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Completed

NCT Number: NCT05776823

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

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.

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Key information

Conditions

Opioid Use Disorder Behavior Chemically-Induced Disorders Drug Misuse Drug Overdose Harm Reduction Mental Disorders Narcotic-Related Disorders Opioid-Related Disorders Overdose Prescription Drug Misuse Substance-Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pulaski County Regional Detention Center

Little Rock, Arkansas, 72204, United States

About this study

The main objectives of this study are:

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pharmacist Narcan Training

Behavioral

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

BIRT

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.

SMC

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).

Substance Use Counselor Narcan Training

Behavioral

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

Primary outcomes

  1. 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).

  2. 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.

Sponsors and collaborators

Lead sponsor

University of Arkansas

Other

Registry information

Official study title

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

Acronym: PLI-MOUD

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Mar 20, 2023
Registry last updated
Apr 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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