Opioid Use DisorderNCT05942313
Predicting and Preventing Adverse Maternal and Child Outcomes of Opioid Use Disorder in Pregnancy
An observational study of Opioid Use Disorder and Pregnancy Related, run by Ilana Hull at 1 site in United States.
Trial summary
This study will be a 12-month prospective, genotype-blinded longitudinal observational study with current standard of clinical care. This study will enroll 100 pregnant women with OUD at UPMC Hospitals with its high volumes. Because of the observational nature of the study, the anticipated dropout rate will be ≤ 20%. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Opioid Use Disorder, Pregnancy Related
- What is being tested?
- Buprenorphine/ Methadone exposure
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Aug 2023to 1 Dec 2026
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: This study will be a 12-month prospective, genotype-blinded longitudinal observational study with current standard of clinical care. This study will enroll 100 pregnant women with OUD at UPMC with its high volumes. Because of the observational nature of the study, the anticipated dropout rate will be ≤ 20%. We expect the effective sample size of evaluable patients will be 200 with longitudinal data.
Who may be able to join
- Pregnant women with OUD and their infant
- Currently on BUP/METH for OUD
- Enrolled in prenatal opioid maintenance program
- Age >18 years
- Singleton pregnancy
- Planned delivery at UPMC's Magee Womans Hospital
- Positive opioid urine screen results
Who cannot join
- Serious maternal medical illness as deemed by the PI that would make it challenging to comply with study procedures
- HIV or AIDS
- Known major fetal congenital abnormalities
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
UPMC Magee-Womens Hospital
Pittsburgh, Pennsylvania, 15213
Ilana Hull, MD, hulli@upmc.edu
Carly Riedmann, MPH, 412-623-4147, riedmannca@upmc.edu
About this study
This study will be a 12-month prospective, genotype-blinded longitudinal observational study with current standard of clinical care. This study will enroll 100 pregnant women with OUD at UPMC Hospitals with its high volumes. Because of the observational nature of the study, the anticipated dropout rate will be ≤ 20%. Investigators expect the effective sample size of evaluable patients will be 200 with longitudinal data.
Read the detailed description
Background: 7% of pregnant women in the U.S. use opioids and 21% of these women report misuse, making opioid use disorder (OUD) a major public health concern during pregnancy. The number of infants born with prenatal opioid exposure, neonatal opioid withdrawal syndrome (NOWS) and costly prolonged hospitalization has increased exponentially. The opioid epidemic is further worsened by the ongoing COVID-19 pandemic. Despite medication treatment for OUD with buprenorphine (BUP) or methadone (METH), these pregnant women continue to be at high risk for early relapse, polysubstance use, and depression. These infants are at risk for not only immediate NOWS and also poor long-term neurodevelopmental and behavioral outcomes. Genetic factors influence 30-60% of opioid adverse events (AEs). In pregnant women on medication management for OUD, and infants receiving opioids for NOWS treatment there is variability in dose required to prevent withdrawal symptoms and craving, likely related to physiological alterations, upregulation of metabolic and biological pathways, determined in part by opioid pharmacogenomics. Investigators have shown that in children and adults, opioid related poor clinical outcomes are related to opioid receptor genetic variations and resulting variations in their metabolism. Maternal depression and anxiety increase the risks for OUD, maternal relapse, NOWS and negatively impact pregnant women and their children. Thus, there is an urgent and unmet clinical need for a reliable tool to proactively predict maternal relapse, NOWS, and improve the safety of pregnant women with OUD and their children.
- Conditions
- Opioid Use Disorder, Pregnancy Related
- Being tested
- Buprenorphine/ Methadone exposure
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Buprenorphine/ Methadone exposureDrug
Also called Opioid Use Disorder
Validate candidate genes- and prenatal opioid exposure- related maternal relapse and NOWS outcome associations in pregnant women and their newborns.
| Study group | Role | What they receive |
|---|---|---|
| Pregnant women with Opioid Use Disorder (OUD) | This study will enroll 100 pregnant women with OUD at UPMC with its high volumes Receives: Drug: Buprenorphine/ Methadone exposure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of maternal opioid relapse
Measured via binary response, yes/no
Measured: Measured from enrollment to 3-months post delivery
Incidence of NOWS
Clinical definition of NOWS: Substance withdrawal encompasses a continuum of variable clinical expression from neonate to neonate; the diagnosis is not limited only to neonates who require pharmacotherapy. Incidence of NOWS measured by binary response, yes/no
Measured: Measured at delivery
Secondary outcomes (2)
Severity of Maternal Opioid Relapse
Severity of maternal opioid relapse measured by requirement of medical treatment (binary response, yes/no)
Measured: Measured from enrollment to 3-months post delivery
Severity of NOWs
Severity of NOWs measured by the need for >3 days of hospital stay (binary response, yes/no)
Measured: Measured at delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2023
- Study start28 Aug 2023
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2026 (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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ilana Hull
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), OpalGenix, Inc
- Responsible party
- Sponsor-investigator, Ilana Hull, University of Pittsburgh
- Investigators
- Ilana Hull, MD, Principal investigator, Univrsity of Pittsburgh / UPMC Magee Womens Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05942313
- Sponsor's protocol ID
- STUDY23010043
- Other IDs
- 1R43DA058430-01
- Status last verified
- Jul 2026
- First submitted
- 3 Jul 2023
- Last updated
- 6 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: We intend to share data that is generated from the grant at the earliest opportunities throughout this research project in counsel with our intellectual property lawyers. The details of the risk prediction algorithms will remain proprietary and will be protected as a trade secret.
