Health TrialsbyHealthPanel

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

ConditionsOpioid Use DisorderOAT
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age25-65
SponsorYale University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Normal screening bloodwork.

Adequate arterial access for placement of an arterial line and blood sampling per study protocol.

Diagnosis of opioid use disorder (OUD) according to DSM-5 criteria.

Actively seeking treatment for OUD.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • [11C]OMAR

    Drug

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

Treatment groups

110 Participants
are divided into 2 treatment groups
Group A: Healthy VolunteersOther 1 intervention
Group B: Opioid Use Disorder in Opioid Agonist Therapy (OAT)Other 1 intervention

Trial outcomes

Primary outcomes

1

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
2

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
3

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
4

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

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Yale University

Lead sponsor

National Institute on Drug Abuse (NIDA)

Collaborator

Source ClinicalTrials.gov
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