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

Opioid Use Disorder Clinical Trial

— PLI-MOUD  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05776823
• Other study ID #: 274818
• Status: Enrolling by invitation
• Phase: N/A
• Start date: May 5, 2023
• Est. completion date: September 30, 2024

Study information

• Verified date: February 2024
• Source: University of Arkansas
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 480
• Est. completion date: September 30, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Opioid Use Disorder
• Opioid-Related Disorders
• Overdose
• Substance-Related Disorders

Intervention

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

Locations

Country	Name	City	State
United States	Pulaski County Regional Detention Center	Little Rock	Arkansas

Sponsors (1)

Lead Sponsor	Collaborator
University of Arkansas

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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