Opioid Use DisorderNCT06008990
Maternal Brain Imaging in Opioid Use Disorder
An observational study of Opioid Use Disorder and Substance-Related Disorders, run by Indiana University at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 100 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Opioid Use Disorder, Substance-Related Disorders, Substance Use
- What is being tested?
- Buprenorphine, Maternal Brain MRI and Blood Samples
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Aug 2023to 31 Oct 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Any woman of the age of 18 or older that is having a single pregnancy, and currently taking buprenorphine for opioid use disorder.
Who may be able to join
- Age: >18 years old
- Any subject that is currently on Buprenorphine at time of screening
- Singleton pregnancy
- Age: >18 years old
- Singleton pregnancy
Who cannot join
- 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
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- Known or suspected major fetal congenital abnormalities
- Pregnant Women with no history of OUD
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Riley Hospital for Children
Indianapolis, Indiana, 46202
About this study
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.
- Conditions
- Opioid Use Disorder, Substance-Related Disorders, Substance Use, Pregnancy Related, Narcotic-Related Disorders, Buprenorphine Dependence
- Being tested
- Buprenorphine, Maternal Brain MRI, Blood Samples, Questionnaires
- Keywords
- Pregnant with Opioid Use Disorder, Opioid Use Disorder, Subutex, Buprenorphine, Pregnant taking buprenorphine/subutex
- Medical subject headings
- Opioid-Related Disorders, Substance-Related Disorders, Narcotic-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BuprenorphineDrug
Pregnant mother must be taking Buprenorphine
Maternal Brain MRIDiagnostic test
Maternal Brain MRI obtained between 24-32 week gestation
Blood SamplesOther
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.
QuestionnairesBehavioural
Participants will answer questionnaires about their medical history, pregnancy, and substance use.
| Study group | Role | What they receive |
|---|---|---|
| Pregnant Mothers with Opioid Use Disorder | Planned recruitment of 20 mothers with Opioid Use Disorder who are on Buprenorphine at the time of screening. Receives: Drug: Buprenorphine; Diagnostic Test: Maternal Brain MRI; Other: Blood Samples; Behavioral: Questionnaires | |
| Pregnant Mothers | Planned recruitment of 20 mothers who do not have any history of opioid use disorder. Receives: Diagnostic Test: Maternal Brain MRI; Behavioral: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During MRI visit between 24-32 weeks gestational age
Secondary outcomes (1)
Correlate alteration in brain rs-fMRI default mode network connectivity with steady state plasma buprenorphine exposure in pregnant women with OUD
Measured: During MRI visit between 24-32 weeks gestational age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2023
- Study start15 Aug 2023
- Primary completion31 Oct 2025
- Study completion31 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid Use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Rupa Radhakrishnan, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06008990
- Sponsor's protocol ID
- RADY-IIR-19466
- Other IDs
- 1R03DA056797-01A1
- Status last verified
- May 2026
- First submitted
- 18 Aug 2023
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maternal Brain Imaging in Opioid Use Disorder
- ClinicalTrials.gov ID
- NCT06008990
- Acronym / sponsor ID
- RADY-IIR-19466
- Conditions
- Opioid Use Disorder, Substance-Related Disorders, Substance Use, Pregnancy Related, Narcotic-Related Disorders, Buprenorphine Dependence
- Keywords
- Pregnant with Opioid Use Disorder, Opioid Use Disorder, Subutex, Buprenorphine, Pregnant taking buprenorphine/subutex
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 15 Aug 2023 (actual)
- Primary completion
- 31 Oct 2025 (actual)
- Study completion
- 31 Oct 2025 (actual)
- First posted
- 24 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pregnant Mothers with Opioid Use Disorder | – | Drug: Buprenorphine, Diagnostic Test: Maternal Brain MRI, Other: Blood Samples, Behavioral: QuestionnairesPlanned recruitment of 20 mothers with Opioid Use Disorder who are on Buprenorphine at the time of screening. |
| Pregnant Mothers | – | Diagnostic Test: Maternal Brain MRI, Behavioral: QuestionnairesPlanned recruitment of 20 mothers who do not have any history of opioid use disorder. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Any woman of the age of 18 or older that is having a single pregnancy, and currently taking buprenorphine for opioid use disorder.
Key inclusion criteria (5 listed)
- Age: >18 years old
- Any subject that is currently on Buprenorphine at time of screening
- Singleton pregnancy
- Age: >18 years old
- Singleton pregnancy
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BuprenorphinePregnant mother must be taking Buprenorphine | Drug | Pregnant Mothers with Opioid Use Disorder |
| Maternal Brain MRIMaternal Brain MRI obtained between 24-32 week gestation | Diagnostic test | Pregnant Mothers, Pregnant Mothers with Opioid Use Disorder |
| Blood SamplesDuring 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. | Other | Pregnant Mothers with Opioid Use Disorder |
| QuestionnairesParticipants will answer questionnaires about their medical history, pregnancy, and substance use. | Behavioural | Pregnant Mothers, Pregnant Mothers with Opioid Use Disorder |
Primary outcome
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.
Time frame: During MRI visit between 24-32 weeks gestational age
1 secondary outcome
Correlate alteration in brain rs-fMRI default mode network connectivity with steady state plasma buprenorphine exposure in pregnant women with OUD
Time frame: During MRI visit between 24-32 weeks gestational age
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Opioid Use Disorder and Substance-Related Disorders, run by Indiana University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: During MRI visit between 24-32 weeks gestational age). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.