OverdoseNCT06236087
Overdose Prevention Centers and Behavioral Health
An observational study of Overdose, run by NYU Langone Health at 1 site in United States.
Trial summary
The aims of this study are: (Aim 1) Identify sources of heterogeneous impacts of opioid prevention center (OPC) use on non-fatal and fatal overdose risk among individuals with histories of polysubstance use (PSU); (Aim 2) Estimate the impact of OPC use on treated psychiatric events among clients with histories of PSU… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Overdose
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2026to 30 Sep 2027
- Phase
- Observational
- 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
- Adult, Older adult
Study population: Aims 1 and 2 of this study will use secondary analysis of an existing de-identified, linked data set curated as part of an ongoing evaluation of the NYC overdose prevention centers. This dataset will include a total of 500 participants linked to NYC administrative health records. This de-identified data source will be accessed through the NYULH Center for Opioid Epidemiology and Policy (COEP). Should it be deemed necessary, a data use agreement will be established between the PI and NYULH/COEP to facilitate access to these de-identified data. Aim 3 of this study will recruit 30 individuals over age 18 who are currently employed by harm reduction programs for a one-time, qualitative interview.
Who may be able to join
- Aims 1 and 2:
- are 18 years of age or older;
- engaged in syringe service program and/or overdose prevention center services in New York City in the past 30 days before the date of enrollment;
- are able to complete assessments in English or Spanish;
- are competent to give written informed consent at the time of the interview;
- are able to provide informed consent;
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- self-report use of illicit opioids (e.g., heroin, fentanyl), illicit stimulants (e.g., powder cocaine, crack, methamphetamine), counterfeit prescription pills (defined as prescription pills obtained through the illicit drug market) or any injection drug use in the past 30 days, and
- are able to participate for at least 6 months following enrollment.
- Aim 3
- are 18 years of age or older;
- are employed by a harm reduction program;
- are able to complete assessments in English; and
- are able to provide informed consent.
Who cannot join
- Individuals not meeting the criteria detailed above for the respective Aims will not be eligible for participation in this study.
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: Assessing the Impact of Overdose Prevention Centers as a Polysubstance Use and Behavioral Health Intervention in New York City
The aims of this study are: (Aim 1) Identify sources of heterogeneous impacts of opioid prevention center (OPC) use on non-fatal and fatal overdose risk among individuals with histories of polysubstance use (PSU); (Aim 2) Estimate the impact of OPC use on treated psychiatric events among clients with histories of PSU, and; (Aim 3) Assess the barriers and facilitators of integrating mental health services into existing syringe service and OPC delivery models.
Read the detailed description
Aims 1 and 2 of this study will use secondary data to identify sources of heterogeneous impacts of OPC use on fatal and nonfatal overdose risk (Aim 1) and estimate the impact of OPC use on treated psychiatric events among clients with histories of PSU (Aim 2). Aim 3 of this study will use qualitative interviews with harm reduction staff to assess barriers and facilitators of integrating mental health services into existing syringe service and OPC delivery models.
- Conditions
- Overdose
- Medical subject headings
- Drug Overdose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Aim 1 & 2 - Dataset | For Aims 1 and 2, an existing, de-identified dataset will be used for secondary analysis, including records for a maximum of 500 individuals. Aim 1 will use machine learning to identify sub-groups for whom OPC use is most and least protective of overdose risk. Identifying key intersectional groups across demographic (e.g., race/ethnicity, gender, and age), PSU factors (e.g., drug types and routes of administration), and socio-behavioral (e.g., mental health history, justice history, and homelessness) characteristics will inform targeted service delivery. Aim 2 will use epidemiological methods to estimate the association of OPC use with mental health services salient to PSU populations (e.g., hospitalization for depression, anxiety, and bipolar disorder). Measuring the association of OPC use with treated mental health outcomes for PSU-involved populations will foster an understanding of the impacts of OPCs on critical but unevaluated outcomes. | |
| Aim 3 - Harm Reduction Staff | For Aim 3, individuals employed at harm reduction programs in NYC will be enrolled for a one-time qualitative interview. Qualitative interviews will explore organizational (i.e., readiness, culture, and priorities), individual (i.e., attitudes and norms), and intervention (i.e., complexity and advantage) characteristics related to the integration of mental health and harm reduction services. Findings will inform efforts to scale ancillary mental health services high-risk PSU population. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Fatal Overdose
Incidence of fatal overdose will be derived from overdose mortality data from the NYC Office of the Chief Medical Examiner.
Measured: Up to Month 12
Incidence of Non-Fatal Overdose
Incidence of nonfatal overdose will be assessed using hospitalization and emergency department data from the NYC Regional Health Information Exchange (RHIO) and Statewide Research and Planning Cooperative System (SPARCS).
Measured: Up to Month 12
Incidence of Psychiatric Services Utilization
Psychiatric services utilization will be assessed from SPARCS, RHIO, and NYS Medicaid.
