This is a sub-study of NIDA CTN Protocol 0080: Medication Treatment for Opioid Use Disorder in Expectant Mothers (MOMs; Unique protocol ID: 2019-0429-1). Participants in MOMs will be offered the opportunity to enroll in this sub-study, which is designed to evaluate conceptual models of the mechanisms by which extended-release buprenorphine (BUP-XR), may improve mother-infant outcomes, compared to sublingual buprenorphine (BUP-SL). The additional data collected in this sub-study will be combined with data from the main MOMs trial. It is hypothesized that: (1) the buprenorphine blood levels will vary, depending on which formulation of buprenorphine was received, (2) the variation in buprenorphine blood levels will be associated with fetal behavior (including fetal heart rate variability) (3) the variation in buprenorphine blood levels will be associated with differences in mother outcomes (including medication adherence and illicit opioid use) (4) the variation in buprenorphine blood levels and in fetal behavior will be associated with infant outcomes (including neonatal opioid withdrawal syndrome and infant development).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
97
Weekly and monthly formulations of injectable, extended-release buprenorphine (BUP-XR).
Sublingual buprenorphine (BUP-SL), administered daily.
Gateway Community Services
Jacksonville, Florida, United States
Massachusetts General Hospital HOPE Clinic
Boston, Massachusetts, United States
Boston Medical Center
Boston, Massachusetts, United States
University of New Mexico Milagro Clinic
Albuquerque, New Mexico, United States
University of Cincinnati Health Perinatal Addictions Program
Cincinnati, Ohio, United States
CODA, Inc.
Portland, Oregon, United States
Pregnancy Recovery Center at Magee-Womens Hospital of UPMC
Pittsburgh, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
University of Utah SUPeRAD Clinic
Salt Lake City, Utah, United States
...and 2 more locations
Cmin of buprenorphine and metabolites in plasma
A blood draw at the estimated time of minimum drug concentration ("trough") to evaluate adequacy of dose for the conceptual model.
Time frame: 2 weeks post-randomization
Cmin of buprenorphine and metabolites in plasma
A blood draw at the estimated time of minimum drug concentration ("trough") to evaluate adequacy of dose for the conceptual model.
Time frame: 4 weeks post-randomization
Fetal heart rate variability
This is the measure of primary interest from the fetal evaluation (non-stress test and biophysical profile).
Time frame: Estimated gestational age (EGA) approximately 36 weeks
Cmin of buprenorphine and metabolites in plasma
A blood draw at the estimated time of minimum drug concentration ("trough") to evaluate trough-to-peak fluctuation for the conceptual model.
Time frame: Estimated gestational age (EGA) approximately 36 weeks
Cmax of buprenorphine and metabolites in plasma
A blood draw at the estimated time of maximum drug concentration ("peak") to evaluate trough-to-peak fluctuation for the conceptual model.
Time frame: Estimated gestational age (EGA) approximately 36 weeks
Concentration of buprenorphine and metabolites in maternal plasma
A blood draw around the time of delivery to evaluate the association between drug concentration and neonatal opioid withdrawal syndrome outcomes.
Time frame: Delivery
Concentration of buprenorphine and metabolites in cord plasma
Cord blood will be collected and used to estimate fetal exposure to buprenorphine.
Time frame: Delivery
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