Opioid Prescription Engagement for Opioid Use Disorder

(HOPE Trial)

Overseen By Kristi Carlston, BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Jerry Cochran

Must not be taking: Buprenorphine

Disqualifiers: Pregnancy, Psychotic episode, others

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

Compensation: Varies

Number of Visits: 3

Duration: 6 months

350 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to assist individuals who might misuse opioids by testing Brief Intervention-Medication Therapy Management (BI-MTM). This approach combines medication management, brief counseling, naloxone dispensing (a medication that can reverse opioid overdoses), and patient guidance (also known as Patient Navigation). The trial will compare this new method to the usual care provided at pharmacies. Suitable participants have screened positive for opioid misuse and are not currently receiving cancer treatment. As an unphased trial, this study provides a unique opportunity to contribute to innovative approaches in opioid misuse support.

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 is best to discuss this with the trial coordinators for more details.

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

Research has shown that the Brief Intervention Medication Therapy Management (BI-MTM) approach is generally easy for people to handle. Studies have found that components like Medication Therapy Management and Screening, Brief Intervention, and Referral to Treatment (SBIRT) effectively identify and address opioid misuse and related safety issues. Trained pharmacists provide these services, which have been safely used in community settings.

Although specific safety data for BI-MTM is limited, its components have been safely integrated into pharmacy practices. The Patient Navigation part of the program connects patients to additional resources, enhancing the approach's comprehensiveness.

Overall, the BI-MTM model employs several proven strategies, and no major reports of negative effects have emerged from its use. This suggests that the intervention is safe for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Brief Intervention Medication Therapy Management (BI-MTM) because it offers a comprehensive approach to addressing opioid use disorder. Unlike standard care, which mainly involves pharmacists providing basic counseling and information, BI-MTM integrates several evidence-based components, including Medication Therapy Management, Screening and Brief Intervention, Referral to Treatment, naloxone dispensing, and Patient Navigation. This multifaceted strategy not only aims to manage medications safely but also actively screens for misuse and provides immediate support and referral, making it a more holistic and potentially more effective option for tackling opioid misuse.

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

Research has shown that the Brief Intervention Medication Therapy Management (BI-MTM), a treatment arm in this trial, can help address opioid misuse. This method employs proven techniques such as medication management and patient support. Studies have found that simple screenings and brief discussions can identify and address opioid misuse. Additionally, pharmacists lead sessions to ensure patients take their medications correctly and safely. By connecting patients with support systems, BI-MTM aims to reduce the risk of misuse and improve adherence to medication plans. ^{1 2 4 6 7}

Who Is on the Research Team?

Gerald Cochran, PhD

Principal Investigator

University of Utah

Are You a Good Fit for This Trial?

This trial is for English-speaking adults who are not on cancer treatment, have a positive opioid misuse screen, and aren't planning to leave the area soon. Pregnant individuals, those without reliable contact information or phone access, buprenorphine-only users, and anyone with recent psychosis or manic episodes cannot participate.

Inclusion Criteria

Patients who have a positive opioid misuse screen on the POMI will be eligible to learn about this study

I am not currently undergoing any cancer treatment.

English speaking

Exclusion Criteria

Have had a psychotic and/or manic episode in the last 30 days (before consent, patients will be asked to screen for psychosis)

Do not provide permission to access their state prescription drug monitoring data

Cannot provide collateral contact information for ≥2 contact persons (to ensure consistent contact/follow up)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Treatment

Participants receive the BI-MTM intervention or Standard of Care at community pharmacies

6 months

Multiple visits (in-person) at point of dispensing

Follow-up

Participants are monitored for changes in opioid medication misuse, depression, and pain

6 months

Assessments at baseline, 2, and 6 months

What Are the Treatments Tested in This Trial?

Interventions

• Patient Navigation
• Standard Medication Counseling (SMC)

Trial Overview The study tests the Brief Intervention-Medication Therapy Management (BI-MTM) across pharmacies to see if it helps prevent opioid abuse. It's a randomized trial where some get standard medication counseling while others receive additional patient navigation support.

How Is the Trial Designed?

