Parenting Intervention for Opioid Use Disorder
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?
How does the parenting intervention with EEG differ from other treatments for opioid use disorder?
Research Team
Amanda Lowell, Ph.D.
Principal Investigator
Yale University
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
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive the Mothering from the Inside Out (MIO) intervention over 12 sessions
Post-treatment Assessment
Participants undergo post-treatment data collection including EEG/ERP and mentalization assessments
Follow-up
Participants are monitored for changes in mentalization and neural markers
Treatment Details
Interventions
- ERPs with electroencephalography (EEG)
- MIO
Find a Clinic Near You
Who Is Running the Clinical Trial?
Yale University
Lead Sponsor
Alkermes, Inc.
Industry Sponsor
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