80 Participants NeededMy employer runs this trial

Mom Power for Opioid Use Disorder

(PIMO Trial)

Recruiting at 1 trial location
JE
MM
Overseen ByMaria Muzik, MD, MSc
Age: 18 - 65
Sex: Female
Trial Phase: Academic
Sponsor: Stony Brook University
Must be taking: Buprenorphine, Methadone
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

Having met the milestones of the R61, this R33 is a 2-site, 2-group, pre/post RCT of mothers with OUD (n=\~80/group). We will test whether the beneficial pre-post changes in OUD mothers randomized to vMP exceed those of mothers assigned to Enhanced Usual Care (EUC) and via changes in Maternal Brain Neurocircuits.

Who Is on the Research Team?

JE

James E Swain, MD, PhD

Principal Investigator

Stony Brook University

Are You a Good Fit for This Trial?

This trial is for mothers diagnosed with opioid use disorder or those receiving treatment like buprenorphine or methadone, who have a child aged 5 years or younger and can understand English well enough to give consent.

Inclusion Criteria

I am a mother diagnosed with opioid use disorder or receiving treatment like methadone.
With a child aged 5 or less
I can read, hear, and understand English well enough to give consent.

Exclusion Criteria

Require immediate clinical care for suicidal/homicidal risk or psychosis
Have ferromagnetic metal in their heads preventing MRI participation
Have severe claustrophobia that prevents participation in neuroimaging
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either the Mom Power intervention or Enhanced Usual Care over a 12-week period

12 weeks
13 virtual sessions for Mom Power, 12 weekly mailings and check-in calls for Enhanced Usual Care

Follow-up

Participants are monitored for changes in mood, anxiety, stress, drug craving, and brain activity using EEG and fMRI

3 years

What Are the Treatments Tested in This Trial?

Interventions

  • Mom Power

Trial Overview

The study compares the effects of a program called Mom Power (delivered virtually) versus enhanced usual care on mothers with opioid use disorder. It looks at changes before and after the intervention, including possible brain changes related to parenting.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Mom PowerExperimental Treatment1 Intervention
Group II: Enhanced Usual CareActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Stony Brook University

Lead Sponsor

Trials
225
Recruited
41,700+

University of Michigan

Collaborator

Trials
1,891
Recruited
6,458,000+