Opioid Use DisorderPIMONCT05614661
Postpartum Intervention for Mothers With Opioid Use Disorders
A study testing Mom Power in people with Opioid Use Disorder, run by Stony Brook University at 2 sites in United States.
Trial summary
Opioid use disorder (OUD) is a fast-growing and devastating epidemic in the US with many mothers suffering cravings, depression, impaired interpersonal interactions and maladaptive parenting behaviors that may lead to child maltreatment and costly utilization of foster care. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Opioid Use Disorder
- What is being tested?
- Mom Power
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 2 sitesUnited States
- Study dates
- 14 Feb 2023to 1 May 2025
- 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- mothers aged 18-50 from SBU or UM 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 (please see Protection of Human Subjects section for clinical management of suicidal risk);
- 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 4) Exclusion from MRI does not necessarily exclude participant from study.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
University of Michigan
Ann Arbor, Michigan, 48109
Maria Muzik, MD, MSc, 734-846-8027, muzik@med.umich.edu
Diana Saum, MSW, 301-633-4402, dcsaum@med.umich.edu
- Recruiting
Stony Brook University
Stony Brook, New York, 11794
James E Swain, MD, PhD, 516-838-7604, james.swain@stonybrookmedicine.edu
Elle Eggers, BSc, 636-667-0135, elle.eggers@stonybrookmedicine.edu
About this study
Official title: Postpartum Intervention for Mothers With Opioid Use Disorders - Brain-Behavior Mechanisms
Opioid use disorder (OUD) is a fast-growing and devastating epidemic in the US with many mothers suffering cravings, depression, impaired interpersonal interactions and maladaptive parenting behaviors that may lead to child maltreatment and costly utilization of foster care. This interdisciplinary multisite project will begin with the high risk R61 phase, in which the investigators will administer the parenting intervention "Mom Power" to mothers with OUD during the first 6 months postpartum and look for effects on drug use, mood and brain mechanisms; and, If validated, the investigators will continue in the R33 with more brain mechanism investigation and outcome studies a larger sample. The completion of this grant will clarify the effects of parenting intervention for mothers with OUD, and yield brain-based biomarkers that may be connected with inexpensive measures toward improved treatment of families suffering OUD, their children and society - which ultimately bears much of the cost for the common trans-generational problems of peripartum drug use.
Read the detailed description
Postpartum Intervention for Mothers with Opioid Use Disorders - Brain-Behavior Mechanisms Opioid use disorder (OUD) is a fast-growing and devastating epidemic in the US with many suffering comorbid mood disorders. Despite receiving "gold standard" buprenorphine treatment to reduce withdrawal, OUD mothers still suffer have cravings, depression, impaired interpersonal interactions and maladaptive parenting behaviors that may lead to child maltreatment and costly utilization of foster care. Parenting interventions have been established to improve parent mood and sensitive caregiving behaviors for high-risk non-OUD populations. "Mom Power" (MP) is an evidence-based 13-session psychosocial mother-child intervention established to enhance emotionally sensitive caregiving, while concurrently reducing parental stress and depression for non-OUD mothers. The investigators have demonstrated feasibility of with virtual MP (vMP) and for MP with substance use disorders. However, vMP for mothers with OUD has not been studied with respect to drug use reduction or mood improvement. The investigators have also established brain mechanisms that regulate parenting. Recent work from the investigators has established that a parenting intervention for non-OUD mothers was associated with a larger enhancement of evoke potential responses (ERPs) for emotional faces relative to neutral faces and that the magnitude of ERP responses to emotional faces was associated with observed maternal sensitivity. Using functional magnetic resonance imaging (fMRI) of the brain, the investigators have also established a Maternal Behavior Neurocircuit (MBN) that regulates flexible responses to the demands of their own infant - such as to the unique, ethologically salient own-baby cry and face stimuli during the early postpartum period. The investigators have established fMRI maternal brain changes associated with MP in non-OUD mothers, and brain effects of OUD on mothers. However, it is unknown how parental brain mechanisms through which parenting interventions may work for mothers with OUD, such as affecting ERP or fMRI responses to baby stimuli in the MBN. Central hypotheses: Mothers with OUD who get virtual MP (vMP), compared to matched controls, will show improved drug craving, mood, and stress symptoms, via changes in pre-specified MBN brain regions. In the high-risk R61 phase, the investigators will establish if vMP (n=25) for OUD can be implemented and improve mood, reduce drug use and affect ERP brain responses to baby pictures compared with control (n=25). If hypotheses in the R61 are confirmed, the investigators will confirm and expand this breakthrough with the R33 Phase (n=160, 80/group), adding richer maternal outcome measures and MBN fMRI. This research will elucidate the effects of parenting intervention MP on drug use and brain function for OUD mothers - with translational potential for biomarker and treatment development.
- Conditions
- Opioid Use Disorder
- Being tested
- Mom Power
- Keywords
- parenting intervention, Opioid Use Disorder, parental stress, maternal brain, evoked response potentials
- 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
Experimental participants will receive virtual Mom Power via phone/internet connection. Control participants will receive mail information and confirmation phone calls.
| Study group | Role | What they receive |
|---|---|---|
| Mom Power | Experimental | Mom Power is an evidence-based 13-session psychosocial mother-child group intervention that improves sensitive caregiving, parental stress, and depression Receives: Behavioral: Mom Power |
| Control | Sham 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.
R61 Milestone 1
To recruit at least N = 50 participants in 11.25 months for the expanded number in the R33
Measured: <2 years
R61 Milestone 2
To end with 80% of mothers in the MP condition attending >=80% of sessions
Measured: <2 years
R61 Milestone 3
To end with >=70% yielding satisfactory pre- and post-intervention ERP and fMRI data
Measured: <2 years
R61 Milestone 4
To show that vMP for OUD significantly affects ERP (LPP and N170) and drug craving, mood, and parenting stress (P<0.05)
Measured: <2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2022
- Study start14 Feb 2023
- Primary completion15 Feb 2025 (estimated)
- Study completion1 May 2025 (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
- Single group
- Model description
- This is a 2-group (Mom Power (MP) vs. control), pre-post RCT of mothers with OUD to test the effect of MP on drug craving, mood and electrophysiological responses to own infant faces (MP n=40; control n= 10)
- Masking
- None (open label)
- Enrolment
- 50 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
- NCT05614661
- Sponsor's protocol ID
- IRB2022-00166
- Acronym
- PIMO
- Status last verified
- Dec 2024
- First submitted
- 5 Nov 2022
- Last updated
- 16 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to make individual participant data (IPD) available to other researchers.
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 16 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postpartum Intervention for Mothers With Opioid Use Disorders - Brain-Behavior Mechanisms
- ClinicalTrials.gov ID
- NCT05614661
- Acronym / sponsor ID
- PIMO / IRB2022-00166
- Conditions
- Opioid Use Disorder
- Keywords
- parenting intervention, Opioid Use Disorder, parental stress, maternal brain, evoked response potentials
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Stony Brook UniversityUniversity, hospital or other
- Collaborators
- University of Michigan
- Study start
- 14 Feb 2023 (actual)
- Primary completion
- 15 Feb 2025 (estimated)
- Study completion
- 1 May 2025 (estimated)
- First posted
- 14 Nov 2022 (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.
Opioid use disorder (OUD) is a fast-growing and devastating epidemic in the US with many mothers suffering cravings, depression, impaired interpersonal interactions and maladaptive parenting behaviors that may lead to child maltreatment and costly utilization of foster care. This interdisciplinary multisite project will begin with the high risk R61 phase, in which the investigators will administer the parenting intervention "Mom Power" to mothers with OUD during the first 6 months postpartum and look for effects on drug use, mood and brain mechanisms; and, If validated, the investigators will continue in the R33 with more brain mechanism investigation and outcome studies a larger sample. The completion of this grant will clarify the effects of parenting intervention for mothers with OUD, and yield brain-based biomarkers that may be connected with inexpensive measures toward improved treatment of families suffering OUD, their children and society - which ultimately bears much of the cost for the common trans-generational problems of peripartum drug use.
Detailed description
Postpartum Intervention for Mothers with Opioid Use Disorders - Brain-Behavior Mechanisms Opioid use disorder (OUD) is a fast-growing and devastating epidemic in the US with many suffering comorbid mood disorders. Despite receiving "gold standard" buprenorphine treatment to reduce withdrawal, OUD mothers still suffer have cravings, depression, impaired interpersonal interactions and maladaptive parenting behaviors that may lead to child maltreatment and costly utilization of foster care. Parenting interventions have been established to improve parent mood and sensitive caregiving behaviors for high-risk non-OUD populations. "Mom Power" (MP) is an evidence-based 13-session psychosocial mother-child intervention established to enhance emotionally sensitive caregiving, while concurrently reducing parental stress and depression for non-OUD mothers. The investigators have demonstrated feasibility of with virtual MP (vMP) and for MP with substance use disorders. However, vMP for mothers with OUD has not been studied with respect to drug use reduction or mood improvement. The investigators have also established brain mechanisms that regulate parenting. Recent work from the investigators has established that a parenting intervention for non-OUD mothers was associated with a larger enhancement of evoke potential responses (ERPs) for emotional faces relative to neutral faces and that the magnitude of ERP responses to emotional faces was associated with observed maternal sensitivity. Using functional magnetic resonance imaging (fMRI) of the brain, the investigators have also established a Maternal Behavior Neurocircuit (MBN) that regulates flexible responses to the demands of their own infant - such as to the unique, ethologically salient own-baby cry and face stimuli during the early postpartum period. The investigators have established fMRI maternal brain changes associated with MP in non-OUD mothers, and brain effects of OUD on mothers. However, it is unknown how parental brain mechanisms through which parenting interventions may work for mothers with OUD, such as affecting ERP or fMRI responses to baby stimuli in the MBN. Central hypotheses: Mothers with OUD who get virtual MP (vMP), compared to matched controls, will show improved drug craving, mood, and stress symptoms, via changes in pre-specified MBN brain regions. In the high-risk R61 phase, the investigators will establish if vMP (n=25) for OUD can be implemented and improve mood, reduce drug use and affect ERP brain responses to baby pictures compared with control (n=25). If hypotheses in the R61 are confirmed, the investigators will confirm and expand this breakthrough with the R33 Phase (n=160, 80/group), adding richer maternal outcome measures and MBN fMRI. This research will elucidate the effects of parenting intervention MP on drug use and brain function for OUD mothers - with translational potential for biomarker and treatment development.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a 2-group (Mom Power (MP) vs. control), pre-post RCT of mothers with OUD to test the effect of MP on drug craving, mood and electrophysiological responses to own infant faces (MP n=40; control n= 10)
| Arm | Type | Receives |
|---|---|---|
| Mom Power | Experimental | Behavioral: Mom PowerMom Power is an evidence-based 13-session psychosocial mother-child group intervention that improves sensitive caregiving, parental stress, and depression |
| Control | Sham 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
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- mothers aged 18-50 from SBU or UM 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 (3 listed)
- require immediate clinical care for suicidal/homicidal risk or psychosis (please see Protection of Human Subjects section for clinical management of suicidal risk);
- 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 4) Exclusion from MRI does not necessarily exclude participant from study.
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 PowerExperimental participants will receive virtual Mom Power via phone/internet connection. Control participants will receive mail information and confirmation phone calls. | Behavioural | Control, Mom Power |
Primary outcome
R61 Milestone 1
Time frame: <2 years
To recruit at least N = 50 participants in 11.25 months for the expanded number in the R33
R61 Milestone 2
Time frame: <2 years
To end with 80% of mothers in the MP condition attending >=80% of sessions
R61 Milestone 3
Time frame: <2 years
To end with >=70% yielding satisfactory pre- and post-intervention ERP and fMRI data
R61 Milestone 4
Time frame: <2 years
To show that vMP for OUD significantly affects ERP (LPP and N170) and drug craving, mood, and parenting stress (P<0.05)
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 16 Dec 2024.
- 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.
- Individual participant dataSharing planned: No. No plan to make individual participant data (IPD) available to other researchers.
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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.
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, 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 3 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 16 Dec 2024. 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. Some participants in this study may receive a placebo. 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 Elle Eggers, BSc (636-667-0135, elle.eggers@stonybrookmedicine.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
R61 Milestone 1 (time frame: <2 years). The study lists 4 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 NCT05614661, 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 16 Dec 2024.