Opioid Use DisorderPIMONCT07632053
Postpartum Intervention for Mothers With Opioid Use Disorders (R33)
A study testing Mom Power in people with Opioid Use Disorder and Parent-Child Relations, run by Stony Brook University at 2 sites in United States.
Trial summary
Having met the milestones of the R61, this R33 is a 2-site, 2-group, pre/post RCT of mothers with OUD (n=~80/group). We will test whether the beneficial pre-post changes in OUD mothers randomized to vMP exceed those of mothers assigned to Enhanced Usual Care (EUC) and via changes in Maternal Brain Neurocircuits. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Opioid Use Disorder, Parent-Child Relations
- What is being tested?
- Mom Power
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Jul 2025to Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- mothers with diagnosis of Opioid Use Disorder (OUD); and/or receiving medication assisted treatment (such as buprenorphine or methadone)
- with a child aged 5 or less
- able to read, hear and understand English adequately enough to provide informed consent
Who cannot join
- require immediate clinical care for suicidal/homicidal risk or psychosis;
- For magnetic resonance imaging (MRI) of the brain, potential participants will be excluded if they: (1) have ferromagnetic metal in their heads (2) have severe claustrophobia that prevents participation in the neuroimaging (3) have serious neurological condition that could interfere with neuroimaging, including a brain tumor, multiple sclerosis or significant head trauma
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Maria Muzik, MD, MSc contact
United States2 sites, 2 recruiting
- Recruiting
University of Michigan
Ann Arbor, Michigan, 48109
Maria Muzik, MD, MSc, 734-846-8027, muzik@med.umich.edu
Olivia Oates, BA, 248-804-2846, oolivia@med.umich.edu
- Recruiting
Stony Brook University
Stony Brook, New York, 11794
James E Swain, MD, PhD, 5168387604, james.swain@stonybrookmedicine.edu
Elle Eggers, BSc, 636-667-0135, elle.eggers@stonybrookmedicine.edu
About this study
Having met the milestones of the R61, this R33 is a 2-site, 2-group, pre/post RCT of mothers with OUD (n=~80/group). We will test whether the beneficial pre-post changes in OUD mothers randomized to vMP exceed those of mothers assigned to Enhanced Usual Care (EUC) and via changes in Maternal Brain Neurocircuits.
Read the detailed description
Informed by the results from the R61 phase, we have fine-tuned the exact hypotheses as follows:
Post-intervention, mothers with OUD randomized to receive MP, compared to control group of enhanced usual care (EUC), will exhibit Hypothesis (a) - lower Evoked Response Potential (ERP) responses to infant's crying and Hypothesis (b) - normalized fMRI-assessed brain activity in key MBN regions, e.g., hypothalamus, amygdala and periaqueductal gray. Hypothesis (c) The pre-to-post improvements in mothers' drug craving, mood and parental stress will be greater for mothers in the vMP vs. EUC conditions.
Hypothesis (d) Assuming Ha-c are confirmed, we will test whether the clinical benefits of vMP are mediated through vMP-induced changes in the MBN.
- Conditions
- Opioid Use Disorder, Parent-Child Relations
- Being tested
- Mom Power
- Keywords
- parenting intervention, opioid use disorder, parental stress, maternal brain, evoked response potentials, brain fMRI
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mom PowerBehavioural
Also called Parenting Intervention
Experimental participants will receive virtual Mom Power via phone/internet connection.
Mom Power (MP), rooted in attachment theory and trauma-informed clinical work is an evidence-based, manualized, 13-session (10 group + 3 individual) intervention delivered across 12-weeks. The manualized intervention rests on five core components paralleling the Strengthening Families/Protective Factors Framework: Parenting Education; Self-Care; Guided Parent-Child Interactions; Social Support; and Connection to Resources.
MP targets reflective function as a critical parental capacity to infer benevolent and developmentally appropriate meaning underlying a child's behavior during stressful parenting moments, and thus promote each parents' own emotion regulation during such moments. In addition, MP counteracts social isolation by capitalizing on peer group structure with facilitated group activities and tight case management.
| Study group | Role | What they receive |
|---|---|---|
| Mom Power | Experimental | Mom Power (MP) is an evidence-based 13-session (1/week delivered virtually) psychosocial mother-child intervention with two experienced therapist facilitators that improves sensitive caregiving, parental stress, and depression. Receives: Behavioral: Mom Power |
| Enhanced Usual Care | Active comparator | Controls participants for the intervention receive 10 weekly mailings, with content relevant for the postpartum period (i.e., information on baby sleep, developmental milestones, box breathing and other self-care/coping strategies, fun games to play with a baby, and community resources, and general parenting); plus 10 brief check-in phone calls verifying that material was received, and additional longer phone calls to assess any imminent family needs and provide resources as needed/requested. Receives: Behavioral: Mom Power |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical trial enrollment counts.
The number of We plan to enroll/comnent for this clinical trial of Mom Power Intervention vs. Enhanced Usual Care.
Measured: 3 years
Mom Power (MP) Intervention vs. Enhanced Usual Care (EUC) session counts.
Mom Power (MP) and Enhanced Usual Care will be administered to as many participants as possible. For MP, participants receive a manualized, 12-week group therapy. For EUC, mothers will recieve 12 weekly mailings with content relevant for the postpartum period (i.e., information on baby sleep, developmental milestones, box breathing and other self-care/coping strategies, fun games to play with a baby, and community resources), but void of specific MP-related parenting concepts. Additionally, control mothers receive 12 brief check-in calls verifying that material was received.
Measured: 3 years
Electroencephalography (EEG) Brain Imaging scans counts.
We will track the number of participants who complete EEG studies on participants before and after each arm.
Measured: 3 years
Functional Magnetic Resonance Imagine (fMRI) Brain Imaging counts before and after MP and EUC.
We will track fMRI studies on participants before and after each arm.
Measured: 3 years
Treatment-related changes in mood as assessed by the Edinburgh Postnatal Depression Scale (EPDS).
We will assess the effects of Mom Power treatment vs. Enhanced Usual Care for mothers with OUD on mood, using the Edinburgh Postnatal Depression Scale (EPDS). This is a 10-item scale with scores range from 0-30, with higher scores indicating more severe depressive symptoms.
Measured: 3 years
Treatment-related changes in anxiety as assessed by PTSD Checklist for DSM-5 (PCL-5).
We will assess the effects of Mom Power treatment vs. Enhanced Usual Care for mothers with OUD on anxiety with the PTSD Checklist for DSM-5 (PCL-5). This is a 20-item scale ranging from 0-80, with higher scores indicating greater PTSD symptom severity.
Measured: 3 years
Treatment-related changes in stress as assessed by the Parenting Stress Index (PSI).
We will assess the effects of Mom Power treatment vs. Enhanced Usual Care for mothers with OUD on parenting stress using the Parenting Stress Index (PSI). The PSI is a 36-item questionnaire with scores ranging from 0-12 for three subscales: parental distress, parent-child interactions, and perceptions of child behaviors. Greater scores indicate greater parenting-related stress.
Measured: 3 years
Treatment-related changes in drug craving as assessed by the Opioid Craving Scale (OCS).
We will assess the effects of Mom Power treatment vs. Enhanced Usual Care for mothers with OUD on drug craving using the Opioid Craving Scale (OCS). This is a 3-item scale. Higher scores indicate greater opioid craving severity, frequency of cravings, and perceived likelihood of opioid use in response to personal triggers.
Measured: 3 years
Treatment-related changes in N170 and late positive potential (LPP) measures as assessed by Electroencephalography (EEG).
We will assess the effects of Mom Power treatment vs. Enhanced Usual Care for mothers with OUD on EEG response potentials evoked by infant stimuli.
Measured: 3 years
Treatment-related changes in brain activity assessed by functional magnetic resonance imaging (fMRI).
We will assess the effects of Mom Power treatment vs. Enhanced Usual Care for mothers with OUD on the brain, with measures of Blood Oxygenation Level Dependent fMRI signals in response to own infant pictures in the amygdala, hypothalamus and periaqueductal gray.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2026
- Study start1 Jul 2025
- Primary completionJul 2028 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This is a 2-site, 2-group, pre-post randomized controlled trial (RCT) of mothers with OUD (up n=80/group). We will extend the R61 findings by testing whether the beneficial pre-post changes in OUD mothers randomized to vMP exceed those of mothers randomized to the control group of enhanced usual care (EUC).
