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

Sponsor
University of Arkansas (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05776823
Collaborator
(none)
240
4
8.9

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Pharmacist Narcan Training
  • Behavioral: BIRT
  • Behavioral: SMC
  • Behavioral: Substance Use Counselor Narcan Training
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
240 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Prevention
Official Title:
Pharmacist-Led Interventions to Increase Access to Medications for Opioid Use Disorder
Anticipated Study Start Date :
Apr 5, 2023
Anticipated Primary Completion Date :
Sep 30, 2023
Anticipated Study Completion Date :
Jan 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Pharmacist Narcan Training

Pharmacist-led 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.

Active Comparator: Substance Use Counselor Narcan Training

Non-clinician intervention

Behavioral: 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.

Experimental: Brief Intervention and Referral to Treatment (BIRT)

BIRT intervention

Behavioral: 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.

Active Comparator: Standard Medication Counseling (SMC)

SMC intervention

Behavioral: 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).

Outcome Measures

Primary Outcome Measures

  1. Opioid overdose training [at month 6]

    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).

  2. Retention [at month 6]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • University of Arkansas

Investigators

  • Principal Investigator: Azizi Ray, PhD, PharmD, UAMS

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Arkansas
ClinicalTrials.gov Identifier:
NCT05776823
Other Study ID Numbers:
  • 274818
First Posted:
Mar 20, 2023
Last Update Posted:
Mar 24, 2023
Last Verified:
Mar 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University of Arkansas
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 24, 2023