Opioid-use DisorderNCT03718104
MOM NEST Study: Maternal Opioid Medication: Naltrexone Efficacy Study
An observational study of Opioid-use Disorder and Neonatal Abstinence Syndrome, run by Boston Medical Center at 2 sites in United States.
Trial summary
This is a multi-center prospective comparative cohort study examining the safety, efficacy, pharmacokinetics, and pharmacogenomics of naltrexone for pregnant women with opioid use disorder. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Opioid-use Disorder, Neonatal Abstinence Syndrome, Pregnancy, High Risk
- What is being tested?
- Pharmacokinetic analysis, Safety and Efficacy and Genetic and epigenetic analysis
- Type of treatment
- Pill or oral medicine
- How many people
- 46 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Dec 2018to 8 May 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Pregnant women with opioid use disorder or alcohol use disorder on prescribed naltrexone, or those with opioid use disorder on buprenorphine/naloxone and their infants.
Who may be able to join
- Pregnant women between 6 - 30 6/7 weeks gestation, receiving prenatal care at Boston Medical Center (BMC) or the University of North Carolina (UNC)
- Plan to deliver infant at BMC or UNC
- Diagnosis of opioid use disorder (OUD) or alcohol use disorder (AUD) in the current pregnancy on prescribed oral or extended-release naltrexone; or buprenorphine/naloxone for the treatment of OUD
- English speaking
- Singleton pregnancy
Who cannot join
- OUD on prescribed methadone, or no maintenance medication
- OUD on Subutex formulation of buprenorphine
- Severe psychiatric illness or cognitively impairing ability to provide informed consent
- Current maternal incarceration
- Women who present for care >31 0/7 weeks
- Multiple gestation pregnancy
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Boston Medical Center
Boston, Massachusetts, 02118
University of North Carolina Chapel Hill
Carrboro, North Carolina, 27510
About this study
Official title: Safety, Efficacy, Pharmacokinetics, and Pharmacogenomics of Extended-Release Naltrexone in Pregnant Women
This is a multi-center prospective comparative cohort study examining the safety, efficacy, pharmacokinetics, and pharmacogenomics of naltrexone for pregnant women with opioid use disorder. Pregnancy, delivery, and maternal and infant outcomes to 12 months post-delivery will be examined and compared with a cohort treated with buprenorphine/naloxone.
Read the detailed description
Fifty pregnant women stabilized pre-pregnancy on oral or extended-release naltrexone (XR-NTX) and 50 comparison women on buprenorphine/naloxone (BPH) from Boston Medical Center and the University of North Carolina will be enrolled in this multi-center prospective comparative cohort study. The specific aims of this project are: 1) Safety and Efficacy: To compare maternal outcomes (safety, relapse, retention in care), fetal outcomes (growth, fetal distress), and infant outcomes (neonatal abstinence syndrome, growth, neurodevelopment) during pregnancy until 12 months post- delivery; An exploratory part of this aim is to collect safety and efficacy data on women receiving NTX for alcohol use disorder (AUD). We will collect maternal, fetal and infant outcomes related to prenatal alcohol exposure. 2) Pharmacokinetics: To determine the pharmacokinetics of NTX in pregnant and postpartum women; 3) Genetics and Epigenetics: To examine the association between genetic variants and epigenetic modification in the mu-opioid receptor (OPRM1) gene, as well as global DNA methylation changes after treatment with NTX and BPH within the mother, placenta, and infant; and 4) Breast milk: To measure breast milk concentrations of NTX and corresponding infant relative dose to determine safety for lactating women.
- Conditions
- Opioid-use Disorder, Neonatal Abstinence Syndrome, Pregnancy, High Risk, Alcohol Use Disorder
- Being tested
- Pharmacokinetic analysis, Safety and Efficacy, Genetic and epigenetic analysis, Breast milk analysis
- Keywords
- naltrexone, buprenorphine/naloxone, maternal relapse, retention in care, pharmacokinetics, pharmacogenetics
- Medical subject headings
- Opioid-Related Disorders, Neonatal Abstinence Syndrome, Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pharmacokinetic analysisOther
Pharmacokinetic analysis of maternal blood, maternal urine, cord blood, infant blood and urine for dyads in the naltrexone group at various time points in the pregnancy, at delivery, and 4 weeks postpartum.
