Mom Power for Opioid Use Disorder

(PIMO Trial)

Recruiting at 1 trial location

Overseen By Elle Eggers, BSc

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: Stony Brook University

Must be taking: Buprenorphine, Methadone

Disqualifiers: Suicidal risk, Psychosis, Neurological condition, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 13

50 Participants Needed

Trial Summary

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.

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. ^{1 2 3 4 5}

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. ^{1 6 7 8 9}

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. ^{1 10 11 12 13}

Research Team

James E Swain, MD, PhD

Principal Investigator

Stony Brook University

Eligibility Criteria

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

Timeline

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

Treatment Details

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.

Participant Groups

Group I: Mom Power Experimental Treatment 1 Intervention

Mom Power is an evidence-based 13-session psychosocial mother-child group intervention that improves sensitive caregiving, parental stress, and depression

Group II: Control Placebo Group 1 Intervention

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.

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+

Findings from Research

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

Pregnant women with opioid use disorder (OUD) who received women-centered treatment through the Pregnancy Recovery Program (PRC) were more likely to start buprenorphine during pregnancy and had higher doses at delivery compared to those in non-PRC programs.

Women in the PRC group showed better engagement in postpartum care, with higher attendance rates for follow-up visits and increased use of long-acting reversible contraception, as well as a smaller decrease in breastfeeding rates during hospitalization.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Pregnancy Recovery Center: A women-centered treatment program for pregnant and postpartum women with opioid use disorder. Krans, EE., Bobby, S., England, M., et al.[2019]

Women with opioid use disorder (OUD) who were on opioid maintenance therapy (OMT) were more likely to continue treatment and maintain custody of their children, highlighting the effectiveness of OMT in supporting recovery.

In contrast, women enrolled in residential treatment programs during pregnancy were less likely to continue treatment or keep custody, suggesting that the type of treatment setting can significantly impact outcomes for mothers with OUD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Continuation in Treatment and Maintenance of Custody of Newborns After Delivery in Women With Opioid Use Disorder. Schauberger, CW., Borgert, AJ., Bearwald, B.[2021]

The MOTHER study is a comprehensive clinical trial investigating the safety and efficacy of methadone and buprenorphine for maternal and prenatal exposure, highlighting the importance of interdisciplinary collaboration in trial design.

The study revealed that multi-site trials face unique challenges, such as variations in patient recruitment and treatment compliance, which can significantly impact the overall results and require flexible study protocols.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Maternal Opioid Treatment: Human Experimental Research (MOTHER)--approach, issues and lessons learned. Jones, HE., Fischer, G., Heil, SH., et al.[2021]

Maternal enrollment in medication for opioid use disorder (MOUD) before pregnancy is linked to better short-term outcomes for opioid-exposed newborns (OENs), suggesting that early intervention can positively impact neonatal health.

Despite improved short-term outcomes, nearly one-third of infants were diagnosed with behavioral and developmental disorders (BDD), indicating that prolonged in-utero opioid exposure may still pose risks to neurodevelopment, highlighting the need for ongoing support and monitoring.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of maternal medication for opioid use disorder on neurodevelopmental outcomes of infants treated for neonatal opioid withdrawal syndrome. King, RS., Peacock-Chambers, E., Wilson, D., et al.[2021]

A study of 4574 women with opioid use disorder (OUD) in British Columbia found that continuous opioid agonist treatment during pregnancy significantly reduced the risk of preterm birth and low birth weight, indicating its efficacy in improving perinatal outcomes.

The research also showed that treatment with buprenorphine-naloxone was more effective than methadone in reducing the odds of adverse outcomes, including neonatal abstinence syndrome, emphasizing the importance of treatment choice for better health results for mothers and infants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Opioid Use Disorder and Perinatal Outcomes. Piske, M., Homayra, F., Min, JE., et al.[2021]

Only 13% of buprenorphine providers and 5% of opioid treatment programs are located in rural areas, highlighting significant geographic barriers for pregnant women seeking opioid agonist therapy in Missouri and Illinois.