Measured: Up to Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2024
- Study start1 Sep 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion30 Sep 2027 (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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Responsible party
- Sponsor
- Investigators
- Bennett Allen, PhD, MPA, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06236087
- Sponsor's protocol ID
- 23-01594
- Other IDs
- 23-A0-00-1010153
- Status last verified
- Feb 2026
- First submitted
- 24 Jan 2024
- Last updated
- 2 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: Bennett.Allen@nyulangone.org. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Impact of Overdose Prevention Centers as a Polysubstance Use and Behavioral Health Intervention in New York City
- ClinicalTrials.gov ID
- NCT06236087
- Acronym / sponsor ID
- 23-01594
- Conditions
- Overdose
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 1 Feb 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 aims of this study are: (Aim 1) Identify sources of heterogeneous impacts of opioid prevention center (OPC) use on non-fatal and fatal overdose risk among individuals with histories of polysubstance use (PSU); (Aim 2) Estimate the impact of OPC use on treated psychiatric events among clients with histories of PSU, and; (Aim 3) Assess the barriers and facilitators of integrating mental health services into existing syringe service and OPC delivery models.
Detailed description
Aims 1 and 2 of this study will use secondary data to identify sources of heterogeneous impacts of OPC use on fatal and nonfatal overdose risk (Aim 1) and estimate the impact of OPC use on treated psychiatric events among clients with histories of PSU (Aim 2). Aim 3 of this study will use qualitative interviews with harm reduction staff to assess barriers and facilitators of integrating mental health services into existing syringe service and OPC delivery models.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aim 1 & 2 - Dataset | – | –For Aims 1 and 2, an existing, de-identified dataset will be used for secondary analysis, including records for a maximum of 500 individuals. Aim 1 will use machine learning to identify sub-groups for whom OPC use is most and least protective of overdose risk. Identifying key intersectional groups across demographic (e.g., race/ethnicity, gender, and age), PSU factors (e.g., drug types and routes of administration), and socio-behavioral (e.g., mental health history, justice history, and homelessness) characteristics will inform targeted service delivery. Aim 2 will use epidemiological methods to estimate the association of OPC use with mental health services salient to PSU populations (e.g., hospitalization for depression, anxiety, and bipolar disorder). Measuring the association of OPC use with treated mental health outcomes for PSU-involved populations will foster an understanding of the impacts of OPCs on critical but unevaluated outcomes. |
| Aim 3 - Harm Reduction Staff | – | –For Aim 3, individuals employed at harm reduction programs in NYC will be enrolled for a one-time qualitative interview. Qualitative interviews will explore organizational (i.e., readiness, culture, and priorities), individual (i.e., attitudes and norms), and intervention (i.e., complexity and advantage) characteristics related to the integration of mental health and harm reduction services. Findings will inform efforts to scale ancillary mental health services high-risk PSU population. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Aims 1 and 2 of this study will use secondary analysis of an existing de-identified, linked data set curated as part of an ongoing evaluation of the NYC overdose prevention centers. This dataset will include a total of 500 participants linked to NYC administrative health records. This de-identified data source will be accessed through the NYULH Center for Opioid Epidemiology and Policy (COEP). Should it be deemed necessary, a data use agreement will be established between the PI and NYULH/COEP to facilitate access to these de-identified data. Aim 3 of this study will recruit 30 individuals over age 18 who are currently employed by harm reduction programs for a one-time, qualitative interview.
Key inclusion criteria (13 listed)
- are 18 years of age or older;
- engaged in syringe service program and/or overdose prevention center services in New York City in the past 30 days before the date of enrollment;
- are able to complete assessments in English or Spanish;
- are competent to give written informed consent at the time of the interview;
- are able to provide informed consent;
Key exclusion criteria (1 listed)
- Individuals not meeting the criteria detailed above for the respective Aims will not be eligible for participation in this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of Fatal Overdose
Time frame: Up to Month 12
Incidence of fatal overdose will be derived from overdose mortality data from the NYC Office of the Chief Medical Examiner.
Incidence of Non-Fatal Overdose
Time frame: Up to Month 12
Incidence of nonfatal overdose will be assessed using hospitalization and emergency department data from the NYC Regional Health Information Exchange (RHIO) and Statewide Research and Planning Cooperative System (SPARCS).
Incidence of Psychiatric Services Utilization
Time frame: Up to Month 12
Psychiatric services utilization will be assessed from SPARCS, RHIO, and NYS Medicaid.
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 2 Mar 2026.
- Individual participant dataSharing planned: Yes. The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: Bennett.Allen@nyulangone.org. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
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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.
Bennett Allen, PhD, MPA 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?
An observational study of Overdose, 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 13 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 2 Mar 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 Bennett Allen, PhD, MPA (646-501-3708, Bennett.Allen@nyulangone.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Fatal Overdose (time frame: Up to Month 12). The study lists 3 primary outcomes in all. 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 2 Mar 2026.