Recruiting
Phase 1

CB1R Availability

Sponsor:

Yale University

Code:

NCT07800520

Conditions

Opioid Use Disorder

OAT

Eligibility Criteria

Sex: All

Age: 25 - 65

Healthy Volunteers: Accepted

Interventions

[11C]OMAR

Study Details

Brief summary:

The goals of this sub-study is to assess CB1R availability in early abstinent individuals with OUD (following opioid agonist therapy - OAT stabilization) and in matched healthy controls.

Conditions

Opioid Use Disorder

OAT

Study ID

NCT07800520

Start date

Oct 1, 2026

Status verified date

Oct, 2026

Completion date

Aug, 2030

Anticipated

Primary completion date

Aug, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 25 - 65

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

110 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

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 in Opioid Agonist Therapy (OAT)

Patients diagnosed with opioid use disorder during the early phase of opioid agonist therapy

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: Day 7 ]
  • Mean Beck Depression Inventory (BDI) score [ Time Frame: Days 7, 28, 49, 70, 90 ]
  • Mean Anxiety Inventory (BAI) score [ Time Frame: Days 7, 28, 49, 70, 90 ]
  • Mean Perceived Stress Scale (PSS) score [ Time Frame: Days 7, 28, 49, 70, 90 ]
  • Mean Opioid Relapse days [ Time Frame: Days 7, 14, 21, 28, 35, 42, 49, 56, 70, 77, 84, 90 ]

Central Contacts and Locations

Central contacts

Anahita Bassir Nia, MD

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

Abigail Dewey

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

Locations

Connecticut Mental Health Center, Clinical Neuroscience Research Unit

Recruiting

New Haven, Connecticut, United States, 06519

Contacts

Abigail Dewey

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

Principal Investigator:

Anahita Bassir Nia, MD

More Information

Sponsor

Yale University

Last update posted

Oct 2, 2026

Last verified

Oct, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-03. This information was provided to ClinicalTrials.gov by Yale University on 2026-10-02. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.