Safety and EfficacyOther
Examination of the safety and efficacy of naltrexone and comparison of outcomes with the buprenorphine/naloxone cohort. Outcomes examined will include: 1) maternal outcomes (relapse, retention in care, preterm labor); 2) fetal outcomes (growth, fetal anomalies, fetal distress, cortisol levels); and 3) infant outcomes (NAS, growth, neurodevelopment via NNNS exam at 4 weeks and Bayley exam at 12 months of age).
Genetic and epigenetic analysisGenetic
Maternal blood and saliva DNA samples will be genotyped for single nucleotide polymorphisms in the mu opioid receptor gene (OPRM1) to look for associations with effectiveness of NTX and BPH. In addition, DNA methylation levels in the OPRM1 promoter within maternal and infant saliva and placenta at delivery and 4 weeks postpartum will be examined. Lastly, we will compare genome-wide DNA methylation levels at delivery and 4 weeks postpartum in mother-infant dyads.
Breast milk analysisOther
Mothers in the naltrexone group will have their breast milk analyzed at 4 weeks post-delivery for naltrexone levels, with corresponding maternal and infant plasma levels.
| Study group | Role | What they receive |
|---|---|---|
| Naltrexone | Pregnant women with opioid use disorder on prescribed oral or extended-release naltrexone and their infants. Biospecimens collected from this group will undergo pharmacokinetic analysis, genetic and epigenetic analysis, and breast milk analysis. This group will also receive safety and efficacy interventions. Receives: Other: Pharmacokinetic analysis; Other: Safety and Efficacy; Genetic: Genetic and epigenetic analysis; Other: Breast milk analysis | |
| Buprenorphine/Naloxone | Pregnant women with opioid use disorder on prescribed buprenorphine/naloxone and their infants. Biospecimens collected from this group will undergo genetic and epigenetic analysis and the group will also receive safety and efficacy interventions. Receives: Other: Safety and Efficacy; Genetic: Genetic and epigenetic analysis | |
| Naltrexone - alcohol use disorder | Pregnant women with alcohol use disorder on prescribed naltrexone (oral or extended-release) and their infants. Biospecimens collected from this group will undergo pharmacokinetic analysis, genetic and epigenetic analysis, and breast milk analysis. This exploratory group will also receive safety and efficacy interventions. Receives: Other: Pharmacokinetic analysis; Genetic: Genetic and epigenetic analysis; Other: Breast milk analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maternal drug use relapse
Maternal relapse of illicit and/or unprescribed drug use from maternal/provider report and or from urine toxicology testing at any point during the pregnancy and up to 12 months after delivery
Measured: up to 12 months post-delivery
Secondary outcomes (20)
Naltrexone side effects or adverse events
Number and type of side effects or adverse events such as injection site reactions, gastrointestinal upset, syncope, headaches, or dizziness reported by participant or provider
Measured: up to 12 months post-delivery
Fetal heart rate monitoring from NST
Mean fetal heart rate (FHR), FHR variability, and episodic accelerations of FHR (count) from each routine care non-stress test (NST) in the third trimesters.
Measured: 27- 41 weeks gestation
Biophysical profile score calculated from NST
The biophysical profile uses electronic fetal heart rate monitoring to examine the fetus. There are five components measured during the biophysical examination (fetal breathing movements, gross body movement, fetal tone, amninotic fluid volume and whether the NST is reactive or nonreactive. A score of 2 points is given for each component The points are then added for a possible maximum score of 10. The test is continued until all criteria are met or 30 minutes have elapsed. HIgher scores are more favorable.
Measured: 27 - 41 weeks gestation
Maternal hair cortisol levels
Hair cortisol levels will be obtained from maternal hair samples obtained at birth and 4 weeks after delivery, and compared between the naltrexone and buprenorphine groups. Higher hair cortisol levels in the mother may indicate exposure to higher levels of stress over the preceding 3 months period.
Measured: Birth and 4 weeks post-delivery
Infant hair cortisol levels
Hair cortisol levels will be obtained from infant hair samples obtained at birth and 4 weeks after delivery, and compared between the naltrexone and buprenorphine groups. Higher hair cortisol levels in the infant may indicate exposure to higher levels of stress over the preceding 3 months period.
Measured: Birth and 4 weeks post-delivery
Fetal growth based on ultrasound measurements
Fetal growth will be assessed at the time of routine growth scans at 18-20, and then q4 weeks until delivery. Fetal size will be compared to Intergrowth standards to produce z-scores and SGA (<10%ile) for averaged 2nd and 3rd trimester measurements.
Measured: 18 - 41 weeks gestation
Congenital fetal anomalies by ultrasound
Fetal, placental, or amniotic fluid anomalies identified during routine ultrasounds in the second and third trimesters will be documented.
Measured: 18 - 41 weeks gestation
Congenital anomalies by physical examination
Infants will be routinely assessed at birth during the physical examination for any external anomalies.
Measured: Birth
Diagnosis of Neonatal Abstinence Syndrome (NAS)
NAS diagnosis will be based on opioid withdrawal signs and symptoms in the infant after delivery as assessed by NAS withdrawal scores (either the Finnegan score or the via the ESC (Eat, Sleep, Console) assessment tool. The Finnegan scale assesses 21 of the most common signs of neonatal drug withdrawal syndrome and is scored on the basis of pathological significance and severity of the adverse symptoms, which sometimes requires pharmacological treatment. Measurements are performed every 4 hours, typically with 2-3 consecutive scores that are equal to or greater than 8, or 1-2 scores of 12 or greater, pharmacologic treatment for withdrawal is started. For the ESC assessment, clinicians assess whether or not the infant has poor feeding, is unable to sleep for at least 1 hour after feeding, and is consolable (rating of 1-3) due to symptoms of opioid withdrawal. Poor feeding, sleeping, or consolability triggers a huddle and possible start of pharmacologic treatment.
Measured: From birth to 30 days
Infant need for pharmacologic treatment
The need for pharmacologic treatment will be recorded as Y/N as will the need for adjunctive agents.
Measured: From birth to 30 days
Infant need for adjunctive agent
The need for adjunctive agents will be recorded as Y/N
Measured: From birth to 30 days
Infant opioid replacement pharmacologic treatment
The total mgs of morphine/methadone needed for pharmacologic treatment and the total number of total opioid treatment days will be obtained from the birth hospitalization medical records.
Measured: From birth to 30 days
Infant birth hospitalization length of stay
Number of continuous days infant hospitalized after birth.
Measured: From birth to 30 days
Infant weight
Growth parameters of infant weight in grams will be obtained by the clinician at birth, 4 weeks, and 12 months at each study visit. Percentiles will be calculated.
Measured: Birth, 4 weeks, and 12 months
Infant length
Growth parameters of infant length measured by the clinician in cm will be obtained at birth, 4 weeks, and 12 months at each study visit. Percentiles will be calculated.
Measured: Birth, 4 weeks, and 12 months
Infant head circumference
Growth parameters of infant head circumference in cm will be obtained by the clinician at birth, 4 weeks, and 12 months at each study visit. Percentiles will be calculated.
Measured: Birth, 4 weeks, and 12 months
Infant neurobehavior-function assessed by the NNNS
The NICU Network Neurobehavioral Scale (NNNS) is a comprehensive assessment of both neurologic integrity and behavioral functioning, including signs of stress. It assesses the full range of infant neurobehavioral performance (orientation to auditory and visual stimuli); infant stress (color changes, tremors, startles), neurologic functioning (reflexes, tone); some features of gestational age; self-soothing capacities; states and their organization. The 13 summary scores (i.e., orientation, habituation, hypertonicity, hypotonicity, excitability, arousal, lethargy, non-optimal reflexes, asymmetric reflexes, stress, self-regulation, quality of movement, handling) are typically used to summarize a clinical examination .
Measured: 4 weeks of age
Infant neurodevelopment assessed by Bayley III
The Bayley III is a standard series of measurements used to assess the development of infants and toddlers, ages 1-42 months. It has 5 scales, 3 administered with child interaction - cognitive, motor, language, and 2 with parent questionnaires- social-emotional, adaptive behavior. A developmental quotient (DQ) is derived from the results.
Measured: 12 months of age
Pharmacokinetic analysis of maternal naltrexone levels
Naltrexone levels from maternal blood and plasma will be obtained at regular intervals for pharmacokinetic analysis.
Measured: 2nd trimester, 3rd trimester, delivery, 2-4 days after delivery, 4 weeks post-delivery
Pharmacokinetic analysis of infant naltrexone levels
Naltrexone levels from infant blood and plasma will be obtained at regular intervals for pharmacokinetic analysis.
Measured: Delivery, 2-4 days after delivery, 4 weeks post-delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2018
- Study start1 Dec 2018
- Primary completion8 May 2024
- Study completion8 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Opioid-use DisorderStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- University of North Carolina, University of California, San Diego, Boston University, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Elisha Wachman, MD, Principal investigator, Boston Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03718104
- Sponsor's protocol ID
- H-37773
- Other IDs
- R01HD096798-01
- Status last verified
- Oct 2024
- First submitted
- 19 Oct 2018
- Last updated
- 4 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jones HE, Chisolm MS, Jansson LM, Terplan M. Naltrexone in the treatment of opioid-dependent pregnant women: the case for a considered and measured approach to research. Addiction. 2013 Feb;108(2):233-47. doi: 10.1111/j.1360-0443.2012.03811.x. Epub 2012 Apr 4.
PubMed 22471668Saia KA, Schiff D, Wachman EM, Mehta P, Vilkins A, Sia M, Price J, Samura T, DeAngelis J, Jackson CV, Emmer SF, Shaw D, Bagley S. Caring for Pregnant Women with Opioid Use Disorder in the USA: Expanding and Improving Treatment. Curr Obstet Gynecol Rep. 2016;5(3):257-263. doi: 10.1007/s13669-016-0168-9. Epub 2016 Jul 1.
PubMed 27563497Wachman EM, Saia K, Miller M, Valle E, Shrestha H, Carter G, Werler M, Jones H. Naltrexone Treatment for Pregnant Women With Opioid Use Disorder Compared With Matched Buprenorphine Control Subjects. Clin Ther. 2019 Sep;41(9):1681-1689. doi: 10.1016/j.clinthera.2019.07.003. Epub 2019 Jul 27.
PubMed 31358302
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety, Efficacy, Pharmacokinetics, and Pharmacogenomics of Extended-Release Naltrexone in Pregnant Women
- ClinicalTrials.gov ID
- NCT03718104
- Acronym / sponsor ID
- H-37773
- Conditions
- Opioid-use Disorder, Neonatal Abstinence Syndrome, Pregnancy, High Risk, Alcohol Use Disorder
- Keywords
- naltrexone, buprenorphine/naloxone, maternal relapse, retention in care, pharmacokinetics, pharmacogenetics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Boston Medical CenterUniversity, hospital or other
- Collaborators
- University of North Carolina, University of California, San Diego, Boston University, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- 8 May 2024 (actual)
- Study completion
- 8 May 2024 (actual)
- First posted
- 24 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multi-center prospective comparative cohort study examining the safety, efficacy, pharmacokinetics, and pharmacogenomics of naltrexone for pregnant women with opioid use disorder. Pregnancy, delivery, and maternal and infant outcomes to 12 months post-delivery will be examined and compared with a cohort treated with buprenorphine/naloxone.
