CB1 Receptors in Opioid Use Disorder Measured with a PET Radioligand

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 1 sub-study uses PET imaging with the CB1R-specific radioligand [11C]OMAR to measure CB1 receptor availability in brain regions of treatment-seeking individuals with OUD during early OAT stabilization, compared with matched healthy controls. Researchers will examine how CB1R levels relate to mood, anxiety, perceived stress, and relapse risk (time to first non-prescribed opioid use) over 90 days. The study will characterize group differences in CB1R availability and explore potential links to emotional states and relapse outcomes. All participants undergo arterial sampling as part of the PET procedure, and safety screening ensures suitability for imaging.

Why it matters

Who can join: the full rules

Inclusion Criteria:

All

* Normal screening bloodwork.
* Adequate arterial access for placement of an arterial line and blood sampling per study protocol.

OUD Participants:

* Diagnosis of opioid use disorder (OUD) according to DSM-5 criteria.
* Actively seeking treatment for OUD.
* Willingness to initiate opioid agonist therapy (OAT) with buprenorphine.

Healthy Controls:

* Good general physical health.
* No current or past diagnosis of any psychiatric or substance use disorders.

Exclusion Criteria:

All

* Any current major medical condition that, in the opinion of the Principal Investigator, poses a risk for PET procedures.
* Prior participation in research studies within the past year that would result in cumulative radiation exposure exceeding annual limits.
* Presence of ferromagnetic metal in the body, pacemaker, or other contraindications to MRI.
* Positive pregnancy test or current lactation.
* History of neurological conditions, including stroke or seizure disorders.
* Hematocrit values lower than 30

OUD Participants

* Current or past diagnosis of a serious psychiatric disorder.
* Current diagnosis of any substance use disorder other than nicotine or opioids.
* Use of any substances within the past 30 days.
* Current use of SSRIs or benzodiazepines or use within the past 30 days.
* Previous enrollment in the main study.

Healthy Controls:

* Current or past diagnosis of any psychiatric disorder.
* Current diagnosis of any substance use disorder (excluding nicotine).
* Use of any substances within the past 30 days.

Where it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.