Phase 2
N=42
Maternal Buprenorphine-naloxone Treatment and the Infant
Maternal Opioid Use Disorder · Opioid Exposed Infant
Bottom Line
View on ClinicalTrials.gov: NCT03291847 ↗Enrolled (actual)
42
Serious AEs
11.5%
Results posted
Dec 2023
Primary outcome: Primary: Fetal Heart Rate at 24 Weeks — 143.64 beats per minute
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- fetal monitoring (Device); Buprenorphine Naloxone (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Johns Hopkins University
- Primary completion
- Dec 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Fetal Heart Rate at 24 Weeks |
143.64 | — |
| PRIMARY Fetal Heart Rate at 28 Weeks Gestation |
139.14 | — |
| PRIMARY Fetal Heart Rate at 32 Weeks Gestation |
135.82 | — |
| PRIMARY Fetal Heart Rate at 36 Weeks Gestation |
131.99 | — |
| PRIMARY Total Fetal Movement at 24 Weeks Gestation |
71.91 | — |
| PRIMARY Total Fetal Movement at 36 Weeks Gestation |
59.07 | — |
| PRIMARY Total Fetal Movement at 28 Weeks Gestation |
70.06 | — |
| PRIMARY Total Fetal Movement at 32 Weeks Gestation |
66.00 | — |
Summary
The purpose of this mechanistic study is to evaluate the effects that maternal buprenorphine-naloxone maintenance have on the neurobehavioral development of the fetus and infant. To accomplish this, the investigators will study a sample of 120 opioid dependent pregnant women that will receive buprenorphine-naloxone as part of substance abuse treatment at a comprehensive care treatment facility for pregnant and parenting women with substance use disorders. Fetal neurobehavior and maternal physiology will be assessed, via an established maternal-fetal data acquisition system, at 4 points during gestation: 24, 28, 32 and 36 weeks. Infant birth parameters and Neonatal Abstinence Syndrome (NAS) spectrum display will be evaluated at birth, and infant neurodevelopment will be assessed during the first month of life.
Eligibility Criteria
Inclusion Criteria
- Current opioid use disorder (OUD) as defined by DSM V criteria
- singleton pregnancies, generally uncomplicated by conditions that jeopardize pregnancy outcome
- Gestation less than 24 weeks
Exclusion Criteria
- Complications of pregnancy, including gestational diabetes, polyhydramnios, hypertension, placenta previa or significant risk of preterm delivery;
- Evidence of fetal malformation detected by prenatal ultrasound;
- Significant general maternal health problems that can affect fetal functioning, including Type I or gestational diabetes, alterations in thyroid functioning, HIV infection or hypertension;
- Significant maternal psychopathology that would preclude informed consent;
- Alcohol use disorder per DSM V criteria (see ascertainment methods below)
- Women stable on methadone maintenance (defined as more than 3 consecutive days of dosing)
- Women coming to treatment reporting "street" methadone use (for more than 3 consecutive days
- Women not planning to receive obstetric care at the Center for Addiction and Pregnancy; - Women not planning to deliver their infants at Johns Hopkins Bayview Medical center
- Women planning for adoption of their infant.
Data sourced from ClinicalTrials.gov (NCT03291847). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.