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Maternal Opioid Treatment: Human Experimental Research - Data Yield Appropriate Decisions (MOTHER DYAD)

University of Vermont logo

University of Vermont

Status

Completed

Conditions

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

Treatments

Other: Opioid agonist treatment
Other: Medically-supervised withdrawal
Behavioral: Comprehensive clinical care

Study type

Observational

Funder types

Other
NIH

Identifiers

NCT04049799
STUDY00000166
R01DA047867 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

Some inclusion/exclusion criteria are purposely omitted at this time to preserve scientific integrity. They will be included after the trial is complete.

Enrollment

88 patients

Sex

Female

Ages

18 to 41 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 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 criteria

  • Non-English speaking

Trial design

88 participants in 2 patient groups

Medically-supervised withdrawal (MSW)
Treatment:
Behavioral: Comprehensive clinical care
Other: Medically-supervised withdrawal
Opioid agonist treatment (OAT)
Treatment:
Behavioral: Comprehensive clinical care
Other: Opioid agonist treatment

Trial contacts and locations

4

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Data sourced from clinicaltrials.gov

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