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Maternal Opioid Treatment: Human Experimental Research - Data Yield Appropriate Decisions

NCT04049799 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 88

Last updated 2024-02-08

No results posted yet for this study

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 of maternal, fetal, and neonatal outcomes. Outcomes will be assessed during pregnancy, at birth and for 12 months postpartum. This study has the potential to impact health service policy and practices in terms of the treatment options of pregnant women with opioid use disorder.

Conditions

  • Opioid-use Disorder
  • Opioid Withdrawal
  • Neonatal Abstinence Syndrome
  • Neonatal Opioid Withdrawal Syndrome

Interventions

OTHER

Medically-supervised withdrawal

6-8 day withdrawal with buprenorphine/naloxone

OTHER

Opioid agonist treatment

Induction and maintenance with buprenorphine/naloxone

BEHAVIORAL

Comprehensive clinical care

Obstetrical visits, counseling, case management, psychiatry services, and urine drug screening

Sponsors & Collaborators

  • University of North Carolina, Chapel Hill

    collaborator OTHER

  • Virginia Commonwealth University

    collaborator OTHER

  • Mountain Area Health Education Center

    collaborator UNKNOWN

  • Johns Hopkins University

    collaborator OTHER

  • National Institute on Drug Abuse (NIDA)

    collaborator NIH

  • University of Vermont

    lead OTHER

Principal Investigators

  • Sarah H Heil, PhD · University of Vermont

Eligibility

Min Age
18 Years
Max Age
41 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-08-08
Primary Completion
2024-02-01
Completion
2024-02-01

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04049799 on ClinicalTrials.gov