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).
Age range
18 Years – 41 Years
Sex
FEMALE
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Cmin of buprenorphine and metabolites in plasma
Timeframe: 2 weeks post-randomization
Cmin of buprenorphine and metabolites in plasma
Timeframe: 4 weeks post-randomization
Fetal heart rate variability
Timeframe: Estimated gestational age (EGA) approximately 36 weeks
Cmin of buprenorphine and metabolites in plasma
Timeframe: Estimated gestational age (EGA) approximately 36 weeks
Cmax of buprenorphine and metabolites in plasma
Timeframe: Estimated gestational age (EGA) approximately 36 weeks
Concentration of buprenorphine and metabolites in maternal plasma
Timeframe: Delivery
Concentration of buprenorphine and metabolites in cord plasma
Timeframe: Delivery