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Opioid Prescription Engagement for Opioid Use Disorder (HOPE Trial)

N/A
Recruiting
Led By Gerald Cochran, PhD
Research Sponsored by Jerry Cochran
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Adult (≥18 years)
Not receiving cancer treatment
Must not have
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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
No Placebo-Only Group

Summary

This trial will test a new intervention to help address the opioid epidemic by preventing opioid use disorder and overdose.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Since this trial focuses on counseling methods rather than medications, traditional side effects like you'd expect from drugs are not applicable here. However, participants may experience emotional discomfort discussing their opioid use.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I am not currently undergoing any cancer treatment.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have a phone for study staff to contact me.
Select...
I am currently only taking buprenorphine for my condition.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in opioid medication misuse.

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Standard of CareExperimental Treatment1 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 Treatment1 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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Patient Navigation
2017
Completed Phase 2
~38910

Find a Location

Who is running the clinical trial?

National Institute on Drug Abuse (NIDA)NIH
2,576 Previous Clinical Trials
3,286,065 Total Patients Enrolled
17 Trials studying Opioid Abuse
339,024 Patients Enrolled for Opioid Abuse
Jerry CochranLead Sponsor
1 Previous Clinical Trials
362 Total Patients Enrolled
1 Trials studying Opioid Abuse
362 Patients Enrolled for Opioid Abuse
Gerald Cochran, PhDPrincipal InvestigatorUniversity of Utah
1 Previous Clinical Trials
106 Total Patients Enrolled

Media Library

Opioid Abuse Research Study Groups: Standard of Care, Brief Intervention Medication Therapy Management (BI-MTM)
~100 spots leftby Jan 2026
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