Overdose Prevention Centers and Behavioral Health

NCT06236087 | Not Yet Recruiting

• 2 other identifiers: 23-0159423-A0-00-1010153
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief 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, and; (Aim 3) Assess the barriers and facilitators of integrating mental health services into existing syringe service and OPC delivery models.

Conditions

Overdose

Outcome Measures

Primary Outcomes (3)

• Incidence of Fatal Overdose

  Incidence of fatal overdose will be derived from overdose mortality data from the NYC Office of the Chief Medical Examiner.

  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).

  Up to Month 12

• Incidence of Psychiatric Services Utilization

  Psychiatric services utilization will be assessed from SPARCS, RHIO, and NYS Medicaid.

  Up to Month 12

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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;
• 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.

You may not qualify if:

• Individuals not meeting the criteria detailed above for the respective Aims will not be eligible for participation in this study.

Sponsors & Collaborators

• NYU Langone Health: lead
• Centers for Disease Control and Prevention: collaborator

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Drug Overdose

Condition Hierarchy (Ancestors)

Prescription Drug Misuse; Drug Misuse; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Bennett Allen, PhD, MPA

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bennett Allen, PhD, MPA

CONTACT

646-501-3708; Bennett.Allen@nyulangone.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2024
• First Posted: February 1, 2024
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): September 30, 2027
• Last Updated: March 2, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
• Access Criteria: The investigator who proposed to use the data will be granted access upon reasonable request. Requests should be directed to bennett.allen@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.

Locations

US (1)