Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| R01DA047867 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| University of North Carolina, Chapel Hill | OTHER |
| Virginia Commonwealth University | OTHER |
| Mountain Area Health Education Center | UNKNOWN |
| Johns Hopkins University |
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Some inclusion/exclusion criteria are purposely omitted at this time to preserve scientific integrity. They will be included after the trial is complete.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Medically-supervised withdrawal (MSW) |
| ||
| Opioid agonist treatment (OAT) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Medically-supervised withdrawal | Other | 6-8 day withdrawal with buprenorphine/naloxone |
|
| 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 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Pregnant women seeking treatment for opioid use disorder
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Sarah H Heil, PhD | University of Vermont | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mountain Area Health Education Center | Asheville | North Carolina | 28803 | United States | ||
| UNC Chapel Hill Horizons |
Not provided
| OTHER |
| National Institute on Drug Abuse (NIDA) | NIH |
Not provided
Not provided
Not provided
| Opioid agonist treatment | Other | Induction and maintenance with buprenorphine/naloxone |
|
|
| Comprehensive clinical care | Behavioral | Obstetrical visits, counseling, case management, psychiatry services, and urine drug screening |
|
| Chapel Hill |
| North Carolina |
| 27510 |
| United States |
| University of Vermont | Burlington | Vermont | 05401 | United States |
| Virginia Commonwealth University | Richmond | Virginia | 23298 | United States |
| ID | Term |
|---|---|
| D009293 | Opioid-Related Disorders |
| D009357 | Neonatal Abstinence Syndrome |
| ID | Term |
|---|---|
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
Not provided
Not provided
| ID | Term |
|---|---|
| D008658 | Inactivation, Metabolic |
| D008283 | Maintenance |
| ID | Term |
|---|---|
| D001711 | Biotransformation |
| D008660 | Metabolism |
| D010599 | Pharmacokinetics |
| D002620 | Pharmacological and Toxicological Phenomena |
| D010829 | Physiological Phenomena |
| D005159 | Health Care Facilities Workforce and Services |
Not provided
Not provided