Clinical trial NCT06236087: Overdose Prevention Centers and Behavioral Health
Official title: Assessing the Impact of Overdose Prevention Centers as a Polysubstance Use and Behavioral Health Intervention in New York City
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Overdose
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: Centers for Disease Control and Prevention
First posted: 2024-02-01
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

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.

Primary outcomes:
measure: Incidence of Fatal Overdose
timeFrame: Up to Month 12
measure: Incidence of Non-Fatal Overdose
timeFrame: Up to Month 12
measure: Incidence of Psychiatric Services Utilization
timeFrame: Up to Month 12
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Health
name: Bennett Allen, PhD, MPA
role: PRINCIPAL_INVESTIGATOR
References: