Examining cannabinoid receptor function in opioid use disorder
Characterization of CB1 Receptors Using [11-C]OMAR in Opioid Use Disorder
This study is trying to see how cannabinoid receptors work in the brains of people with opioid use disorder compared to healthy individuals.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Yale University Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (New Haven, Connecticut) |
| Trial ID | NCT05683184 on ClinicalTrials.gov |
What this trial studies
This research aims to investigate the function of endocannabinoids in individuals with opioid use disorder by measuring the availability of cannabinoid receptor 1 (CB1R) using Positron Emission Tomography (PET) imaging. Participants will include both healthy individuals and those diagnosed with opioid use disorder, who will undergo screening, MRI, PET scans, and follow-up visits. The study utilizes the radioligand [11C] OMAR to assess brain cannabinoid receptors in vivo.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with a DSM-5 diagnosis of opioid use disorder who are physically healthy.
Not a fit: Patients with current neuro-psychiatric illnesses or severe systemic diseases, as well as those with claustrophobia, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to a better understanding of the role of endocannabinoids in opioid use disorder, potentially informing new treatment strategies.
How similar studies have performed: While the specific approach of using [11C] OMAR in this context may be novel, studies examining cannabinoid receptors in relation to substance use disorders have shown promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Able to provide informed consent * Male and female 18 years and older * DSM-5 diagnosis of opioid use disorder (for OUD group) * Physically healthy i.e., no clinically unstable medical conditions * Written informed consent and have capacity to consent and comply with study procedures Exclusion Criteria: * Current neuro-psychiatric illness or severe systemic disease (opioid use disorder is permitted in the OUD group). * Presence of ferromagnetic metal in the body or heart pacemaker * Have had exposure to ionizing radiation that in combination with the study tracer would result in a cumulative exposure that exceeds recommended exposure limits * Are claustrophobic
Where this trial is running
New Haven, Connecticut
- Connecticut Mental Health Center, Clinical Neuroscience Research Unit — New Haven, Connecticut, United States (Recruiting)
Study contacts
- Principal investigator: Anahita Bassir Nia, MD — Yale University
- Study coordinator: Anahita Bassir Nia, MD
- Email: anahita.bassirnia@yale.edu
- Phone: 203-974-7540
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.