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Clinical Trials/NCT06236087
NCT06236087
Not yet recruiting
Not Applicable

Assessing the Impact of Overdose Prevention Centers as a Polysubstance Use and Behavioral Health Intervention in New York City

NYU Langone Health1 site in 1 country500 target enrollmentSeptember 1, 2025
ConditionsOverdose

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Overdose
Sponsor
NYU Langone Health
Enrollment
500
Locations
1
Primary Endpoint
Incidence of Psychiatric Services Utilization
Status
Not yet recruiting
Last Updated
last year

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
September 1, 2025
End Date
September 30, 2027
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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.
  • are 18 years of age or older;
  • are employed by a harm reduction program;

Exclusion Criteria

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

Outcomes

Primary Outcomes

Incidence of Psychiatric Services Utilization

Time Frame: Up to Month 12

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

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).

Study Sites (1)

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