mABC for Opioid Addiction

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
University of Delaware, Newark, DEOpioid Addiction+2 MoremABC - Behavioral
Eligibility
18 - 70
Female
What conditions do you have?
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Study Summary

This trial will study if the mABC Intervention, adapted for use with peripartum mothers receiving medication-assisted treatment for opioid use disorder, is more effective than a control intervention in improving parenting and infant outcomes.

Eligible Conditions
  • Opioid Addiction
  • Parenting
  • Infant Development

Treatment Effectiveness

Effectiveness Progress

1 of 3

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Steps 2 Change (S2C)
2
CI-581-a
2
Rapid-wean

Study Objectives

14 Primary · 3 Secondary · Reporting Duration: Infant age of 12 months

Month 12
Infant attachment
Infant behavioral regulation
Infant cognitive development
Infant diurnal cortisol production
Infant methylation of μ-opioid receptor (OPRM1) gene
Infant parasympathetic nervous system activity
Maternal depression
Maternal executive functioning
Maternal methylation of oxytocin receptor (OXTR) gene
Maternal methylation of μ-opioid receptor (OPRM1) gene
Maternal neural activity (Event related potentials - ERP) - Child emotion task
Maternal neural activity (Event related potentials - ERP) - Own child-other child task
Maternal neural activity (Event related potentials - ERP) - Reward sensitivity task
Nervous System Diseases, Parasympathetic
Maternal sensitivity
Maternal substance use
Pre-intervention (3rd trimester)
Maternal parasympathetic nervous system activity during Still Face

Trial Safety

Safety Progress

1 of 3

Similar Trials

1
Steps 2 Change (S2C)
3
CI-581-a
3
Rapid-wean

Trial Design

2 Treatment Groups

Modified DEF
1 of 2
Modified ABC
1 of 2

Active Control

Experimental Treatment

200 Total Participants · 2 Treatment Groups

Primary Treatment: mABC · No Placebo Group · N/A

Modified ABC
Behavioral
Experimental Group · 1 Intervention: mABC · Intervention Types: Behavioral
Modified DEF
Behavioral
ActiveComparator Group · 1 Intervention: mDEF · Intervention Types: Behavioral

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: infant age of 12 months

Who is running the clinical trial?

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
1,843 Previous Clinical Trials
2,152,604 Total Patients Enrolled
University of DelawareLead Sponsor
136 Previous Clinical Trials
36,586 Total Patients Enrolled
Mary Dozier, Ph.D.Principal Investigator - University of Delaware
University of Delaware
4 Previous Clinical Trials
780 Total Patients Enrolled

Eligibility Criteria

Age 18 - 70 · Female Participants · 1 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Pregnant women in their third trimester who are dependent on opioids and are taking medication to help with addiction.
References

Frequently Asked Questions

Who meets the criteria for involvement in this research?

"To be considered for inclusion in this trial, prospective participants must possess parentage and fall within the ages 18 to 70. This clinical investigation is looking to recruit a total of 200 individuals." - Anonymous Online Contributor

Unverified Answer

Is this evaluation currently enrolling participants?

"Affirmative. The clinicaltrial.gov page reveals that the first posting of this study was dated 5/1/2020, and it is still currently seeking 200 participants from 1 sites." - Anonymous Online Contributor

Unverified Answer

How many participants have voluntarily signed up for this clinical experiment?

"Affirmative. Per the information listed on clinicaltrials.gov, this medical study is still actively searching for participants and was initially published on May 1st 2020. The trial requires 200 enrollees from a single location to be admitted into it." - Anonymous Online Contributor

Unverified Answer

Does this research include individuals under the age of fifty-five?

"Participants must meet the age criteria of being at least 18 and no more than 70 years old to qualify for this trial." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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