Parenting Intervention for Opioid Use Disorder

Overseen By Helena Rutherford, PhD

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: Yale University

Must be taking: Opioid use disorder medications

Disqualifiers: Non-English-speaking, Legal issues, others

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

Compensation: Varies

Number of Visits: 14

Duration: 12 weeks

15 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial aims to assist mothers with opioid use disorder (OUD) by testing a parenting program designed to improve brain function related to stress and reward. Researchers will examine how mothers' brains respond to infant cues before and after completing the program, using ERPs with electroencephalography (EEG) to measure brain activity. Participants will attend two lab visits and participate in 12 sessions of the parenting intervention. Mothers with infants aged 4-12 months, who are in substance use treatment and taking medication for OUD, are well-suited for this trial. As an unphased study, this trial offers a unique opportunity for mothers to contribute to groundbreaking research that could enhance parenting support for those with OUD.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it requires participants to be on medication for opioid use disorder (MOUD), so you should continue with that treatment.

What prior data suggests that this intervention is safe for mothers with opioid use disorder?

Previous studies have safely used electroencephalography (EEG) to study brain function in people with opioid use disorder (OUD). EEG, a non-invasive method that records brain activity, generally receives good tolerance, with no significant reports of harm in these settings.

Research has found the Mothering from the Inside Out (MIO) program to be a safe and effective intervention. MIO, an evidence-based parenting program for mothers with addiction issues, focuses on improving parenting skills and has been used for many years without major safety concerns.

Both EEG and MIO have demonstrated safety in earlier research, indicating they are well-tolerated by participants. Those considering joining a trial involving these treatments can rely on their solid safety record. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores innovative ways to help mothers with opioid use disorder (OUD) through brain-based interventions. Unlike standard treatments that primarily focus on medication or counseling, this trial uses Event-Related Potentials (ERPs) and electroencephalography (EEG) to study brain responses to infant stimuli. This approach aims to link neural markers to maternal mentalization, offering insights that could enhance parenting interventions. Additionally, the trial incorporates "Mothering from the Inside Out" (MIO), a specialized program designed to improve parenting skills in mothers with OUD, which could lead to more personalized and effective care strategies.

What evidence suggests that this trial's treatments could be effective for opioid use disorder?

This trial will compare two approaches for mothers with opioid use disorder (OUD). One arm uses Event-Related Potentials (ERPs) with electroencephalography (EEG) to track changes in brain function, which can help predict treatment response. Research has shown that certain brain scan markers, like the P300 wave, can track changes in brain function in people with OUD. EEGs reveal how the brain reacts to different stimuli, enhancing understanding of OUD.

The other arm combines ERPs with the "Mothering from the Inside Out" (MIO) program. Studies on the MIO program, designed for mothers with addictions, have shown positive results in improving parenting and reducing stress. The MIO program helps mothers understand and manage their emotions and behaviors, leading to better care for their children. Together, these methods aim to support mothers with OUD by improving brain function and parenting skills. ^{2 6 7 8 9}

Who Is on the Research Team?

Amanda Lowell, Ph.D.

Principal Investigator

Yale University

Helena Rutherford, PhD

Principal Investigator

Yale University

Are You a Good Fit for This Trial?

This trial is for mothers aged 21-45 with infants aged 4-12 months, who are receiving treatment for opioid use disorder and on medication-assisted therapy. It's not suitable for those with severe addiction needing detox, non-English speakers, individuals unable to complete the study due to legal issues or cannot give informed consent, or if the child spends less than half the time in their mother's custody.

Inclusion Criteria

I am between 21 and 45 years old.

Biological mother of infants between 4-months and 12-months of age

I am currently in a program for substance use and taking medication for opioid addiction.

Exclusion Criteria

Physiological addiction to a substance that requires detoxification, defined as difficulties with physiological withdrawal from substances (e.g. delirium tremens, shaking, nausea)

Child spends less than 50% of time in mother's custody

Non-English-speaking

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2.5 hours

1 visit (in-person)

Treatment

Participants receive the Mothering from the Inside Out (MIO) intervention over 12 sessions

12 weeks

12 visits (in-person)

Post-treatment Assessment

Participants undergo post-treatment data collection including EEG/ERP and mentalization assessments

2.5 hours

1 visit (in-person)

Follow-up

Participants are monitored for changes in mentalization and neural markers

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• ERPs with electroencephalography (EEG)
• MIO

Trial Overview The study tests how an evidence-based parenting intervention affects brain changes in mothers with OUD using EEG technology. Participants will have one lab visit before treatment, attend 12 sessions of the intervention, and then another lab visit after completing these sessions.

