NCT04948307

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 437 (actual)
• Sponsor: Orexo AB · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Medication-assisted treatment, the current standard for opioid addiction, is the use of medications in combination with counseling and behavioral therapies to provide a "whole-patient" approach to the treatment of OUD. However, patients may not have optimal access to face-to-face clinical behavioral health services. Digital therapeutics can help bridge the gap between accessible services and optimal treatment of OUD, the primary goal of which is to reduce the use of opioids. OXD01 is a device-based digital therapeutic, designed to offer individuals diagnosed with OUD quality psychotherapy intervention based on cognitive behavioral therapy and motivational interviewing. This study is being conducted to determine the value of OXD01 when combined with medication to change opioid use patterns in subjects with OUD. Note: No investigational product will be administered as part of this study.

Conditions

• Opioid-use Disorder

Interventions

Type	Name	Description
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

Timeline

• Start date: 2021-06-30
• Primary completion: 2023-04-12
• Completion: 2023-05-10
• First posted: 2021-07-01
• Last updated: 2025-06-27
• Results posted: 2025-06-27

Locations

21 sites across 1 country: United States

Regulatory

• FDA-regulated device study