Maternal Opioid Treatment: Human Experimental Research - Data Yield Appropriate Decisions
NCT ID: NCT04049799
Last Updated: 2024-02-08
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
88 participants
OBSERVATIONAL
2019-08-08
2024-02-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Medically-supervised withdrawal (MSW)
Medically-supervised withdrawal
6-8 day withdrawal with buprenorphine/naloxone
Comprehensive clinical care
Obstetrical visits, counseling, case management, psychiatry services, and urine drug screening
Opioid agonist treatment (OAT)
Opioid agonist treatment
Induction and maintenance with buprenorphine/naloxone
Comprehensive clinical care
Obstetrical visits, counseling, case management, psychiatry services, and urine drug screening
Interventions
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Medically-supervised withdrawal
6-8 day withdrawal with buprenorphine/naloxone
Opioid agonist treatment
Induction and maintenance with buprenorphine/naloxone
Comprehensive clinical care
Obstetrical visits, counseling, case management, psychiatry services, and urine drug screening
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Have a single fetus pregnancy between 6-30 weeks estimated gestational age
* Willing to participate in the study
Exclusion Criteria
18 Years
41 Years
FEMALE
No
Sponsors
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University of North Carolina, Chapel Hill
OTHER
Virginia Commonwealth University
OTHER
Mountain Area Health Education Center
UNKNOWN
Johns Hopkins University
OTHER
National Institute on Drug Abuse (NIDA)
NIH
University of Vermont
OTHER
Responsible Party
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Sarah Heil
Professor
Principal Investigators
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Sarah H Heil, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Vermont
Locations
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Mountain Area Health Education Center
Asheville, North Carolina, United States
UNC Chapel Hill Horizons
Chapel Hill, North Carolina, United States
University of Vermont
Burlington, Vermont, United States
Virginia Commonwealth University
Richmond, Virginia, United States
Countries
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Other Identifiers
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STUDY00000166
Identifier Type: -
Identifier Source: org_study_id
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