How Is the Trial Designed?

Group I: Secondary Objective: ERPs + Mothering from the Inside Out (MIO) Experimental Treatment 2 Interventions

Use Event-Related Potentials (ERPs) elicited by unknown infant face and cry stimuli to determine whether neural response changes with participation in an evidence-based parenting intervention designed specifically for mothers with OUD: Mothering from the Inside Out (MIO).

Group II: Primary Objective: Event-Related Potentials (ERPs) Experimental Treatment 1 Intervention

Use ERPs elicited by unknown infant face and cry stimuli to determine whether neural markers translate to maternal mentalization in mothers with opioid use disorder (OUD) at 4-12 months postpartum

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials

1,963

Recruited

3,046,000+

Alkermes, Inc.

Industry Sponsor

Trials

118

Recruited

27,200+

Richard Pops

Alkermes, Inc.

Chief Executive Officer since 1991

BA in Economics from Stanford University

Dr. Craig Hopkinson

Alkermes, Inc.

Chief Medical Officer since 2017

MD

Published Research Related to This Trial

A scoping review of 44 studies found that certain EEG markers, like lower oddball P3 and higher resting beta activity, can predict negative treatment outcomes in individuals with substance use disorders (SUDs).

Abstinence from substances was associated with changes in EEG patterns, such as a decrease in cue-elicited P3 amplitude and resting beta power, suggesting that EEG could be a useful tool for tracking treatment progress and outcomes in SUDs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A scoping review of electroencephalographic (EEG) markers for tracking neurophysiological changes and predicting outcomes in substance use disorder treatment. Bel-Bahar, TS., Khan, AA., Shaik, RB., et al.[2023]

In a study involving 20 abstinent opioid-dependent men, their brothers, and 20 matched controls, the opioid-dependent group showed significantly poorer performance on cognitive tests and had altered P300 event-related potentials, indicating executive dysfunction.

The intermediate performance of the brothers suggests a shared genetic vulnerability to opioid dependence, highlighting the potential of P300 and cognitive functions as endophenotypes for further genetic research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Auditory P300 event-related potentials and neurocognitive functions in opioid dependent men and their brothers. Singh, SM., Basu, D., Kohli, A., et al.[2016]

A pilot study involving 8 male participants demonstrated that a wireless sleep EEG monitor (Sleep Profiler™) is a feasible tool for objectively measuring sleep outcomes during opioid withdrawal, with participants using it 85.6% of scheduled nights.

The wireless EEG provided more detailed insights into sleep architecture compared to self-reported sleep diaries, revealing significant associations between sleep quality and withdrawal severity, which could inform future treatment interventions for sleep issues in opioid use disorder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Wireless electroencephalography (EEG) to monitor sleep among patients being withdrawn from opioids: Evidence of feasibility and utility. Dunn, KE., Finan, PH., Huhn, AS., et al.[2023]

The study identified three distinct QEEG subtypes among 57 cocaine-dependent adults (16 females, 41 males), with subtype membership significantly linked to treatment length, indicating that neurophysiological differences may influence treatment outcomes.

Cluster 2 showed the highest retention in treatment (80% remaining beyond 25 weeks), while Clusters 1 and 3 had higher dropout rates, suggesting that these subtypes reflect varying levels of vulnerability to cocaine addiction and treatment response.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcome related electrophysiological subtypes of cocaine dependence. Prichep, LS., Alper, KR., Sverdlov, L., et al.[2019]

In a study involving 265 boys, researchers found that the P300 amplitude, a brain response measured during an oddball task, did not mediate the link between parental substance use disorder (SUD) and the child's neurobehavioral disinhibition.

While both parental SUD and the child's P300 amplitude contributed to the variance in neurobehavioral disinhibition, the expected association between parental SUD and the child's P300 amplitude was not observed after accounting for other psychological factors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association among parental substance use disorder, p300 amplitude, and neurobehavioral disinhibition in preteen boys at high risk for substance use disorder. Habeych, ME., Sclabassi, RJ., Charles, PJ., et al.[2007]

Boys aged 10-12 years who are at risk for substance use disorders, due to having fathers with substance dependence, show moderate differences in event-related potentials (ERPs) compared to boys without this risk, particularly in P3 amplitude and various latency measures.

