NCT05614661 · Stony Brook University
Postpartum Intervention for Mothers With Opioid Use Disorders
(PIMO)
What this 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.
View original scientific description
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.
Interventions
BEHAVIORAL
Mom Power
Experimental participants will receive virtual Mom Power via phone/internet connection. Control participants will receive mail information and confirmation phone calls.
Primary outcome measures
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)
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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: 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.
Where
- Ann Arbor, Michigan
- Stony Brook, New York
Collaborators
University of Michigan
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Dec 16, 2024 · Source of record for eligibility and locations