Neonatal Abstinence Syndrome, Neonatal Opioid Withdrawal Syndrome, Opioid-use Disorder, Opioid Withdrawal
Conditions
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.
Interventions
OTHERMedically-supervised withdrawal
6-8 day withdrawal with buprenorphine/naloxone
OTHEROpioid agonist treatment
Induction and maintenance with buprenorphine/naloxone
BEHAVIORALComprehensive clinical care
Obstetrical visits, counseling, case management, psychiatry services, and urine drug screening
Sponsors
University of North Carolina, Chapel Hill
Virginia Commonwealth University
Mountain Area Health Education Center
Johns Hopkins University
National Institute on Drug Abuse (NIDA)
University of Vermont
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 41 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 mothers with illicit substance use at delivery | At delivery | Positive vs. negative for any illicit substance in the urine |
| 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 neonates receiving medication treatment for neonatal abstinence syndrome (NAS) | At hospital discharge, an average of 10 days after delivery | Yes vs. no |
| Total average amount of medication given to treat NAS | At hospital discharge, an average of 10 days after delivery | Morphine Equivalent Dose in mg |
| Total average length of neonatal hospital stay | At hospital discharge, an average of 10 days after delivery | Days |
Countries
United States
Outcome results
None listed