Status:
TERMINATED
Brain Mechanisms of Pharmacotherapy in Opioid Use Disorder
Lead Sponsor:
University of Pennsylvania
Conditions:
Opioid Dependence
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
This study will investigate the mechanisms of cognitive-behavioral response to medications used for relapse prevention in opioid use disorder (opioid addiction, OUD), through investigation of the neur...
Detailed Description
This proposal seeks to identify the neural circuits underlying the cognitive effects of medication assisted therapy (MAT) for OUD. The study will examine the neurocognitive effects of MAT by comparing...
Eligibility Criteria
Inclusion
- Males and Females
- 18-65 Years old
- OUD by DSM5 Criteria, confirmed by history and physical examination including urine toxicology, medical records and self-report
- Opioids are the drug of choice
- Interested in injectable extended release agonist or antagonist treatment
- Have a stable address, working command of English language, and telephone access.
- Women of childbearing age must use an effective contraceptive
Exclusion
- Psychiatric Co-morbidities:
- Lifetime diagnoses of any psychotic disorder, e.g. schizophrenia, schizoaffective disorder, bipolar disorder type 1.
- Psychiatric Co-morbidities: Psychiatric disorders requiring current medication treatment, e.g. moderate to severe depression. Mild to moderate Depressive and Anxiety disorders and Attention Deficit Hyperactivity Disorder that do not require prescription stimulants and DSM5 Cluster B and C personality disorders are also allowed.
- Polysubstance users whose drug of choice is not opioids.
- Contraindications for XRNTX or XRBUP e.g. active liver disease.
- Medical and surgical conditions such as malignancy that may affect patients' ability to receive XRNTX or XRBUP treatment because it may interfere with opioid analgesia
- Contraindications for MRI, e.g. claustrophobia, indwelling foreign magnetic agents.
Key Trial Info
Start Date :
August 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 31 2024
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT04454411
Start Date
August 1 2022
End Date
August 31 2024
Last Update
August 6 2025
Active Locations (1)
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1
3535 Market Street, Suite 4100, University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104