Buprenorphine Dependence, Narcotic-Related Disorders, Opioid Use Disorder, Pregnancy Related, Substance-Related Disorders, Substance Use
Conditions
Keywords
Pregnant with Opioid Use Disorder, Opioid Use Disorder, Subutex, Buprenorphine, Pregnant taking buprenorphine/subutex
Brief summary
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.
Interventions
DRUGBuprenorphine
Pregnant mother must be taking Buprenorphine
DIAGNOSTIC_TESTMaternal Brain MRI
Maternal Brain MRI obtained between 24-32 week gestation
OTHERBlood Samples
During the MRI visit blood samples will be drawn: one hour prior to MRI, immediately before MRI, and one hour post MRI to test for Buprenorphine levels.
BEHAVIORALQuestionnaires
Participants will answer questionnaires about their medical history, pregnancy, and substance use.
Sponsors
Indiana University
National Institute on Drug Abuse (NIDA)
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 100 Years
Healthy volunteers
Yes
Inclusion criteria
Pregnant Women with OUD Inclusion Criteria: * Age: \>18 years old * Any subject that is currently on Buprenorphine at time of screening * Singleton pregnancy
Exclusion criteria
* Serious maternal medical illness * HIV or AIDs * Polysubstance use * Score \>9 on the PHQ-9, and score \>0 on item 9 which is about suicidality * Score of 8 or more on GAD-7 * Any contraindications for MRI * Known or suspected major fetal congenital abnormalities Pregnant Women with no history of OUD Inclusion: * Age: \>18 years old * Singleton pregnancy Exclusion: * Serious maternal medical illness * HIV or AIDS * Score of \>9 on the PHQ-9, and a score of \>0 on item 9 which is about suicidality * Score of 8 or more on GAD-7 * Known or suspected major fetal congenital abnormalities * Any contraindications for MRI * Opioid or polysubstance abuse as identified on urine screening
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Identify alterations in Default mode network connectivity in women with prenatal opioid use disorder compares to control pregnant women without OUD on maternal brain MRI. | During MRI visit between 24-32 weeks gestational age |
Secondary
| Measure | Time frame |
|---|---|
| Correlate alteration in brain rs-fMRI default mode network connectivity with steady state plasma buprenorphine exposure in pregnant women with OUD | During MRI visit between 24-32 weeks gestational age |
Countries
United States
Outcome results
None listed