drugset / Trial / NCT04212065
Long Acting Subcutaneous vs Short Acting Sublingual Buprenorphine in Pregnant and Lactating Women
RandomizedParallel-groupOpen-labelTreatment
Summary
This is a non-inferiority, open label, randomized trial of women on buprenorphine Medication Assisted Therapy for opioid use disorder in pregnancy.Patients will be randomized to either the long acting monthly subcutaneous SublocadeTM or to short acting sublingual Suboxone®.
Timeline
- Start
- 2020-02-21
- Primary completion
- 2020-09-01
- Completion
- 2020-09-01
Outcome
Outcome not reported
Stopped: “closed due to new safety concerns of subcutaneous buprenorphine in pregnant patients”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Buprenorphine | Other / unclassified | 8 mg | Subcutaneous |
| Comparator | Buprenorphine | Other / unclassified | 300 mg | Subcutaneous |