Maternal Opioid Use DisorderPhase 2NCT03291847

Maternal Buprenorphine-naloxone Treatment and the Infant

A Phase 2 study testing fetal monitoring and Buprenorphine Naloxone in people with Maternal Opioid Use Disorder and Opioid Exposed Infant, run by Johns Hopkins University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 44 years, women only
Conditions the study is for: Maternal Opioid Use Disorder, Opioid Exposed Infant
What is being tested?: fetal monitoring and Buprenorphine Naloxone
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 42 participants
Where: 1 siteUnited States
Study dates: 1 Jun 2018to 15 Dec 2023
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 44 years
Women only
No healthy volunteers
Adult

Who may be able to join

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

Who cannot join

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)

Show all 9Show fewer

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Johns Hopkins Bayview Medical Center
Baltimore, Maryland, 21224

Other trials in United States

About this study

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

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.

Read the 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
Being tested: fetal monitoring, Buprenorphine Naloxone
Keywords: maternal opioid use, neonatal abstinence syndrome, buprenorphine-naloxone
Medical subject headings: Neonatal Abstinence Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

fetal monitoringDevice
Also called maternal physiology monitoring
Maternal fetal monitoring
Buprenorphine NaloxoneDrug
Also called Suboxone
Treatment for opioid use disorder

Study groups in NCT03291847
Study group	Role	What they receive
Buprenorphine-naloxone treated	Experimental	Participants receiving buprenorphine-naloxone treatment for opioid use disorder during pregnancy Receives: Device: fetal monitoring; Drug: Buprenorphine Naloxone

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 32 weeks of gestation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jun 201815 Dec 2023

First posted25 Sep 2017
Study start1 Jun 2018
Primary completion27 Dec 2022
Study completion15 Dec 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Maternal Opioid Use DisorderStudies of the same condition, open and under way.
More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Basic science
Allocation: Not applicable
Intervention model: Single group
Model description: 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.
Masking: None (open label)
Enrolment: 42 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03291847
Sponsor's protocol ID: IRB00093171
Other IDs: 1R01DA041367-01A1
Status last verified: Feb 2024
First submitted: 14 Sep 2017
Last updated: 26 Feb 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Improving Outcomes for Early Postpartum Mothers in Outpatient MOUD Treatment
Substance Use Treatment, Perinatal Substance Use
RecruitingObservational study
Predicting and Preventing Adverse Maternal and Child Outcomes of Opioid Use Disorder in Pregnancy
Opioid Use Disorder, Pregnancy Related
Recruiting
Adapting the Penny Chatbot for Perinatal OUD Patients: COPILOT
Perinatal Opioid Use Disorder, Opioid Use Disorder
Recruiting
An Intervention Mapping Approach to Closing the Gap in Maternal OUD and Infant NAS Care (SUPPORT)
Opioid Use Disorder, Neonatal Abstinence Syndrome
Recruiting
Postpartum Intervention for Mothers With Opioid Use Disorders (R33)
Opioid Use Disorder, Parent-Child Relations

All Maternal Opioid Use Disorder trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Maternal Buprenorphine-naloxone Treatment During the Perinatal Period: Fetal and Infant Effects
ClinicalTrials.gov ID: NCT03291847
Acronym / sponsor ID: IRB00093171
Conditions: Maternal Opioid Use Disorder, Opioid Exposed Infant
Keywords: maternal opioid use, neonatal abstinence syndrome, buprenorphine-naloxone
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 42 participants (actual)
Lead sponsor: Johns Hopkins UniversityUniversity, hospital or other
Collaborators: National Institute on Drug Abuse (NIDA)
Study start: 1 Jun 2018 (actual)
Primary completion: 27 Dec 2022 (actual)
Study completion: 15 Dec 2023 (actual)
First posted: 25 Sep 2017 (actual)
Results: Posted 20 Dec 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Basic science
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: 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.