Detailed description
Fifty pregnant women stabilized pre-pregnancy on oral or extended-release naltrexone (XR-NTX) and 50 comparison women on buprenorphine/naloxone (BPH) from Boston Medical Center and the University of North Carolina will be enrolled in this multi-center prospective comparative cohort study. The specific aims of this project are: 1) Safety and Efficacy: To compare maternal outcomes (safety, relapse, retention in care), fetal outcomes (growth, fetal distress), and infant outcomes (neonatal abstinence syndrome, growth, neurodevelopment) during pregnancy until 12 months post- delivery; An exploratory part of this aim is to collect safety and efficacy data on women receiving NTX for alcohol use disorder (AUD). We will collect maternal, fetal and infant outcomes related to prenatal alcohol exposure. 2) Pharmacokinetics: To determine the pharmacokinetics of NTX in pregnant and postpartum women; 3) Genetics and Epigenetics: To examine the association between genetic variants and epigenetic modification in the mu-opioid receptor (OPRM1) gene, as well as global DNA methylation changes after treatment with NTX and BPH within the mother, placenta, and infant; and 4) Breast milk: To measure breast milk concentrations of NTX and corresponding infant relative dose to determine safety for lactating women.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Naltrexone | – | Other: Pharmacokinetic analysis, Other: Safety and Efficacy, Genetic: Genetic and epigenetic analysis, Other: Breast milk analysisPregnant women with opioid use disorder on prescribed oral or extended-release naltrexone and their infants. Biospecimens collected from this group will undergo pharmacokinetic analysis, genetic and epigenetic analysis, and breast milk analysis. This group will also receive safety and efficacy interventions. |
| Buprenorphine/Naloxone | – | Other: Safety and Efficacy, Genetic: Genetic and epigenetic analysisPregnant women with opioid use disorder on prescribed buprenorphine/naloxone and their infants. Biospecimens collected from this group will undergo genetic and epigenetic analysis and the group will also receive safety and efficacy interventions. |
| Naltrexone - alcohol use disorder | – | Other: Pharmacokinetic analysis, Genetic: Genetic and epigenetic analysis, Other: Breast milk analysisPregnant women with alcohol use disorder on prescribed naltrexone (oral or extended-release) and their infants. Biospecimens collected from this group will undergo pharmacokinetic analysis, genetic and epigenetic analysis, and breast milk analysis. This exploratory group will also receive safety and efficacy interventions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Pregnant women with opioid use disorder or alcohol use disorder on prescribed naltrexone, or those with opioid use disorder on buprenorphine/naloxone and their infants.
Key inclusion criteria (5 listed)
- Pregnant women between 6 - 30 6/7 weeks gestation, receiving prenatal care at Boston Medical Center (BMC) or the University of North Carolina (UNC)
- Plan to deliver infant at BMC or UNC
- Diagnosis of opioid use disorder (OUD) or alcohol use disorder (AUD) in the current pregnancy on prescribed oral or extended-release naltrexone; or buprenorphine/naloxone for the treatment of OUD
- English speaking
- Singleton pregnancy
Key exclusion criteria (6 listed)
- OUD on prescribed methadone, or no maintenance medication
- OUD on Subutex formulation of buprenorphine
- Severe psychiatric illness or cognitively impairing ability to provide informed consent
- Current maternal incarceration
- Women who present for care >31 0/7 weeks
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 |
|---|---|---|
| Pharmacokinetic analysisPharmacokinetic analysis of maternal blood, maternal urine, cord blood, infant blood and urine for dyads in the naltrexone group at various time points in the pregnancy, at delivery, and 4 weeks postpartum. | Other | Naltrexone, Naltrexone - alcohol use disorder |
| Safety and EfficacyExamination of the safety and efficacy of naltrexone and comparison of outcomes with the buprenorphine/naloxone cohort. Outcomes examined will include: 1) maternal outcomes (relapse, retention in care, preterm labor); 2) fetal outcomes (growth, fetal anomalies, fetal distress, cortisol levels); and 3) infant outcomes (NAS, growth, neurodevelopment via NNNS exam at 4 weeks and Bayley exam at 12 months of age). | Other | Buprenorphine/Naloxone, Naltrexone |
