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

Pregnancy Related Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05942313
• Other study ID #: STUDY23010043
• Secondary ID: 1R43DA058430-01
• Status: Recruiting
• Start date: August 28, 2023
• Est. completion date: December 1, 2025

Study information

• Verified date: August 2023
• Source: University of Pittsburgh
• Contact: Amy Monroe, MPH, MBA
• Phone: 412-623-6382
• Email: monroeal[@]upmc.edu
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 1, 2025
• Est. primary completion date: December 1, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Opioid Use Disorder
• Opioid-Related Disorders
• Pregnancy Related
• Substance-Related Disorders

Intervention

Drug:
• Buprenorphine/ Methadone exposure
Validate candidate genes- and prenatal opioid exposure- related maternal relapse and NOWS outcome associations in pregnant women and their newborns.

Locations

Country	Name	City	State
United States	UPMC Magee-Womens Hospital	Pittsburgh	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
Elizabeth Krans, MD	National Institute on Drug Abuse (NIDA), OpalGenix, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of maternal opioid relapse	Measured via binary response, yes/no	Measured from enrollment to 3-months post delivery
Primary	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	Severity of Maternal Opioid Relapse	Severity of maternal opioid relapse measured by requirement of medical treatment (binary response, yes/no)	Measured from enrollment to 3-months post delivery
Secondary	Severity of NOWs	Severity of NOWs measured by the need for >3 days of hospital stay (binary response, yes/no)	Measured at delivery