ClinicalTrials.gg
WithdrawnNCT05645016Updated Apr 2, 2026

Tailoring Overdose Education for Black Churches

An interventional study of COEST in Opioid Overdose, sponsored by New York State Psychiatric Institute. Withdrawn at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-02.

Sponsored by New York State Psychiatric Institute · Not applicable, Interventional, and Health services research

Why this study was withdrawn
The U.S. Department of Health and Human Services Office of Human Research Protections issued an FWA restriction on NYSPI research that included a pause of human subjects research as of June 23, 2023.
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Opioid Overdose

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03

In context

Opiate Overdose

70 studies on the registry are indexed under Opiate Overdose; 11 are open to participants now.

Browse Opiate Overdose studies →

Lead sponsor

New York State Psychiatric Institute is the lead sponsor of 435 studies on the registry; 27 are open to participants now.

Of its 51 completed or terminated interventional studies of FDA-regulated products, 45 (88%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. 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.
  2. Age 18 and older.

Exclusion criteria

Exclusion Criteria:

  1. Unable to provide .
  2. Less than 18 years old.
  3. Does not identify as belonging to one of the four stakeholder groups.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    Adapted Comprehensive Overdose Education and Skills Training (COEST)

    Behavioral: COEST

Interventions

  • BehavioralCOEST

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

06

What researchers measure

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.

    Time frame: Baseline and 6 Months after COEST training

Secondary outcomes

  1. Opioid Overdose Knowledge Scale (OOKS)

    The OOKS measures knowledge about risk factors for having an opioid overdose, signs of an opioid overdose, actions to be taken in an overdose situation, naloxone effects and administration, adverse effects and aftercare procedures. The scale also identifies misinformation. The OOKS is a 14-item scale (Score Range: 0-45).

    Time frame: Baseline and 6 Months after COEST training

  2. Brief Opioid Stigma Scale (BOOS)

    The BOSS was developed to assess stereotype awareness ("aware"), stereotype agreement ("agree"), and self-esteem decrement ("harm") surrounding opioid dependence. The BOSS is a 12-item scale (Score Range: 12-60)

    Time frame: Baseline and 6 Months after COEST training

07

Study locations

1 site
  • New York State Psychiatric Institute
    New York, New York 10032, United States
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 2, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05645016
Responsible party
Sandra D. Comer (Professor of Clinical Neurobiology, New York State Psychiatric Institute) — Principal investigator
First posted
Dec 9, 2022
Start date
Apr 1, 2023
Primary completion
Dec 30, 2026 (estimated)
Completion
Mar 30, 2027 (estimated)
Last update
Apr 2, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

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