Brain Mechanisms of Pharmacotherapy in Opioid Use Disorder

• Status: Not yet recruiting
• Trial end date: 2027-01-01
• Target enrollment: 0
• Participant gender: All

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 neural circuits underlying key cognition functions. The study will use previously validated cognitive probes, functional Magnetic Resonance Imaging (fMRI), and novel extended-release injectable preparations of opioid partial agonist buprenorphine and antagonist naltrexone, in OUD patients to explain the individual heterogeneity of OUD treatment response.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Pennsylvania
• Treatments: Buprenorphine; Naltrexone

Criteria

Inclusion Criteria:

1. Males and Females

2. 18-65 Years old

3. OUD by DSM5 Criteria, confirmed by history and physical examination including urine toxicology, medical records and self-report

4. Opioids are the drug of choice

5. Interested in injectable extended release agonist or antagonist treatment

6. Have a stable address, working command of English language, and telephone access.

7. Women of childbearing age must use an effective contraceptive

Exclusion Criteria:

1. Psychiatric Co-morbidities:

1. Lifetime diagnoses of any psychotic disorder, e.g. schizophrenia, schizoaffective disorder, bipolar disorder type 1.

2. 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.

3. Polysubstance users whose drug of choice is not opioids.

2. Contraindications for XRNTX or XRBUP e.g. active liver disease.

3. 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

4. Contraindications for MRI, e.g. claustrophobia, indwelling foreign magnetic agents.