Status:
COMPLETED
Maternal Opioid Treatment: Human Experimental Research - Data Yield Appropriate Decisions
Lead Sponsor:
University of Vermont
Collaborating Sponsors:
University of North Carolina, Chapel Hill
Virginia Commonwealth University
Conditions:
Opioid-use Disorder
Opioid Withdrawal
Eligibility:
FEMALE
18-41 years
Brief Summary
This study will compare medically-supervised withdrawal (MSW, 'detoxification') to opioid agonist treatment (OAT, 'maintenance') with buprenorphine for pregnant women with opioid use disorder in terms...
Detailed Description
Some inclusion/exclusion criteria are purposely omitted at this time to preserve scientific integrity. They will be included after the trial is complete.
Eligibility Criteria
Inclusion
- Be ages 18 to 41, inclusive
- Have a single fetus pregnancy between 6-30 weeks estimated gestational age
- Willing to participate in the study
Exclusion
- Non-English speaking
Key Trial Info
Start Date :
August 8 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 1 2024
Estimated Enrollment :
88 Patients enrolled
Trial Details
Trial ID
NCT04049799
Start Date
August 8 2019
End Date
February 1 2024
Last Update
February 8 2024
Active Locations (4)
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1
Mountain Area Health Education Center
Asheville, North Carolina, United States, 28803
2
UNC Chapel Hill Horizons
Chapel Hill, North Carolina, United States, 27510
3
University of Vermont
Burlington, Vermont, United States, 05401
4
Virginia Commonwealth University
Richmond, Virginia, United States, 23298