Health TrialsbyHealthPanel

Postpartum Intervention for Mothers With Opioid Use Disorders

ConditionOpioid Use Disorder
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-50
SponsorStony Brook University

About this trial

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

This trial accepts healthy volunteers

Qualifiers

mothers aged 18-50 from SBU or UM with diagnosis of Opioid Use Disorder (OUD); and/or receiving medication assisted treatment (such as buprenorphine or methadone)

with a child aged 5 or less

able to read, hear and understand English adequately enough to provide informed consent

Disqualifiers

require immediate clinical care for suicidal/homicidal risk or psychosis (please see Protection of Human Subjects section for clinical management of suicidal risk);

Trial design

Design model

Single group

Treatments tested in this trial

  • Mom Power

    Behavioral

    Experimental participants will receive virtual Mom Power via phone/internet connection. Control participants will receive mail information and confirmation phone calls.

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Mom PowerExperimental treatment 1 intervention
Group B: ControlSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

R61 Milestone 1

To recruit at least N = 50 participants in 11.25 months for the expanded number in the R33

Time frame
<2 years
2

R61 Milestone 2

To end with 80% of mothers in the MP condition attending \>=80% of sessions

Time frame
<2 years
3

R61 Milestone 3

To end with \>=70% yielding satisfactory pre- and post-intervention ERP and fMRI data

Time frame
<2 years
4

R61 Milestone 4

To show that vMP for OUD significantly affects ERP (LPP and N170) and drug craving, mood, and parenting stress (P\<0.05)

Time frame
<2 years

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Stony Brook University

Lead sponsor

University of Michigan

Collaborator

Source ClinicalTrials.gov
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