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

April 2, 2026 updated by: University of Arkansas

Pharmacist-Led Interventions to Increase Access to Medications for Opioid Use Disorder

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

267

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72204
        • Pulaski County Regional Detention Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria

Narcan Training:

  • a Re-Entry program participant 7-14 days from release from carceral setting
  • provide collateral contact information for ≥2 persons (to ensure consistent contact/follow up)
  • have a reliable landline or mobile phone to be contacted by pharmacist
  • plan to remain in the Little Rock area for at least 6 months
  • able to read and write English
  • able to provide informed consent
  • possesses manual dexterity; physical ability to roll a person onto her/his/their back and side
  • have no allergy to naloxone hydrochloride (active ingredient in Narcan nasal spray)-
  • identified on the RODS screener as positive for OUD.

BIRT/SMC:

  • a Re-Entry program participant 7-14 days from release from the carceral setting
  • provide contact information for ≥2 persons (to ensure consistent contact/follow -up)
  • have a reliable landline or mobile phone to be contacted by pharmacist
  • plan to remain in the Little Rock area for at least 6 months
  • able to read and write English; able to provide informed consent
  • identified with OUD.

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pharmacist Narcan Training
Pharmacist-led intervention
Behavioral: Pharmacist Narcan Training
A 20-45-minute didactic presentation conducted with a skills training component designed to demonstrate appropriate administration of the Narcan nasal spray.
Active Comparator: Substance Use Counselor Narcan Training
Non-clinician intervention
Behavioral: Substance Use Counselor Narcan Training
A 20-45-minute didactic presentation conducted with a skills training component designed to demonstrate appropriate administration of the Narcan nasal spray.
Experimental: Brief Intervention and Referral to Treatment (BIRT)
BIRT intervention
Behavioral: BIRT
BIRT participants will receive a 30-45-minute session delivered by the pharmacist to introduce and encourage treatment options, MOUD information, OUD information, and treatment facility information (i.e., flyers (RDD study/CAST clinic/State Opioid Response III funded agencies) and educational materials), and a referral to treatment/linkage to service providers.
Active Comparator: Standard Medication Counseling (SMC)
SMC intervention
Behavioral: SMC
SMS participants will receive a 5-10-minute counseling session delivered by the pharmacist providing MOUD information, OUD information, and treatment facility information (i.e., flyers (RDD study/CAST clinic/State Opioid Response III funded agencies) and educational materials).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Opioid overdose training
Time Frame: 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).
at month 6
Retention
Time Frame: 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.
at month 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Arkansas

Investigators

  • Principal Investigator: Meghan N Breckling, PharmD, UAMS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 5, 2023

Primary Completion (Actual)

May 21, 2025

Study Completion (Actual)

May 21, 2025

Study Registration Dates

First Submitted

March 1, 2023

First Submitted That Met QC Criteria

March 17, 2023

First Posted (Actual)

March 20, 2023

Study Record Updates

Last Update Posted (Actual)

April 6, 2026

Last Update Submitted That Met QC Criteria

April 2, 2026

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 274818

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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