[11C]OMAR for Opioid Use Disorder
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?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo PET imaging to assess CB1R availability during early opioid agonist therapy
Follow-up
Participants are monitored for CB1R availability, mood, anxiety, stress, and opioid relapse over a 90-day period
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
Patients diagnosed with opioid use disorder during the early phase of opioid agonist therapy
Healthy volunteers with no current or past major medical or psychiatric history
Find a Clinic Near You
Who Is Running the Clinical Trial?
Yale University
Lead Sponsor
National Institute on Drug Abuse (NIDA)
Collaborator
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 ...
4.
centerwatch.com
centerwatch.com/clinical-trials/listings/NCT05683184/omar-opioid-use-disorder?phase=2&page=8&state=CT&city=West%20HavenOMAR 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 ...
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