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predicting and Preventing Adverse Maternal and Child Outcomes of Opioid Use Disorder in Pregnancy
- ClinicalTrials.gov ID
- NCT05942313
- Acronym / sponsor ID
- STUDY23010043
- Conditions
- Opioid Use Disorder, Pregnancy Related
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Ilana HullUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), OpalGenix, Inc
- Study start
- 28 Aug 2023 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 12 Jul 2023 (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 study will be a 12-month prospective, genotype-blinded longitudinal observational study with current standard of clinical care. This study will enroll 100 pregnant women with OUD at UPMC Hospitals with its high volumes. Because of the observational nature of the study, the anticipated dropout rate will be ≤ 20%. Investigators expect the effective sample size of evaluable patients will be 200 with longitudinal data.
Detailed description
Background: 7% of pregnant women in the U.S. use opioids and 21% of these women report misuse, making opioid use disorder (OUD) a major public health concern during pregnancy. The number of infants born with prenatal opioid exposure, neonatal opioid withdrawal syndrome (NOWS) and costly prolonged hospitalization has increased exponentially. The opioid epidemic is further worsened by the ongoing COVID-19 pandemic. Despite medication treatment for OUD with buprenorphine (BUP) or methadone (METH), these pregnant women continue to be at high risk for early relapse, polysubstance use, and depression. These infants are at risk for not only immediate NOWS and also poor long-term neurodevelopmental and behavioral outcomes. Genetic factors influence 30-60% of opioid adverse events (AEs). In pregnant women on medication management for OUD, and infants receiving opioids for NOWS treatment there is variability in dose required to prevent withdrawal symptoms and craving, likely related to physiological alterations, upregulation of metabolic and biological pathways, determined in part by opioid pharmacogenomics. Investigators have shown that in children and adults, opioid related poor clinical outcomes are related to opioid receptor genetic variations and resulting variations in their metabolism. Maternal depression and anxiety increase the risks for OUD, maternal relapse, NOWS and negatively impact pregnant women and their children. Thus, there is an urgent and unmet clinical need for a reliable tool to proactively predict maternal relapse, NOWS, and improve the safety of pregnant women with OUD and their children.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pregnant women with Opioid Use Disorder (OUD) | – | Drug: Buprenorphine/ Methadone exposureThis study will enroll 100 pregnant women with OUD at UPMC with its high volumes |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study will be a 12-month prospective, genotype-blinded longitudinal observational study with current standard of clinical care. This study will enroll 100 pregnant women with OUD at UPMC with its high volumes. Because of the observational nature of the study, the anticipated dropout rate will be ≤ 20%. We expect the effective sample size of evaluable patients will be 200 with longitudinal data.
Key inclusion criteria (7 listed)
- Pregnant women with OUD and their infant
- Currently on BUP/METH for OUD
- Enrolled in prenatal opioid maintenance program
- Age >18 years
- Singleton pregnancy
Key exclusion criteria (3 listed)
- Serious maternal medical illness as deemed by the PI that would make it challenging to comply with study procedures
- HIV or AIDS
- Known major fetal congenital abnormalities
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/ Methadone exposureAlso: Opioid Use DisorderValidate candidate genes- and prenatal opioid exposure- related maternal relapse and NOWS outcome associations in pregnant women and their newborns. | Drug | Pregnant women with Opioid Use Disorder (OUD) |
Primary outcome
Incidence of maternal opioid relapse
Time frame: Measured from enrollment to 3-months post delivery
Measured via binary response, yes/no
Incidence of NOWS
Time frame: Measured at delivery
Clinical definition of NOWS: Substance withdrawal encompasses a continuum of variable clinical expression from neonate to neonate; the diagnosis is not limited only to neonates who require pharmacotherapy. Incidence of NOWS measured by binary response, yes/no
2 secondary outcomes
Severity of Maternal Opioid Relapse
Time frame: Measured from enrollment to 3-months post delivery
Severity of NOWs
Time frame: Measured at delivery
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 6 Aug 2026.
- Individual participant dataSharing planned: Yes. We intend to share data that is generated from the grant at the earliest opportunities throughout this research project in counsel with our intellectual property lawyers. The details of the risk prediction algorithms will remain proprietary and will be protected as a trade secret.
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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.
Ilana Hull, MD principal investigator
Univrsity of Pittsburgh / UPMC Magee Womens Hospital
1 site 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 Pregnancy Related, run by Ilana Hull 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 7 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 6 Aug 2026. 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.
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?
Contact Amy Monroe, MPH, MBA (412-623-6382, monroeal@upmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of maternal opioid relapse (time frame: Measured from enrollment to 3-months post 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 6 Aug 2026.