At a glance
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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
In Brief
A clinical study evaluating OXD01 digital therapy and Standard of Care for Opioid-use Disorder. Completed, enrolled 437 participants across 21 sites.
Detailed 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.
Study Details
Timeline
Interventions
OXD01 digital therapy, 1-2 times per week 15-30 minutes each time.
Sublingual buprenorphine/naloxone Medication-assisted treatment, the current standard for opioid addiction; the use of medications in combination with counseling