Overview

Open Label Comparison of Injectable Buprenorphine ( Brixadi®) and Naltrexone (Vivitrol®) for Opioid Use Disorder

Status:
Not yet recruiting

Trial end date:
2028-07-01

Target enrollment:
0

Participant gender:
All

Summary

This project aims to elucidate the brain effects of opioid use disorder (OUD) treatments. The study will investigate the cognitive effects of extended-release preparations of a partial opioid agonist and an antagonist. To this end, the study will use up to three monthly injections of buprenorphine (XRBUP, Brixadi®) and naltrexone (XRNTX, Vivitrol®). Domain-specific brain activity will be induced by cognitive tasks and recorded with Magnetic Resonance Imaging. Participants will be imaged at baseline and in the interval between the 1st and 2nd injection and followed for up to three months.

Phase:

Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

University of Pennsylvania

Treatments:

Buprenorphine
Naltrexone

Criteria

Inclusion Criteria

1. 18-65 Years old

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

3. Opioids are the drug of choice

4. Interested in either injectable extended release agonist or antagonist treatment

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

Exclusion Criteria

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

2. Psychiatric disorders requiring current medication treatment, e.g. moderate to severe
depression, with the exception of mild to moderate Depressive and Anxiety disorders
and Attention Deficit Hyperactivity Disorder that does not require prescription
stimulants.

3. Polysubstance users whose drug of choice is not an opioid.

4. Medical contraindications for the study medications, e.g. active liver disease.

5. 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.

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

7. Women of childbearing age who do not use an effective contraceptive.