Recruiting

Opioid Use Disorder

Sponsor:

Ilana Hull

Code:

NCT05942313

Conditions

Opioid Use Disorder

Pregnancy Related

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Buprenorphine/ Methadone exposure

Study Details

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

Study ID

NCT05942313

Start date

Aug 28, 2023

Status verified date

Jul, 2026

Completion date

Dec 1, 2026

Anticipated

Primary completion date

Dec 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Design

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

Arms

Pregnant women with Opioid Use Disorder (OUD)

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

Interventions

Buprenorphine/ Methadone exposure

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

Primary outcome measure

  • Incidence of maternal opioid relapse [ Time Frame: Measured from enrollment to 3-months post delivery ]
  • Incidence of NOWS [ Time Frame: Measured at delivery ]

Central Contacts and Locations

Central contacts

Amy Monroe, MPH, MBA

412-623-6382monroeal@upmc.edu

Carly Riedmann, MPH

412-623-4147riedmannca@upmc.edu

Locations

UPMC Magee-Womens Hospital

Recruiting

Pittsburgh, Pennsylvania, United States, 15213

Contacts

Ilana Hull, MD

hulli@upmc.edu

Carly Riedmann, MPH

412-623-4147riedmannca@upmc.edu

More Information

Sponsor

Ilana Hull

Last update posted

Aug 6, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ilana Hull on 2026-08-06.