Group I: Standard of Care Experimental Treatment 1 Intervention

Standard of Care is the treatment as usual condition, which follows federal and Utah state pharmacy requirements for pharmacists where in patients filling prescriptions receive information and opt-in counseling. Specifically, SMC in Utah requires pharmacists to: (1) offer counseling, (2) document counseling has been offered, (3) offer a counseling process for patients not present, and (4) discuss generic substitution.The duration of SMC in the current study is a single 5-10 minute session delivered by a University of Utah pharmacist other than the study pharmacist that possesses a similar level of education and professional licensing.

Group II: Brief Intervention Medication Therapy Management (BI-MTM) Experimental Treatment 1 Intervention

Brief Intervention Medication Therapy Management (BI-MTM) is the overarching model made up of 4 evidence-based components: Medication Therapy Management (MTM); Screening, Brief Intervention, and Referral to Treatment (SBIRT); naloxone dispensing, and Patient Navigation (PN). Each component is sequentially delivered within the model and addresses a critical aspect of opioid medication misuse and risk. The pharmacy-based portion of BI-MTM (MTM+SBIRT+naloxone) will be delivered by a PharmD level pharmacist, and PN will be delivered by a bachelor's level interventionist.

Who Is Running the Clinical Trial?

Jerry Cochran

Lead Sponsor

Trials

2

Recruited

380+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Published Research Related to This Trial

The implementation of New Jersey's Office-Based Addiction Treatment (OBAT) Program in 2019 led to a steady increase in provider enrollment and utilization of medications for opioid use disorder (MOUD), indicating improved access to treatment for patients.

While enhanced reimbursements and patient navigation services were beneficial, barriers such as limited enrollment of primary care physicians and administrative challenges hindered broader uptake of the program, suggesting that further adaptations could enhance its effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation of an office-based addiction treatment model for Medicaid enrollees: A mixed methods study. Treitler, P., Enich, M., Bowden, C., et al.[2023]

In a study of 46,952 hospital patients, 158 received naloxone due to opioid-related issues, highlighting the ongoing risk of opioid oversedation in hospitalized patients.

The study suggests that implementing better sedation assessments and coordinated pain management strategies could help prevent the need for naloxone by reducing the reliance on opioids and minimizing the use of multiple sedating medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation of required sedation assessment in nursing workflow to address naloxone utilization. Hardison, E., Bloomer, A., Wally, MK., et al.[2023]

Implementing a low barrier model of medication for opioid use disorder (MOUD) at a Federally Qualified Health Center significantly increased the likelihood of patients receiving MOUD prescriptions within 6 months, with 97.3% of the intervention group receiving prescriptions compared to 70% in the traditional treatment group.

While retention in care at 3 months was similar between the low barrier and traditional groups, the intervention group showed a higher retention rate at 6 months (53.1% vs 45.6%), although this difference was not statistically significant, indicating that further research is needed to enhance patient retention in low barrier MOUD programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low barrier medication for opioid use disorder at a federally qualified health center: a retrospective cohort study. Carter, J., Li, Z., Chen, H., et al.[2022]

A study involving 35 individuals (19 currently and 16 formerly in treatment) revealed that physical capability, such as managing side effects and pain, significantly impacts retention in medications for opioid use disorder (MOUD).

Motivation was identified as the most critical factor for engagement in MOUD, influenced by personal recognition of addiction, readiness to quit, and the perceived consequences of disengagement, highlighting the need for tailored support strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Application of the COM-B model to patient barriers and facilitators of retention in medication treatment for opioid use disorder in rural Northeastern United States: A qualitative study. Poulsen, MN., Asdell, PB., Berrettini, W., et al.[2023]

In a study of 147 patients on high-dose opioid therapy, 34% reduced their opioid dosage after implementing the Opioid Safety Initiative, with the median daily dose decreasing from 315 mg to 278 mg.

There was a notable improvement in adherence to safety policies, including an increase in informed consent completion from 31% to 48% and biannual urine drug screenings from 44% to 61%, indicating enhanced monitoring practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of multidisciplinary chart reviews on opioid dose reduction and monitoring practices. Rivich, J., McCauliff, J., Schroeder, A.[2019]

Patient navigation (PN) significantly improved treatment adherence and engagement in opioid use disorder (OUD) among pregnant individuals, with better outcomes in medication use and substance use disorder treatment attendance compared to usual care (UC).

