Ignite Creation Date:
2025-12-24 @ 4:15 PM
Ignite Modification Date:
2026-02-18 @ 2:48 AM
Study NCT ID:
NCT03911466
Status:
COMPLETED
Last Update Posted:
2025-02-20
First Post:
2019-04-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Medication Treatment for Opioid Use Disorder in Expectant Mothers: Conceptual Model Assessments Sub-study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009293', 'term': 'Opioid-Related Disorders'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D009357', 'term': 'Neonatal Abstinence Syndrome'}], 'ancestors': [{'id': 'D000079524', 'term': 'Narcotic-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002047', 'term': 'Buprenorphine'}, {'id': 'D000069479', 'term': 'Buprenorphine, Naloxone Drug Combination'}], 'ancestors': [{'id': 'D009019', 'term': 'Morphinans'}, {'id': 'D053610', 'term': 'Opiate Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D010616', 'term': 'Phenanthrenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D009270', 'term': 'Naloxone'}, {'id': 'D004338', 'term': 'Drug Combinations'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-12-16', 'size': 217151, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2023-11-01T08:03', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 97}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-07-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2024-11-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-19', 'studyFirstSubmitDate': '2019-04-09', 'studyFirstSubmitQcDate': '2019-04-09', 'lastUpdatePostDateStruct': {'date': '2025-02-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-04-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cmin of buprenorphine and metabolites in plasma', 'timeFrame': '2 weeks post-randomization', 'description': 'A blood draw at the estimated time of minimum drug concentration ("trough") to evaluate adequacy of dose for the conceptual model.'}, {'measure': 'Cmin of buprenorphine and metabolites in plasma', 'timeFrame': '4 weeks post-randomization', 'description': 'A blood draw at the estimated time of minimum drug concentration ("trough") to evaluate adequacy of dose for the conceptual model.'}, {'measure': 'Fetal heart rate variability', 'timeFrame': 'Estimated gestational age (EGA) approximately 36 weeks', 'description': 'This is the measure of primary interest from the fetal evaluation (non-stress test and biophysical profile).'}, {'measure': 'Cmin of buprenorphine and metabolites in plasma', 'timeFrame': 'Estimated gestational age (EGA) approximately 36 weeks', 'description': 'A blood draw at the estimated time of minimum drug concentration ("trough") to evaluate trough-to-peak fluctuation for the conceptual model.'}, {'measure': 'Cmax of buprenorphine and metabolites in plasma', 'timeFrame': 'Estimated gestational age (EGA) approximately 36 weeks', 'description': 'A blood draw at the estimated time of maximum drug concentration ("peak") to evaluate trough-to-peak fluctuation for the conceptual model.'}, {'measure': 'Concentration of buprenorphine and metabolites in maternal plasma', 'timeFrame': 'Delivery', 'description': 'A blood draw around the time of delivery to evaluate the association between drug concentration and neonatal opioid withdrawal syndrome outcomes.'}, {'measure': 'Concentration of buprenorphine and metabolites in cord plasma', 'timeFrame': 'Delivery', 'description': 'Cord blood will be collected and used to estimate fetal exposure to buprenorphine.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['CTN-0080', 'clinical trials network', 'medication assisted treatment', 'pharmacokinetics'], 'conditions': ['Opioid-Related Disorders', 'Drug Addiction', 'Pregnancy Related', 'Substance Abuse', 'Drug Abuse', 'Neonatal Abstinence Syndrome', 'Neonatal Opioid Withdrawal Syndrome', 'Drug Abuse in Pregnancy']}, 'referencesModule': {'references': [{'pmid': '37023858', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nIt 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).'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '41 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participating in the MOMs trial (Unique protocol ID: 2019-0429-1)\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT03911466', 'acronym': 'MOMs-CMA', 'briefTitle': 'Medication Treatment for Opioid Use Disorder in Expectant Mothers: Conceptual Model Assessments Sub-study', 'organization': {'class': 'OTHER', 'fullName': 'University of Cincinnati'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': '2019-0429-2'}, 'secondaryIdInfos': [{'id': 'UG1DA013732', 'link': 'https://reporter.nih.gov/quickSearch/UG1DA013732', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BUP-XR', 'description': '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.\n\nThe 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.).', 'interventionNames': ['Drug: Buprenorphine Injection']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'BUP-SL', 'description': 'Daily sublingual buprenorphine, with or without naloxone, based on site preference, during pregnancy and during the 12-month postpartum phase.\n\nThe 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.).', 'interventionNames': ['Drug: Buprenorphine Sublingual Product']}], 'interventions': [{'name': 'Buprenorphine Injection', 'type': 'DRUG', 'otherNames': ['CAM2038'], 'description': 'Weekly and monthly formulations of injectable, extended-release buprenorphine (BUP-XR).', 'armGroupLabels': ['BUP-XR']}, {'name': 'Buprenorphine Sublingual Product', 'type': 'DRUG', 'otherNames': ['Subutex', 'Suboxone'], 'description': 'Sublingual buprenorphine (BUP-SL), administered daily.', 'armGroupLabels': ['BUP-SL']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32204', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Gateway Community Services', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital HOPE Clinic', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02118', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Boston Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '87106', 'city': 'Albuquerque', 'state': 'New Mexico', 'country': 'United States', 'facility': 'University of New Mexico Milagro Clinic', 'geoPoint': {'lat': 35.08449, 'lon': -106.65114}}, {'zip': '45229', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'University of Cincinnati Health Perinatal Addictions Program', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '97214', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'CODA, Inc.', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Pregnancy Recovery Center at Magee-Womens Hospital of UPMC', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '29425', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Medical University of South Carolina', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'zip': '37232', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt University Medical Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '84108', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'University of Utah SUPeRAD Clinic', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '98107', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Addiction Recovery Services (ARS), Swedish Medical Center', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '25701', 'city': 'Huntington', 'state': 'West Virginia', 'country': 'United States', 'facility': 'Marshall Health MARC Program', 'geoPoint': {'lat': 38.41925, 'lon': -82.44515}}], 'overallOfficials': [{'name': 'T. John Winhusen, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Cincinnati'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'ipdSharing': 'YES', 'description': "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."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'T. John Winhusen, PhD', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Drug Abuse (NIDA)', 'class': 'NIH'}, {'name': 'The Emmes Company, LLC', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor; Vice Chair and Division Director of Addiction Sciences', 'investigatorFullName': 'T. John Winhusen, PhD', 'investigatorAffiliation': 'University of Cincinnati'}}}}