ACTIVE_NOT_RECRUITING

Maternal Brain Imaging in Opioid Use Disorder

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This research study aims to learn more about opioid use disorder (OUD) during pregnancy and how outcomes for pregnant women and their newborns can be improved. During pregnancy, people with OUD are prescribed medication-assisted therapy (MAT). The investigators are interested to know how the medication is broken down by the body during pregnancy and how effective it is. The investigators also want to learn if this medication and OUD have any effect on the different parts of the brain when compared to mothers without OUD.

Official Title

Maternal Brain Imaging in Opioid Use Disorder

Quick Facts

Study Start:2023-08-15
Study Completion:2026-07-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06008990

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 100 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age: \>18 years old
  2. * Any subject that is currently on Buprenorphine at time of screening
  3. * Singleton pregnancy
  1. * Serious maternal medical illness
  2. * HIV or AIDs
  3. * Polysubstance use
  4. * Score \>9 on the PHQ-9, and score \>0 on item 9 which is about suicidality
  5. * Score of 8 or more on GAD-7
  6. * Any contraindications for MRI
  7. * Known or suspected major fetal congenital abnormalities
  8. * Age: \>18 years old
  9. * Singleton pregnancy
  10. * Serious maternal medical illness
  11. * HIV or AIDS
  12. * Score of \>9 on the PHQ-9, and a score of \>0 on item 9 which is about suicidality
  13. * Score of 8 or more on GAD-7
  14. * Known or suspected major fetal congenital abnormalities
  15. * Any contraindications for MRI
  16. * Opioid or polysubstance abuse as identified on urine screening

Contacts and Locations

Study Locations (Sites)

Riley Hospital for Children
Indianapolis, Indiana, 46202
United States

Collaborators and Investigators

Sponsor: Indiana University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-08-15
Study Completion Date2026-07-31

Study Record Updates

Study Start Date2023-08-15
Study Completion Date2026-07-31

Terms related to this study

Keywords Provided by Researchers

  • Pregnant with Opioid Use Disorder
  • Opioid Use Disorder
  • Subutex
  • Buprenorphine
  • Pregnant taking buprenorphine/subutex

Additional Relevant MeSH Terms

  • Opioid Use Disorder
  • Substance-Related Disorders
  • Substance Use
  • Pregnancy Related
  • Narcotic-Related Disorders
  • Buprenorphine Dependence