Maternal Buprenorphine-naloxone Treatment and the Infant
Condition: Maternal Opioid Use Disorder; Opioid Exposed Infant
MeSH terms: Opioid-Related Disorders
Intervention: fetal monitoring; Buprenorphine Naloxone
Intervention description: Maternal fetal monitoring; Treatment for opioid use disorder
Intervention MeSH terms: Buprenorphine; Buprenorphine, Naloxone Drug Combination; Naloxone
Phase: Phase 2
Study type: Interventional
Primary purpose: Basic Science
Intervention model: Single Group Assignment
Intervention model description: A group of n=40 study participants will receive buprenorphine-naloxone medication assisted therapy for the treatment of opioid use disorder during pregnancy. This group will undergo fetal monitoring at 24, 28, 32 and 36 weeks of gestation.
Masking: None (Open Label)
Enrollment: 42.0
Sex: Female
Minimum age: 18 Years
Maximum age: 44 Years
Healthy volunteers: No
Keywords: maternal opioid use; neonatal abstinence syndrome; buprenorphine-naloxone

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.