Clinical trial NCT05776823: Pharmacist-Led Interventions to Increase Access to Medications for Opioid Use Disorders (PLI-MOUD)
Official title: Pharmacist-Led Interventions to Increase Access to Medications for Opioid Use Disorder
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Opioid Use Disorder
Overdose
Keywords: Harm Reduction
Criminal Justice
Pharmacy Practice
Lead sponsor: University of Arkansas
Sponsor class: OTHER
First posted: 2023-03-20
Enrollment: 267
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility 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

Primary outcomes:
measure: Opioid overdose training
timeFrame: at month 6
measure: Retention
timeFrame: at month 6
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Pulaski County Regional Detention Center
state: Arkansas
Study officials:
affiliation: UAMS
name: Meghan N Breckling, PharmD
role: PRINCIPAL_INVESTIGATOR
References: