Opioid Use DisorderNCT06415994
Multimodal Fetal and Placental Imaging and Biomarkers of Clinical Outcomes in Opioid Use Disorder
An observational study of Opioid Use Disorder and Substance-Related Disorders, run by Senthil Sadhasivam at 2 sites in United States.
Trial summary
The goal of this observational study is to learn about the long term effects of prenatal opioid exposure. The main objectives are: Long term goal: to improve the safety and efficacy of maternal Opioid Use Disorder (OUD) and eliminate neonatal opioid withdrawal syndrome (NOWS) and poor childhood neurodevelopment. Read more about this study
- Who is it for?
- Ages 18 to 100 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Opioid Use Disorder, Substance-Related Disorders, Pregnancy Related
- What is being tested?
- Buprenorphine or Methadone Treatment, Fetal and Placental MRI and Child Developmental Assessment
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 250 participants
- Where
- 2 sitesUnited States
- Study dates
- 13 Feb 2024to 1 Dec 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 100 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Any woman of the age of 18 or older that is having a single pregnancy, and currently taking buprenorphine or methadone for opioid use disorder.
Who may be able to join
- Age >18 years
- Currently taking buprenorphine or methadone for OUD and are enrolled in a prenatal opioid maintenance program
- Singleton Pregnancy
- Planned delivery at Indiana University or University of Pittsburgh study sites
- Prenatal buprenorphine or methadone exposure
- Born to mother enrolled in Opioid Use Disorder arm of study
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- Women >18 Years of age
- Healthy singleton pregnancy
- Planned delivery at Indiana University or University of Pittsburgh study sites
- Born to control pregnant mother enrolled in study
Who cannot join
- Serious maternal medical illness as deemed by study physician investigators that would make it challenging to comply with study procedures
- Known or suspected major fetal/ neonatal congenital abnormalities
- HIV or AIDS
- Infants with prenatal opioid exposure:
- Major congenital anomalies or genetic syndromes affecting neurodevelopment
- Control Pregnant Women:
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- Serious maternal medical illness as deemed by study physician investigators that would make it challenging to comply with study procedures
- HIV or AIDS
- Known or suspected major fetal congenital abnormalities
- Any history of opioid misuse before or during pregnancy-per self-report and clinical notes.
- Control infants:
- Any major congenital anomalies, genetic abnormalities, neurologic abnormalities, syndromes, or chronic medical conditions affecting neurodevelopment.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
Riley Hospital for Children
Indianapolis, Indiana, 46202
University of Pittsburgh
Pittsburgh, Pennsylvania, 15260
About this study
The goal of this observational study is to learn about the long term effects of prenatal opioid exposure. The main objectives are:
- Long term goal: to improve the safety and efficacy of maternal Opioid Use Disorder (OUD) and eliminate neonatal opioid withdrawal syndrome (NOWS) and poor childhood neurodevelopment.
- To characterize prenatal opioid exposure (POE) related placental and fetal brain structural and functional disruptions using longitudinal placenta-fetal brain magnetic resonance imaging (MRI) and determine proteomic, genomic, and epigenetic signatures of NOWS and poor infant neurodevelopment.
Read more
In this study participants will:
- Receive two placental-fetal MRIs, one during second trimester and one in third trimester.
- Answer surveys relating to their medical and social history.
- Have blood drawn during pregnancy and delivery.
- Child development follow up: answer surveys on their child's development milestones and at one year of life they will undergo a development assessment.
- Conditions
- Opioid Use Disorder, Substance-Related Disorders, Pregnancy Related, Narcotic-Related Disorders, Buprenorphine Dependence, Methadone Dependence
- Being tested
- Buprenorphine or Methadone Treatment, Fetal and Placental MRI, Child Developmental Assessment, Questionnaires, Blood and Placental Samples
- Keywords
- Pregnant with Opioid Use Disorder, Opioid Use Disorder, Subutex, Buprenorphine, Pregnant taking buprenorphine/subutex
- Medical subject headings
- Opioid-Related Disorders, Substance-Related Disorders, Narcotic-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Buprenorphine or Methadone TreatmentDrug
Pregnant mothers must be taking Buprenorphine or Methadone
Fetal and Placental MRIDiagnostic test
Two MRIs :
- Second Trimester
- Third Trimester
Child Developmental AssessmentBehavioural
At 1 year of life child will receive a developmental assessment
QuestionnairesBehavioural
Participants will answer questionnaires on their medical history, pregnancy, substance use, and after birth: their child's development
Blood and Placental SamplesOther
At each MRI visit a blood sample will be collected for substances, DNA, RNA, epigenetics, and placental biomarkers.
