Healthy Opioid Prescription Engagement (HOPE)
July 15, 2026 updated by: Jerry Cochran
Healthy Opioid Prescription Engagement 2.0
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.
Study Overview
Status
Active, not recruiting
Intervention / Treatment
Detailed Description
This study examines a community pharmacy-based intervention to reduce opioid medication misuse.
Despite a recent national decline in opioid prescribing, 10.3 million Americans in 2018 reported misusing a prescribed opioid, and within this population, >36% of those who misused obtained the opioid medication by filling a prescription.
The point of medication dispensing, namely, the community pharmacy, is an untapped resource to address prescription opioid misuse-especially when considering the >60,000 pharmacies employing >170,000 pharmacists in the US.
This study aims to conduct a fully-powered RCT of the BI-MTM intervention in community pharmacy settings that will accomplish 3 Specific Aims.
The first Aim will demonstrate the pharmacist-led BI-MTM intervention is superior to standard medication counseling (SMC) for mitigating opioid medication misuse.
This will be accomplished by conducting a powered single-blinded randomized trial to test the efficacy of BI-MTM (n=175) vs. SMC (n=175).
Participants will be screened/recruited for eligibility at point of dispensing in 14 community pharmacies in Utah, a high opioid prescribing and opioid-adverse event state.
Participants will be assessed at baseline, 2, and 6 months for opioid medication misuse.
Participant-level state prescription drug monitoring data will also be linked with patient outcomes to assess objective changes in medication misuse behaviors (e.g., early refills and doctor/pharmacy shopping).
The second Aim will identify the pathway by which BI-MTM results in improvements for depression, pain, and subsequently opioid misuse.
To accomplish this, a path analysis will assess relationships of BI-MTM: (1) on depression, pain, and misuse, (2) depression on misuse, and (3) pain on misuse.
The final Aim will explore latent transitions of baseline to post-intervention misuse classes by intervention group.
This will be accomplished by using mixture modeling, specifically multi-group latent transition analysis.
The observed misuse indicators will be used to estimate latent class transitions across time, grouping by treatment condition and adjusting for baseline covariates.
Completing SA1- 3 advance the understanding of BI-MTM efficacy and set the stage for a national multisite trial.
Study Type
Interventional
Enrollment (Estimated)
350
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Utah
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Salt Lake City, Utah, United States, 84108
- University of Utah
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Adult (≥18 years)
- English speaking
- Not receiving cancer treatment
- Who have a positive opioid misuse screen on the POMI will be eligible to learn about this study
Exclusion Criteria:
- Are pregnant (given potential pre/post-natal opioid use complications among pregnant women/offspring
- Can-not provide collateral contact information for ≥2 contact persons (to ensure consistent contact/follow up)
- Do not have a reliable land line or mobile phone to be contacted by study staff
- Are filling only buprenorphine (given some formulations are not indicated for pain)
- Plan to leave the area for an extended period of time in the next 6 months
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Brief Intervention Medication Therapy Management (BI-MTM)
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.
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PN involves 8 weekly telephonic sessions lasting 30-45 minutes (telephonic to support lower-costs/sustainability).
In session 1, the navigator reviews with the participant a report of scores from the baseline assessment to understand the participant's current health needs/challenges; session 1 also involves development of therapeutic alliance/rapport and goal setting.
Sessions 2-4 focus on goal setting and identifying barriers and problem resolutions.
The navigator elicits motivation and discusses this in context of readiness to change heath behavior and self-management skills.
Sessions 2-4 also involve navigators supporting/assisting patients to fill out paperwork and enroll in needed social services and/or mental/behavioral/physical healthcare, including but not limited to primary care.
Sessions 5-7 focus on encouraging and reinforcing treatment adherence, review-ing and identifying other care needs, and offering linkages to service providers as applicable
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Other: Standard of Care
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.
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SMC participants receive a single medication information/counseling session delivered by a University of Utah pharmacist to: (1) offer counseling, (2) document counseling was offered, (3) offer a counseling process for patients not present (not applicable to this study given all patients must screen in person), and (4) discuss generic substitution.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change in opioid medication misuse.
Time Frame: 6 months
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This outcome will be assessed using the Prescription Opioid Misuse Index (POMI).
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6 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Gerald Cochran, PhD, University of Utah
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 8, 2021
Primary Completion (Actual)
June 19, 2026
Study Completion (Estimated)
July 1, 2027
Study Registration Dates
First Submitted
November 8, 2021
First Submitted That Met QC Criteria
November 18, 2021
First Posted (Actual)
December 2, 2021
Study Record Updates
Last Update Posted (Actual)
July 17, 2026
Last Update Submitted That Met QC Criteria
July 15, 2026
Last Verified
July 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 141016
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
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