Predicting and Preventing Adverse Maternal and Child Outcomes of Opioid Use Disorder in Pregnancy

NCT05942313 | Recruiting FDA Drug

• 2 other identifiers: STUDY230100431R43DA058430-01
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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%. Investigators expect the effective sample size of evaluable patients will be 200 with longitudinal data.

Conditions

Opioid Use Disorder; Pregnancy Related

Outcome Measures

Primary Outcomes (2)

• Incidence of maternal opioid relapse

  Measured via binary response, yes/no

  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 at delivery

Secondary Outcomes (2)

• Severity of Maternal Opioid Relapse

  Measured from enrollment to 3-months post delivery

• Severity of NOWs

  Measured at delivery

Study Arms (1)

Pregnant women with Opioid Use Disorder (OUD)

This study will enroll 100 pregnant women with OUD at UPMC with its high volumes

Drug: Buprenorphine/ Methadone exposure

Interventions

Buprenorphine/ Methadone exposure DRUG

Validate candidate genes- and prenatal opioid exposure- related maternal relapse and NOWS outcome associations in pregnant women and their newborns.

Also known as: Opioid Use Disorder

Pregnant women with Opioid Use Disorder (OUD)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ilana Hull: lead
• National Institute on Drug Abuse (NIDA): collaborator
• OpalGenix, Inc: collaborator

Study Sites (1)

UPMC Magee-Womens Hospital

Pittsburgh, Pennsylvania, 15213, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Genotyping will be examining CYP2B6, CYP2D6, CYP3A4, OPRM1, OPRK1, ABCB1, FAAH, OCT1, COMT, ABCC3, ADRB2, PNOC and other genes using a comprehensive (1500 genes) Thermo Fisher PharmacoScan panel and OPRM1 epigenetic analyses using Infinium MethylationEPIC kit at College of American Pathologists (CAP) and Clinical Laboratory Improvement Amendments (CLIA) accredited UPMC Genome Center (UGC) and preprocessed as we previously published. Other significant genes and epigenetic associations will be pursued in future genome-wide analysis studies. Infant blood samples will be no more than 3ml/kg in total volume.

MeSH Terms

Conditions

Opioid-Related Disorders

Interventions

Buprenorphine

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Ilana Hull, MD

  Univrsity of Pittsburgh / UPMC Magee Womens Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amy Monroe, MPH, MBA

CONTACT

412-623-6382; monroeal@upmc.edu

Carly Riedmann, MPH

CONTACT

412-623-4147; riedmannca@upmc.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: July 3, 2023
• First Posted: July 12, 2023
• Study Start: August 28, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 19, 2026

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: Data will become available after completion of the two-year enrollment period.
• Access Criteria: This information will be held in a commercial cloud-based data portal with a password and encrypted security, such as commercial sources BOX, Dropbox, Engnyte, and Sharepoint. Access to the electronic portal will only be provided after the receiving party has signed a confidentiality agreement. The data will not be downloadable but rather only allow for viewing from the cloud-supported site. This is the process used during corporate due diligence in determining the potential to invest and is an industry-accepted approach. This approach will be used for potential investors and additional collaborators on future projects.

Locations

US (1)