OXD01 in Combination With Sublingual Buprenorphine/Naloxone for Treatment of Opioid Use Disorder
Public ClinicalTrials.gov record NCT04948307. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Randomized, Open-label, Parallel-group Study to Evaluate the Efficacy of the Digital Therapeutic OXD01 (MODIA™) in Combination With Sublingual Buprenorphine/Naloxone for the Treatment of Opioid Use Disorder
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT04948307
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 437 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 65 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 30, 2021 (Actual)
- Primary completion
- Apr 12, 2023 (Actual)
- Completion
- May 10, 2023 (Actual)
- Last update posted
- Jun 27, 2025
2021 – 2023
United States locations
- U.S. sites
- 21
- U.S. states
- 13
- U.S. cities
- 20
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Parkway Medical Center | Birmingham | Alabama | 35215 | — |
| North County Clinical Research | Oceanside | California | 92054 | — |
| Artemis Institute for Clinical Research | San Diego | California | 92103 | — |
| Wetlin Research Associates, Inc | San Diego | California | 92120 | — |
| Humanity Clinical Research | Pembroke Pines | Florida | 33024 | — |
| Southern Illinois Associates LLC | Glen Carbon | Illinois | 62034 | — |
| Otrimed Clinical Research | Edgewood | Kentucky | 41017 | — |
| Patient First Medical Clinic | Dearborn | Michigan | 48126 | — |
| Precise Research Centers | Flowood | Mississippi | 39232 | — |
| PsychCare Consultants Research | St Louis | Missouri | 63128 | — |
| Dr. Vando Medical Services PC | The Bronx | New York | 10466 | — |
| Midwest Clinical Research Center | Dayton | Ohio | 45417 | — |
| North Star Medical Research | Middleburg Heights | Ohio | 44130 | — |
| Neuro-Behavioral Clinical Research Center | North Canton | Ohio | 44720 | — |
| CincyScience | West Chester | Ohio | 45069 | — |
| Pahl Pharmaceuticals Professions | Oklahoma City | Oklahoma | 73112 | — |
| Thalia Medical Center | Haverford | Pennsylvania | 19041 | — |
| MD Medical Management | Kingston | Pennsylvania | 18704 | — |
| Medically Assisted Recovery Service | Philadelphia | Pennsylvania | 19116 | — |
| Institute of Addiction Medicine | Plymouth Meeting | Pennsylvania | 19462 | — |
| Aspen Clinical Research | Orem | Utah | 84058 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04948307, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 27, 2025 · Synced Oct 28, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04948307 live on ClinicalTrials.gov.