sharing requests will be reviewed by the study PI and study team. The protocol and statistical analysis plan will be posted on Clinicaltrials.gov only as required by federal regulation or supporting awards and agreements.
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventing Overdose in Supportive Housing: Stepped Wedge Randomized Controlled Trial of a Multi-Sector, Upstream Intervention
- ClinicalTrials.gov ID
- NCT07214519
- Acronym / sponsor ID
- POP+ / (Pending) POP+
- Conditions
- Overdose, Substance Use
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 2,940 participants (estimated)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 1 Jul 2027 (estimated)
- Primary completion
- 30 Sep 2030 (estimated)
- Study completion
- 31 Mar 2031 (estimated)
- First posted
- 9 Oct 2025 (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.
This community-partnered study examines a technical assistance intervention designed to help permanent supportive housing agencies implement evidence-based practices to prevent tenant overdose and improve tenant health.
Detailed description
Homelessness and housing instability are strongly linked with overdose risk. Permanent supportive housing (PSH) -subsidized housing paired with supportive services-is a key strategy to end homelessness yet supportive housing tenants face high overdose risk due to a confluence of factors. This multi-sector, community-partnered, stepped wedge randomized controlled trial evaluates the impact of a technical assistance intervention designed to support supportive housing agencies in sustainably implementing evidence-based practices to reduce tenant overdose and improve tenant health more broadly. The technical assistance intervention will be delivered to supportive housing agencies in New Jersey and New York who are enrolled in the trial. Outcomes include PSH agency implementation of overdose prevention practices and downstream tenant overdose, substance use, and other health-related outcomes. Outcomes will be assessed using surveys, administrative data, and agency records. This trial is a part of the HEAL Initiative (https://heal.nih.gov/).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Wave 1: Control, Intervention, Sustainment | Experimental | Behavioral: TA InterventionParticipants at agencies assigned to wave 1 will receive the control condition from months 1-6; intervention for months 6-12; and sustainment from months 12-45. |
| Wave 2: Control, Intervention, Sustainment | Experimental | Behavioral: TA InterventionParticipants at agencies assigned to wave 2 will receive the control condition from months 1-13; intervention for months 13-19; and sustainment from months 19-45. |
| Wave 3: Control, Intervention, Sustainment | Experimental | Behavioral: TA InterventionParticipants at agencies assigned to wave 3 will receive the control condition from months 1-20; intervention for months 20-26; and sustainment from months 26-45. |
| Wave 4: Control, Intervention, Sustainment | Experimental | Behavioral: TA InterventionParticipants at agencies assigned to wave 4 will receive the control condition from months 1-27; intervention for months 27-33; and sustainment from months 33-45. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Serve at least 40 tenants in New York and/or New Jersey
- Have a significant concern for overdose (as demonstrated by past year tenant overdose)
- Be willing to complete all activities required for participation in the trial
- Must live in an enrolled Supportive Housing Agency
- Must be 18 years and older
Key exclusion criteria (1 listed)
- See inclusion criteria.
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 |
|---|---|---|
| TA InterventionTechnical assistance (TA) intervention designed to support PSH agencies in sustainably implementing evidence-based practices to reduce tenant overdose and improve tenant health more broadly. | Behavioural | Wave 1: Control, Intervention, Sustainment, Wave 2: Control, Intervention, Sustainment, Wave 3: Control, Intervention, Sustainment, Wave 4: Control, Intervention, Sustainment |
Primary outcome
Composite Score of Agency-Level Fidelity to Overdose Prevention Evidence-Based Practices
Time frame: Baseline, Month 12 (End of Wave 1), Month 19 (End of Wave 2), Month 26 (End of Wave 3), Month 33 (End of Wave 4)
Fidelity will be measured as the extent to which an intervention is implemented as intended by researchers; the specific method of measurement will be determined during the trial's preparatory phase, in consultation with multiple stakeholders. The measurement will comprise a composite score of multiple measures.
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 6 May 2026.
- Individual participant dataSharing planned: Yes. The data that will be shared / made available to the research community resulting from this project includes: analytic summary matrices for focus groups; analytic summary matrices for one-on-one qualitative interviews; deidentified survey data; summary data for analyses using administrative datasets and accompanying code; and all metadata and other documentation. Study data will be available no later than the time of an associated publication or within 3 months following the end of the study, whichever is first. Deidentified data will be made available after completion of a data use agreement (DUA). Data sharing requests will be reviewed by the study PI and study team. The protocol and statistical analysis plan will be posted on Clinicaltrials.gov only as required by federal regulation or supporting awards and agreements.
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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.
Kelly Doran, MD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TA Intervention in people with Overdose and Substance Use, run by NYU Langone Health 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 7 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: opening soon, as of the sponsor's last update on 6 May 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 Kelly Doran, MD (212-263-5850, Kelly.Doran@nyulangone.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite Score of Agency-Level Fidelity to Overdose Prevention Evidence-Based Practices (time frame: Baseline, Month 12 (End of Wave 1), Month 19 (End of Wave 2), Month 26 (End of Wave 3), Month 33 (End of Wave 4)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 May 2026.