Pharmacist-Integrated Care for Opioid Use Disorder

(PharmICO Trial)

No longer recruiting at 3 trial locations

Overseen By Susan Vonderheide, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Trustees of Dartmouth College

Must be taking: MOUD

Disqualifiers: Non-English speakers, Legal issues, others

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

Compensation: Varies

Number of Visits: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how pharmacists can better assist individuals with opioid use disorder (OUD) through a new care model called PrIMO. The goal is to determine if including pharmacists in the care team improves access and effectiveness of medication treatment for OUD. Individuals who have received medication treatment for OUD at a participating clinic and experienced the PrIMO model for at least 14 days may qualify for this trial. As an unphased trial, this study provides a unique opportunity to contribute to innovative care models that could enhance OUD treatment.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your healthcare provider.

What prior data suggests that this pharmacist-integrated model is safe for opioid use disorder treatment?

Research has shown that the PrIMO model, which involves pharmacists in the care of people with Opioid Use Disorder (OUD), is promising in terms of safety. One study found that 85% of patients remained in the program for six months, indicating good treatment adherence and tolerance. Additionally, urine tests revealed that 91% of the patients were free of opioids, suggesting effective management with few side effects.

While PrIMO is not a medication but a method of care, involving pharmacists in medication management can enhance the safety of OUD treatments. This approach aims to reduce opioid overdoses, with predictions indicating a decrease of up to 36.6% in fatal overdoses involving opioids. This evidence supports the idea that the PrIMO model is well-tolerated and could be beneficial in safely managing OUD. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Pharmacist-Integrated Care for Opioid Use Disorder trial because it explores a novel approach by integrating pharmacists more directly into patient care. Unlike standard treatments that primarily rely on medications like methadone or buprenorphine, this method leverages the expertise of pharmacists to enhance patient support and management. By involving pharmacists, the trial aims to improve outcomes through better medication adherence and personalized care, potentially offering a more holistic approach to treating opioid use disorder.

What evidence suggests that this pharmacist-integrated care model is effective for opioid use disorder?

Research has shown that the PrIMO model, which includes pharmacists in the care of people with opioid use disorder (OUD), can lead to better treatment outcomes. In this trial, some patients will receive care through the PrIMO model. Patients in this model tend to stay in treatment longer and adhere more closely to their medication plans. Studies have found that the PrIMO model reduces the number of patients who rely on opioids long-term. Additionally, healthcare providers in this model report satisfaction when treating OUD patients, and patients have positive experiences with their care. This model aims to make medication treatments for OUD more accessible, addressing the issue that only a small percentage of those who need treatment actually receive it. ^{1 6 7 8 9}

Who Is on the Research Team?

Lisa A Marsch, PhD

Principal Investigator

Geisel School of Medicine at Dartmouth College

Are You a Good Fit for This Trial?

This trial is for adults over 18 who work at a clinic as providers, pharmacists, technicians, or administrators. It's also for adult patients at these clinics who are receiving or have received medication treatment for opioid use disorder (MOUD) and have been exposed to the PrIMO model. Participants must not be incarcerated or facing legal issues that prevent study involvement.

Inclusion Criteria

I am 18 or older and have been treated with MOUD at a clinic using the PrIMO model for at least 14 days.

Exclusion Criteria

Site Staff Unwilling or unable to provide consent or are currently in jail, prison, or other overnight facility as required by court of law; or have pending legal action that could prevent participation in study activities

Timeline for a Trial Participant

Pre-implementation

Data collection and preparation for the PrIMO model implementation

3 months

Implementation Launch

Launch of the PrIMO model at clinical sites and initial participant enrollment

2 weeks

Patient Enrollment and Treatment

Patients are enrolled and receive care under the PrIMO model

6 months

Follow-up at 3 and 6 months post-baseline

Follow-up

Participants are monitored for outcomes and sustainability of the PrIMO model

12 months post-launch

What Are the Treatments Tested in This Trial?

Interventions

• PrIMO

Trial Overview The trial is testing a new way of treating opioid addiction by integrating pharmacists into the care team. This Phase 1 project will assess how feasible and acceptable it is to implement this pharmacist-integrated model in diverse outpatient clinical settings.

How Is the Trial Designed?

Group I: Site Staff Experimental Treatment 1 Intervention

Providers, Pharmacists, Pharmacy Technicians, Administrators to receive survey assessments

Group II: Patients Experimental Treatment 1 Intervention

Subset of patients receiving PrIMO care to receive survey assessments

Who Is Running the Clinical Trial?

Trustees of Dartmouth College

Lead Sponsor

Trials

32

Recruited

14,500+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Published Research Related to This Trial

A qualitative study involving 22 patients, 24 clinical staff, and 5 clinic leaders identified key themes for improving the integration of HIV and opioid use disorder (OUD) care, emphasizing the need to address social risks and knowledge gaps about treatments.

The development of a new measurement tool based on these insights aims to enhance service delivery for patients with HIV and OUD by focusing on patient-centered policies and effective communication between organizations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"No more falling through the cracks": A qualitative study to inform measurement of integration of care of HIV and opioid use disorder. Oldfield, BJ., Muñoz, N., Boshnack, N., et al.[2023]

Citations

1. ctnnortheastnode.org ctnnortheastnode.org/wp-content/uploads/2021/08/CTN-0116-Brief-Study-Overview_FINAL.pdf

BRIEF STUDY OVERVIEW - Impact of the PrIMO model: treatment outcomes for patients exposed to the PrIMO model (e.g., MOUD treatment retention, medication regimen adherence, and ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10949656/

Implementing a pharmacist-integrated collaborative model ... In collaboration with other efforts made at the clinic, the PrIMO model helped reduce the number of patients on long-term opioids, long-term ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40578798/

Evaluation of a primary care-based Medication for Opioid ... Medical providers surveyed (N = 9) felt satisfied in their work treating patients with opioid use disorder and patients (N = 24) reported ...

4. cdc.gov cdc.gov/mmwr/volumes/73/wr/mm7325a1.htm

Treatment for Opioid Use Disorder: Population Estimates In 2022, 3.7% of US adults aged ≥18 years needed OUD treatment. Among these, only 25.1% received medications for OUD.

5. scholarworks.waldenu.edu scholarworks.waldenu.edu/cgi/viewcontent.cgi?article=14829&context=dissertations

Experiences of Individuals With Opioid Use Disorder in ... Prior to MAT programs, counseling and detoxification (abstinence) programs without medications were not working, with frequent relapse occurrences and poor long ...

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2949875925001237

Evaluation of a primary care-based Medication for Opioid ... Data collected from July 1, 2022 to December 31, 2022 showed a 6-month retention rate of 85 % (N = 186). Urine drug screens were opioid-negative for 91 % of ...

7. psychiatryonline.org psychiatryonline.org/doi/full/10.1176/appi.ajp.20230918

Harm Reduction for Opioid Use Disorder: Strategies and ... Outcomes besides abstinence that could be considered include reductions in substance use patterns that are associated with a high likelihood of ...

8. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2817002

Public Health Interventions and Overdose-Related ... The model projected decreases of up to 35.2% in nonfatal and 36.6% in fatal opioid-involved overdoses among persons with OUD.

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8262000/

Receipt of medications for opioid use disorder among ... Results. Among 303,262 eligible youth, 2131 (0.7%) had a documented OUD diagnosis. The prevalence of OUD increased by ascending age groups.