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NCT04948307 · ClinicalTrials.gov registry record · NA

OXD01 in Combination With Sublingual Buprenorphine/Naloxone for Treatment of Opioid Use Disorder

A NA study of Opioid Use Disorder, sponsored by Orexo AB.

Completed
Registry status
NA
Development phase
437
Enrollment target
20
Study locations

NCT04948307 is a NA study of Opioid Use Disorder that has completed, run by Orexo AB. The registered enrollment target is 437 participants, below the 4,655-participant average among 257 other Opioid Use Disorder trials with a reported enrollment target (91% lower). The trial reports 20 study locations across 12 states.

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The verdict

NCT04948307, a NA study of Opioid Use Disorder, has completed, sponsored by Orexo AB.

COMPLETED
Registry status
NA
Development phase
437 participants
Enrollment target
20
Study locations

Study Summary

This is an open-label, randomized, parallel-group multicenter study designed to evaluate the efficacy of the digital therapeutic OXD01 (MODIA) combined with sublingual buprenorphine/naloxone standard of care (SL BUP/NAL SOC) background therapy compared to SL BUP/NAL alone to change opioid use patterns in subjects with opioid use disorder (OUD). Approximately 400 subjects will be randomized. The study will include a screening visit and a randomization visit, followed by 24 weeks of study treatment. Subjects will be scheduled for evaluation visits, which will include a urine drug screen (UDS) and a self-report of drug use, weekly during the first four weeks of treatment, then every other week from weeks 5 through 12, then monthly through week 25. Subjects will also return to the site for only a UDS and a self-report of drug use each week between the evaluation visits. The primary objective of the study is to determine whether the combination of sublingual (SL) buprenorphine/naloxone (BUP/NAL) standard of care (SOC) background therapy and the digital therapeutic OXD01 is superior to SL BUP/NAL alone to reduce opioid use.

Conditions Studied

Opioid Use Disorder

Interventions

  • OTHER Standard of Care
  • DEVICE OXD01 digital therapy

Study Locations (20)

Ohio

  • Midwest Clinical Research Center - Dayton
  • North Star Medical Research - Middleburg Heights
  • Neuro-Behavioral Clinical Research Center - North Canton
  • CincyScience - West Chester

Pennsylvania

  • Thalia Medical Center - Haverford
  • MD Medical Management - Kingston
  • Medically Assisted Recovery Service - Philadelphia
  • Institute of Addiction Medicine - Plymouth Meeting

California

  • North County Clinical Research - Oceanside
  • Artemis Institute for Clinical Research - San Diego
  • Wetlin Research Associates, Inc - San Diego

Alabama

  • Parkway Medical Center - Birmingham

Florida

  • Humanity Clinical Research - Pembroke Pines

Illinois

  • Southern Illinois Associates LLC - Glen Carbon

Kentucky

  • Otrimed Clinical Research - Edgewood

Michigan

  • Patient First Medical Clinic - Dearborn

Trial Details

FieldValue
Enrollment Target 437 participants
Start Date 2021-06-30
Est. Completion 2023-05-10
Phase NA

Sponsor

Orexo AB

4 total trials

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What the Registry Record Tells You About NCT04948307

The ClinicalTrials.gov registry entry for NCT04948307 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 437 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 4,655-participant average among 257 other Opioid Use Disorder trials with a reported enrollment target (91% lower). The listed sponsor is Orexo AB, which has 4 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Opioid Use Disorder appearing as the primary indexed condition, and to 2 interventions - of which Standard of Care is the first listed.

NCT04948307 reports 20 study locations spanning 12 distinct geographic areas - top geographies include Ohio, Pennsylvania, California.

Frequently Asked Questions

What is clinical trial NCT04948307 about?

NCT04948307 is a clinical study titled "OXD01 in Combination With Sublingual Buprenorphine/Naloxone for Treatment of Opioid Use Disorder". This is an open-label, randomized, parallel-group multicenter study designed to evaluate the efficacy of the digital therapeutic OXD01 (MODIA) combined with sublingual buprenorphine/naloxone standard of care (SL BUP/NAL SOC) background therapy compared to SL BUP/NAL alone to change opioid use patter...

What is the current status of trial NCT04948307?

This trial is currently completed. It is a NA study. The enrollment target is 437 participants. The study started on 2021-06-30. Estimated completion is 2023-05-10.

What conditions does trial NCT04948307 study?

This clinical trial studies the following conditions: Opioid Use Disorder.

What interventions are being tested in trial NCT04948307?

The interventions under investigation include: Standard of Care (OTHER), OXD01 digital therapy (DEVICE).

Who is sponsoring clinical trial NCT04948307?

This trial is sponsored by Orexo AB, which has 4 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04948307 being conducted?

This trial has 20 study locations across Alabama, California, Florida, Illinois, Kentucky. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.