Opioid Prescription Engagement for Opioid Use Disorder

(HOPE Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Gerald Cochran, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Jerry Cochran

Must not be taking: Buprenorphine

Disqualifiers: Pregnancy, Psychotic episode, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

This study is a randomized controlled trial across 14 community pharmacies to test the efficacy of the Brief Intervention-Medication Therapy Management intervention (BI-MTM). The establishment of the BI-MTM model will result in a major impact for addressing the opioid epidemic, preventing opioid use disorder and overdose, and safeguarding patient health in a novel community-based service setting.

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.

What data supports the effectiveness of the treatment Patient Navigation for Opioid Use Disorder?

Research shows that Patient Navigation (PN) can help pregnant individuals with opioid use disorder (OUD) by improving their engagement and retention in treatment. This approach includes personalized support and planning, which has been shown to potentially improve health outcomes for both mothers and their children. ^{1 2 3 4 5}

Is patient navigation safe for individuals with opioid use disorder?

Patient navigation has been studied in various contexts, including for pregnant individuals with opioid use disorder and hospital patients with substance use disorders, and no specific safety concerns have been reported in these studies. ^{2 6 7 8 9}

How is the Patient Navigation treatment different from other treatments for opioid use disorder?

Patient Navigation is unique because it focuses on guiding patients through the healthcare system, helping them set and achieve medical and personal goals, and providing one-on-one support, unlike traditional treatments that primarily focus on medication. It includes case management, motivational interviewing, and relapse prevention, making it a comprehensive approach to improving treatment engagement and retention. ^{2 3 4 5 10}

Research Team

Gerald Cochran, PhD

Principal Investigator

University of Utah

Eligibility Criteria

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.

I am 18 years old or older.

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)

Trial Timeline

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

Treatment Details

Interventions

• Patient Navigation (Behavioral Intervention)
• Standard Medication Counseling (SMC) (Behavioral Intervention)

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.

Participant Groups

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+

Dr. Nora Volkow

National Institute on Drug Abuse (NIDA)

Chief Executive Officer since 2003

MD from National Autonomous University of Mexico

Dr. Nora Volkow

National Institute on Drug Abuse (NIDA)

Chief Medical Officer since 2003

MD from National Autonomous University of Mexico

Findings from Research

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]

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 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]

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]

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]

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]

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]

References

1. England 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. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Patient navigation for pregnant individuals with opioid use disorder: Results of a randomized multi-site pilot trial. [2023]

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

A pilot multisite study of patient navigation for pregnant women with opioid use disorder. [2021]

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

Implementation of an office-based addiction treatment model for Medicaid enrollees: A mixed methods study. [2023]

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

Low barrier medication for opioid use disorder at a federally qualified health center: a retrospective cohort study. [2022]

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

Implementation of required sedation assessment in nursing workflow to address naloxone utilization. [2023]

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

Cost and Cost Savings of Navigation Services to Avoid Rehospitalization for a Comorbid Substance Use Disorder Population. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Impact of multidisciplinary chart reviews on opioid dose reduction and monitoring practices. [2019]

9. United States 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. [2021]

10. England 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. [2022]