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Tailoring Overdose Education for Black Churches

Church-Tailored Opioid Overdose Education and Naloxone Distribution to Target Overdose and Stigma Among African-American Communities

Status
Withdrawn
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05645016
Enrollment
0
Registered
2022-12-09
Start date
2023-04-01
Completion date
2027-03-30
Last updated
2026-04-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Opioid Overdose

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.

Interventions

BEHAVIORALCOEST

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

Sponsors

New York State Psychiatric Institute
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Intervention model description

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).

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

1. Unable to provide informed consent. 2. Less than 18 years old. 3. Does not identify as belonging to one of the four stakeholder groups.

Design outcomes

Primary

MeasureTime frameDescription
Change in Frequency of Naloxone Utilization/Overdose InterventionBaseline and 6 Months after COEST trainingAll 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.

Secondary

MeasureTime frameDescription
Opioid Overdose Knowledge Scale (OOKS)Baseline and 6 Months after COEST trainingThe 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).
Brief Opioid Stigma Scale (BOOS)Baseline and 6 Months after COEST trainingThe 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)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 3, 2026