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

Trial Summary

What is the purpose of this trial?

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.

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.

What data supports the effectiveness of the treatment Pharmacist Narcan Training, Substance Use Counselor Narcan Training?

Research shows that pharmacist-led programs, like the clinical video telehealth clinic, have been effective in increasing access to naloxone (a medication that can reverse opioid overdoses) for high-risk patients, especially in rural areas. Additionally, training programs for pharmacists have improved their knowledge and confidence in preventing opioid overdoses, which suggests that similar training for substance use counselors could also be beneficial. ^{1 2 3 4 5}

Is pharmacist-led naloxone training safe for humans?

Pharmacist-led naloxone training programs have been implemented in various settings to improve opioid safety and prevent overdoses. These programs involve pharmacists and pharmacy students providing education and naloxone distribution, which have been shown to be feasible and effective in reaching at-risk populations without any reported safety concerns. ^{1 2 3 5 6}

How is the pharmacist-led access to medications for opioid use disorder treatment different from other treatments?

This treatment is unique because it involves pharmacists leading the effort to improve access to naloxone, a medication that can reverse opioid overdoses, through video telehealth clinics. This approach helps reach high-risk patients in both urban and rural areas, making it more accessible compared to traditional methods. ^{1 4 6 7 8}

Research Team

Meghan N Breckling, PharmD

Principal Investigator

UAMS

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Description of a pharmacist-led clinical video telehealth group clinic for opioid overdose prevention and naloxone education. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

Implementation and assessment of a naloxone-training program for first-year student pharmacists. [2019]

3. England pubmed.ncbi.nlm.nih.gov

Clinical pharmacist involvement in expanding naloxone distribution in a veteran population. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Preparing student pharmacists to identify opioid misuse, prevent overdose and prescribe naloxone. [2020]

5. England pubmed.ncbi.nlm.nih.gov

Integration of Pharmacy Student Interns into a Naloxone Telephone Outreach Service. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Orienting patients to greater opioid safety: models of community pharmacy-based naloxone. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Expanding naloxone education in the doctor of pharmacy curriculum. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Impact of a Multicomponent Educational Intervention on Community Pharmacy-Based Naloxone Services Implementation: A Pragmatic Randomized Controlled Trial. [2023]