Connecticut Mental Health Center, Clinical Neuroscience Research Unit
New Haven, Connecticut, 06519, United States
NCT Number: NCT07800520
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.
Trial opening soon.
Get Notified25 year–65 year
All sexes
Interventional
Phase 1
New Haven, Connecticut, 06519, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
All
OUD Participants:
Healthy Controls:
Exclusion criteria
All
OUD Participants
Healthy Controls:
For each [11C]OMAR PET scan, up to 20 mCi of [11C]OMAR will be administered.
Other names: [11C] JHU75528
Time frame: Day 7
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: Days 7, 28, 49, 70, 90
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
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
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, 14, 21, 28, 35, 42, 49, 56, 70, 77, 84, 90
Mean Opioid Relapse days assessed using Timeline Follow Back (TLFB)
Contact information is provided by the study sponsor or research team.
Abigail Dewey
CONTACT
Anahita Bassir Nia, MD
CONTACT
Yale University
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07795840
Chemically-Induced Disorders, Mental Disorders
Ann Arbor, Michigan, United States
View Trial DetailsNCT07435077
Acute Pain, Agnosia
Winston-Salem, North Carolina, United States
View Trial DetailsNCT07770555
Behavior, Chemically-Induced Disorders
Pittsburgh, Pennsylvania, United States
View Trial DetailsNCT06854029
Blood-Borne Infections, Chemically-Induced Disorders
Durham, North Carolina, United States
View Trial Details