An observational study in Opioid-Related Disorders, Drug Addiction and Pregnancy Related, sponsored by T. John Winhusen, PhD. Completed at 12 sites in United States. Open to female participants aged 18 Years to 41 Years. Per ClinicalTrials.gov, last updated 2026-03-16.
Sponsored by T. John Winhusen, PhD · Observational
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).
Participants in this study were recruited from the main CTN-0080 MOMs (NCT03918850) study sample.
Exclusion Criteria:
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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.).
Drug: Buprenorphine Injection
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.).
Drug: Buprenorphine Sublingual Product
Weekly and monthly formulations of injectable, extended-release buprenorphine (BUP-XR).
Also known as: CAM2038
Sublingual buprenorphine (BUP-SL), administered daily.
Also known as: Subutex, Suboxone
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
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — Data will be transmitted by the study Data and Statistics Center to the designated party for de-identification, posting, storing, and archiving on NIDA's Data Share website. Data Share is an online repository of data from studies funded by the National Institute on Drug Abuse. All de-identified individual participant data is expected to be made available.
Supporting information: Study protocol
This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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T. John Winhusen, PhD