Back to resultsPharmacist-Led Interventions to Increase Access to Medications for Opioid Use Disorders (PLI-MOUD) (PLI-MOUD)
Primary Purpose
Opioid Use Disorder, Overdose
Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Pharmacist Narcan Training
BIRT
SMC
Substance Use Counselor Narcan Training
Sponsored by
About this trial
This is an interventional prevention trial for Opioid Use Disorder focused on measuring Harm Reduction, Criminal Justice, Pharmacy Practice
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
Sites / Locations
- Pulaski County Regional Detention Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Active Comparator
Experimental
Active Comparator
Arm Label
Pharmacist Narcan Training
Substance Use Counselor Narcan Training
Brief Intervention and Referral to Treatment (BIRT)
Standard Medication Counseling (SMC)
Arm Description
Pharmacist-led intervention
Non-clinician intervention
BIRT intervention
SMC intervention
Outcomes
Primary Outcome Measures
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).
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05776823
Brief Title
Pharmacist-Led Interventions to Increase Access to Medications for Opioid Use Disorders (PLI-MOUD)
Acronym
PLI-MOUD
Official Title
Pharmacist-Led Interventions to Increase Access to Medications for Opioid Use Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
May 5, 2023 (Actual)
Primary Completion Date
September 30, 2023 (Anticipated)
Study Completion Date
January 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Arkansas
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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:
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid Use Disorder, Overdose
Keywords
Harm Reduction, Criminal Justice, Pharmacy Practice
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
240 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Pharmacist Narcan Training
Arm Type
Experimental
Arm Description
Pharmacist-led intervention
Arm Title
Substance Use Counselor Narcan Training
Arm Type
Active Comparator
Arm Description
Non-clinician intervention
Arm Title
Brief Intervention and Referral to Treatment (BIRT)
Arm Type
Experimental
Arm Description
BIRT intervention
Arm Title
Standard Medication Counseling (SMC)
Arm Type
Active Comparator
Arm Description
SMC intervention
Intervention Type
Behavioral
Intervention Name(s)
Pharmacist Narcan Training
Intervention Description
A 20-45-minute didactic presentation conducted with a skills training component designed to demonstrate appropriate administration of the Narcan nasal spray.
Intervention Type
Behavioral
Intervention Name(s)
BIRT
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
SMC
Intervention Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Substance Use Counselor Narcan Training
Intervention Description
A 20-45-minute didactic presentation conducted with a skills training component designed to demonstrate appropriate administration of the Narcan nasal spray.
Primary Outcome Measure Information:
Title
Opioid overdose training
Description
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).
Time Frame
at month 6
Title
Retention
Description
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.
Time Frame
at month 6
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Azizi Ray, PhD, PharmD
Organizational Affiliation
UAMS
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pulaski County Regional Detention Center
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72204
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Pharmacist-Led Interventions to Increase Access to Medications for Opioid Use Disorders (PLI-MOUD)
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