Pharmacist-Led Interventions to Increase Access to Medications for Opioid Use Disorders (PLI-MOUD)

Not Applicable

Active, not recruiting

• Conditions: Overdose; Opioid Use Disorder
• Interventions: Behavioral: Pharmacist Narcan Training; Behavioral: Substance Use Counselor Narcan Training; Behavioral: BIRT; Behavioral: SMC

• Registration Number: NCT05776823
• Lead Sponsor: University of Arkansas

Brief Summary

The purpose of this study is to investigate the impact of a pharmacist-led intervention to expand access to medications for opioid use disorder (MOUD) on racial/ethnic differences in opioid-related overdose among individuals diagnosed with opioid use disorder (OUD) currently incarcerated in a carceral setting. In this study, participants will be screened for opioid use, trained to administer Narcan nasal spray, receive motivational counseling and referral to treatment post-release from a carceral setting (a Re-Entry program) into the community.

Detailed Description

The main objectives of this study are:

1. To increase understanding of racial/ethnic differences in the prevalence of OUD.

2. To test if a pharmacist-led intervention is more effective than a substance use counselor (lay person) in increasing knowledge and confidence among different racial/ethnic groups related to administering Narcan nasal spray in an opioid overdose situation.

3. To test if a pharmacist-delivered an evidence-based intervention, q brief intervention and referral to treatment (BIRT) versus standard medication counseling (SMC) is more effective in increasing access to MOUD.

Study Timeline

• Study First Submitted: 2023-03-01
• Study First Submitted QC: 2023-03-17
• Study First Posted: 2023-03-20
• Study Start: 2023-05-05
• Status Verified: 2024-10
• Last Update Submitted: 2025-04-07
• Last Update Posted: 2025-04-10
• Primary Completion: 2026-03-17
• Study Completion: 2026-03-17

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 267

Inclusion Criteria

Not provided

Exclusion Criteria

Narcan training:

• not a RE-entry program participant
• identified substance use disorders other than OUD

BIRT/SMC:

• not a RE-entry program participant
• identified substance use disorders other than OUD

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pharmacist Narcan Training	Pharmacist Narcan Training	Pharmacist-led intervention
Substance Use Counselor Narcan Training	Substance Use Counselor Narcan Training	Non-clinician intervention
Brief Intervention and Referral to Treatment (BIRT)	BIRT	BIRT intervention
Standard Medication Counseling (SMC)	SMC	SMC intervention

Primary Outcome Measures

Name	Time	Method
Retention	at month 6	Participants, regardless of treatment arm, will receive follow-up telephone interviews at 6 months post-release from the carceral setting into the community. Interviews will address the primary question whether MOUD treatment was initiated and maintained.
Opioid overdose training	at month 6	Participants' knowledge about opioid overdose and confidence to recognize and respond to opioid overdose situations as a function of the trainer. Participants will complete a brief validated survey, the adapted Perceived Competence Scale. The questions on the survey are rated on a 7-point scale and participants indicate how true four statements are about their ability to recognize and respond to overdoses: the scale, 1 (not at all true) to 7 (very true).

Trial Locations

Locations (1)

Pulaski County Regional Detention Center; 🇺🇸 Little Rock, Arkansas, United States