[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 explore the functioning of the brain's natural cannabinoid system in individuals with opioid use disorder (OUD). Researchers will measure the availability of cannabinoid receptors—places in the brain where cannabinoids attach—using a special imaging method. The treatment involves [11C]OMAR, a compound that helps visualize these receptors. Ideal candidates for this trial are those diagnosed with OUD who do not have other major health issues and can manage study procedures. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative treatment.
Do I need to stop my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team.
Is there any evidence suggesting that [11C]OMAR is likely to be safe for humans?
Research has shown that [11C]OMAR is used in brain imaging studies to examine cannabinoid receptors. These studies employ PET scans to observe receptor function in individuals. In past research involving individuals with cannabis use disorder, [11C]OMAR demonstrated changes in receptor activity without major side effects. Other studies have also investigated receptor activity and reported no significant safety concerns.
Since [11C]OMAR is in an early phase trial, the primary goal is to assess its safety in humans. Although detailed safety information remains limited, researchers are closely monitoring for any side effects to ensure safety. So far, research has not identified any serious safety issues, which is encouraging. However, further studies are necessary to fully understand its safety profile.12345Why are researchers excited about this trial?
Most treatments for opioid use disorder, like methadone or buprenorphine, work by binding to opioid receptors to reduce withdrawal symptoms and cravings. But [11C]OMAR offers a different approach by using a radiolabeled compound for imaging purposes, which helps researchers visualize and understand the brain's receptor activity in individuals with opioid use disorder. This could lead to better insights into how the disorder affects the brain and potentially open up new avenues for treatment. Researchers are excited about this because it could pave the way for more targeted therapies in the future, improving outcomes for patients.
What evidence suggests that [11C]OMAR might be an effective treatment for opioid use disorder?
Research has shown that [11C]OMAR is used to study the function of certain brain receptors, known as cannabinoid receptors. These receptors play a role in various brain functions and may be linked to opioid use disorder (OUD). In this trial, researchers will study participants with OUD and healthy volunteers using [11C]OMAR to understand these receptors' functions. While [11C]OMAR does not directly treat OUD, it aids scientists in learning how opioids affect the brain. This knowledge could lead to better treatments in the future. Early findings suggest that studying these receptors could offer valuable insights into managing OUD.678910
Who Is on the Research Team?
Anahita Bassir Nia, MD
Principal Investigator
Yale University
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Imaging
Participants undergo MRI and PET scans to image brain cannabinoid receptors
Follow-up
Participants are monitored for safety and effectiveness after imaging
What Are the Treatments Tested in This Trial?
Interventions
- [11C]OMAR
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Patients diagnosed with opioid use disorder
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
1.
researchgate.net
researchgate.net/publication/8365096_Using_11_CDiprenorphine_to_Image_Opioid_Receptor_Occupancy_by_Methadone_in_Opioid_Addiction_Clinical_and_Preclinical_Studies(PDF) Using [ 11 C]Diprenorphine to Image Opioid ...
Substitute methadone prescribing is one of the main modes of treatment for opioid dependence with established evidence for improved health and social outcomes.
Long-term follow-up assessment of opioid use outcomes ...
Among adults with comorbid opioid use disorder and mental disorders, treatment with buprenorphine–naloxone produced greater reductions in opioid use than ...
Mediating effect of craving on the impact of buprenorphine/ ...
Upon mediation analysis, the average direct effect of treatment on opioid use was 0.465 (95 % CI = 0.183 to 0.751, p < 0.001). The average causal mediated ...
4.
files-profile.medicine.yale.edu
files-profile.medicine.yale.edu/documents/373e57c6-e857-41f6-91a8-51c06aa73a4fThe Connecticut Opioid REsponse (CORE) Initiative
Medications for opioid use disorder (MOUD), particularly methadone and buprenorphine, are the most effective form of treatment for opioid ...
Using Data Science to Improve Outcomes for Persons with ...
Even if patients receive MOUD, 40%-55% of persons discontinue MOUD within a year after initiation, and recent data show a six-fold increase in mortality in the ...
Project Details
Pilot data: Individuals with OUD (n=2) showed 12.76% lower cortical CB1R availability compared to matched historical controls from our repository of [11C]OMAR ...
Biomarkers of the Endocannabinoid System in Substance ...
Another study using [11C]OMAR studied the changes in CB1R availability in women with CUD (n = 10), who displayed significantly lower VT than healthy female ...
Imaging the cannabinoid CB1 receptor in humans with [11C ...
The Radiotracer [(11)C]OMAR was developed for positron emission tomography (PET) imaging of cannabinoid type-1 receptors (CB1R).
9.
researchgate.net
researchgate.net/publication/284018489_Rapid_Changes_in_CB1_Receptor_Availability_in_Cannabis_Dependent_Males_after_Abstinence_from_CannabisRapid Changes in CB1 Receptor Availability in Cannabis ...
For example, females with PTSD show higher CB1R binding ([ 11 C]OMAR, ↑VT globally) [133], while chronic CUD males exhibit reduced binding [121] ...
Opioid Use Disorder (OUD) (DBCOND0110310) - DrugBank
Associated Data ; NCT04785456. rTMS for Suicidality in Opioid Use Disorder, No drug interventions ; NCT05233085. A Safety Study of AZD4041 in Healthy Participants.
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