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stony Brook University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Michigan
- Responsible party
- Principal investigator, James Edward Swain, Stony Brook University
- Investigators
- James E Swain, MD, PhD, Principal investigator, Stony Brook University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07632053
- Sponsor's protocol ID
- 4R33DA053688
- Acronym
- PIMO
- Status last verified
- Jun 2026
- First submitted
- 16 May 2026
- Last updated
- 9 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Across both Stony Brook Medicine and Michigan Medicine, we will comply with the mission of NIH that findings derived from sponsored research must be shared for the advancement of research. Therefore, we plan to present at scientific meetings and publish in journals, as relevant data become available, so that these data can be readily available to qualified individuals in the scientific and clinical community. We will maintain a readily accessible but secure documentation of data collected under this grant so that it is accessible to other investigators. As soon as the manuscripts addressing the specific aims of the proposed study are accepted for publication, data sets created in this research program will be made available for other qualified researchers upon request for purposes of scientific scrutiny, research or review. The datasets will be de-identified before distribution.
Publications
Rosenblum K, Lawler J, Alfafara E, Miller N, Schuster M, Muzik M. Improving Maternal Representations in High-Risk Mothers: A Randomized, Controlled Trial of the Mom Power Parenting Intervention. Child Psychiatry Hum Dev. 2018 Jun;49(3):372-384. doi: 10.1007/s10578-017-0757-5.
PubMed 28936602Muzik M, Rosenblum KL, Alfafara EA, Schuster MM, Miller NM, Waddell RM, Stanton Kohler E. Mom Power: preliminary outcomes of a group intervention to improve mental health and parenting among high-risk mothers. Arch Womens Ment Health. 2015 Jun;18(3):507-21. doi: 10.1007/s00737-014-0490-z. Epub 2015 Jan 11.
PubMed 25577336Ho SS, Muzik M, Rosenblum KL, Morelen D, Nakamura Y, Swain JE. Potential Neural Mediators of Mom Power Parenting Intervention Effects on Maternal Intersubjectivity and Stress Resilience. Front Psychiatry. 2020 Dec 8;11:568824. doi: 10.3389/fpsyt.2020.568824. eCollection 2020.
PubMed 33363481Swain JE, Ho SS, Rosenblum KL, Morelen D, Dayton CJ, Muzik M. Parent-child intervention decreases stress and increases maternal brain activity and connectivity during own baby-cry: An exploratory study. Dev Psychopathol. 2017 May;29(2):535-553. doi: 10.1017/S0954579417000165.
PubMed 28401845Swain JE, Ho SS, Fox H, Garry D, Brummelte S. Effects of opioids on the parental brain in health and disease. Front Neuroendocrinol. 2019 Jul;54:100766. doi: 10.1016/j.yfrne.2019.100766. Epub 2019 May 22.
PubMed 31128130Swain JE, Ho SS. Early postpartum resting-state functional connectivity for mothers receiving buprenorphine treatment for opioid use disorder: A pilot study. J Neuroendocrinol. 2019 Sep;31(9):e12770. doi: 10.1111/jne.12770. Epub 2019 Jul 29.
PubMed 31287922Swain JE, Ho SS. Opioids and maternal brain-behavior adaptation. Neuropsychopharmacology. 2021 Jan;46(1):265-266. doi: 10.1038/s41386-020-00858-7. No abstract available.
PubMed 32913343Swain JE, Ho SS. Reduced Child-Oriented Face Mirroring Brain Responses in Mothers With Opioid Use Disorder: An Exploratory Study. Front Psychol. 2022 Feb 4;12:770093. doi: 10.3389/fpsyg.2021.770093. eCollection 2021.
PubMed 35185679Swain JE, Ho SS. Brain circuits for maternal sensitivity and pain involving anterior cingulate cortex among mothers receiving buprenorphine treatment for opioid use disorder. J Neuroendocrinol. 2023 Jul;35(7):e13316. doi: 10.1111/jne.13316. Epub 2023 Jul 25.