The study found that these at-risk boys exhibited significantly longer latencies in alpha power synchronization and desynchronization, suggesting that neurocognitive factors may play a crucial role in their potential vulnerability to developing substance use disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Event-related potentials and alpha synchronization in preadolescent boys at risk for psychoactive substance use. Brigham, J., Herning, RI., Moss, HB.[2007]

Patients with prescription opioid use disorder (OUD) showed increased β-brain oscillations and δ activity in their EEG readings compared to healthy volunteers, indicating potential neuronal dysfunction.

Higher levels of β and δ oscillations were linked to greater impulsivity in patients, suggesting that these altered brain activities may reflect chronic imbalances in the brain's control systems related to impulse and inhibition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Resting State EEG Activity Related to Impulsivity in People with Prescription Opioid Use Disorder. Corace, K., Baysarowich, R., Willows, M., et al.[2022]

This study analyzed EEG signals from patients with opioid use disorder (OUD), methamphetamine/stimulant use disorder (MUD), and alcohol use disorder (AUD), revealing significant differences in spectral powers based on the type of substance use, which could enhance understanding of mental health in these patients.

The research highlights the importance of advanced EEG data analysis techniques, such as topographic data conversion, which may improve diagnostic and prognostic capabilities for substance use disorders using machine learning and artificial intelligence in the future.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Characteristic changes in EEG spectral powers of patients with opioid-use disorder as compared with those with methamphetamine- and alcohol-use disorders. Minnerly, C., Shokry, IM., To, W., et al.[2021]

In a study involving eight male participants who were heroin-dependent and stabilized on methadone, self-administration (SA) of fentanyl led to greater increases in slow-frequency EEG activity compared to passive administration (PA), indicating different neurobiological effects between the two methods of drug intake.

The EEG changes observed during fentanyl self-administration were significantly reduced when participants were pretreated with naloxone, suggesting that the neurobiological responses to self-administration are mediated by opioid receptors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mu-opioid self-administration vs passive administration in heroin abusers produces differential EEG activation. Greenwald, MK., Roehrs, TA.[2015]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12044540/

Positive Emotion Dysregulation in Opioid Use Disorder and ... To understand how pre- to posttreatment changes in positive ER predicted proximal outcomes, clinical measures were also collected at 3-month ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6978215/

Bouncing back: Brain rehabilitation amid opioid and stimulant ... Conversely, individuals with attenuated ERN amplitude likely show problems learning from mistakes that forecast continued drug use despite negative consequences ...

3. withpower.com withpower.com/trial/phase-opioid-use-disorder-oud-8-2022-7b9c7

Parenting Intervention for Opioid Use Disorder What data supports the effectiveness of the treatment ERPs with EEG for opioid use disorder? Research shows that EEG markers, like the P300 amplitude, can ...

4. nature.com nature.com/articles/s41398-025-03569-z

Blunted anterior midcingulate response to reward in opioid ... While ERP results may indicate MCC reward dysfunction in OUD, confirming structural abnormalities is essential to interpret these findings ...

5. frontiersin.org frontiersin.org/journals/human-neuroscience/articles/10.3389/fnhum.2022.995534/full

A scoping review of electroencephalographic (EEG) ... A scoping review of electroencephalographic (EEG) markers for tracking neurophysiological changes and predicting outcomes in substance use disorder treatment.

6. sciencedirect.com sciencedirect.com/science/article/pii/S2213158219304152

Brain rehabilitation amid opioid and stimulant epidemics This review focuses on the question: What do we know about changes in brain function during recovery from opioids and stimulants such as methamphetamine and ...

7. journals.plos.org journals.plos.org/plosone/article?id=10.1371/journal.pone.0248794

Characteristic changes in EEG spectral powers of patients ... Characteristic changes in EEG spectral powers of patients with opioid-use disorder as compared with those with methamphetamine- and alcohol-use disorders.

8. mdpi.com mdpi.com/2227-9059/11/9/2460

Gender-Specific Interactions in a Visual Object Recognition ... These findings suggest important gender by OUD differences in cognitive processing and reflection of performance in this simple visual task.

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9619053/

A scoping review of electroencephalographic (EEG) markers ... The main findings are that odd ball P3 and resting beta have strong evidence as useful potential biomarkers of SUD treatment outcomes.