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Pilot for Improved Office Based Treatment of Opioid-Dependence
The goal of this study is to evaluate whether using a novel drug-device combination to deliver buprenorphine/naloxone (B/N) to patients in office-based treatment for Opioid Use Disorder (OUD) is an effective way to improve compliance and treatment outcomes. The system introduces psychological and behavioral supports in addition to securing the medication between doses.
Details
| Lead sponsor | MedicaSafe, Inc. |
|---|---|
| Phase | NA |
| Status | UNKNOWN |
| Enrolment | 80 |
| Start date | 2018-12-01 |
| Completion | 2020-09 |
Conditions
- Opioid-use Disorder
Interventions
- BupreCare
- Buprenorphine/naloxone
- MEMS
Primary outcomes
- Compliance — Compliance checks will be done every 14 days. Total compliance for each subject will be looked at across the 12-week period of participation.
Determined by the number of days medication was taken appropriately compared to total days study medication should have been taken. For BupreCare, this will be done using the treatment reports from the device. For MEMS, this will be done with the data from the MEMS device. For TAU, this will be done with pill counts. Pill counts and dispensation reports will be supplemented by the Timeline Follow-back Assessment.
Countries
United States