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Pharmacist-Integrated Care for Opioid Use Disorder (PharmICO Trial)
N/A
Waitlist Available
Led By Lisa A Marsch, PhD
Research Sponsored by Trustees of Dartmouth College
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months pre-model launch through 12 months post-model launch
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to see if including pharmacists in the healthcare team can improve treatment for patients with opioid addiction. It will test this approach in several outpatient clinics to see how well it works and how acceptable it is to both patients and staff.
Who is the study for?
This trial is for adults over 18 who work at a clinic as providers, pharmacists, technicians, or administrators. It's also for adult patients at these clinics who are receiving or have received medication treatment for opioid use disorder (MOUD) and have been exposed to the PrIMO model. Participants must not be incarcerated or facing legal issues that prevent study involvement.
What is being tested?
The trial is testing a new way of treating opioid addiction by integrating pharmacists into the care team. This Phase 1 project will assess how feasible and acceptable it is to implement this pharmacist-integrated model in diverse outpatient clinical settings.
What are the potential side effects?
Since this trial focuses on implementing a service model rather than a specific medical intervention, traditional side effects like those seen with medications are not applicable here.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 months pre-model launch through 12 months post-model launch
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months pre-model launch through 12 months post-model launch
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Stages of Implementation Completion (SIC) Tool
Secondary study objectives
Applied Mental Health Research Dissemination & Implementation (AMHR) Tool
Beliefs on MOUD Modified
Clinical Sustainability Assessment Tool for PrIMO
+5 moreAwards & 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: Site StaffExperimental Treatment1 Intervention
Providers, Pharmacists, Pharmacy Technicians, Administrators to receive survey assessments
Group II: PatientsExperimental Treatment1 Intervention
Subset of patients receiving PrIMO care to receive survey assessments
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Substance Use Disorder, particularly opioid use disorder, include medications such as methadone, buprenorphine, and naltrexone. Methadone and buprenorphine are opioid agonists that work by binding to the same receptors in the brain as other opioids, reducing cravings and withdrawal symptoms without producing the same high, thus helping to stabilize the patient.
Naltrexone is an opioid antagonist that blocks opioid receptors, preventing the euphoric effects of opioids and reducing the risk of relapse. These mechanisms are crucial for SUD patients as they help manage withdrawal symptoms, reduce cravings, and prevent relapse, thereby supporting long-term recovery.
Integrating pharmacists into the care model can enhance access to these medications and ensure better adherence, ultimately improving treatment outcomes.
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Who is running the clinical trial?
Trustees of Dartmouth CollegeLead Sponsor
29 Previous Clinical Trials
11,341 Total Patients Enrolled
National Institute on Drug Abuse (NIDA)NIH
2,593 Previous Clinical Trials
3,328,547 Total Patients Enrolled
Lisa A Marsch, PhDPrincipal InvestigatorGeisel School of Medicine at Dartmouth College
5 Previous Clinical Trials
2,147 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 or older and have been treated with MOUD at a clinic using the PrIMO model for at least 14 days.I am over 18 and work at the clinic in a key role.
Research Study Groups:
This trial has the following groups:- Group 1: Patients
- Group 2: Site Staff
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.