Maternal Buprenorphine-naloxone Treatment and the Infant

NCT ID: NCT03291847

Last Updated: 2024-02-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-06-01
• Study Completion Date: 2023-12-15

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, 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.

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 histories, drug use histories, demographic information and psychosocial information will be extracted from patient charts. Weekly urine toxicology testing will provide information regarding other substance use/misuse during the time of study participation. Study participants will undergo 2 60 minute maternal and fetal neurophysiologic monitoring sessions on one day at 4 points during gestation: 24, 28, 32 and 36 weeks, at times of trough (just before sublingual buprenorphine-naloxone or methadone daily dose) and peak (2 1/2 hours after dosing) maternal drug levels. Fetal cardiac (heart rate, heart rate variability, heart rate accelerations) and movement (total fetal movement, number and duration of movement bouts) and the correlation between the two (fetal heart rate-movement coupling) will be determined. Maternal physiologic measures will include heart period and variability, vagal tone, skin conductance and respiratory data. All maternal and fetal measures, with the exception of blood pressure, will be computed in 1-minute intervals and averaged over the 60 min recording. Infant birth data and birth parameters, and neonatal abstinence syndrome scores will be extracted from patient charts. Infants will undergo neurobehavioral testing using the Neonatal Intensive Care Unit (NICU) Network Neurobehavioral Scale, a 30 minute harmless assessment of infant functioning, on days 3, 14 and 30 of life.

Conditions

Maternal Opioid Use Disorder; Opioid Exposed Infant

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Buprenorphine-naloxone treated

Participants receiving buprenorphine-naloxone treatment for opioid use disorder during pregnancy

Group Type: EXPERIMENTAL

fetal monitoring

Intervention Type: DEVICE

Maternal fetal monitoring

Buprenorphine Naloxone

Intervention Type: DRUG

Treatment for opioid use disorder

Interventions

fetal monitoring

Maternal fetal monitoring

Intervention Type: DEVICE

Buprenorphine Naloxone

Treatment for opioid use disorder

Intervention Type: DRUG

Other Intervention Names

maternal physiology monitoring; Suboxone

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 44 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lauren M Jansson, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Johns Hopkins Bayview Medical Center

Baltimore, Maryland, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

1R01DA041367-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB00093171

Identifier Type: -

Identifier Source: org_study_id