Pivotal modia™ Study
About the Pivotal modia™ Study
The pivotal, randomized, open-label, parallel-group study will evaluate whether the use of modia™ in combination with sublingual buprenorphine/naloxone background therapy is superior to sublingual buprenorphine/naloxone alone to reduce opioid use. The study is designed to enroll an estimated 400 participants aged 18 to 65 across the United States who are voluntarily seeking treatment for documented moderate to severe OUD. Participants will be evaluated over the course of 24 weeks, including a screening period where they will be stabilized on buprenorphine/naloxone, with a primary endpoint defined as the subject having ≥80% of urine drug tests negative for opioids and negative self-reports for illicit opioid use during the study period.