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Mom Power for Opioid Use Disorder (PIMO Trial)

N/A
Recruiting
Led By James E Swain, MD, PhD
Research Sponsored by Stony Brook University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up <2 years
Awards & highlights

PIMO Trial Summary

This trial will investigate an intervention, "Mom Power", to help mothers with OUD in the US, aiming to reduce drug use, depression, and foster care costs. If successful, the findings may lead to improved treatment of families with OUD.

Who is the study for?
This trial is for English-speaking mothers aged 18-50 with a child under the age of 6, who have been diagnosed with Opioid Use Disorder (OUD) or are receiving medication-assisted treatment. It's not suitable for those at immediate risk of harm to themselves or others, with serious neurological conditions, metal in their heads that affects MRI scans, or severe claustrophobia.Check my eligibility
What is being tested?
The 'Mom Power' intervention is being tested on new mothers with OUD to see if it helps reduce drug use, improve mood and parenting behaviors. The study will also look into how this intervention may change brain mechanisms related to these improvements.See study design
What are the potential side effects?
Since 'Mom Power' is a behavioral intervention rather than a medication, traditional side effects like you'd expect from drugs aren't relevant. However, participants might experience emotional discomfort discussing personal issues during therapy sessions.

PIMO Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~<2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and <2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
R61 Milestone 1
R61 Milestone 2
R61 Milestone 3
+1 more

PIMO Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Mom PowerExperimental Treatment1 Intervention
Mom Power is an evidence-based 13-session psychosocial mother-child group intervention that improves sensitive caregiving, parental stress, and depression
Group II: ControlPlacebo Group1 Intervention
Controls participants for the intervention receive 10 weekly mailings, with content relevant for the postpartum period (i.e., information on baby sleep, developmental milestones, box breathing and other self-care/coping strategies, fun games to play with a baby, and community resources, and general parenting); plus 10 brief check-in phone calls verifying that material was received, and additional longer phone calls to assess any imminent family needs and provide resources as needed/requested.

Find a Location

Who is running the clinical trial?

Stony Brook UniversityLead Sponsor
216 Previous Clinical Trials
39,921 Total Patients Enrolled
University of MichiganOTHER
1,798 Previous Clinical Trials
6,378,088 Total Patients Enrolled
James E Swain, MD, PhDPrincipal InvestigatorStony Brook University

Media Library

Mom Power Clinical Trial Eligibility Overview. Trial Name: NCT05614661 — N/A
Opioid Use Disorder Research Study Groups: Mom Power, Control
Opioid Use Disorder Clinical Trial 2023: Mom Power Highlights & Side Effects. Trial Name: NCT05614661 — N/A
Mom Power 2023 Treatment Timeline for Medical Study. Trial Name: NCT05614661 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the total number of individuals receiving treatment in this medical experiment?

"Indeed, according to data hosted on clinicaltrials.gov, this experiment is actively recruiting patients. The trial was first introduced on February 14th 2023 and recently updated May 15th 2023. A total of 50 people will be recruited from two different medical centres."

Answered by AI

Are individuals aged 30 or above eligible to participate in this trial?

"This clinical trial is seeking participants aged 18 to 50. There are 349 trials available for minors and 981 studies designed for recipients over the age of 65."

Answered by AI

Is there still room for participants in this research trial?

"As evidenced on clinicaltrials.gov, this medical investigation is currently recruiting participants. The listing was first uploaded to the website in February of 2023 and has been refreshed as recently as May 15th 2023."

Answered by AI

Do I fulfill the criteria necessary to become involved in this medical research?

"This clinical trial is seeking 50 individuals who suffer from opioid use disorder and are between 18-50 years of age. Qualified participants must be postpartum women, possess the ability to comprehend English sufficiently for informed consent, have birthed a medically healthy infant that has passed their 34th week gestation without major malformations nor developmental delay, and finally be willing to participate in either MP or enhanced usual care at OUD clinics."

Answered by AI
~6 spots leftby Jun 2024