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

Study Overview
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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: 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.

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

Conditions
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Opioid Use Disorder, Overdose

Intervention / Treatment
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* Behavioral: Pharmacist Narcan Training
* Behavioral: BIRT
* Behavioral: SMC
* Behavioral: Substance Use Counselor Narcan Training


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pharmacist Narcan Training<br>Pharmacist-led intervention | Behavioral: Pharmacist Narcan Training<br>* A 20-45-minute didactic presentation conducted with a skills training component designed to demonstrate appropriate administration of the Narcan nasal spray.<br>|
| Active Comparator: Substance Use Counselor Narcan Training<br>Non-clinician intervention | Behavioral: Substance Use Counselor Narcan Training<br>* A 20-45-minute didactic presentation conducted with a skills training component designed to demonstrate appropriate administration of the Narcan nasal spray.<br>|
| Experimental: Brief Intervention and Referral to Treatment (BIRT)<br>BIRT intervention | Behavioral: BIRT<br>* 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.<br>|
| Active Comparator: Standard Medication Counseling (SMC)<br>SMC intervention | Behavioral: SMC<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pharmacy Practice, Harm Reduction, Criminal Justice