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Trial record 12 of 34 for:    substance abuse | Not yet recruiting Studies

Maternal Buprenorphine-naloxone Treatment and the Infant

This study is not yet open for participant recruitment.
Verified September 2017 by Johns Hopkins University
Sponsor:
ClinicalTrials.gov Identifier:
NCT03291847
First Posted: September 25, 2017
Last Update Posted: September 25, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Johns Hopkins University
  Purpose
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.

Condition Intervention Phase
Maternal Opioid Use Disorder Opioid Exposed Infant Device: fetal monitoring Drug: Buprenorphine Naloxone Drug: Methadone Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
One group of n=40 study participants will receive buprenorphine-naloxone medication assisted therapy for the treatment of opioid use disorder during pregnancy, a second group of n=40 will receive methadone as standard of care. Subjects will undergo identical study procedures.
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Maternal Buprenorphine-naloxone Treatment During the Perinatal Period: Fetal and Infant Effects

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • Fetal Heart Rate (FHR) 24 [ Time Frame: 24 weeks of gestation ]
    Fetal heart rate in msec, mean over 60 minutes gestation

  • FHR28 [ Time Frame: 28 weeks of gestation ]
    Fetal heart rate in msec, mean over 60 minutes gestation

  • FHR32 [ Time Frame: 32 weeks of gestation ]
    Fetal heart rate in msec, mean over 60 minutes

  • FHR36 [ Time Frame: 36 weeks of gestation ]
    Fetal heart rate in msec, mean over 60 minutes


Secondary Outcome Measures:
  • Neonatal abstinence syndrome severity score (NAS)1 [ Time Frame: day 1 of life ]
    NAS lists 21 symptoms most frequently observed in opiate-exposed infants. Baseline score is recorded two hours after birth or admission to the nursery. If the infant's score at any scoring interval is ≥ 8, scoring is increased to 2-hourly and continued for 24 hours from the last total score of 8 or higher. If the 2-hourly score is ≤ 7 for 24 hours then 4-hourly scoring intervals may be resumed. If pharmacotherapy is not needed the infant is scored for the first 4 days of life at 4-hourly intervals. If pharmacotherapy is required the infant is scored at 2- or 4-hourly intervals, depending on whether the abstinence score is less than or greater than 8 throughout the duration of therapeutic period. If after cessation of pharmacotherapy the score is less than 8 for the following 3 days, scoring may be discontinued.

  • NAS2 [ Time Frame: day 2 of life ]
    Neonatal abstinence syndrome severity score

  • NAS3 [ Time Frame: day 3 of life ]
    Neonatal abstinence syndrome severity score

  • NAS4 [ Time Frame: day 4 of life ]
    Neonatal abstinence syndrome severity score


Estimated Enrollment: 80
Anticipated Study Start Date: January 2018
Estimated Study Completion Date: September 2022
Estimated Primary Completion Date: June 2022 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Buprenorphine-naloxone treated
Participants receiving buprenorphine-naloxone treatment for opioid use disorder during pregnancy
Device: fetal monitoring
Maternal fetal monitoring
Other Name: maternal physiology monitoring
Drug: Buprenorphine Naloxone
Treatment for opioid use disorder
Other Name: Suboxone
Active Comparator: Methadone treated
Participants receiving methadone treatment for opioid use disorder during pregnancy
Device: fetal monitoring
Maternal fetal monitoring
Other Name: maternal physiology monitoring
Drug: Methadone
Treatment for opioid use disorder

Detailed Description:
The project population will be 80 pregnant women with opioid use disorder, 40 inducted as outpatients to buprenorphine-naloxone maintenance, and 40 matched methadone controls. 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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 44 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Pregnant women with opioid use disorder
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03291847


Contacts
Contact: Lauren M Jansson, MD 410-550-5438 ljansson@jhmi.edu

Sponsors and Collaborators
Johns Hopkins University
National Institute on Drug Abuse (NIDA)
Investigators
Principal Investigator: Lauren M Jansson, MD Johns Hopkins University
  More Information

Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT03291847     History of Changes
Other Study ID Numbers: IRB00093171
First Submitted: September 14, 2017
First Posted: September 25, 2017
Last Update Posted: September 25, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Data sharing will be considered upon individual request

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Johns Hopkins University:
maternal opioid use
neonatal abstinence syndrome
buprenorphine-naloxone

Additional relevant MeSH terms:
Analgesics, Opioid
Buprenorphine
Methadone
Buprenorphine, Naloxone Drug Combination
Naloxone
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists
Antitussive Agents
Respiratory System Agents