Status:
COMPLETED
Maternal Buprenorphine-naloxone Treatment and the Infant
Lead Sponsor:
Johns Hopkins University
Collaborating Sponsors:
National Institute on Drug Abuse (NIDA)
Conditions:
Maternal Opioid Use Disorder
Opioid Exposed Infant
Eligibility:
FEMALE
18-44 years
Phase:
PHASE2
Brief 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, t...
Detailed Description
The project population will be 40 pregnant women with opioid use disorder inducted as outpatients to buprenorphine-naloxone maintenance. Subject treatment data, including medical and obstetric histori...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 15 2023
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT03291847
Start Date
June 1 2018
End Date
December 15 2023
Last Update
February 26 2024
Active Locations (1)
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1
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, United States, 21224