Tailoring Overdose Education for Black Churches

NCT05645016 | Withdrawn

• 1 other identifier: 8208
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Church-based interventions are culturally acceptable, reduce access barriers, and can be brought to scale in under-resourced communities. For Overdose Education and Naloxone Distribution (OEND) to be efficacious in Black churches, tailoring may be needed. For this audience, standard OEND curricula may need to be adapted to their level of knowledge of substance use disorders (SUDs), and limited general mental health literacy, and specifically address stigma related to SUDs and medications for opioid use disorder (MOUD). Finally, a tailored implementation strategy may need to address contextual variations (e.g., denomination and membership size) across churches. The proposed pilot study aims to identify the socio-cultural modifications that will be needed to adapt our previously developed training (i.e., COEST) to target Black communities of faith. In a pilot randomized controlled trial (RTC) of adapted COEST in a stepped-wedge design.

Conditions

Opioid Overdose

Outcome Measures

Primary Outcomes (1)

• Change in Frequency of Naloxone Utilization/Overdose Intervention

  All study participants will receive an overdose response kit containing two doses of intranasal naloxone. Participants are asked to notify study staff immediately if they utilize naloxone in an attempt to reverse an opioid overdose.

  Baseline and 6 Months after COEST training

Secondary Outcomes (2)

• Opioid Overdose Knowledge Scale (OOKS)

  Baseline and 6 Months after COEST training

• Brief Opioid Stigma Scale (BOOS)

  Baseline and 6 Months after COEST training

Study Arms (1)

Adapted Comprehensive Overdose Education and Skills Training (COEST)

EXPERIMENTAL

Behavioral: COEST

Interventions

COEST BEHAVIORAL

Adapted version of our COEST training, targeting Black church members.

Adapted Comprehensive Overdose Education and Skills Training (COEST)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Identify as one of the following group members of the Black church: Clergy; Individual with OUD and/or stimulant use disorder; Family member or friend of an individual with OUD; Formerly incarcerated.
• Age 18 and older.

You may not qualify if:

• Unable to provide informed consent.
• Less than 18 years old.
• Does not identify as belonging to one of the four stakeholder groups.

Sponsors & Collaborators

• New York State Psychiatric Institute: lead

Study Sites (1)

New York State Psychiatric Institute

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Opiate Overdose

Condition Hierarchy (Ancestors)

Drug Overdose; Prescription Drug Misuse; Drug Misuse; Substance-Related Disorders; Chemically-Induced Disorders; Opioid-Related Disorders; Narcotic-Related Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Clinical Neurobiology

Model Details: The design is a two-arm cluster randomized trial with randomization at the level of the church (4 Churches), and analyses at the level of the individual participants (i.e., church members).

Study Record Dates

• First Submitted: November 30, 2022
• First Posted: December 9, 2022
• Study Start: April 1, 2023
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): March 30, 2027
• Last Updated: April 2, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)