At delivery: A sample of placenta will be collected for RNA, DNA, and epigenetic analysis.
| Study group | Role | What they receive |
|---|---|---|
| Pregnant Mothers with Opioid Use Disorder | 150 pregnant mothers with opioid use disorder who are on buprenorphine or methadone treatment Receives: Drug: Buprenorphine or Methadone Treatment; Diagnostic Test: Fetal and Placental MRI; Behavioral: Child Developmental Assessment; Behavioral: Questionnaires; Other: Blood and Placental Samples | |
| Pregnant Mothers | 100 pregnant mother who to not have a history of opioid use disorder Receives: Diagnostic Test: Fetal and Placental MRI; Behavioral: Child Developmental Assessment; Behavioral: Questionnaires; Other: Blood and Placental Samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alterations in fetal brain volume
Comparing changes in fetal brain volume using MRI between babies who have had prenatal opioid exposure (POE) and controls
Measured: Between 20 weeks gestation and delivery
Differences in placenta signal
Comparing differences in placenta signal using MRI between the POE group and controls
Measured: Between 20 weeks gestation and delivery
Secondary outcomes (6)
Placental epigenetic changes related to POE
Compare placental DNA methylation in POE group and control group
Measured: Between 20 weeks gestation and delivery
Placental dysfunction biomarkers related to POE
Compare concentrations of blood proteins in POE group vs controls
Measured: Between 20 weeks gestation and delivery
Neonatal Opioid Withdrawal Syndrome (NOWS) severity
Measuring NOWs severity in the POE group using eat sleep console scores
Measured: After birth through one year of life
Length of Hospital Stay
Measuring NOWs severity in the POE group using length of hospital stay
Measured: After birth through one year of life
Ages and Stages Questionnaire Scores during infancy
Comparing neurodevelopment of POE group and controls using the ages and stages questionnaire at multiple time points in baby's first year of life. This questionnaire assesses infants developmental level. Scores can identify whether child is below cutoff and needs professional intervention, close to cutoff and requires more developmental support and learning, or above cutoff and on track.
Measured: After birth through one year of life
Neurocognitive and behavioral development assessment (Bayley-4) at one year of age
Comparing neurodevelopment of POE group and controls using the Bayley's 4 assessment at one year of age. This assessment is administered by professionals to identify development delays in children.
Measured: After birth through one year of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2024
- Study start13 Feb 2024
- Primary completion1 Dec 2028 (estimated)
- Study completion1 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Senthil Sadhasivam
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor-investigator, Senthil Sadhasivam, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06415994
- Sponsor's protocol ID
- STUDY23110104
- Other IDs
- R01DA059321, RADY-IIR-19751
- Status last verified
- Jul 2026
- First submitted
- 4 Mar 2024
- Last updated
- 14 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multimodal Fetal and Placental Imaging and Biomarkers of Clinical Outcomes in Opioid Use Disorder
- ClinicalTrials.gov ID
- NCT06415994
- Acronym / sponsor ID
- STUDY23110104
- Conditions
- Opioid Use Disorder, Substance-Related Disorders, Pregnancy Related, Narcotic-Related Disorders, Buprenorphine Dependence, Methadone Dependence
- Keywords
- Pregnant with Opioid Use Disorder, Opioid Use Disorder, Subutex, Buprenorphine, Pregnant taking buprenorphine/subutex
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Senthil SadhasivamUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 13 Feb 2024 (actual)
- Primary completion
- 1 Dec 2028 (estimated)
- Study completion
- 1 Dec 2029 (estimated)
- First posted
- 16 May 2024 (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.
The goal of this observational study is to learn about the long term effects of prenatal opioid exposure. The main objectives are:
- Long term goal: to improve the safety and efficacy of maternal Opioid Use Disorder (OUD) and eliminate neonatal opioid withdrawal syndrome (NOWS) and poor childhood neurodevelopment.
