Medication Treatment for Opioid Use Disorder in Expectant Mothers: Conceptual Model Assessments Sub-study
NCT ID: NCT03911466
Last Updated: 2025-02-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
97 participants
INTERVENTIONAL
2020-07-21
2024-11-06
Brief Summary
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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).
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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BUP-XR
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.).
Buprenorphine Injection
Weekly and monthly formulations of injectable, extended-release buprenorphine (BUP-XR).
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.).
Buprenorphine Sublingual Product
Sublingual buprenorphine (BUP-SL), administered daily.
Interventions
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Buprenorphine Injection
Weekly and monthly formulations of injectable, extended-release buprenorphine (BUP-XR).
Buprenorphine Sublingual Product
Sublingual buprenorphine (BUP-SL), administered daily.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
41 Years
FEMALE
No
Sponsors
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National Institute on Drug Abuse (NIDA)
NIH
The Emmes Company, LLC
INDUSTRY
T. John Winhusen, PhD
OTHER
Responsible Party
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T. John Winhusen, PhD
Professor; Vice Chair and Division Director of Addiction Sciences
Principal Investigators
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T. John Winhusen, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Cincinnati
Locations
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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
Addiction Recovery Services (ARS), Swedish Medical Center
Seattle, Washington, United States
Marshall Health MARC Program
Huntington, West Virginia, United States
Countries
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References
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Kropp FB, Smid MC, Lofwall MR, Wachman EM, Martin PR, Murphy SM, Wilder CM, Winhusen TJ. Collaborative care programs for pregnant and postpartum individuals with opioid use disorder: Organizational characteristics of sites participating in the NIDA CTN0080 MOMs study. J Subst Use Addict Treat. 2023 Jun;149:209030. doi: 10.1016/j.josat.2023.209030. Epub 2023 Apr 4.
Provided Documents
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Document Type: Informed Consent Form
Other Identifiers
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2019-0429-2
Identifier Type: -
Identifier Source: org_study_id
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