Clinical trial NCT05942313: Predicting and Preventing Adverse Maternal and Child Outcomes of Opioid Use Disorder in Pregnancy
Official title: Predicting and Preventing Adverse Maternal and Child Outcomes of Opioid Use Disorder in Pregnancy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Opioid Use Disorder
Pregnancy Related
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
name: OpalGenix, Inc
First posted: 2023-07-12
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of maternal opioid relapse
timeFrame: Measured from enrollment to 3-months post delivery
measure: Incidence of NOWS
timeFrame: Measured at delivery
Secondary outcomes:
measure: Severity of Maternal Opioid Relapse
timeFrame: Measured from enrollment to 3-months post delivery
measure: Severity of NOWs
timeFrame: Measured at delivery
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: UPMC Magee-Womens Hospital
state: Pennsylvania
Study officials:
affiliation: Univrsity of Pittsburgh / UPMC Magee Womens Hospital
name: Ilana Hull, MD
role: PRINCIPAL_INVESTIGATOR
References: