A Phase 1 interventional study of [11C]OMAR in Opioid Use Disorder and OAT, sponsored by Yale University. Recruiting at 1 site in United States. Open to participants aged 25 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-02.
Sponsored by Yale University · Phase 1, Interventional, and Diagnostic
Among 106 studies in Opioid-Related Disorders by Yale University — 20 open to participants now, 24 under way, 1 of them phase 3. Opioid-Related Disorders · Yale University.
Among the 106 studies in Opioid-Related Disorders by Yale University, this one is the 40th largest by planned enrollment of the 94 interventional ones that give a count, is one of 8 that started in 2026, is one of 9 in phase 1, reaches primary completion later than 23 of the 23 other live ones, and was the 105th registered.
1,472 studies on the registry are indexed under Opioid-Related Disorders; 290 are open to participants now.
Browse Opioid-Related Disorders studies →20 of the 106 studies in Opioid-Related Disorders by Yale University are open now, in 4 countries. Recruiting first, the newest first:
Yale University · Sites in United States
Yale University · Sites in United States
Yale University · Sites in United States
Yale University · Sites in United States
Yale University · Sites in United States
By country, each count listing its studies:
Of the 210 Opioid-Related Disorders studies recruiting now, 122 (58%) set no upper age limit and 74 (35%) stop at 75 or younger; 14 take children under 18; 52 take healthy volunteers.
This study: 25 Years to 65 Years · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
106 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 13 · Phase 2 26 · Phase 3 7 · Phase 4 9
First in 1988; this study’s year is marked. 8 started in 2026.
This study's planned enrollment of 110 is above the median of 63 across 1,166 interventional studies indexed under Opioid-Related Disorders.
Median enrollment 62 across the 94 interventional studies, 108 across the 11 observational. Of the 75 that completed or were terminated, 26 (35%) have results posted.
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Yale University is the lead sponsor of 1,770 studies on the registry; 294 are open to participants now.
Of its 221 completed or terminated interventional studies of FDA-regulated products, 129 (58%) have results posted.
10 of the studies in Opioid-Related Disorders by Yale University that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06494904Phase 3Yale UniversityStandard Versus High Dose ED-Initiated Buprenorphine Induction | 2027-09 |
| NCT05333341Yale UniversityPain Care at Home to Amplify Function (Pain CHAMP) | 2026-11-30 |
| NCT01730781Yale UniversityImaging Cannabinoid Receptors Using Positron Emission Tomography (PET) Scanning | 2026-12 |
| NCT06160284Yale UniversityExploration of Synaptotrophic Effects of Psilocybin in Opioid Use Disorder (OUD) | 2027-01 |
| NCT06207162Yale UniversityLongitudinal Neural Fingerprinting of Opioid-use Trajectories | 2027-01 |
Among the 106 studies in Opioid-Related Disorders by Yale University, from their registry updates:
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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.
Investigators will use PET imaging to investigate CB1R availability in treatment-seeking individuals with OUD during the early phase of OAT, compared to healthy controls (HCs). Using PET imaging with the CB1R-specific radioligand [¹¹C]OMAR, investigators will assess CB1R availability in predefined brain regions. Investigators will characterize group differences in CB1R availability, evaluate the relationship between CB1R alterations and negative emotional states, including mood, anxiety, and perceived stress, as well as risk of opioid relapse (defined as time to first use of non-prescribed opioids) over a 90-day follow-up period.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
All
OUD Participants:
Healthy Controls:
Exclusion Criteria:
All
OUD Participants
Healthy Controls:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Healthy volunteers with no current or past major medical or psychiatric history
Drug: [11C]OMAR
Patients diagnosed with opioid use disorder during the early phase of opioid agonist therapy
Drug: [11C]OMAR
For each \[11C\]OMAR PET scan, up to 20 mCi of \[11C\]OMAR will be administered.
Also known as: [11C] JHU75528
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Days 7, 28, 49, 70, 90
Mean Opioid Relapse days
Mean Opioid Relapse days assessed using Timeline Follow Back (TLFB)
Time frame: Days 7, 14, 21, 28, 35, 42, 49, 56, 70, 77, 84, 90
Plan to share: No
No publications or documents are linked to this record.
Started Oct 2026 (actual). Primary completion is estimated for Aug 2030, 46 months after the start.
Of 53 non-industry phase 1 interventional studies under Opioid-Related Disorders, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 47. This study's planned 46 months is above that.
Counting every sponsor, half of 77 studies reached it within 19 months; a quarter within 9 and three quarters within 33.
Start moved once since we started tracking on Sep 25, 2026: Sep 2026 → Oct 2026, on Oct 2, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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