Arm	Type	Receives
Buprenorphine-naloxone treated	Experimental	Device: fetal monitoring, Drug: Buprenorphine NaloxoneParticipants receiving buprenorphine-naloxone treatment for opioid use disorder during pregnancy

Who may qualify

Ages: 18 to 44 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (9 listed)

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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
fetal monitoringAlso: maternal physiology monitoringMaternal fetal monitoring	Device	Buprenorphine-naloxone treated
Buprenorphine NaloxoneAlso: SuboxoneTreatment for opioid use disorder	Drug	Buprenorphine-naloxone treated

Primary outcome

Fetal Heart Rate at 24 Weeks
Time frame: 24 weeks of gestation
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
Fetal Heart Rate at 28 Weeks Gestation
Time frame: 28 weeks of 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.
Fetal Heart Rate at 32 Weeks Gestation
Time frame: 32 weeks of 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
Fetal Heart Rate at 36 Weeks Gestation
Time frame: 36 weeks of 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.
Total Fetal Movement at 24 Weeks Gestation
Time frame: 24 weeks of 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.
Total Fetal Movement at 36 Weeks Gestation
Time frame: 36 weeks of 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.
Total Fetal Movement at 28 Weeks Gestation
Time frame: 28 weeks of 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.
Total Fetal Movement at 32 Weeks Gestation
Time frame: 32 weeks of 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.

Results and safety

Results posted to the registry on 20 Dec 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Buprenorphine-naloxone Treated	42	24

Primary outcome: Fetal Heart Rate at 24 Weeks

Time frame: 24 weeks of gestation. Mean (Standard Deviation). Unit: beats per minute

Measure	Buprenorphine-naloxone Treated n = 13
Value	143.64 (4.38)

Population analysed: Fetal monitoring performed for all participants enrolled in the study at that gestational age who met criteria for monitoring

Primary outcome: Fetal Heart Rate at 28 Weeks Gestation

Time frame: 28 weeks of gestation. Mean (Standard Deviation). Unit: beats per minute

Measure	Buprenorphine-naloxone Treated n = 16
Value	139.14 (3.93)

Population analysed: Fetal monitoring performed for all participants enrolled in the study at that gestational age who met criteria for monitoring

Primary outcome: Fetal Heart Rate at 32 Weeks Gestation

Time frame: 32 weeks of gestation. Mean (Standard Deviation). Unit: beats per minute

Measure	Buprenorphine-naloxone Treated n = 19
Value	135.82 (146.83)

Population analysed: Fetal monitoring performed for all participants enrolled in the study at that gestational age who met criteria for monitoring

Primary outcome: Fetal Heart Rate at 36 Weeks Gestation

Time frame: 36 weeks of gestation. Mean (Standard Deviation). Unit: beats per minute

Measure	Buprenorphine-naloxone Treated n = 15
Value	131.99 (5.52)

Population analysed: Fetal monitoring performed for all participants enrolled in the study at that gestational age who met criteria for monitoring

Adverse events

Time frame: From the time of protocol enrollment up to 30 days of infant age, an average of 6 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Buprenorphine-naloxone Treated	3 of 26 (11.5%)	0 of 26 (0%)	0 of 26

Limitations and caveats (from the sponsor): The COVID pandemic greatly affected the program from which participants were drawn and thereby subject enrollment.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Maternal Opioid Use Disorder

Recruiting
Improving Outcomes for Early Postpartum Mothers in Outpatient MOUD Treatment
Substance Use Treatment, Perinatal Substance Use
RecruitingObservational study
Predicting and Preventing Adverse Maternal and Child Outcomes of Opioid Use Disorder in Pregnancy
Opioid Use Disorder, Pregnancy Related
Recruiting
Adapting the Penny Chatbot for Perinatal OUD Patients: COPILOT
Perinatal Opioid Use Disorder, Opioid Use Disorder
Recruiting
An Intervention Mapping Approach to Closing the Gap in Maternal OUD and Infant NAS Care (SUPPORT)
Opioid Use Disorder, Neonatal Abstinence Syndrome
Recruiting
Postpartum Intervention for Mothers With Opioid Use Disorders (R33)
Opioid Use Disorder, Parent-Child Relations

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Lauren M Jansson, MD principal investigator

Johns Hopkins University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing fetal monitoring and Buprenorphine Naloxone in people with Maternal Opioid Use Disorder and Opioid Exposed Infant, run by Johns Hopkins University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Dec 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Fetal Heart Rate at 24 Weeks (time frame: 24 weeks of gestation). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03291847.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2024.