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

NCT ID: NCT05776823

Last Updated: 2025-09-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

267 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-05

Study Completion Date

2026-03-17

Brief Summary

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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

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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.

Conditions

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Opioid Use Disorder Overdose

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Pharmacist Narcan Training

Pharmacist-led intervention

Group Type EXPERIMENTAL

Pharmacist Narcan Training

Intervention Type BEHAVIORAL

A 20-45-minute didactic presentation conducted with a skills training component designed to demonstrate appropriate administration of the Narcan nasal spray.

Substance Use Counselor Narcan Training

Non-clinician intervention

Group Type ACTIVE_COMPARATOR

Substance Use Counselor Narcan Training

Intervention Type BEHAVIORAL

A 20-45-minute didactic presentation conducted with a skills training component designed to demonstrate appropriate administration of the Narcan nasal spray.

Brief Intervention and Referral to Treatment (BIRT)

BIRT intervention

Group Type EXPERIMENTAL

BIRT

Intervention Type BEHAVIORAL

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.

Standard Medication Counseling (SMC)

SMC intervention

Group Type ACTIVE_COMPARATOR

SMC

Intervention Type BEHAVIORAL

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).

Interventions

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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.

Intervention Type 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.

Intervention Type 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).

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Arkansas

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Meghan N Breckling, PharmD

Role: PRINCIPAL_INVESTIGATOR

UAMS

Locations

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Pulaski County Regional Detention Center

Little Rock, Arkansas, United States

Site Status

Countries

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United States

Other Identifiers

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274818

Identifier Type: -

Identifier Source: org_study_id

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