Brain Mechanisms of Pharmacotherapy in Opioid Use Disorder

NCT04454411 | Terminated Phase 2 Results FDA Drug

• 1 other identifier: 843403
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Opioid Dependence

Keywords

naltrexone; buprenorphine; neuroimaging

Outcome Measures

Primary Outcomes (2)

• fMRI Signal

  Brain fMRI response to neurocognitive probes

  up to 90 days

• Urine Toxicology: Opioid

  Rapid semi-quantitative ELISA urine drug screen test for morphine, oxycodone and methadone, followed by (cut off levels): Methadone (MTD) Methadone 300 ng/mL Opiates (OPI 300) Morphine Morphine \*\*300 ng/mL Oxycodone (OXY) Oxycodone 100 ng/mL

  Through the study completion, up to 120 days

Secondary Outcomes (3)

• Anxiety

  Through the study completion, up to 120 days

• Depression

  Through the study completion, up to 120 days

• Non-opioid Urine Toxicology

  Through the study completion, up to 120 days

Study Arms (2)

Buprenorphine

EXPERIMENTAL

Participants assigned to treatment with extended-release buprenorphine

Drug: Brixadi

Naltrexone

ACTIVE COMPARATOR

Participants assigned to treatment with extended-release naltrexone

Drug: Vivitrol

Interventions

Brixadi DRUG

Extended release injectable Buprenorphine

Also known as: Buprenorphine Injectable Product

Buprenorphine

Vivitrol DRUG

Extended release injectable Naltrexone

Also known as: Naltrexone Injectable Product

Naltrexone

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and Females
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

3535 Market Street, Suite 4100, University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders

Interventions

Buprenorphine; vivitrol

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Results Point of Contact

• Title: James Loughead, Ph.D.
• Organization: University of Pennsylvania

loughead@pennmedicine.upenn.edu

215-205-1876

Study Officials

• James Loughead, Ph.D.

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2020
• First Posted: July 1, 2020
• Study Start: August 1, 2022
• Primary Completion: August 31, 2024
• Study Completion: August 31, 2024
• Last Updated: August 6, 2025
• Results First Posted: August 6, 2025

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)