NCT05683184

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
8mo left

Started Mar 2023

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress84%
Mar 2023Dec 2026

First Submitted

Initial submission to the registry

December 20, 2022

Completed
24 days until next milestone

First Posted

Study publicly available on registry

January 13, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

March 10, 2023

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2026

Last Updated

April 28, 2026

Status Verified

April 1, 2026

Enrollment Period

3.8 years

First QC Date

December 20, 2022

Last Update Submit

April 26, 2026

Conditions

Opioid Use DisorderHealthy Control

Outcome Measures

Primary Outcomes (1)

  • CB1R Availability

    To compare cortical CB1R availability in individuals diagnosed with opioid use disorder on chronic methadone maintenance vs. matched healthy controls.

    One time within 4 weeks of screening

Secondary Outcomes (1)

  • Serum Endocannabinoid Levels

    One time within 4 weeks of screening

Study Arms (2)

Healthy Volunteers

OTHER

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

Drug: [11C]OMAR

Opioid Use Disorder

OTHER

Patients diagnosed with opioid use disorder

Drug: [11C]OMAR

Interventions

[11C]OMARDRUG

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

Also known as: [11C] JHU75528
Healthy VolunteersOpioid Use Disorder

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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 DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Anahita Bassir Nia, MD

    Yale University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Anahita Bassir Nia, MD

CONTACT

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

Angelina Contreras

CONTACT

203-626-1105angelina.contreras@yale.edu

Study Design

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

Study Record Dates

First Submitted

December 20, 2022

First Posted

January 13, 2023

Study Start

March 10, 2023

Primary Completion (Estimated)

December 15, 2026

Study Completion (Estimated)

December 15, 2026

Last Updated

April 28, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)