Maternal Buprenorphine-naloxone Treatment and the Infant

NCT03291847 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: IRB000931711R01DA041367-01A1
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Maternal Opioid Use Disorder; Opioid Exposed Infant

Keywords

maternal opioid use; neonatal abstinence syndrome; buprenorphine-naloxone

Outcome Measures

Primary Outcomes (8)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

Study Arms (1)

Buprenorphine-naloxone treated

EXPERIMENTAL

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

Device: fetal monitoring; Drug: Buprenorphine Naloxone

Interventions

fetal monitoring DEVICE

Maternal fetal monitoring

Also known as: maternal physiology monitoring

Buprenorphine-naloxone treated

Buprenorphine Naloxone DRUG

Treatment for opioid use disorder

Also known as: Suboxone

Buprenorphine-naloxone treated

Eligibility Criteria

• Age: 18 Years - 44 Years
• Gender Eligibility Details: Pregnant women with opioid use disorder
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Johns Hopkins University: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Johns Hopkins Bayview Medical Center

Baltimore, Maryland, 21224, United States

Location

MeSH Terms

Conditions

Neonatal Abstinence Syndrome

Interventions

Fetal Monitoring; Buprenorphine, Naloxone Drug Combination

Condition Hierarchy (Ancestors)

Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Obstetrical and Gynecological; Diagnostic Techniques and Procedures; Diagnosis; Monitoring, Physiologic; Buprenorphine; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Naloxone; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Drug Combinations; Pharmaceutical Preparations

Limitations and Caveats

The COVID pandemic greatly affected the program from which participants were drawn and thereby subject enrollment.

Results Point of Contact

• Title: Lauren Jansson
• Organization: Johns Hopkins University School of Medicine

ljansson@jhmi.edu

4105504114

Study Officials

• Lauren M Jansson, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 14, 2017
• First Posted: September 25, 2017
• Study Start: June 1, 2018
• Primary Completion: December 27, 2022
• Study Completion: December 15, 2023
• Last Updated: February 26, 2024
• Results First Posted: December 20, 2023

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)