PubMed 37491982Ho SS, Nakamura Y, Gopang M, Swain JE. Intersubjectivity as an antidote to stress: Using dyadic active inference model of intersubjectivity to predict the efficacy of parenting interventions in reducing stress-through the lens of dependent origination in Buddhist Madhyamaka philosophy. Front Psychol. 2022 Jul 29;13:806755. doi: 10.3389/fpsyg.2022.806755. eCollection 2022.
PubMed 35967689
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postpartum Intervention for Mothers With Opioid Use Disorders (R33)
- ClinicalTrials.gov ID
- NCT07632053
- Acronym / sponsor ID
- PIMO / 4R33DA053688
- Conditions
- Opioid Use Disorder, Parent-Child Relations
- Keywords
- parenting intervention, opioid use disorder, parental stress, maternal brain, evoked response potentials, brain fMRI
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Stony Brook UniversityUniversity, hospital or other
- Collaborators
- University of Michigan
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- Jul 2028 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 8 Jun 2026 (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.
Having met the milestones of the R61, this R33 is a 2-site, 2-group, pre/post RCT of mothers with OUD (n=~80/group). We will test whether the beneficial pre-post changes in OUD mothers randomized to vMP exceed those of mothers assigned to Enhanced Usual Care (EUC) and via changes in Maternal Brain Neurocircuits.
Detailed description
Informed by the results from the R61 phase, we have fine-tuned the exact hypotheses as follows:
Post-intervention, mothers with OUD randomized to receive MP, compared to control group of enhanced usual care (EUC), will exhibit Hypothesis (a) - lower Evoked Response Potential (ERP) responses to infant's crying and Hypothesis (b) - normalized fMRI-assessed brain activity in key MBN regions, e.g., hypothalamus, amygdala and periaqueductal gray. Hypothesis (c) The pre-to-post improvements in mothers' drug craving, mood and parental stress will be greater for mothers in the vMP vs. EUC conditions.
Hypothesis (d) Assuming Ha-c are confirmed, we will test whether the clinical benefits of vMP are mediated through vMP-induced changes in the MBN.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a 2-site, 2-group, pre-post randomized controlled trial (RCT) of mothers with OUD (up n=80/group). We will extend the R61 findings by testing whether the beneficial pre-post changes in OUD mothers randomized to vMP exceed those of mothers randomized to the control group of enhanced usual care (EUC).
| Arm | Type | Receives |
|---|---|---|
| Mom Power | Experimental | Behavioral: Mom PowerMom Power (MP) is an evidence-based 13-session (1/week delivered virtually) psychosocial mother-child intervention with two experienced therapist facilitators that improves sensitive caregiving, parental stress, and depression. |
| Enhanced Usual Care | Active comparator | Behavioral: Mom PowerControls participants for the intervention receive 10 weekly mailings, with content relevant for the postpartum period (i.e., information on baby sleep, developmental milestones, box breathing and other self-care/coping strategies, fun games to play with a baby, and community resources, and general parenting); plus 10 brief check-in phone calls verifying that material was received, and additional longer phone calls to assess any imminent family needs and provide resources as needed/requested. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- mothers with diagnosis of Opioid Use Disorder (OUD); and/or receiving medication assisted treatment (such as buprenorphine or methadone)
- with a child aged 5 or less
- able to read, hear and understand English adequately enough to provide informed consent
Key exclusion criteria (2 listed)
- require immediate clinical care for suicidal/homicidal risk or psychosis;
- For magnetic resonance imaging (MRI) of the brain, potential participants will be excluded if they: (1) have ferromagnetic metal in their heads (2) have severe claustrophobia that prevents participation in the neuroimaging (3) have serious neurological condition that could interfere with neuroimaging, including a brain tumor, multiple sclerosis or significant head trauma
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 |
|---|---|---|
| Mom PowerAlso: Parenting InterventionExperimental participants will receive virtual Mom Power via phone/internet connection. Mom Power (MP), rooted in attachment theory and trauma-informed clinical work is an evidence-based, manualized, 13-session (10 group + 3 individual) intervention delivered across 12-weeks. The manualized intervention rests on five core components paralleling the Strengthening Families/Protective Factors Framework: Parenting Education; Self-Care; Guided Parent-Child Interactions; Social Support; and Connection to Resources. MP targets reflective function as a critical parental capacity to infer benevolent and developmentally appropriate meaning underlying a child's behavior during stressful parenting moments, and thus promote each parents' own emotion regulation during such moments. In addition, MP counteracts social isolation by capitalizing on peer group structure with facilitated group activities and tight case management. | Behavioural | Enhanced Usual Care, Mom Power |
Primary outcome
Clinical trial enrollment counts.
Time frame: 3 years
The number of We plan to enroll/comnent for this clinical trial of Mom Power Intervention vs. Enhanced Usual Care.
Mom Power (MP) Intervention vs. Enhanced Usual Care (EUC) session counts.
Time frame: 3 years
Mom Power (MP) and Enhanced Usual Care will be administered to as many participants as possible. For MP, participants receive a manualized, 12-week group therapy. For EUC, mothers will recieve 12 weekly mailings with content relevant for the postpartum period (i.e., information on baby sleep, developmental milestones, box breathing and other self-care/coping strategies, fun games to play with a baby, and community resources), but void of specific MP-related parenting concepts. Additionally, control mothers receive 12 brief check-in calls verifying that material was received.
Electroencephalography (EEG) Brain Imaging scans counts.
Time frame: 3 years
We will track the number of participants who complete EEG studies on participants before and after each arm.
Functional Magnetic Resonance Imagine (fMRI) Brain Imaging counts before and after MP and EUC.
Time frame: 3 years
We will track fMRI studies on participants before and after each arm.
Treatment-related changes in mood as assessed by the Edinburgh Postnatal Depression Scale (EPDS).
Time frame: 3 years
We will assess the effects of Mom Power treatment vs. Enhanced Usual Care for mothers with OUD on mood, using the Edinburgh Postnatal Depression Scale (EPDS). This is a 10-item scale with scores range from 0-30, with higher scores indicating more severe depressive symptoms.
Treatment-related changes in anxiety as assessed by PTSD Checklist for DSM-5 (PCL-5).
Time frame: 3 years
We will assess the effects of Mom Power treatment vs. Enhanced Usual Care for mothers with OUD on anxiety with the PTSD Checklist for DSM-5 (PCL-5). This is a 20-item scale ranging from 0-80, with higher scores indicating greater PTSD symptom severity.
Treatment-related changes in stress as assessed by the Parenting Stress Index (PSI).
Time frame: 3 years
We will assess the effects of Mom Power treatment vs. Enhanced Usual Care for mothers with OUD on parenting stress using the Parenting Stress Index (PSI). The PSI is a 36-item questionnaire with scores ranging from 0-12 for three subscales: parental distress, parent-child interactions, and perceptions of child behaviors. Greater scores indicate greater parenting-related stress.
Treatment-related changes in drug craving as assessed by the Opioid Craving Scale (OCS).
Time frame: 3 years
We will assess the effects of Mom Power treatment vs. Enhanced Usual Care for mothers with OUD on drug craving using the Opioid Craving Scale (OCS). This is a 3-item scale. Higher scores indicate greater opioid craving severity, frequency of cravings, and perceived likelihood of opioid use in response to personal triggers.
Treatment-related changes in N170 and late positive potential (LPP) measures as assessed by Electroencephalography (EEG).
Time frame: 3 years
We will assess the effects of Mom Power treatment vs. Enhanced Usual Care for mothers with OUD on EEG response potentials evoked by infant stimuli.
Treatment-related changes in brain activity assessed by functional magnetic resonance imaging (fMRI).
Time frame: 3 years
We will assess the effects of Mom Power treatment vs. Enhanced Usual Care for mothers with OUD on the brain, with measures of Blood Oxygenation Level Dependent fMRI signals in response to own infant pictures in the amygdala, hypothalamus and periaqueductal gray.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2026.
- Background: PubMed 28936602Rosenblum K, Lawler J, Alfafara E, Miller N, Schuster M, Muzik M. Improving Maternal Representations in High-Risk Mothers: A Randomized, Controlled Trial of the Mom Power Parenting Intervention. Child Psychiatry Hum Dev. 2018 Jun;49(3):372-384. doi: 10.1007/s10578-017-0757-5.
- Background: PubMed 25577336Muzik M, Rosenblum KL, Alfafara EA, Schuster MM, Miller NM, Waddell RM, Stanton Kohler E. Mom Power: preliminary outcomes of a group intervention to improve mental health and parenting among high-risk mothers. Arch Womens Ment Health. 2015 Jun;18(3):507-21. doi: 10.1007/s00737-014-0490-z. Epub 2015 Jan 11.
- Background: PubMed 33363481Ho SS, Muzik M, Rosenblum KL, Morelen D, Nakamura Y, Swain JE. Potential Neural Mediators of Mom Power Parenting Intervention Effects on Maternal Intersubjectivity and Stress Resilience. Front Psychiatry. 2020 Dec 8;11:568824. doi: 10.3389/fpsyt.2020.568824. eCollection 2020.
- Background: PubMed 28401845Swain JE, Ho SS, Rosenblum KL, Morelen D, Dayton CJ, Muzik M. Parent-child intervention decreases stress and increases maternal brain activity and connectivity during own baby-cry: An exploratory study. Dev Psychopathol. 2017 May;29(2):535-553. doi: 10.1017/S0954579417000165.
- Background: PubMed 31128130Swain JE, Ho SS, Fox H, Garry D, Brummelte S. Effects of opioids on the parental brain in health and disease. Front Neuroendocrinol. 2019 Jul;54:100766. doi: 10.1016/j.yfrne.2019.100766. Epub 2019 May 22.
- Background: PubMed 31287922Swain JE, Ho SS. Early postpartum resting-state functional connectivity for mothers receiving buprenorphine treatment for opioid use disorder: A pilot study. J Neuroendocrinol. 2019 Sep;31(9):e12770. doi: 10.1111/jne.12770. Epub 2019 Jul 29.
- Background: PubMed 32913343Swain JE, Ho SS. Opioids and maternal brain-behavior adaptation. Neuropsychopharmacology. 2021 Jan;46(1):265-266. doi: 10.1038/s41386-020-00858-7. No abstract available.
- Background: PubMed 35185679Swain JE, Ho SS. Reduced Child-Oriented Face Mirroring Brain Responses in Mothers With Opioid Use Disorder: An Exploratory Study. Front Psychol. 2022 Feb 4;12:770093. doi: 10.3389/fpsyg.2021.770093. eCollection 2021.
- Background: PubMed 37491982Swain JE, Ho SS. Brain circuits for maternal sensitivity and pain involving anterior cingulate cortex among mothers receiving buprenorphine treatment for opioid use disorder. J Neuroendocrinol. 2023 Jul;35(7):e13316. doi: 10.1111/jne.13316. Epub 2023 Jul 25.
- Background: PubMed 35967689Ho SS, Nakamura Y, Gopang M, Swain JE. Intersubjectivity as an antidote to stress: Using dyadic active inference model of intersubjectivity to predict the efficacy of parenting interventions in reducing stress-through the lens of dependent origination in Buddhist Madhyamaka philosophy. Front Psychol. 2022 Jul 29;13:806755. doi: 10.3389/fpsyg.2022.806755. eCollection 2022.
- Home website of the Mom Power Intervention based at the University of Michigan.Link provided by the sponsor.
- Description of related research activity at Stony Brook University.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Across both Stony Brook Medicine and Michigan Medicine, we will comply with the mission of NIH that findings derived from sponsored research must be shared for the advancement of research. Therefore, we plan to present at scientific meetings and publish in journals, as relevant data become available, so that these data can be readily available to qualified individuals in the scientific and clinical community. We will maintain a readily accessible but secure documentation of data collected under this grant so that it is accessible to other investigators. As soon as the manuscripts addressing the specific aims of the proposed study are accepted for publication, data sets created in this research program will be made available for other qualified researchers upon request for purposes of scientific scrutiny, research or review. The datasets will be de-identified before distribution.
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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.
Maria Muzik, MD, MSc contact
James E Swain, MD, PhD principal investigator
Stony Brook University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mom Power in people with Opioid Use Disorder and Parent-Child Relations, run by Stony Brook University at 2 sites 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 3 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 9 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact James E Swain, MD, PhD (516-838-7604, james.swain@stonybrookmedicine.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical trial enrollment counts. (time frame: 3 years). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07632053, which also lists 10 linked publications.
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 9 Jun 2026.