Primary Objective: Event-Related Potentials (ERPs) for Opioid Use Disorder (OUD)

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Yale Child Studies Center, New Haven, CT
Opioid Use Disorder (OUD)+2 More
ERPs with electroencephalography (EEG) - Behavioral
Eligibility
18 - 65
Female
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Study Summary

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.

Eligible Conditions

  • Opioid Use Disorder (OUD)

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Opioid Use Disorder (OUD)

Study Objectives

5 Primary · 9 Secondary · Reporting Duration: Week 1 and Week 15

Week 1
Mothers' experience of childhood adversity assessed using the Adverse Childhood Experiences Scale (ACES)
Mothers' experience of childhood maltreatment assessed using the Childhood Trauma Questionnaire (CTQ)
Week 15
Change in maternal mentalization measured by coding of reflective functioning (RF) on the one-hour Parent Development Interview (PDI)
Change in mothers' Event-related potentials (ERPs) elicited by unknown infant face and cry stimuli
Change in mothers' anxiety assessed using the Generalized Anxiety Disorder-7 (GAD-7)
Change in mothers' certainty about mental states assessed using the self-report Certainty about Mental States Questionnaire (CAMSQ)
Change in mothers' depression assessed using the Edinburgh Postnatal Depression Scale (EPDS)
Change in mothers' depression assessed using the Patient Health Questionnaire-2 (PHQ-2)
Change in mothers' internalized stigma assessed using the Brief Opioid Stigma Scale (BOSS)
Change in mothers' internalized stigma assessed using the Substance Use Stigma Mechanism Scale (SU-SMS)
Change in mothers' mind-mindedness assessed using the Five-Minute Speech Sample (MM)
Change in mothers' reflective functioning assessed using the self-report Parental Reflective Functioning Questionnaire (PRFQ)
Change in mothers' stress assessed using the Parenting Stress Index- Short Form (PSI-SF)
Week 2
Mothers' baseline substance use assessed using the Addiction Severity Index (ASI-Lite)

Trial Safety

Safety Progress

1 of 3

Other trials for Opioid Use Disorder (OUD)

Trial Design

2 Treatment Groups

Primary Objective: Event-Related Potentials (ERPs)
1 of 2
Secondary Objective: ERPs + Mothering from the Inside Out (MIO)
1 of 2
Experimental Treatment

30 Total Participants · 2 Treatment Groups

Primary Treatment: Primary Objective: Event-Related Potentials (ERPs) · No Placebo Group · N/A

Primary Objective: Event-Related Potentials (ERPs)
Behavioral
Experimental Group · 1 Intervention: ERPs with electroencephalography (EEG) · Intervention Types: Behavioral
Secondary Objective: ERPs + Mothering from the Inside Out (MIO)Experimental Group · 2 Interventions: ERPs with electroencephalography (EEG), MIO · Intervention Types: Behavioral, Behavioral

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: week 1 and week 15
Closest Location: Yale Child Studies Center · New Haven, CT
Photo of New Haven  1Photo of New Haven  2Photo of New Haven  3
N/AFirst Recorded Clinical Trial
1 TrialsResearching Opioid Use Disorder (OUD)
0 CompletedClinical Trials

Eligibility Criteria

Age 18 - 65 · Female Participants · 3 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are the biological mother of infants between 4-months and 12-months of age.
You are aged 21 to 45 years.
You are enrolled in substance use treatment and on mediation for opioid use disorder.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.