OMAR Opioid Use Disorder
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorYale University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
[11C]OMAR
DrugFor each \[11C\]OMAR PET scan, up to 20 mCi of \[11C\]OMAR will be administered.
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: Healthy VolunteersOther 1 intervention
Group B: Opioid Use DisorderOther 1 intervention
Trial outcomes
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.
Time frame
One time within 4 weeks of screeningSecondary outcomes
1
Serum Endocannabinoid Levels
To explore group differences in serum endocannabinoid levels in individuals diagnosed with opioid use disorder on chronic methadone maintenance vs. matched healthy controls.
Time frame
One time within 4 weeks of screeningSponsors 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