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

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