While opioid treatment programs were more likely to accept new pregnant patients and had shorter wait times, the majority of buprenorphine providers required multiple contact attempts and had longer wait times, indicating a need for improved access and reliability in treatment options for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Barriers to accessing opioid agonist therapy in pregnancy. Bedrick, BS., O'Donnell, C., Marx, CM., et al.[2022]

Current policies strongly support breastfeeding for women on opioid maintenance therapy who are stable and HIV-negative, yet actual breastfeeding rates in this group remain low compared to the general population.

Barriers to breastfeeding include misinformation from healthcare professionals, highlighting the need for better education and targeted interventions to improve breastfeeding outcomes among women with opioid use disorder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Breastfeeding in Women on Opioid Maintenance Therapy: A Review of Policy and Practice. Clark, RRS.[2020]

A qualitative meta-synthesis of nine studies revealed that pregnant women with opioid use disorder (OUD) are motivated to seek treatment primarily for the safety and custody of their unborn babies, highlighting the importance of maternal-infant health in treatment engagement.

Barriers to accessing treatment include fears about the baby's health, concerns over potential legal repercussions, stigma, and negative experiences with treatment providers, indicating a need for supportive and validating treatment environments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A qualitative meta-synthesis of pregnant women's experiences of accessing and receiving treatment for opioid use disorder. Tsuda-McCaie, F., Kotera, Y.[2022]

Pregnant and parenting women with opioid use disorder require comprehensive care that addresses their unique challenges, including trauma, stigma, and access to treatment, to improve their health and that of their children.

The Maternal Addiction Treatment, Education, and Research program has successfully provided a model of care that includes patient navigation, low-barrier medications, trauma-responsive therapy, and support services, which are essential for engaging these women in treatment and promoting family health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comprehensive and compassionate responses for opioid use disorder among pregnant and parenting women. Hand, DJ., Fischer, AC., Gannon, ML., et al.[2021]

Medication-assisted treatment (MAT) with methadone or buprenorphine is the most accepted approach for treating pregnant women with opioid use disorder (OUD), as it helps prevent relapse and treatment dropout, and is not associated with more severe neonatal abstinence syndrome (NAS).

Breastfeeding is beneficial for infants when mothers are on a stable dose of opioid agonist medication, and NAS is generally less severe with prenatal exposure to buprenorphine compared to methadone, indicating that careful management can lead to positive outcomes for both mother and child.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Klaman, SL., Isaacs, K., Leopold, A., et al.[2021]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Optimizing Pregnancy Treatment Interventions for Moms (OPTI-Mom): A Pilot Study. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Prenatal Treatment and Outcomes of Women With Opioid Use Disorder. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Predictors of Initiation of Medication for Opioid Use Disorder and Retention in Treatment Among U.S. Pregnant Women, 2013-2017. [2021]

4. England pubmed.ncbi.nlm.nih.gov

The Pregnancy Recovery Center: A women-centered treatment program for pregnant and postpartum women with opioid use disorder. [2019]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Continuation in Treatment and Maintenance of Custody of Newborns After Delivery in Women With Opioid Use Disorder. [2021]

6. England pubmed.ncbi.nlm.nih.gov

Maternal Opioid Treatment: Human Experimental Research (MOTHER)--approach, issues and lessons learned. [2021]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Impact of maternal medication for opioid use disorder on neurodevelopmental outcomes of infants treated for neonatal opioid withdrawal syndrome. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Opioid Use Disorder and Perinatal Outcomes. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Barriers to accessing opioid agonist therapy in pregnancy. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Breastfeeding in Women on Opioid Maintenance Therapy: A Review of Policy and Practice. [2020]

11. Australia pubmed.ncbi.nlm.nih.gov

A qualitative meta-synthesis of pregnant women's experiences of accessing and receiving treatment for opioid use disorder. [2022]

12. England pubmed.ncbi.nlm.nih.gov

Comprehensive and compassionate responses for opioid use disorder among pregnant and parenting women. [2021]

13. Netherlands pubmed.ncbi.nlm.nih.gov

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]