- To characterize prenatal opioid exposure (POE) related placental and fetal brain structural and functional disruptions using longitudinal placenta-fetal brain magnetic resonance imaging (MRI) and determine proteomic, genomic, and epigenetic signatures of NOWS and poor infant neurodevelopment.
In this study participants will:
- Receive two placental-fetal MRIs, one during second trimester and one in third trimester.
- Answer surveys relating to their medical and social history.
- Have blood drawn during pregnancy and delivery.
- Child development follow up: answer surveys on their child's development milestones and at one year of life they will undergo a development assessment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pregnant Mothers with Opioid Use Disorder | – | Drug: Buprenorphine or Methadone Treatment, Diagnostic Test: Fetal and Placental MRI, Behavioral: Child Developmental Assessment, Behavioral: Questionnaires, Other: Blood and Placental Samples150 pregnant mothers with opioid use disorder who are on buprenorphine or methadone treatment |
| Pregnant Mothers | – | Diagnostic Test: Fetal and Placental MRI, Behavioral: Child Developmental Assessment, Behavioral: Questionnaires, Other: Blood and Placental Samples100 pregnant mother who to not have a history of opioid use disorder |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Any woman of the age of 18 or older that is having a single pregnancy, and currently taking buprenorphine or methadone for opioid use disorder.
Key inclusion criteria (10 listed)
- Age >18 years
- Currently taking buprenorphine or methadone for OUD and are enrolled in a prenatal opioid maintenance program
- Singleton Pregnancy
- Planned delivery at Indiana University or University of Pittsburgh study sites
- Prenatal buprenorphine or methadone exposure
Key exclusion criteria (12 listed)
- Serious maternal medical illness as deemed by study physician investigators that would make it challenging to comply with study procedures
- Known or suspected major fetal/ neonatal congenital abnormalities
- HIV or AIDS
- Major congenital anomalies or genetic syndromes affecting neurodevelopment
- Serious maternal medical illness as deemed by study physician investigators that would make it challenging to comply with study procedures
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 |
|---|---|---|
| Buprenorphine or Methadone TreatmentPregnant mothers must be taking Buprenorphine or Methadone | Drug | Pregnant Mothers with Opioid Use Disorder |
| Fetal and Placental MRITwo MRIs : * Second Trimester * Third Trimester | Diagnostic test | Pregnant Mothers, Pregnant Mothers with Opioid Use Disorder |
| Child Developmental AssessmentAt 1 year of life child will receive a developmental assessment | Behavioural | Pregnant Mothers, Pregnant Mothers with Opioid Use Disorder |
| QuestionnairesParticipants will answer questionnaires on their medical history, pregnancy, substance use, and after birth: their child's development | Behavioural | Pregnant Mothers, Pregnant Mothers with Opioid Use Disorder |
| Blood and Placental SamplesAt each MRI visit a blood sample will be collected for substances, DNA, RNA, epigenetics, and placental biomarkers. At delivery: A sample of placenta will be collected for RNA, DNA, and epigenetic analysis. | Other | Pregnant Mothers, Pregnant Mothers with Opioid Use Disorder |
Primary outcome
Alterations in fetal brain volume
Time frame: Between 20 weeks gestation and delivery
Comparing changes in fetal brain volume using MRI between babies who have had prenatal opioid exposure (POE) and controls
Differences in placenta signal
Time frame: Between 20 weeks gestation and delivery
Comparing differences in placenta signal using MRI between the POE group and controls
6 secondary outcomes
Placental epigenetic changes related to POE
Time frame: Between 20 weeks gestation and delivery
Placental dysfunction biomarkers related to POE
Time frame: Between 20 weeks gestation and delivery
Neonatal Opioid Withdrawal Syndrome (NOWS) severity
Time frame: After birth through one year of life
Length of Hospital Stay
Time frame: After birth through one year of life
Ages and Stages Questionnaire Scores during infancy
Time frame: After birth through one year of life
Neurocognitive and behavioral development assessment (Bayley-4) at one year of age
Time frame: After birth through one year of life
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2026.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Substance-Related Disorders, run by Senthil Sadhasivam 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 10 inclusion and 12 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: enrolling by invitation, as of the sponsor's last update on 14 Jul 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Alterations in fetal brain volume (time frame: Between 20 weeks gestation and delivery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Jul 2026.