| Genetic and epigenetic analysisMaternal blood and saliva DNA samples will be genotyped for single nucleotide polymorphisms in the mu opioid receptor gene (OPRM1) to look for associations with effectiveness of NTX and BPH. In addition, DNA methylation levels in the OPRM1 promoter within maternal and infant saliva and placenta at delivery and 4 weeks postpartum will be examined. Lastly, we will compare genome-wide DNA methylation levels at delivery and 4 weeks postpartum in mother-infant dyads. | Genetic | Buprenorphine/Naloxone, Naltrexone, Naltrexone - alcohol use disorder |
| Breast milk analysisMothers in the naltrexone group will have their breast milk analyzed at 4 weeks post-delivery for naltrexone levels, with corresponding maternal and infant plasma levels. | Other | Naltrexone, Naltrexone - alcohol use disorder |
Primary outcome
Maternal drug use relapse
Time frame: up to 12 months post-delivery
Maternal relapse of illicit and/or unprescribed drug use from maternal/provider report and or from urine toxicology testing at any point during the pregnancy and up to 12 months after delivery
20 secondary outcomes
Naltrexone side effects or adverse events
Time frame: up to 12 months post-delivery
Fetal heart rate monitoring from NST
Time frame: 27- 41 weeks gestation
Biophysical profile score calculated from NST
Time frame: 27 - 41 weeks gestation
Maternal hair cortisol levels
Time frame: Birth and 4 weeks post-delivery
Infant hair cortisol levels
Time frame: Birth and 4 weeks post-delivery
Fetal growth based on ultrasound measurements
Time frame: 18 - 41 weeks gestation
Congenital fetal anomalies by ultrasound
Time frame: 18 - 41 weeks gestation
Congenital anomalies by physical examination
Time frame: Birth
Diagnosis of Neonatal Abstinence Syndrome (NAS)
Time frame: From birth to 30 days
Infant need for pharmacologic treatment
Time frame: From birth to 30 days
Infant need for adjunctive agent
Time frame: From birth to 30 days
Infant opioid replacement pharmacologic treatment
Time frame: From birth to 30 days
Infant birth hospitalization length of stay
Time frame: From birth to 30 days
Infant weight
Time frame: Birth, 4 weeks, and 12 months
Infant length
Time frame: Birth, 4 weeks, and 12 months
Infant head circumference
Time frame: Birth, 4 weeks, and 12 months
Infant neurobehavior-function assessed by the NNNS
Time frame: 4 weeks of age
Infant neurodevelopment assessed by Bayley III
Time frame: 12 months of age
Pharmacokinetic analysis of maternal naltrexone levels
Time frame: 2nd trimester, 3rd trimester, delivery, 2-4 days after delivery, 4 weeks post-delivery
Pharmacokinetic analysis of infant naltrexone levels
Time frame: Delivery, 2-4 days after delivery, 4 weeks post-delivery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2024.
- Background: PubMed 22471668Jones HE, Chisolm MS, Jansson LM, Terplan M. Naltrexone in the treatment of opioid-dependent pregnant women: the case for a considered and measured approach to research. Addiction. 2013 Feb;108(2):233-47. doi: 10.1111/j.1360-0443.2012.03811.x. Epub 2012 Apr 4.
- Background: PubMed 27563497Saia KA, Schiff D, Wachman EM, Mehta P, Vilkins A, Sia M, Price J, Samura T, DeAngelis J, Jackson CV, Emmer SF, Shaw D, Bagley S. Caring for Pregnant Women with Opioid Use Disorder in the USA: Expanding and Improving Treatment. Curr Obstet Gynecol Rep. 2016;5(3):257-263. doi: 10.1007/s13669-016-0168-9. Epub 2016 Jul 1.
- Background: PubMed 31358302Wachman EM, Saia K, Miller M, Valle E, Shrestha H, Carter G, Werler M, Jones H. Naltrexone Treatment for Pregnant Women With Opioid Use Disorder Compared With Matched Buprenorphine Control Subjects. Clin Ther. 2019 Sep;41(9):1681-1689. doi: 10.1016/j.clinthera.2019.07.003. Epub 2019 Jul 27.
- Individual participant dataSharing planned: No
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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.
Elisha Wachman, MD principal investigator
Boston Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Opioid-use Disorder and Neonatal Abstinence Syndrome, run by Boston Medical Center at 2 sites 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 5 inclusion and 6 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 4 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Maternal drug use relapse (time frame: up to 12 months post-delivery). 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 NCT03718104, which also lists 3 linked publications.
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 4 Nov 2024.