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

Completed

• Conditions: Opioid-use Disorder; Opioid Withdrawal; Neonatal Abstinence Syndrome; Neonatal Opioid Withdrawal Syndrome
• Interventions: Other: Medically-supervised withdrawal; Other: Opioid agonist treatment; Behavioral: Comprehensive clinical care

• Registration Number: NCT04049799
• Lead Sponsor: University of Vermont

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.

Study Timeline

• Study First Submitted: 2019-07-23
• Study First Submitted QC: 2019-08-07
• Study Start: 2019-08-08
• Study First Posted: 2019-08-08
• Status Verified: 2024-02
• Primary Completion: 2024-02-01
• Study Completion: 2024-02-01
• Last Update Submitted: 2024-02-06
• Last Update Posted: 2024-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 88

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

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Exclusion Criteria

• Non-English speaking

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Medically-supervised withdrawal (MSW)	Medically-supervised withdrawal	-
Medically-supervised withdrawal (MSW)	Comprehensive clinical care	-
Opioid agonist treatment (OAT)	Opioid agonist treatment	-
Opioid agonist treatment (OAT)	Comprehensive clinical care	-

Primary Outcome Measures

Name	Time	Method
Proportion of mothers with illicit substance use at delivery	At delivery	Positive vs. negative for any illicit substance in the urine
Total average length of neonatal hospital stay	At hospital discharge, an average of 10 days after delivery	Days
Total average amount of medication given to treat NAS	At hospital discharge, an average of 10 days after delivery	Morphine Equivalent Dose in mg
Proportion of mother-child dyads with delivery complications	At delivery	Yes vs. no code for the presence or absence of delivery complications such as uterine rupture, placental abruption, low birth weight, chorioamnionitis, and meconium staining
Proportion of mothers who discontinued 1st treatment choice prior to delivery	Antepartum period
Proportion of mothers engaged in treatment at delivery	Antepartum period	Behavior health treatment or medical treatment in past 21 days
Proportion of neonates receiving medication treatment for neonatal abstinence syndrome (NAS)	At hospital discharge, an average of 10 days after delivery	Yes vs. no

Trial Locations

Locations (4)

Mountain Area Health Education Center; 🇺🇸 Asheville, North Carolina, United States

University of Vermont; 🇺🇸 Burlington, Vermont, United States

Virginia Commonwealth University; 🇺🇸 Richmond, Virginia, United States

UNC Chapel Hill Horizons; 🇺🇸 Chapel Hill, North Carolina, United States