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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
HOPE Trial 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.Check my eligibility
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.See study design
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.
HOPE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
I am not currently undergoing any cancer treatment.
HOPE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in opioid medication misuse.
HOPE 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
2,468 Previous Clinical Trials
2,618,998 Total Patients Enrolled
16 Trials studying Opioid Abuse
338,788 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
Research Study Groups:
This trial has the following groups:- Group 1: Standard of Care
- Group 2: Brief Intervention Medication Therapy Management (BI-MTM)
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this experiment have any ongoing recruitment?
"This study, which was initially posted on November 8th 2021, is still recruiting participants. According to information hosted on clinicaltrials.gov the trial has been updated as recently as December 1st 2021."
Answered by AI
What is the current population of participants in this trial?
"Affirmative. According to information posted on clinicaltrials.gov, this medical trial is presently searching for participants and was first made available on November 8th 2021. It requires 350 patients from one site alone before it can move forward."
Answered by AI
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