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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.

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I am currently only taking buprenorphine for my condition.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

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

0 / 4Eligibility criteria met