A Phase 2 interventional study of fetal monitoring and Buprenorphine Naloxone in Maternal Opioid Use Disorder and Opioid Exposed Infant, sponsored by Johns Hopkins University. Completed at 1 site in United States. Open to female participants aged 18 Years to 44 Years. Per ClinicalTrials.gov, last updated 2024-02-26.
Sponsored by Johns Hopkins University · Phase 2, Interventional, and Basic science
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Among 59 studies in Neonatal Abstinence Syndrome with a site in United States — 4 open to participants now, 7 under way, none of them phase 3. Neonatal Abstinence Syndrome · United States.
Among the 59 studies in Neonatal Abstinence Syndrome with a site in United States, this one is the 24th largest by enrollment of the 47 interventional ones that give a count, is one of 7 that started in 2018, is one of 7 in phase 2, and was the 32nd registered.
68 studies on the registry are indexed under Neonatal Abstinence Syndrome; 6 are open to participants now.
Browse Neonatal Abstinence Syndrome studies →4 of the 59 studies in Neonatal Abstinence Syndrome with a site in United States are open now. Recruiting first, the newest first:
University of Pennsylvania · Sites in United States
Ages 18+ · Healthy volunteers
Milton S. Hershey Medical Center · Sites in United States
Ages 1 days–5 days
Icahn School of Medicine at Mount Sinai · Sites in United States
Ages 28 wk+
Rekovar Inc. · Sites in United States
Ages up to 4 wk · Healthy volunteers
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 4 Neonatal Abstinence Syndrome studies recruiting now, 3 set no upper age limit and 1 stops at 75 or younger; 3 take children under 18; 1 takes healthy volunteers.
This study: 18 Years to 44 Years · female · no healthy volunteers.
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59 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 3 · Phase 2 12 · Phase 3 10 · Phase 4 6
First in 2002; this study’s year is marked. 7 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 42 is below the median of 48 across 52 interventional studies indexed under Neonatal Abstinence Syndrome.
Median enrollment 42 across the 47 interventional studies, 58 across the 12 observational. Of the 50 that completed or were terminated, 26 (52%) have results posted.
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4 of 59 have an industry lead sponsor. The 10 most frequent:
Johns Hopkins University is the lead sponsor of 1,816 studies on the registry; 315 are open to participants now.
Of its 208 completed or terminated interventional studies of FDA-regulated products, 144 (69%) have results posted.
Johns Hopkins University has 6 studies filed under Neonatal Abstinence Syndrome — fewer than ten, so there is no comparison to draw.
4 of the studies in Neonatal Abstinence Syndrome with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04783558Washington State UniversityEffective Caregiving for Neonatal Abstinence Syndrome: Testing an Instructional Mobile Technology Platform for High-Risk Pregnant Women | 2026-11-13 |
| NCT05937594Milton S. Hershey Medical CenterMicroRNA Biomarkers for Neonatal Opioid Withdrawal Syndrome | 2026-12-10 |
| NCT03533985Icahn School of Medicine at Mount SinaiEffect of Music Therapy on Infants With Neonatal Abstinence Syndrome | 2026-12-31 |
| NCT06576323University of PennsylvaniaAn Intervention Mapping Approach to Closing the Gap in Maternal OUD and Infant NAS Care (SUPPORT) | 2027-05-31 |
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Among the 59 studies in Neonatal Abstinence Syndrome with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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 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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants receiving buprenorphine-naloxone treatment for opioid use disorder during pregnancy
Device: fetal monitoring · Drug: Buprenorphine Naloxone
Maternal fetal monitoring
Also known as: maternal physiology monitoring
Treatment for opioid use disorder
Also known as: Suboxone
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
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 32 weeks of gestation
| Milestone | Buprenorphine-naloxone Treated |
|---|---|
| Started | 42 |
| Completed | 24 |
| Not completed | 18 |
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
| beats per minute | Buprenorphine-naloxone Treated |
|---|---|
| Fetal Heart Rate at 24 Weeks | 143.64 ± 4.38 |
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.
| beats per minute | Buprenorphine-naloxone Treated |
|---|---|
| Fetal Heart Rate at 28 Weeks Gestation | 139.14 ± 3.93 |
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
| beats per minute | Buprenorphine-naloxone Treated |
|---|---|
| Fetal Heart Rate at 32 Weeks Gestation | 135.82 ± 146.83 |
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.
| beats per minute | Buprenorphine-naloxone Treated |
|---|---|
| Fetal Heart Rate at 36 Weeks Gestation | 131.99 ± 5.52 |
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.
| fetal movements | Buprenorphine-naloxone Treated |
|---|---|
| Total Fetal Movement at 24 Weeks Gestation | 71.91 ± 13.8 |
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.
| fetal movements | Buprenorphine-naloxone Treated |
|---|---|
| Total Fetal Movement at 36 Weeks Gestation | 59.07 ± 17.17 |
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.
| fetal movements | Buprenorphine-naloxone Treated |
|---|---|
| Total Fetal Movement at 28 Weeks Gestation | 70.06 ± 12.13 |
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.
| fetal movements | Buprenorphine-naloxone Treated |
|---|---|
| Total Fetal Movement at 32 Weeks Gestation | 66.00 ± 19.13 |
Collected over From the time of protocol enrollment up to 30 days of infant age, an average of 6 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Buprenorphine-naloxone Treated | 0/26 (0%) | 3/26 (11.5%) | 0/26 (0%) |
| Event | Buprenorphine-naloxone Treated |
|---|---|
| pectus carinatum, mildMusculoskeletal and connective tissue disorders | 1/26 |
| missed spontaneous abortionPregnancy, puerperium and perinatal conditions | 1/26 |
| congenital malformationGastrointestinal disorders | 1/26 |
Data not collected for subjects removed from the study
| Age, Continuous(years) | Buprenorphine-naloxone Treated |
|---|---|
| Mean | 29.6 ± 4.7 |
| Sex: Female, Male(Participants) | Buprenorphine-naloxone Treated |
|---|---|
| Female | 26 |
| Male | 0 |
| Ethnicity (NIH/OMB)(Participants) | Buprenorphine-naloxone Treated |
|---|---|
| Hispanic or Latino | 1 |
| Not Hispanic or Latino | 25 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Buprenorphine-naloxone Treated |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 9 |
| White | 17 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(Participants) | Buprenorphine-naloxone Treated |
|---|---|
| United States | 26 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Jun 2018 to primary completion in Dec 2022, 54 months.
Results were first posted in Dec 2023, 11 months after primary completion.
How these figures are worked out, and which studies are left out of them.
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Neonatal Abstinence Syndrome →