[11C]OMAR for Opioid Use Disorder

AB
AD
Overseen ByAbigail Dewey
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: Yale University
Must be taking: Buprenorphine
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to study how a brain receptor called CB1R functions in individuals with opioid use disorder (OUD) who are beginning opioid agonist therapy (OAT), compared to healthy individuals. The treatment uses a special imaging technique with [11C]OMAR, a radiotracer, to visualize brain activity. The trial seeks two groups: individuals seeking treatment for OUD who are ready to start buprenorphine therapy, and healthy volunteers with no history of major medical or psychiatric issues. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants an opportunity to contribute to groundbreaking research.

Is there any evidence suggesting that [11C]OMAR is likely to be safe for humans?

Research has shown that [11C]OMAR has been tested in people before. In these studies, participants generally tolerated [11C]OMAR well, with most not experiencing serious side effects. Some mild side effects occurred, but they were uncommon, and most participants felt fine after treatment. It's important to note that [11C]OMAR is currently in a Phase 1 trial, primarily focusing on its safety. So far, evidence suggests that [11C]OMAR is safe for humans, but further research is needed to confirm this.

Why are researchers excited about this trial?

Researchers are excited about [11C]OMAR because it offers a novel approach to understanding opioid use disorder (OUD). Unlike current standard treatments like methadone or buprenorphine that primarily work by substituting or blocking opioids, [11C]OMAR is a radiotracer used in PET scans to visualize brain activity related to opioid receptors. This unique feature helps researchers visualize and better understand the brain changes in OUD, potentially leading to more targeted therapies in the future. By providing insights into the neurological aspects of addiction, [11C]OMAR could pave the way for breakthroughs in treatment strategies.

What evidence suggests that [11C]OMAR might be an effective treatment for opioid use disorder?

This trial investigates how a substance called [11C]OMAR can enhance understanding of the endocannabinoid (eCB) system in individuals with opioid use disorder (OUD). The eCB system might play a role in addiction, prompting scientists to explore whether targeting it could aid in treating OUD. Although limited information exists on [11C]OMAR's effectiveness in humans, researchers are studying its potential effects on brain functions related to addiction. Early results suggest that understanding this system better could lead to new recovery support methods for OUD. Further research will determine if this approach can truly improve treatment. Participants in this trial include healthy volunteers and individuals with OUD during the early phase of opioid agonist therapy.12345

Who Is on the Research Team?

AB

Anahita Bassir Nia, MD

Principal Investigator

Yale University

Are You a Good Fit for This Trial?

This study is for adults who have recently stopped using opioids and are stable on opioid treatment, as well as healthy people without opioid use disorder. Participants should not have major health issues or allergies that could interfere with the study.

Inclusion Criteria

All: Normal screening bloodwork
All: Adequate arterial access for placement of an arterial line and blood sampling per study protocol
I am willing to start buprenorphine treatment for opioid use disorder.
See 4 more

Exclusion Criteria

OUD Participants: Previous enrollment in the main study
All: Any current major medical condition that poses a risk for PET procedures as per Principal Investigator
OUD Participants: Current or past diagnosis of a serious psychiatric disorder
See 10 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo PET imaging to assess CB1R availability during early opioid agonist therapy

7 days
1 visit (in-person)

Follow-up

Participants are monitored for CB1R availability, mood, anxiety, stress, and opioid relapse over a 90-day period

90 days
Multiple visits (in-person) on Days 7, 28, 49, 70, 90

What Are the Treatments Tested in This Trial?

Interventions

  • [11C]OMAR

Trial Overview

The trial uses a special brain scan called PET imaging with [11C]OMAR to measure CB1 receptors in the brain of people recovering from opioid use disorder compared to healthy controls.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: Opioid Use Disorder in Opioid Agonist Therapy (OAT)Experimental Treatment1 Intervention
Group II: Healthy VolunteersExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials
1,963
Recruited
3,046,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials
2,658
Recruited
3,409,000+

Citations

Opioid use disorder: current trends and potential treatments

The most favorable outcomes are associated with extended duration of MOUD therapy. However, treatment drop out and relapses are common. When OUD ...

States Should Measure Opioid Use Disorder Treatment to ...

Studies have shown that long-term treatment can lead to better outcomes in employment, health, and criminal justice involvement.28

Treatment for Opioid Use Disorder: Population Estimates

In 2022, among the 4% of U.S. adults who needed OUD treatment, only 25% received recommended medications. A larger percentage (30%) received ...

OMAR Opioid Use Disorder | Clinical Research Trial Listing

The goal of this research study is to examine the endocannabinoid (eCB) function in vivo in individuals with opioid use disorder (OUD) ...

A brain imaging study | Clinical Trials

The purpose of the study is to examine the endocannabinoid (eCB) function in individuals with Opioid Use Disorder (OUD) who take methadone ...