Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
OXD01 in Combination With Sublingual Buprenorphine/Naloxone for Treatment of Opioid Use Disorder
NCT04948307 · View on ClinicalTrials.gov ↗
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
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
| Field | Value |
|---|---|
| Enrollment Target | 437 participants |
| Start Date | 2021-06-30 |
| Est. Completion | 2023-05-10 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04948307
The ClinicalTrials.gov registry entry for NCT04948307 describes a study currently listed as completed. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 437 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Orexo AB, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04948307 reports 20 study locations spanning 12 distinct geographic areas — top geographies include Ohio, Pennsylvania, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04948307?
The interventions under investigation include: Standard of Care (OTHER), OXD01 digital therapy (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04948307?
This trial is sponsored by Orexo AB, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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