Pharmacist-Led Access to Medications for Opioid Use Disorder

(PLI-MOUD Trial)

Overseen By Azizi Ray, PhD, PharmD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Arkansas

Disqualifiers: Substance use disorders, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

267 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how training and support from pharmacists can assist people with opioid use disorder (OUD) after they leave jail. It aims to determine if this approach can reduce the risk of opioid overdoses, particularly among various racial and ethnic groups. Participants will receive Narcan training, a nasal spray used to counteract opioid overdoses, along with counseling and support to facilitate their return to the community. The trial seeks individuals with OUD who are part of a re-entry program and are about to be released from jail. As an unphased trial, this study offers a unique opportunity to contribute to innovative approaches that could significantly improve community reintegration for individuals with OUD.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It focuses on opioid use disorder and Narcan training, so it's best to discuss your medications with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that naloxone training programs are generally easy for people to handle. Studies found that pharmacists spent about 3.8 hours learning about naloxone, which improved their ability to manage opioid overdoses. One report revealed that trained individuals successfully revived someone in 90% of overdose cases, demonstrating the training's effectiveness and safety.

For the Brief Intervention and Referral to Treatment (BIRT), research indicates it is a safe and helpful method. It has effectively reduced risky behaviors, such as substance use. Participants in these programs often report reduced drug use, suggesting positive results without major safety issues.

Overall, both naloxone training and BIRT have proven to be safe, with no major side effects reported in studies. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it's exploring how different training methods for Narcan administration can enhance access to medications for opioid use disorder. Unlike standard treatments that focus solely on medication, this trial examines the impact of training pharmacists and substance use counselors in Narcan administration, aiming to improve emergency response and overdose prevention. By empowering more healthcare providers and counselors to effectively administer Narcan, the trial could lead to faster, more widespread intervention in overdose situations, ultimately saving more lives and improving community health outcomes.

What evidence suggests that this trial's treatments could be effective for opioid use disorder?

Research has shown that pharmacist-led training, one of the interventions in this trial, can greatly enhance people's knowledge and confidence in using naloxone, a medication that can reverse opioid overdoses. In studies, participants significantly improved their skills and understanding after the training. Additionally, possessing naloxone and knowing how to use it correlates with better outcomes in overdose situations.

Another intervention in this trial is the Brief Intervention and Referral to Treatment (BIRT) approach. Studies have found that BIRT can effectively reduce substance use in individuals with substance use disorders. Evidence suggests that BIRT, which includes screening and motivational discussions, helps connect people to further treatment. While results can vary, it has shown positive impacts, especially in healthcare settings. ^{6 7 8 9 10}

Who Is on the Research Team?

Meghan N Breckling, PharmD

Principal Investigator

UAMS

Are You a Good Fit for This Trial?

This trial is for individuals with opioid use disorder who are soon to be released from incarceration in Little Rock. They must plan to stay in the area, have no allergy to naloxone, and be able to perform physical tasks like rolling a person over. Participants need reliable phone access, contact information for follow-ups, and must understand English.

Inclusion Criteria

Narcan Training: Plan to remain in the Little Rock area for at least 6 months

Narcan Training: Able to read and write English

BIRT/SMC: Plan to remain in the Little Rock area for at least 6 months

Exclusion Criteria

Narcan Training: Not a Re-Entry program participant

Narcan Training: Identified substance use disorders other than OUD

BIRT/SMC: Not a Re-Entry program participant

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive pharmacist-led interventions including Narcan training and motivational counseling

6 months

Regular visits as per intervention protocol

Follow-up

Participants are monitored for retention and effectiveness of MOUD treatment post-release

6 months

Follow-up telephone interviews

What Are the Treatments Tested in This Trial?

Interventions

• Pharmacist Narcan Training
• Substance Use Counselor Narcan Training

Trial Overview The study tests pharmacist-led interventions aimed at increasing access to medications that treat opioid addiction. It includes Narcan training for overdose response, motivational counseling, and referral programs post-release from carceral settings.

