Overdose Prevention Centers and Behavioral Health

NYU Langone Health

Status: Not yet enrolling

Conditions: Overdose

Study type: Observational

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT06236087

23-A0-00-1010153 (Other Grant/Funding Number)

23-01594

Details and patient eligibility

About

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.

Full 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.

Enrollment: 500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

500 participants in 2 patient groups

Aim 1 & 2 - Dataset

Description:

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

Description:

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.