Overdose Prevention Centers and Behavioral Health

Overdose Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06236087
• Other study ID #: 23-01594
• Secondary ID: 23-A0-00-1010153
• Status: Not yet recruiting
• Start date: March 15, 2024
• Est. completion date: September 30, 2026

Study information

• Verified date: January 2024
• Source: NYU Langone Health
• Contact: Bennett Allen, PhD, MPA
• Phone: 646-501-3708
• Email: Bennett.Allen[@]nyulangone.org
• Is FDA regulated: No
• Study type: Observational

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 500
• Est. completion date: September 30, 2026
• Est. primary completion date: December 31, 2024
• Gender: All
• Age group: 18 Years and older

Eligibility

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. 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.

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Drug Overdose
• Overdose

Locations

Country	Name	City	State
United States	NYU Langone Health	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
NYU Langone Health	Centers for Disease Control and Prevention

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Incidence of Psychiatric Services Utilization	Psychiatric services utilization will be assessed from SPARCS, RHIO, and NYS Medicaid.	Up to Month 12