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

University of Arkansas

Status: Active, not recruiting

Conditions: Opioid Use Disorder; Overdose

Treatments: Behavioral: BIRT; Behavioral: SMC; Behavioral: Pharmacist Narcan Training; Behavioral: Substance Use Counselor Narcan Training

Study type: Interventional

Funder types: Other

Identifiers

NCT05776823

274818

Details and patient eligibility

About

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.

Full 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.

Enrollment: 267 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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267 participants in 4 patient groups

Pharmacist Narcan Training

Experimental group

Description:

Pharmacist-led intervention

Treatment:

Behavioral: Pharmacist Narcan Training

Substance Use Counselor Narcan Training

Active Comparator group

Description:

Non-clinician intervention

Treatment:

Behavioral: Substance Use Counselor Narcan Training

Brief Intervention and Referral to Treatment (BIRT)

Experimental group

Description:

BIRT intervention

Treatment:

Behavioral: BIRT

Standard Medication Counseling (SMC)

Active Comparator group

Description:

SMC intervention

Treatment:

Behavioral: SMC