Maternal Buprenorphine-naloxone Treatment and the Infant

• Status: Recruiting
• Trial end date: 2022-09-01
• Target enrollment: 0
• Participant gender: Female

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. The investigators will compare the neurodevelopment of the buprenorphine-naloxone-exposed fetuses and infants to that of methadone and buprenorphine-only exposed fetuses and infants.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johns Hopkins University
• Collaborator: National Institute on Drug Abuse (NIDA)
• Treatments: Analgesics, Opioid; Buprenorphine; Buprenorphine, Naloxone Drug Combination; Methadone; Naloxone

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.