Maternal Buprenorphine-naloxone Treatment and the Infant
Status:
Recruiting
Trial end date:
2022-09-01
Target enrollment:
Participant gender:
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
Details
Lead Sponsor:
Johns Hopkins University
Collaborator:
National Institute on Drug Abuse (NIDA)
Treatments:
Analgesics, Opioid Buprenorphine Buprenorphine, Naloxone Drug Combination Methadone Naloxone