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

NCT04948307 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 437

Last updated 2025-06-27

Study results available
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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

  • Opioid-use Disorder

Interventions

DEVICE

OXD01 digital therapy

OXD01 digital therapy, 1-2 times per week 15-30 minutes each time.

OTHER

Standard of Care

Sublingual buprenorphine/naloxone Medication-assisted treatment, the current standard for opioid addiction; the use of medications in combination with counseling

Sponsors & Collaborators

  • Orexo AB

    lead INDUSTRY

Principal Investigators

  • David Capano, PharmD · Orexo US, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-30
Primary Completion
2023-04-12
Completion
2023-05-10
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04948307 on ClinicalTrials.gov