Characterization of CB1 Receptors Using [11-C]OMAR in Opioid Use Disorder

NCT07800520 | Recruiting Phase 1 FDA Drug

• 2 other identifiers: 2000033525_a1R01DA063712-01A1
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (5)

• CB1R Availability

  To compare cortical CB1R availability (volume of distribution, mL/cm3) assessed using brain PET imaging in individuals diagnosed with opioid use disorder on chronic methadone maintenance vs. matched healthy controls.

  Day 7

• Mean Beck Depression Inventory (BDI) score

  A 21-question self-report tool to assess depression symptoms. Total score range 0 to 63, higher scores indicating more severe symptoms.

  Days 7, 28, 49, 70, 90

• Mean Anxiety Inventory (BAI) score

  A 21-question self-report tool to assess anxiety symptoms. Total score range 0 to 63, higher scores indicating more severe anxiety.

  Days 7, 28, 49, 70, 90

• Mean Perceived Stress Scale (PSS) score

  The PSS is a 10-item self- report scale. PSS scores are obtained by reversing responses to the four positively stated items (items 4, 5, 7, \& 8) and then summing across all scale items. Total score range from 0-40 with higher scores indicate greater levels of stress.

  Days 7, 28, 49, 70, 90

• Mean Opioid Relapse days

  Mean Opioid Relapse days assessed using Timeline Follow Back (TLFB)

  Days 7, 14, 21, 28, 35, 42, 49, 56, 70, 77, 84, 90

Study Arms (2)

Healthy Volunteers

OTHER

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

Drug: [11C]OMAR

Opioid Use Disorder in Opioid Agonist Therapy (OAT)

OTHER

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

Drug: [11C]OMAR

Interventions

[11C]OMAR DRUG

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

Also known as: [11C] JHU75528

Healthy Volunteers; Opioid Use Disorder in Opioid Agonist Therapy (OAT)

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yale University: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Connecticut Mental Health Center, Clinical Neuroscience Research Unit

New Haven, Connecticut, 06519, United States

RECRUITING

MeSH Terms

Conditions

Opioid-Related Disorders

Interventions

4-cyano-1-(2,4-dichlorophenyl)-5-(4-methoxyphenyl)-N-(piperidin-1-yl)-1H-pyrazole-3-carboxamide

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Anahita Bassir Nia, MD

  Yale University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anahita Bassir Nia, MD

CONTACT

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

Abigail Dewey

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Psychiatry

Study Record Dates

• First Submitted: August 28, 2026
• First Posted: September 2, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): August 1, 2030
• Study Completion (Estimated): August 1, 2030
• Last Updated: October 2, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)