Pharmacist-Led Interventions to Increase Access to Medications for Opioid Use Disorders (PLI-MOUD)
PLI-MOUD
1 other identifier
interventional
267
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2023
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 1, 2023
CompletedFirst Posted
Study publicly available on registry
March 20, 2023
CompletedStudy Start
First participant enrolled
May 5, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 17, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
March 17, 2026
CompletedSeptember 5, 2025
September 1, 2025
2.9 years
March 1, 2023
September 3, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Opioid overdose training
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
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
Study Arms (4)
Pharmacist Narcan Training
EXPERIMENTALPharmacist-led intervention
Substance Use Counselor Narcan Training
ACTIVE COMPARATORNon-clinician intervention
Brief Intervention and Referral to Treatment (BIRT)
EXPERIMENTALBIRT intervention
Standard Medication Counseling (SMC)
ACTIVE COMPARATORSMC intervention
Interventions
A 20-45-minute didactic presentation conducted with a skills training component designed to demonstrate appropriate administration of the Narcan nasal spray.
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.
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).
A 20-45-minute didactic presentation conducted with a skills training component designed to demonstrate appropriate administration of the Narcan nasal spray.
Eligibility Criteria
You may qualify if:
- 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
- +2 more criteria
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Pulaski County Regional Detention Center
Little Rock, Arkansas, 72204, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Meghan N Breckling, PharmD
UAMS
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 1, 2023
First Posted
March 20, 2023
Study Start
May 5, 2023
Primary Completion
March 17, 2026
Study Completion
March 17, 2026
Last Updated
September 5, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will not share