The pilot study, involving 102 pregnant participants, demonstrated that those receiving PN had fewer reported overdoses at 2 and 6 months postpartum, suggesting that PN may enhance safety and effectiveness in managing OUD during pregnancy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient navigation for pregnant individuals with opioid use disorder: Results of a randomized multi-site pilot trial. Cochran, G., Smid, MC., Krans, EE., et al.[2023]

The opioid crisis has significantly impacted pregnant women, with a fourfold increase in opioid use disorder (OUD) diagnoses over the past decade, highlighting the urgent need for targeted interventions.

The OPTI-Mom 2.0 study aims to evaluate a patient navigation (PN) intervention designed to improve care engagement and treatment retention for pregnant women with OUD, potentially reducing adverse outcomes for both mothers and their children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pilot multisite study of patient navigation for pregnant women with opioid use disorder. Cochran, G., Smid, MC., Krans, EE., et al.[2021]

The NavSTAR intervention, which provided patient navigation for hospitalized patients with comorbid substance use disorders, resulted in significant cost savings of $17,780 per participant by reducing emergency department visits and inpatient hospital stays over a 12-month period.

The study suggests that implementing patient navigation services can be an effective strategy for healthcare payors and policymakers to lower hospital costs associated with patients suffering from substance use disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cost and Cost Savings of Navigation Services to Avoid Rehospitalization for a Comorbid Substance Use Disorder Population. Orme, S., Zarkin, GA., Dunlap, LJ., et al.[2023]

The HOPE smartphone application, designed for patients with opioid use disorder (OUD), demonstrated a 56% retention rate in care over six months, indicating its potential effectiveness in supporting treatment engagement.

Participants using the app showed improved self-control and self-efficacy related to drug abstinence, suggesting that mHealth tools can help bridge barriers to clinic attendance and enhance recovery outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Six-month outcomes of the HOPE smartphone application designed to support treatment with medications for opioid use disorder and piloted during an early statewide COVID-19 lockdown. Hodges, J., Waselewski, M., Harrington, W., et al.[2022]

The Stratification Tool for Opioid Risk Mitigation (STORM) is being used by the Veterans Health Administration to identify patients at high risk for opioid-related adverse events, aiming to improve opioid safety amidst a growing crisis.

A randomized evaluation of STORM's implementation will provide valuable insights into how mandated case reviews can affect opioid prescribing practices and potentially reduce overdose incidents.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized program evaluation of the Veterans Health Administration Stratification Tool for Opioid Risk Mitigation (STORM): A research and clinical operations partnership to examine effectiveness. Minegishi, T., Frakt, AB., Garrido, MM., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7868881/

Brief intervention medication therapy management BIMTM is an intervention consisting of 9 sessions. One medication management session is delivered by a pharmacist in a community pharmacy setting.

2. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT03149718

NCT03149718 | Community Pharmacists and Opioid Misuse BI-MTM is designed to: (1) eliminate opioid medication misuse, (2) promote opioid regimen adherence, (3) connect participants with Patient Navigation to ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10186861/

A scoping literature review of pharmacy-based opioid ... Screening and brief interventions (SBI) are an effective prevention strategy to identify and address opioid misuse and safety risks.

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1551714422000854

A study protocol for an interdisciplinary behavioral health trial This study is testing the efficacy of a pharmacist-led intervention—Brief Intervention-Medication Therapy Management (BI-MTM)—compared to standard medication ...

5. japha-innovations.org japha-innovations.org/article/S2949-9690(25)00019-3/fulltext

Exploratory analysis of pharmacist involvement in ... The HOPE study utilizes a Brief-Intervention MTM (BI-MTM) model, incorporating MI skills into MTM sessions to target opioid medication misuse.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT03149718

NCT03149718 | Community Pharmacists and Opioid Misuse BI-MTM is designed to: (1) eliminate opioid medication misuse, (2) promote opioid regimen adherence, (3) connect participants with Patient Navigation to ...

7. researchgate.net researchgate.net/publication/348691817_Brief_intervention_medication_therapy_management_Establishment_of_an_opioid_misuse_intervention_model_delivered_in_a_community_pharmacy

Establishment of an opioid misuse intervention model ... The authors developed the Brief Intervention Medication Therapy Management (BIMTM) model, through which pharmacists play a key role in reducing ...