Medication Treatment for Opioid Use Disorder in Expectant Mothers: Conceptual Model Assessments Sub-study (MOMs-CMA)
Opioid-Related Disorders, Drug Addiction, Pregnancy Related
About this trial
This is an interventional treatment trial for Opioid-Related Disorders focused on measuring CTN-0080, clinical trials network, medication assisted treatment, pharmacokinetics
Eligibility Criteria
Inclusion Criteria:
- Participating in the MOMs trial (Unique protocol ID: 2019-0429-1)
Exclusion Criteria:
-
Sites / Locations
- Gateway Community Services
- Massachusetts General Hospital HOPE Clinic
- Boston Medical Center
- University of New Mexico Milagro Clinic
- University of Cincinnati Health Perinatal Addictions Program
- CODA, Inc.
- Pregnancy Recovery Center at Magee-Womens Hospital of UPMC
- Medical University of South Carolina
- Vanderbilt University Medical Center
- University of Utah SUPeRAD Clinic
- Addiction Recovery Services (ARS), Swedish Medical Center
- Marshall Health MARC Program
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
BUP-XR
BUP-SL
Weekly subcutaneous Buprenorphine Injection (CAM2038) during pregnancy. During the 12-month postpartum phase, participants who are breastfeeding will continue receiving subcutaneous Buprenorphine Injection weekly; participants who are not breastfeeding will receive subcutaneous Buprenorphine Injection monthly. The target doses will be 24 mg for the weekly formulation and 96 mg for the monthly formulation, but the actual dose may be lower or higher as determined by the prescribing clinician (e.g., based on craving/withdrawal experienced by the participant, etc.).
Daily sublingual buprenorphine, with or without naloxone, based on site preference, during pregnancy and during the 12-month postpartum phase. The target dose will be 16 mg daily, but the actual dose may be lower or higher as determined by the prescribing clinician (e.g., based on craving/withdrawal experienced by the participant, etc.).