ClinicalTrials.gg
CompletedNCT05776823PLI-MOUDUpdated Apr 6, 2026

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

An interventional study of Pharmacist Narcan Training and BIRT in Opioid Use Disorder and Overdose, sponsored by University of Arkansas. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-06.

Sponsored by University of Arkansas · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
267
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.
02

Conditions studied

  • Opioid Use Disorder
  • Overdose

Keywords

  • Harm Reduction
  • Criminal Justice
  • Pharmacy Practice
03

In context

Opioid-Related Disorders

1,472 studies on the registry are indexed under Opioid-Related Disorders; 290 are open to participants now.

This study's enrollment of 267 is above the median of 63 across 1,166 interventional studies indexed under Opioid-Related Disorders.

Browse Opioid-Related Disorders studies →

Lead sponsor

University of Arkansas is the lead sponsor of 399 studies on the registry; 38 are open to participants now.

Of its 37 completed or terminated interventional studies of FDA-regulated products, 34 (92%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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
  • 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

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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
267 participants (actual)

Study arms

  • Experimental
    Pharmacist Narcan Training

    Pharmacist-led intervention

    Behavioral: Pharmacist Narcan Training

  • Active comparator
    Substance Use Counselor Narcan Training

    Non-clinician intervention

    Behavioral: Substance Use Counselor Narcan Training

  • Experimental
    Brief Intervention and Referral to Treatment (BIRT)

    BIRT intervention

    Behavioral: BIRT

  • Active comparator
    Standard Medication Counseling (SMC)

    SMC intervention

    Behavioral: SMC

Interventions

  • BehavioralPharmacist Narcan Training

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

  • BehavioralBIRT

    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.

  • BehavioralSMC

    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).

  • BehavioralSubstance 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.

06

What researchers measure

Primary outcomes

  1. 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).

    Time frame: at month 6

  2. 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.

    Time frame: at month 6

07

Study locations

1 site
  • Pulaski County Regional Detention Center
    Little Rock, Arkansas 72204, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from May 2023 to primary completion in May 2025, 24 months.

Of 464 non-industry interventional studies with no phase under Opioid-Related Disorders, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 47. This study's 24 months is below that.

Counting every sponsor, half of 495 studies reached it within 29 months; a quarter within 13 and three quarters within 46.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 1, 2023
First posted
Mar 20, 2023
StartActual
May 5, 2023
Primary completionActual
May 21, 2025
CompletionActual
May 21, 2025
Last update
Apr 6, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 6, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05776823
Responsible party
Sponsor
First posted
Mar 20, 2023
Start date
May 5, 2023
Primary completion
May 21, 2025
Completion
May 21, 2025
Last update
Apr 6, 2026

Study contacts

Meghan N Breckling, PharmD
principal investigator · UAMS

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.

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