Recruiting
Phase 1

OMAR

Sponsor:

Yale University

Code:

NCT05683184

Conditions

Healthy Control

Opioid Use Disorder

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

[11C]OMAR

Study Details

Brief summary:

The goal of this research study is to examine the endocannabinoid (eCB) function in vivo in individuals with opioid use disorder (OUD) by measuring cannabinoid receptor 1 (CB1R) availability.

Conditions

Healthy Control

Opioid Use Disorder

Study ID

NCT05683184

Start date

Mar 10, 2023

Status verified date

Aug, 2026

Completion date

Dec 15, 2027

Anticipated

Primary completion date

Dec 15, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

30 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

other: Healthy Volunteers

Healthy volunteers with no current or past major medical or psychiatric history

other: Opioid Use Disorder

Patients diagnosed with opioid use disorder

Interventions

[11C]OMAR

For each \[11C\]OMAR PET scan, up to 20 mCi of \[11C\]OMAR will be administered.

Primary outcome measure

  • CB1R Availability [ Time Frame: One time within 4 weeks of screening ]

Central Contacts and Locations

Central contacts

Anahita Bassir Nia, MD

203-974-7540anahita.bassirnia@yale.edu

Abby Dewey

475-441-4190abigail.dewey@yale.edu

Locations

Connecticut Mental Health Center, Clinical Neuroscience Research Unit

Recruiting

New Haven, Connecticut, United States, 06519

Contacts

Abby Dewey

475-441-4190abigail.dewey@yale.edu

Principal Investigator:

Anahita Bassir Nia, MD

More Information

Sponsor

Yale University

Last update posted

Sep 1, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Yale University on 2026-09-01.