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NCT05614661
Postpartum Intervention for Mothers With Opioid Use Disorders
Conditions: Opioid Use Disorder
Sex: Female
Ages: 18 Years – 50 Years
Healthy volunteers: 1
Phase: NA
Enrollment: 50
Sponsor: Stony Brook University
Summary
Opioid use disorder (OUD) is a fast-growing and devastating epidemic in the US with many mothers suffering cravings, depression, impaired interpersonal interactions and maladaptive parenting behaviors that may lead to child maltreatment and costly utilization of foster care.
This interdisciplinary multisite project will begin with the high risk R61 phase, in which the investigators will administer the parenting intervention "Mom Power" to mothers with OUD during the first 6 months postpartum and look for effects on drug use, mood and brain mechanisms; and, If validated, the investigators will continue in the R33 with more brain mechanism investigation and outcome studies a larger sample.
The completion of this grant will clarify the effects of parenting intervention for mothers with OUD, and yield brain-based biomarkers that may be connected with inexpensive measures toward improved treatment of families suffering OUD, their children and society - which ultimately bears much of the cost for the common trans-generational problems of peripartum drug use.
Eligibility Criteria
Inclusion Criteria:Postpartum women (early months postpartum) aged 18+ with OUD maintained on BT who are 1) able to read, hear and understand English adequately enough to provide informed consent and fully comprehend all study requirements and 2) having birthed a medically healthy infant > 34 weeks' gestation, without major malformation or developmental delay, and 3) willing to engage in MP or enhanced usual care at OUD clinicsExclusion Criteria:1) require immediate clinical care for suicidal or homicidal risk (please see Protection of Human Subjects section for clinical management of suicidal risk);2) meet DSM-5 criteria forfor bipolar or a psychotic disorder;3) have medical conditions requiring medication including HIV; hepatitis; kidney disease; chronic hypertension; heart disease; coronary artery disease; autoimmune disorders including lupus, Type 1 or Type 2 diabetes or gestational diabetes on insulin; asthma requiring steroid inhaler.
Source: ClinicalTrials.gov (NCT05614661). StuddyBuddy aggregates publicly available trial information.