NYC study to see if harm reduction cuts overdose deaths in shelters

NCT ID NCT07170072

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Aug 26, 2026 · Updated 3 times

Summary

This study will use data from NYC homeless shelters, Medicaid, and vital records to see if harm reduction programs reduce fatal and non-fatal overdoses. Researchers will also look at whether these programs help people start treatment for substance use disorder and use health services more. No participants will be directly enrolled; the study relies on existing records from 2021 to 2026.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could provide evidence to improve harm reduction strategies and reduce overdose deaths in homeless populations.
What could go wrong
This is an observational study, not a treatment trial, so it won't directly test a new drug or therapy. Results may not apply to other cities or groups.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 80 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2025

Expected to finish

Mar 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Aims 1a, 1b, and 2: Analysis of administrative data will include the population of individuals in the NYC single-adult homeless services system during 2021-2026. Aim 3: Qualitative interview and focus group participants will include homeless clients who have received one or more of the HRSP interventions and homeless services providers and administrators who have delivered the HRSP interventions.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: For Aims 1a, 1b, and 2: There will be no participant enrollment or direct contact with individuals as these aims will involve the use of an analytic dataset comprised of linked administrative NYC homeless services, Medicaid, and vital records. The dataset will include records for individuals who entered the NYC DHS single-adult shelter system during calendar years 2021-2026, as well as a matched comparison group(s) (as identified through Medicaid data) during the same years. The matched comparison group will be comprised of individuals age 18 and older with active Medicaid coverage at the time of observation. For Aim 3 Homeless Services Client participant group: To be eligible for participation in this study, an individual must meet all of the following criteria: * Adult 18 year of age or older * Speak English * Is staying or has stayed in an NYC single-adult shelter that has implemented HRSP interventions * Report past-year drug use * Able and willing to provide consent For Aim 3 Homeless Services Staff participant group: To be eligible for participation in this study, an individual must meet all of the following criteria: * 18 years of age or older * Speak English * Works at an adult shelter service provider agency that implemented HRSP or received HRSP interventions (role may include case manager, security staff, shelter director, medical staff, organizational leadership) * Able and willing to provide consent For Aim 3 Homeless Services Stakeholder participant group: To be eligible for participation in this study, an individual must meet all of the following criteria: * 18 years of age or older * Speak English * Works in a role in which they have key insight to the HRSP interventions, including planning and implementation (role may include homeless services administrator or other key stakeholder) * Able and willing to provide consent Exclusion Criteria: Aims 1a, 1b, and 2: Children under age 18 years of age will be excluded. Aim 3: Under age 18 years old, currently a prisoner (we are not sampling from locations where we expect to encounter prisoners), unable to communicate in English (because the interview and focus group guides will not be validated for use in other languages), and unable to provide informed consent. For Aim 3 Homeless Services Client participant group: those who are not staying or have not stayed at a shelter with HRSP interventions and those who do not report past-year drug use will not be excluded. For Aim 3 Homeless Services Staff participant group: those who have not been employed in a shelter with the HRSP interventions will be excluded. In alignment with standard techniques of purposeful sampling and the study goal of ensuring a range of experiences is captured in the qualitative interviews, additional targeting or exclusion criteria might be set by investigators as needed to ensure that a diverse range of experiences is included among qualitative interview participants.

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Conditions

The condition(s) this trial relates to.

Drug Overdose Harm Reduction poisoning

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • NYU Langone Health

    RECRUITING

    New York, New York, 10016, United States

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