How Is the Trial Designed?

Group I: Pharmacist Narcan Training Experimental Treatment 1 Intervention

Pharmacist-led intervention

Group II: Brief Intervention and Referral to Treatment (BIRT) Experimental Treatment 1 Intervention

BIRT intervention

Group III: Substance Use Counselor Narcan Training Active Control 1 Intervention

Non-clinician intervention

Group IV: Standard Medication Counseling (SMC) Active Control 1 Intervention

SMC intervention

Who Is Running the Clinical Trial?

University of Arkansas

Lead Sponsor

Trials

500

Recruited

153,000+

Published Research Related to This Trial

A pharmacist-led clinical video telehealth (CVT) clinic effectively increased access to opioid overdose education and naloxone distribution for at-risk patients across both urban and rural areas, prescribing 21% of the health care system's naloxone in just six months.

Patients receiving naloxone through the CVT clinic were more likely to be high-risk due to the concurrent use of opioids and benzodiazepines, highlighting the clinic's focus on those most in need of intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Description of a pharmacist-led clinical video telehealth group clinic for opioid overdose prevention and naloxone education. Jensen, AN., Beam, CM., Douglass, AR., et al.[2020]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9850124/

Using SBIRT (Screen, Brief Intervention, and Referral ... This practice has been shown to be highly effective in reducing substance use among patients with substance use disorders. Most often, screening conversations ...

2. cdr.lib.unc.edu cdr.lib.unc.edu/concern/honors_theses/6682x861r

Brief Intervention and Referral to Treatment (SBIRT) in ... Brief Intervention and Referral to Treatment (SBIRT) in Patients with Opioid Use Disorders in Primary Care: Evidence for Efficacy.

3. link.springer.com link.springer.com/article/10.1007/s11606-025-09785-z

Implementation Strategies to Enhance Safety-Net Hospitals ... Although evidence on the effectiveness of SBIRT for OUD is mixed, two studies have linked hospital-based SBIRT for OUD to positive patient ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9198157/

Efficacy of Brief Intervention for Unhealthy Drug Use in ... This study aims to determine the efficacy of BI for unhealthy drug use and the expected length of effects, and describe subgroup analyses by outpatient setting.

5. sciencedirect.com sciencedirect.com/science/article/pii/S268811522500150X

Emergency Department-Based Medication for Opioid Use ... All 373,797 ED patients were screened for OUD over the 5 years, and 1072 (2.8%) were inducted into the MOUD program. A total of 53 patients (4.9%) were inducted ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12445236/

Implementation Strategies to Enhance Safety-Net Hospitals ... One model is Screening, Brief Intervention, and Referral to Treatment (SBIRT), an evidence-based approach to assess the severity of substance ...

7. samhsa.gov samhsa.gov/substance-use/treatment/sbirt

Screening, Brief Intervention, and Referral to Treatment ... The percentage of clients who reported they had not used alcohol or illegal drugs within the past 30 days increased by 128.8% between initial ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT00913770?cond=Disease%20model%20of%20addiction&viewType=Table&rank=9

Models of Screening, Brief Intervention With a Facilitated ... Screening, brief intervention and referral to treatment has been effective in decreasing high risk behaviors such as alcohol and tobacco use, and unsafe sexual ...

9. journals.lww.com journals.lww.com/c-orthopaedicpractice/fulltext/2022/03000/screening,_brief_intervention,_and_referral_to.3.aspx

Screening, brief intervention, and referral to treatment... Patients who screened as medium or high risk were 5.8 and 8.4 times more likely, respectively, to receive intervention compared with patients who screened to ...

10. medicine.yale.edu medicine.yale.edu/sbirt/

SBIRT: Screening Brief Intervention & Referral to Treatment Opioid Use Disorders. SBIRT: Screening Brief Intervention & Referral to ... This fact is apparent from the data collected from the National Survey of Drug Use and ...