OAT, Opioid Use Disorder
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DRUG[11C]OMAR
For each \[11C\]OMAR PET scan, up to 20 mCi of \[11C\]OMAR will be administered.
Sponsors
Yale University
National Institute on Drug Abuse (NIDA)
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
25 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
All * Normal screening bloodwork. * Adequate arterial access for placement of an arterial line and blood sampling per study protocol. OUD Participants: * Diagnosis of opioid use disorder (OUD) according to DSM-5 criteria. * Actively seeking treatment for OUD. * Willingness to initiate opioid agonist therapy (OAT) with buprenorphine. Healthy Controls: * Good general physical health. * No current or past diagnosis of any psychiatric or substance use disorders.
Exclusion criteria
All * 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. * History of neurological conditions, including stroke or seizure disorders. * Hematocrit values lower than 30 OUD Participants * Current or past diagnosis of a serious psychiatric disorder. * Current diagnosis of any substance use disorder other than nicotine or opioids. * Use of any substances within the past 30 days. * Current use of SSRIs or benzodiazepines or use within the past 30 days. * Previous enrollment in the main study. Healthy Controls: * Current or past diagnosis of any psychiatric disorder. * Current diagnosis of any substance use disorder (excluding nicotine). * Use of any substances within the past 30 days.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| CB1R Availability | 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. |
| Mean Beck Depression Inventory (BDI) score | 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. |
| Mean Anxiety Inventory (BAI) score | 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. |
| Mean Perceived Stress Scale (PSS) score | 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. |
| Mean Opioid Relapse days | Days 7, 14, 21, 28, 35, 42, 49, 56, 70, 77, 84, 90 | Mean Opioid Relapse days assessed using Timeline Follow Back (TLFB) |
Countries
United States
Contacts
CONTACTAnahita Bassir Nia, MD
CONTACTAbigail Dewey
PRINCIPAL_INVESTIGATORAnahita Bassir Nia, MD
Yale University
Outcome results
None listed