Opioid Use DisorderPLI-MOUDNCT05776823
Pharmacist-Led Interventions to Increase Access to Medications for Opioid Use Disorders (PLI-MOUD)
A study testing Pharmacist Narcan Training, BIRT and SMC in people with Opioid Use Disorder and Overdose, run by University of Arkansas at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid Use Disorder, Overdose
- What is being tested?
- Pharmacist Narcan Training, BIRT and SMC
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 267 participants
- Where
- 1 siteUnited States
- Study dates
- 5 May 2023to 21 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 17Show fewer
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Pulaski County Regional Detention Center
Little Rock, Arkansas, 72204
About this study
Official title: Pharmacist-Led Interventions to Increase Access to Medications for Opioid Use Disorder
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.
Read the 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.
- Conditions
- Opioid Use Disorder, Overdose
- Being tested
- Pharmacist Narcan Training, BIRT, SMC, Substance Use Counselor Narcan Training
- Keywords
- Harm Reduction, Criminal Justice, Pharmacy Practice
- Medical subject headings
- Opioid-Related Disorders, Drug Overdose, Harm Reduction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pharmacist Narcan TrainingBehavioural
A 20-45-minute didactic presentation conducted with a skills training component designed to demonstrate appropriate administration of the Narcan nasal spray.
BIRTBehavioural
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.
SMCBehavioural
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 TrainingBehavioural
A 20-45-minute didactic presentation conducted with a skills training component designed to demonstrate appropriate administration of the Narcan nasal spray.
| Study group | Role | What they receive |
|---|---|---|
| Pharmacist Narcan Training | Experimental | Pharmacist-led intervention Receives: Behavioral: Pharmacist Narcan Training |
| Substance Use Counselor Narcan Training | Active comparator | Non-clinician intervention Receives: Behavioral: Substance Use Counselor Narcan Training |
| Brief Intervention and Referral to Treatment (BIRT) | Experimental | BIRT intervention Receives: Behavioral: BIRT |
| Standard Medication Counseling (SMC) | Active comparator | SMC intervention Receives: Behavioral: SMC |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: at month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2023
- Study start5 May 2023
- Primary completion21 May 2025
- Study completion21 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid Use DisorderStudies of the same condition, open and under way.
- More trials run by University of ArkansasThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 267 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arkansas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Meghan N Breckling, PharmD, Principal investigator, UAMS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05776823
- Sponsor's protocol ID
- 274818
- Acronym
- PLI-MOUD
- Status last verified
- Sep 2025
- First submitted
- 1 Mar 2023
- Last updated
- 6 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacist-Led Interventions to Increase Access to Medications for Opioid Use Disorder
- ClinicalTrials.gov ID
- NCT05776823
- Acronym / sponsor ID
- PLI-MOUD / 274818
- Conditions
- Opioid Use Disorder, Overdose
- Keywords
- Harm Reduction, Criminal Justice, Pharmacy Practice
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 267 participants (actual)
- Lead sponsor
- University of ArkansasUniversity, hospital or other
- Study start
- 5 May 2023 (actual)
- Primary completion
- 21 May 2025 (actual)
- Study completion
- 21 May 2025 (actual)
- First posted
- 20 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Pharmacist Narcan Training | Experimental | Behavioral: Pharmacist Narcan TrainingPharmacist-led intervention |
| Substance Use Counselor Narcan Training | Active comparator | Behavioral: Substance Use Counselor Narcan TrainingNon-clinician intervention |
| Brief Intervention and Referral to Treatment (BIRT) | Experimental | Behavioral: BIRTBIRT intervention |
| Standard Medication Counseling (SMC) | Active comparator | Behavioral: SMCSMC intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- 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
Key exclusion criteria (6 listed)
- not a RE-entry program participant
- identified substance use disorders other than OUD
- not a RE-entry program participant
- identified substance use disorders other than OUD
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pharmacist Narcan TrainingA 20-45-minute didactic presentation conducted with a skills training component designed to demonstrate appropriate administration of the Narcan nasal spray. | Behavioural | Pharmacist Narcan Training |
| BIRTBIRT 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. | Behavioural | Brief Intervention and Referral to Treatment (BIRT) |
| SMCSMS 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). | Behavioural | Standard Medication Counseling (SMC) |
| Substance Use Counselor Narcan TrainingA 20-45-minute didactic presentation conducted with a skills training component designed to demonstrate appropriate administration of the Narcan nasal spray. | Behavioural | Substance Use Counselor Narcan Training |
Primary outcome
Opioid overdose training
Time frame: 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).
Retention
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Meghan N Breckling, PharmD principal investigator
UAMS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pharmacist Narcan Training, BIRT and SMC in people with Opioid Use Disorder and Overdose, run by University of Arkansas at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Opioid overdose training (time frame: at month 6). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2026; AzTrials last refreshed its copy on 6 Nov 2026.