Maternal Buprenorphine-naloxone Treatment and the Infant

Maternal Opioid Use Disorder Clinical Trial

Official title:

Maternal Buprenorphine-naloxone Treatment During the Perinatal Period: Fetal and Infant Effects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03291847
• Other study ID #: IRB00093171
• Secondary ID: 1R01DA041367-01A
• Status: Completed
• Phase: Phase 2
• Start date: June 1, 2018
• Est. completion date: December 15, 2023

Study information

• Verified date: February 2024
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: December 15, 2023
• Est. primary completion date: December 27, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 44 Years

Eligibility

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.

Related Conditions & MeSH terms

• Maternal Opioid Use Disorder
• Opioid Exposed Infant
• Opioid-Related Disorders

Intervention

Device:
• fetal monitoring
Maternal fetal monitoring

Drug:
• Buprenorphine Naloxone
Treatment for opioid use disorder

Locations

Country	Name	City	State
United States	Johns Hopkins Bayview Medical Center	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fetal Heart Rate at 24 Weeks	Fetal heart rate in beats per minute, mean over 60 minutes gestation. Fetal heart rate in msec at 24 weeks of gestation at times of peak maternal plasma drug concentrations	24 weeks of gestation
Primary	Fetal Heart Rate at 28 Weeks Gestation	Fetal heart rate in beats per minute, mean over 60 minutes gestation. Fetal heart rate at 28 weeks of gestation at times of tpeak maternal plasma drug concentrations.	28 weeks of gestation
Primary	Fetal Heart Rate at 32 Weeks Gestation	Fetal heart rate in beats per minute, mean over 60 minutes. Fetal heart rate at 32 weeks of gestation at times of peak maternal plasma drug concentrations	32 weeks of gestation
Primary	Fetal Heart Rate at 36 Weeks Gestation	Fetal heart rate in beats per minute, mean over 60 minutes. Fetal heart rate at 36 weeks of gestation at times of peak maternal plasma drug concentrations.	36 weeks of gestation
Primary	Total Fetal Movement at 24 Weeks Gestation	Total fetal movement at 24 weeks of gestation. Total number of fetal moves over 60 minutes via fetal monitoring at time of peak maternal plasma drug concentrations at 24 weeks of gestation.	24 weeks of gestation
Primary	Total Fetal Movement at 36 Weeks Gestation	Total fetal movement over 60 minutes via fetal monitoring at 36 weeks of gestation. Nimber of fetal movements over 60 minutes via fetal monitoring at times of peak maternal plasma drug concentrations at 36 weeks of gestation.	36 weeks of gestation
Primary	Total Fetal Movement at 28 Weeks Gestation	Total fetal movement over 60 minutes via fetal monitoring. Total fetal movement over 60 minutes via fetal monitoring at times of trough and peak maternal plasma drug concentrations at 28 weeks of gestation.	28 weeks of gestation
Primary	Total Fetal Movement at 32 Weeks Gestation	Total fetal movement over 60 minutes via fetal monitoring at 32 weeks of gestation. Number of fetal moves over 60 minutes via fetal monitoring at times of peak maternal plasma drug concentrations at 32 weeks of gestation.	32 weeks of gestation