What side effects are associated with this type of intervention?

The most common treatments for Substance Use Disorder (SUD) include methadone, buprenorphine, and naltrexone. Methadone can cause side effects such as constipation, nausea, vomiting, drowsiness, and respiratory depression. Buprenorphine may lead to headaches, insomnia, constipation, and sweating. Naltrexone can cause nausea, headache, dizziness, and fatigue. All these medications carry a risk of precipitating withdrawal symptoms if not used correctly. It is important for patients to be closely monitored by healthcare providers to manage these side effects effectively.

What prior FDA approvals exist?

The FDA has approved several medications for the treatment of Substance Use Disorder, particularly for opioid use disorder. Key medications include methadone, buprenorphine, and naltrexone. Methadone is a long-acting opioid agonist that reduces withdrawal symptoms and cravings. Buprenorphine, a partial opioid agonist, helps to alleviate withdrawal symptoms and reduce cravings with a lower risk of misuse. Naltrexone, an opioid antagonist, blocks the effects of opioids and is used to prevent relapse. These medications are central to Medication for Opioid Use Disorder (MOUD) programs, which aim to improve access and adherence to treatment, often through integrated care models involving pharmacists.

What other types of research exist?

Promising, novel alternatives to the Pharmacist-Integrated Model of MOUD for SUD patients include: 1) Telemedicine-based MOUD programs, which increase access to treatment through virtual consultations and remote monitoring. 2) Mobile health (mHealth) applications that provide real-time support, medication reminders, and progress tracking. 3) Community-based peer support programs that leverage the experiences of individuals in recovery to provide mentorship and support. 4) Integration of MOUD with primary care settings to offer a holistic approach to patient health. 5) Use of long-acting injectable or implantable formulations of medications like buprenorphine to improve adherence and reduce the need for frequent dosing.

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months pre-model launch through 12 months post-model launch for reporting.

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 more

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: 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

Do I qualify?Apply below to find out

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.