15 Participants Needed

Parenting Intervention for Opioid Use Disorder

AL
HR
Overseen ByHelena Rutherford, PhD
Age: 18 - 65
Sex: Female
Trial Phase: Academic
Sponsor: Yale University
Must be taking: Opioid use disorder medications
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

Opioid use disorder (OUD) remains a major public health problem particularly for mothers in the perinatal period, for whom stress, relapse rates, and risk for overdose are elevated. The perinatal period is characterized by significant neural reorganization that determines outcomes for mothers and infants. OUD is also associated with neural reorganization, specifically neural circuitry implicated in stress regulation and reward processes. Interventions should therefore take advantage of this changing perinatal biology to enhance treatment response by targeting the aberrant neural circuitry compromised by maternal OUD. The investigators have developed and refined an evidence-based intervention for mothers with OUD designed to target these neural mechanisms and enhance the reward of caregiving; however, this has yet to be formally tested. Therefore, the investigators will examine maternal neuroplasticity using high-dense array electroencephalography (EEG) in mothers with OUD in response to our intervention. There will be 1 laboratory visit at pre-treatment, followed by 12 sessions of the evidence-based parenting intervention, and 1 laboratory visit at post-treatment. This study will attempt to validate the importance of taking advantage of the neuroplasticity in the perinatal period to optimize outcomes for mothers 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 data supports the effectiveness of the treatment ERPs with EEG for opioid use disorder?

Research shows that EEG markers, like the P300 amplitude, can help track brain changes and predict treatment outcomes in substance use disorders. Studies have found that lower P300 amplitudes are linked to worse outcomes, suggesting that EEG could be useful in understanding and improving treatment for opioid use disorder.12345

Is the parenting intervention for opioid use disorder safe for humans?

The studies reviewed focus on EEG (a test that measures brain activity) in opioid use disorder, but they do not provide specific safety data for the parenting intervention itself. However, EEG monitoring has been used safely in humans to study brain activity related to opioid use.35678

How does the parenting intervention with EEG differ from other treatments for opioid use disorder?

This treatment is unique because it uses electroencephalography (EEG) to monitor brain activity, which can help track neurophysiological changes and predict treatment outcomes, offering a more objective way to assess the effectiveness of the intervention compared to traditional methods.13469

Research Team

AL

Amanda Lowell, Ph.D.

Principal Investigator

Yale University

HR

Helena Rutherford, PhD

Principal Investigator

Yale University

Eligibility Criteria

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
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Timeline

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

Treatment Details

Interventions

  • ERPs with electroencephalography (EEG)
  • MIO
Trial OverviewThe 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.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: Secondary Objective: ERPs + Mothering from the Inside Out (MIO)Experimental Treatment2 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 Treatment1 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

Find a Clinic Near You

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

Findings from Research

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

References

A scoping review of electroencephalographic (EEG) markers for tracking neurophysiological changes and predicting outcomes in substance use disorder treatment. [2023]
Association among parental substance use disorder, p300 amplitude, and neurobehavioral disinhibition in preteen boys at high risk for substance use disorder. [2007]
Outcome related electrophysiological subtypes of cocaine dependence. [2019]
Event-related potentials and alpha synchronization in preadolescent boys at risk for psychoactive substance use. [2007]
Auditory P300 event-related potentials and neurocognitive functions in opioid dependent men and their brothers. [2016]
Wireless electroencephalography (EEG) to monitor sleep among patients being withdrawn from opioids: Evidence of feasibility and utility. [2023]
Mu-opioid self-administration vs passive administration in heroin abusers produces differential EEG activation. [2015]
Resting State EEG Activity Related to Impulsivity in People with Prescription Opioid Use Disorder. [2022]
Characteristic changes in EEG spectral powers of patients with opioid-use disorder as compared with those with methamphetamine- and alcohol-use disorders. [2021]