NCT05776823

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
267

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 1, 2023

Completed
19 days until next milestone

First Posted

Study publicly available on registry

March 20, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

May 5, 2023

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 17, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 17, 2026

Completed
Last Updated

September 5, 2025

Status Verified

September 1, 2025

Enrollment Period

2.9 years

First QC Date

March 1, 2023

Last Update Submit

September 3, 2025

Conditions

Keywords

Harm ReductionCriminal JusticePharmacy Practice

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Study Arms (4)

Pharmacist Narcan Training

EXPERIMENTAL

Pharmacist-led intervention

Behavioral: Pharmacist Narcan Training

Substance Use Counselor Narcan Training

ACTIVE COMPARATOR

Non-clinician intervention

Behavioral: Substance Use Counselor Narcan Training

Brief Intervention and Referral to Treatment (BIRT)

EXPERIMENTAL

BIRT intervention

Behavioral: BIRT

Standard Medication Counseling (SMC)

ACTIVE COMPARATOR

SMC intervention

Behavioral: SMC

Interventions

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

Pharmacist Narcan Training
BIRTBEHAVIORAL

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.

Brief Intervention and Referral to Treatment (BIRT)
SMCBEHAVIORAL

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).

Standard Medication Counseling (SMC)

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

Substance Use Counselor Narcan Training

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • +2 more criteria

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pulaski County Regional Detention Center

Little Rock, Arkansas, 72204, United States

Location

MeSH Terms

Conditions

Opioid-Related DisordersDrug OverdoseHarm Reduction

Condition Hierarchy (Ancestors)

Narcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental DisordersPrescription Drug MisuseDrug MisuseBehavior

Study Officials

  • Meghan N Breckling, PharmD

    UAMS

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 1, 2023

First Posted

March 20, 2023

Study Start

May 5, 2023

Primary Completion

March 17, 2026

Study Completion

March 17, 2026

Last Updated

September 5, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations