Tailoring Overdose Education for Black Churches

Opioid Overdose Clinical Trial

Official title:

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT05645016
• Other study ID #: 8208
• Status: Suspended
• Phase: N/A
• Start date: April 1, 2023
• Est. completion date: September 30, 2025

Study information

• Verified date: August 2023
• Source: New York State Psychiatric Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 96
• Est. completion date: September 30, 2025
• Est. primary completion date: April 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Drug Overdose
• Opiate Overdose
• Opioid Overdose

Intervention

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

Locations

Country	Name	City	State
United States	New York State Psychiatric Institute	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
New York State Psychiatric Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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).	Baseline and 6 Months after COEST training
Secondary	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)	Baseline and 6 Months after COEST training