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

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

Official Title
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Medically-supervised Withdrawal vs. Agonist Maintenance in the Treatment of Pregnant Women With Opioid Use Disorder: Maternal, Fetal, and Neonatal Outcomes

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

Intervention / Treatment
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* Other: Medically-supervised withdrawal
* Other: Opioid agonist treatment
* Behavioral: Comprehensive clinical care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 41 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Medically-supervised withdrawal (MSW)<br> | Other: Medically-supervised withdrawal<br>* 6-8 day withdrawal with buprenorphine/naloxone<br>* Other names: Detoxification;Behavioral: Comprehensive clinical care<br>* Obstetrical visits, counseling, case management, psychiatry services, and urine drug screening<br>|
| Opioid agonist treatment (OAT)<br> | Other: Opioid agonist treatment<br>* Induction and maintenance with buprenorphine/naloxone<br>* Other names: Maintenance;Behavioral: Comprehensive clinical care<br>* Obstetrical visits, counseling, case management, psychiatry services, and urine drug screening<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of mothers who discontinued 1st treatment choice prior to delivery |  | Antepartum period | 
| Proportion of mothers engaged in treatment at delivery | Behavior health treatment or medical treatment in past 21 days | Antepartum period | 
| Proportion of mothers with illicit substance use at delivery | Positive vs. negative for any illicit substance in the urine | At delivery | 
| Proportion of mother-child dyads with delivery complications | 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 | At delivery | 
| Proportion of neonates receiving medication treatment for neonatal abstinence syndrome (NAS) | Yes vs. no | At hospital discharge, an average of 10 days after delivery | 
| Total average amount of medication given to treat NAS | Morphine Equivalent Dose in mg | At hospital discharge, an average of 10 days after delivery | 
| Total average length of neonatal hospital stay | Days | At hospital discharge, an average of 10 days after delivery |