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Postpartum Intervention for Mothers With Opioid Use Disorders

Stony Brook University · with University of Michigan · NCT05614661

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18–50 · Women only
Healthy volunteers
Accepted
Study type
Interventional · Not applicable
Target enrollment
50
US sites recruiting
2
Study start
February 14, 2023
Record last updated
December 16, 2024

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: Mom Power

Conditions: Opioid Use Disorder

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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:
  • 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.

Recruiting US locations

  • University of Michigan

    Ann Arbor, MI 48109

    Site contact: Maria Muzik, MD, MSc · 734-846-8027 · muzik@med.umich.edu

  • Stony Brook University

    Stony Brook, NY 11794

    Site contact: James E Swain, MD, PhD · 516-838-7604 · james.swain@stonybrookmedicine.edu

Study contacts (from the official record)

  • Elle Eggers, BSc · 636-667-0135 · elle.eggers@stonybrookmedicine.edu
  • Diana Saum, MA, MSW · 3016334402 · dcsaum@med.umich.edu
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Postpartum Intervention for Mothers With Opioid Use Disorders (NCT05614661) | Bored Studies