RECRUITING

Neuroplasticity in Maternal Opioid Use Disorder (OUD)

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Neuroplasticity in Maternal Opioid Use Disorder (OUD)

Quick Facts

Study Start:2023-01-01
Study Completion:2024-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05495984

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:21 Years to 45 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Biological mother of infants between 4-months and 12-months of age
  2. * 21-45 years of age at time of recruitment
  3. * Enrolled in substance use treatment and on mediation for opioid use disorder (MOUD).
  1. * Incapable of giving informed consent
  2. * Child spends less than 50% of time in mother's custody.
  3. * Non-English-speaking
  4. * Unable to complete the study because of pending legal cases or unable to supply two forms of contact for the purpose of follow-up
  5. * Physiological addiction to a substance that requires detoxification, defined as difficulties with physiological withdrawal from substances (e.g. delirium tremens, shaking, nausea).

Contacts and Locations

Study Contact

Amanda Lowell, PhD
CONTACT
321-277-2516
amanda.lowell@yale.edu
Helena Rutherford, PhD
CONTACT
203-737-3408
helena.rutherford@yale.edu

Principal Investigator

Amanda Lowell, Ph.D.
PRINCIPAL_INVESTIGATOR
Yale University
Helena Rutherford, PhD
PRINCIPAL_INVESTIGATOR
Yale University

Study Locations (Sites)

Yale Child Studies Center
New Haven, Connecticut, 06520
United States

Collaborators and Investigators

Sponsor: Yale University

  • Amanda Lowell, Ph.D., PRINCIPAL_INVESTIGATOR, Yale University
  • Helena Rutherford, PhD, PRINCIPAL_INVESTIGATOR, Yale University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-01-01
Study Completion Date2024-12-31

Study Record Updates

Study Start Date2023-01-01
Study Completion Date2024-12-31

Terms related to this study

Additional Relevant MeSH Terms

  • Opioid Use Disorder