Medication Treatment for Opioid Use Disorder in Expectant Mothers: Conceptual Model Assessments Sub-study (MOMs-CMA)
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|ClinicalTrials.gov Identifier: NCT03911466|
Recruitment Status : Recruiting
First Posted : April 11, 2019
Last Update Posted : December 19, 2020
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).
|Condition or disease||Intervention/treatment||Phase|
|Opioid-Related Disorders Drug Addiction Pregnancy Related Substance Abuse Drug Abuse Neonatal Abstinence Syndrome Neonatal Opioid Withdrawal Syndrome Drug Abuse in Pregnancy||Drug: Buprenorphine Injection Drug: Buprenorphine Sublingual Product||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||300 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||NIDA CTN Protocol 0080: Medication Treatment for Opioid Use Disorder in Expectant Mothers (MOMs): a Pragmatic Randomized Trial Comparing Extended-release and Daily Buprenorphine Formulations: Conceptual Model Assessments (CMA) Sub-study|
|Actual Study Start Date :||July 21, 2020|
|Estimated Primary Completion Date :||December 31, 2025|
|Estimated Study Completion Date :||December 31, 2026|
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
Weekly and monthly formulations of injectable, extended-release buprenorphine (BUP-XR).
Other Name: CAM2038
Active Comparator: BUP-SL
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
Sublingual buprenorphine (BUP-SL), administered daily.
- Cmin of buprenorphine and metabolites in plasma [ Time Frame: 2 weeks post-randomization ]A blood draw at the estimated time of minimum drug concentration ("trough") to evaluate adequacy of dose for the conceptual model.
- Cmin of buprenorphine and metabolites in plasma [ Time Frame: 4 weeks post-randomization ]A blood draw at the estimated time of minimum drug concentration ("trough") to evaluate adequacy of dose for the conceptual model.
- Fetal heart rate variability [ Time Frame: Estimated gestational age (EGA) approximately 36 weeks ]This is the measure of primary interest from the fetal evaluation (non-stress test and biophysical profile).
- Cmin of buprenorphine and metabolites in plasma [ Time Frame: Estimated gestational age (EGA) approximately 36 weeks ]A blood draw at the estimated time of minimum drug concentration ("trough") to evaluate trough-to-peak fluctuation for the conceptual model.
- Cmax of buprenorphine and metabolites in plasma [ Time Frame: Estimated gestational age (EGA) approximately 36 weeks ]A blood draw at the estimated time of maximum drug concentration ("peak") to evaluate trough-to-peak fluctuation for the conceptual model.
- Concentration of buprenorphine and metabolites in maternal plasma [ Time Frame: Delivery ]A blood draw around the time of delivery to evaluate the association between drug concentration and neonatal opioid withdrawal syndrome outcomes.
- Concentration of buprenorphine and metabolites in cord plasma [ Time Frame: Delivery ]Cord blood will be collected and used to estimate fetal exposure to buprenorphine.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03911466
|Contact: Frankie Kropp, MSemail@example.com|
|Contact: Ben Kropp, MSLSfirstname.lastname@example.org|
|United States, California|
|Zuckerberg San Francisco General||Recruiting|
|San Francisco, California, United States, 94110|
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|Gateway Community Services||Recruiting|
|Jacksonville, Florida, United States, 32204|
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|Massachusetts General Hospital HOPE Clinic||Recruiting|
|Boston, Massachusetts, United States, 02114|
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|Boston, Massachusetts, United States, 02118|
|United States, New Mexico|
|University of New Mexico Milagro Clinic||Recruiting|
|Albuquerque, New Mexico, United States, 87106|
|United States, Ohio|
|University of Cincinnati Health Perinatal Addictions Program||Recruiting|
|Cincinnati, Ohio, United States, 45229|
|United States, Oregon|
|Portland, Oregon, United States, 97214|
|United States, Pennsylvania|
|Pregnancy Recovery Center at Magee-Womens Hospital of UPMC||Recruiting|
|Pittsburgh, Pennsylvania, United States, 15213|
|United States, South Carolina|
|Medical University of South Carolina||Recruiting|
|Charleston, South Carolina, United States, 29425|
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|Vanderbilt University Medical Center||Recruiting|
|Nashville, Tennessee, United States, 37232|
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|University of Utah SUPeRAD Clinic||Recruiting|
|Salt Lake City, Utah, United States, 84108|
|United States, Washington|
|Addiction Recovery Services (ARS), Swedish Medical Center||Recruiting|
|Seattle, Washington, United States, 98107|
|Principal Investigator:||Theresa Winhusen, PhD||University of Cincinnati|