Trial · NCT03291847

Maternal Buprenorphine-naloxone Treatment and the Infant

NCT03291847, Phase 2, Completed, Johns Hopkins University; results first posted 2023-12-20

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Maternal Buprenorphine-naloxone Treatment and the Infant. Trials, record NCT03291847. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03291847

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Maternal Buprenorphine-naloxone Treatment and the Infant
NCT number: NCT03291847
Status: Completed
Phases: Phase 2
Enrollment: 42 participants, actual
Lead sponsor: Johns Hopkins University
Conditions: Maternal Opioid Use Disorder, Opioid Exposed Infant
Interventions: fetal monitoring, Buprenorphine Naloxone
First posted: 2017-09-25
Last updated: 2024-02-26
Results first posted: 2023-12-20
Limitations and caveats: The COVID pandemic greatly affected the program from which participants were drawn and thereby subject enrollment.

Source ClinicalTrials.gov

Registered outcomes8

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Fetal Heart Rate at 24 Weeks	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
Primary	Fetal Heart Rate at 28 Weeks Gestation	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.
Primary	Fetal Heart Rate at 32 Weeks Gestation	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
Primary	Fetal Heart Rate at 36 Weeks Gestation	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.
Primary	Total Fetal Movement at 24 Weeks Gestation	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.
Primary	Total Fetal Movement at 36 Weeks Gestation	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.
Primary	Total Fetal Movement at 28 Weeks Gestation	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.
Primary	Total Fetal Movement at 32 Weeks Gestation	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.

Source ClinicalTrials.gov

Outcomes8

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Fetal Heart Rate at 24 Weeks	24 weeks of gestation	Fetal monitoring performed for all participants enrolled in the study at that gestational age who met criteria for monitoring	beats per minute	MEAN
PRIMARY	Fetal Heart Rate at 28 Weeks Gestation	28 weeks of gestation	Fetal monitoring performed for all participants enrolled in the study at that gestational age who met criteria for monitoring	beats per minute	MEAN
PRIMARY	Fetal Heart Rate at 32 Weeks Gestation	32 weeks of gestation	Fetal monitoring performed for all participants enrolled in the study at that gestational age who met criteria for monitoring	beats per minute	MEAN
PRIMARY	Fetal Heart Rate at 36 Weeks Gestation	36 weeks of gestation	Fetal monitoring performed for all participants enrolled in the study at that gestational age who met criteria for monitoring	beats per minute	MEAN
PRIMARY	Total Fetal Movement at 24 Weeks Gestation	24 weeks of gestation	Fetal monitoring performed for all participants enrolled in the study at that gestational age who met criteria for monitoring	fetal movements	MEAN
PRIMARY	Total Fetal Movement at 36 Weeks Gestation	36 weeks of gestation	Fetal monitoring performed for all participants enrolled in the study at that gestational age who met criteria for monitoring	fetal movements	MEAN
PRIMARY	Total Fetal Movement at 28 Weeks Gestation	28 weeks of gestation	Fetal monitoring performed for all participants enrolled in the study at that gestational age who met criteria for monitoring	fetal movements	MEAN
PRIMARY	Total Fetal Movement at 32 Weeks Gestation	32 weeks of gestation	Fetal monitoring performed for all participants enrolled in the study at that gestational age who met criteria for monitoring	fetal movements	MEAN

Source ClinicalTrials.gov

Results by group8

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Fetal Heart Rate at 24 Weeks	Buprenorphine-naloxone Treated	143.64	Standard Deviation 4.38	beats per minute
Fetal Heart Rate at 28 Weeks Gestation	Buprenorphine-naloxone Treated	139.14	Standard Deviation 3.93	beats per minute
Fetal Heart Rate at 32 Weeks Gestation	Buprenorphine-naloxone Treated	135.82	Standard Deviation 146.83	beats per minute
Fetal Heart Rate at 36 Weeks Gestation	Buprenorphine-naloxone Treated	131.99	Standard Deviation 5.52	beats per minute
Total Fetal Movement at 24 Weeks Gestation	Buprenorphine-naloxone Treated	71.91	Standard Deviation 13.8	fetal movements
Total Fetal Movement at 36 Weeks Gestation	Buprenorphine-naloxone Treated	59.07	Standard Deviation 17.17	fetal movements
Total Fetal Movement at 28 Weeks Gestation	Buprenorphine-naloxone Treated	70.06	Standard Deviation 12.13	fetal movements
Total Fetal Movement at 32 Weeks Gestation	Buprenorphine-naloxone Treated	66.00	Standard Deviation 19.13	fetal movements

Source ClinicalTrials.gov

Participant flow3

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Buprenorphine-naloxone Treated	42
Overall Study	COMPLETED	Buprenorphine-naloxone Treated	24
Overall Study	NOT COMPLETED	Buprenorphine-naloxone Treated	18

Source ClinicalTrials.gov

Adverse events3

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
serious	pectus carinatum, mild	Musculoskeletal and connective tissue disorders	Buprenorphine-naloxone Treated	1	26	1
serious	missed spontaneous abortion	Pregnancy, puerperium and perinatal conditions	Buprenorphine-naloxone Treated	1	26	1
serious	congenital malformation	Gastrointestinal disorders	Buprenorphine-naloxone Treated	1	26	1

Source ClinicalTrials.gov

Adverse event totals3

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Buprenorphine-naloxone Treated	0	26
Total, other adverse events	Buprenorphine-naloxone Treated	0	26
Total, serious adverse events	Buprenorphine-naloxone Treated	3	26

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
R01DA041367	Maternal buprenorphine-naloxone treatment during the perinatal period: Fetal and infant effects	JANSSON, LAUREN M	JOHNS HOPKINS UNIVERSITY	NATIONAL INSTITUTE ON DRUG ABUSE	2017 to 2022

Source NIH RePORTER

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT03291847

GET https://conductscience.org/api/trials/v1/NCT03291847/registered

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