Clinical trial NCT04049799: Maternal Opioid Treatment: Human Experimental Research - Data Yield Appropriate Decisions
Official title: Medically-supervised Withdrawal vs. Agonist Maintenance in the Treatment of Pregnant Women With Opioid Use Disorder: Maternal, Fetal, and Neonatal Outcomes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Opioid-use Disorder
Opioid Withdrawal
Neonatal Abstinence Syndrome
Neonatal Opioid Withdrawal Syndrome
Lead sponsor: University of Vermont
Sponsor class: OTHER
Collaborators: name: University of North Carolina, Chapel Hill
name: Virginia Commonwealth University
name: Mountain Area Health Education Center
name: Johns Hopkins University
name: National Institute on Drug Abuse (NIDA)
First posted: 2019-08-08
Enrollment: 88
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 41
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant women seeking treatment for opioid use disorder

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 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.

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 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

Primary outcomes:
measure: Proportion of mothers who discontinued 1st treatment choice prior to delivery
timeFrame: Antepartum period
measure: Proportion of mothers engaged in treatment at delivery
timeFrame: Antepartum period
measure: Proportion of mothers with illicit substance use at delivery
timeFrame: At delivery
measure: Proportion of mother-child dyads with delivery complications
timeFrame: At delivery
measure: Proportion of neonates receiving medication treatment for neonatal abstinence syndrome (NAS)
timeFrame: At hospital discharge, an average of 10 days after delivery
measure: Total average amount of medication given to treat NAS
timeFrame: At hospital discharge, an average of 10 days after delivery
measure: Total average length of neonatal hospital stay
timeFrame: At hospital discharge, an average of 10 days after delivery
Secondary outcomes:
Other outcomes:
Locations:
city: Asheville
country: United States
facility: Mountain Area Health Education Center
state: North Carolina
city: Chapel Hill
country: United States
facility: UNC Chapel Hill Horizons
state: North Carolina
city: Burlington
country: United States
facility: University of Vermont
state: Vermont
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: University of Vermont
name: Sarah H Heil, PhD
role: PRINCIPAL_INVESTIGATOR
References: