50 Participants Needed

Mom Power for Opioid Use Disorder

(PIMO Trial)

Recruiting at 1 trial location
DS
DP
EE
Overseen ByElle Eggers, BSc
Age: 18 - 65
Sex: Female
Trial Phase: Academic
Sponsor: Stony Brook University
Must be taking: Buprenorphine, Methadone
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Do I need to stop my current medications to join the trial?

The trial does not specify if you need to stop taking your current medications. However, it mentions that participants can be on medication-assisted treatment like buprenorphine or methadone.

Is Mom Power for Opioid Use Disorder safe for humans?

Research shows that treatments for opioid use disorder during pregnancy, like methadone and buprenorphine, have been studied for safety and are generally considered safe for both mothers and infants.12345

How is the Mom Power treatment for opioid use disorder different from other treatments?

Mom Power is unique because it focuses on providing comprehensive care for pregnant and parenting women with opioid use disorder, addressing not just the addiction but also mental health, trauma, and family health. It includes patient navigation to access care, trauma-responsive therapy, and support services, which are designed to improve the health of both the mother and child.56789

What data supports the effectiveness of the treatment Mom Power for Opioid Use Disorder?

Research on women-centered treatment programs for pregnant women with opioid use disorder shows positive outcomes, such as improved engagement with treatment services and better mental health. These findings suggest that similar approaches, like Mom Power, could be effective in supporting women with opioid use disorder.510111213

Who Is on the Research Team?

JE

James E Swain, MD, PhD

Principal Investigator

Stony Brook University

Are You a Good Fit for This Trial?

This trial is for English-speaking mothers aged 18-50 with a child under the age of 6, who have been diagnosed with Opioid Use Disorder (OUD) or are receiving medication-assisted treatment. It's not suitable for those at immediate risk of harm to themselves or others, with serious neurological conditions, metal in their heads that affects MRI scans, or severe claustrophobia.

Inclusion Criteria

Mothers able to read, hear, and understand English adequately enough to provide informed consent
I am a mother aged 18-50 with opioid addiction or on medication like buprenorphine.
I am a mother with a child aged 5 or younger.

Exclusion Criteria

Excluded from MRI if they have ferromagnetic metal in their heads
I do not have a serious brain condition like a tumor, MS, or major head injury.
Excluded from MRI if they have severe claustrophobia that prevents participation in the neuroimaging
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

R61 Phase

Implementation of virtual Mom Power (vMP) intervention to improve mood, reduce drug use, and affect ERP brain responses to baby pictures

11.25 months
13 sessions (virtual)

R33 Phase

Expansion of the study with additional maternal outcome measures and MBN fMRI

Additional time to complete 2-year timeframe

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Mom Power
Trial Overview The 'Mom Power' intervention is being tested on new mothers with OUD to see if it helps reduce drug use, improve mood and parenting behaviors. The study will also look into how this intervention may change brain mechanisms related to these improvements.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Mom PowerExperimental Treatment1 Intervention
Group II: ControlPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Stony Brook University

Lead Sponsor

Trials
225
Recruited
41,700+

University of Michigan

Collaborator

Trials
1,891
Recruited
6,458,000+

Published Research Related to This Trial

The pilot study involving 21 pregnant women with opioid dependence showed that a patient navigation (PN) intervention significantly improved abstinence from illicit opioids and reduced depression, indicating its potential effectiveness in this population.
Participants also demonstrated increased engagement with substance use treatment services and achieved adequate prenatal care, suggesting that the PN model could enhance overall health outcomes for pregnant women with opioid use disorder.
Optimizing Pregnancy Treatment Interventions for Moms (OPTI-Mom): A Pilot Study.Cochran, GT., Hruschak, V., Abdullah, W., et al.[2023]
In a study of 113 pregnant women with opioid use disorder, the majority were treated with either buprenorphine (52.2%) or methadone (47.8%), with a live birth rate of 90.8%, indicating that effective treatment can lead to positive pregnancy outcomes.
Despite the high prevalence of social challenges and substance use, opioid relapse rates were similar between those treated with buprenorphine and methadone (44.7% overall), highlighting the need for ongoing support and care in this population.
Prenatal Treatment and Outcomes of Women With Opioid Use Disorder.Brogly, SB., Saia, KE., Werler, MM., et al.[2021]
Among 42,239 treatment episodes for opioid use disorder (OUD) in pregnant women from 2013 to 2017, only 47.4% received medications like methadone or buprenorphine, indicating a significant gap in treatment adherence to guidelines.
While the administration of medications for OUD increased from 41.0% to 52.0% over the study period, retention in treatment actually declined from 39.0% to 33.0%, suggesting that simply providing medication is not enough to ensure long-term treatment success.
Predictors of Initiation of Medication for Opioid Use Disorder and Retention in Treatment Among U.S. Pregnant Women, 2013-2017.Nguemeni Tiako, MJ., Friedman, A., Culhane, J., et al.[2021]

Citations

Optimizing Pregnancy Treatment Interventions for Moms (OPTI-Mom): A Pilot Study. [2023]
Prenatal Treatment and Outcomes of Women With Opioid Use Disorder. [2021]
Predictors of Initiation of Medication for Opioid Use Disorder and Retention in Treatment Among U.S. Pregnant Women, 2013-2017. [2021]
The Pregnancy Recovery Center: A women-centered treatment program for pregnant and postpartum women with opioid use disorder. [2019]
Continuation in Treatment and Maintenance of Custody of Newborns After Delivery in Women With Opioid Use Disorder. [2021]
Maternal Opioid Treatment: Human Experimental Research (MOTHER)--approach, issues and lessons learned. [2021]
Impact of maternal medication for opioid use disorder on neurodevelopmental outcomes of infants treated for neonatal opioid withdrawal syndrome. [2021]
Opioid Use Disorder and Perinatal Outcomes. [2021]
Barriers to accessing opioid agonist therapy in pregnancy. [2022]
10.United Statespubmed.ncbi.nlm.nih.gov
Breastfeeding in Women on Opioid Maintenance Therapy: A Review of Policy and Practice. [2020]
A qualitative meta-synthesis of pregnant women's experiences of accessing and receiving treatment for opioid use disorder. [2022]
Comprehensive and compassionate responses for opioid use disorder among pregnant and parenting women. [2021]
Treating Women Who Are Pregnant and Parenting for Opioid Use Disorder and the Concurrent Care of Their Infants and Children: Literature Review to Support National Guidance. [2021]
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