mABC Intervention for Opioid Addiction

(mABC Trial)

Overseen By Mary Dozier, Ph.D.

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of Delaware

Must be taking: Medication-assisted treatment

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 13

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a special program called mABC (modified Attachment and Biobehavioral Catch-Up) to assist pregnant women undergoing treatment for opioid addiction. The goal is to determine if this program can help these mothers become more nurturing and improve their babies' development. The trial includes two groups: one will participate in the mABC program, which emphasizes nurturing, and the other will engage in a similar program, called mDEF, which focuses on play and development. Pregnant women in their third trimester receiving medication-assisted treatment for opioid addiction may be suitable candidates. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance support for mothers and their babies.

Will I have to stop taking my current medications?

The trial does not specify whether you need to stop taking your current medications. However, it mentions that participants should be on medication-assisted treatment for opioid use disorder, so you may need to continue that specific treatment.

What prior data suggests that the mABC intervention is safe for peripartum mothers?

Research has shown that the modified Attachment and Biobehavioral Catch-Up (mABC) Intervention helps mothers dealing with opioid dependence. It aims to improve mother-infant interactions by encouraging more sensitive and nurturing behaviors, supporting better outcomes for both.

Regarding safety, while specific data for mABC isn't detailed, the intervention is non-invasive. It involves home visits and guidance, which are considered low-risk.

The modified DEF program, also part of this study, is another home-visiting intervention. It encourages playful interactions to aid infant development. Like mABC, it is non-invasive and supports families without physical treatments.

Both interventions are designed to be safe and supportive for mothers and their infants. Reports have not indicated negative effects, as the programs provide educational and behavioral support rather than medication or medical procedures. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the mABC and mDEF interventions because these techniques focus on enhancing parental behaviors to support children affected by opioid addiction in their families. Unlike traditional treatments that often center around medication or therapy for the individual with addiction, mABC and mDEF aim to create a nurturing and stimulating home environment. The mABC intervention is designed to increase parental sensitivity and decrease frightening behavior, while the mDEF intervention encourages playful interactions that boost infant cognitive and motor development. This family-centered approach is promising because it addresses the broader social and developmental impacts of opioid addiction, potentially leading to more comprehensive and lasting improvements.

What evidence suggests that this trial's treatments could be effective for opioid addiction?

Research has shown that the modified Attachment and Biobehavioral Catch-Up (mABC) Program, one of the interventions in this trial, can improve how mothers with opioid addiction care for their children. The mABC program aims to increase gentle and responsive caregiving while reducing negative behaviors. Studies suggest that this results in more loving parenting and better attachment and behavior in infants. Meanwhile, the modified DEF (mDEF) program, another intervention in this trial, focuses on playful activities to enhance infants' thinking and movement skills, although limited data exists on its effectiveness for families affected by opioids. Overall, both programs in this trial are designed to support better interactions between parents and children and improve infant development in these challenging situations. ^{1 2 3 4 5}

Who Is on the Research Team?

Mary Dozier, PhD

Principal Investigator

University of Delaware

Are You a Good Fit for This Trial?

This trial is for opioid-dependent pregnant women in their third trimester who are on medication-assisted treatment. There are no specific exclusion criteria listed, so it may be open to a wide range of individuals within this group.

Inclusion Criteria

Opioid-dependent pregnant women in third trimester of pregnancy on medication-assisted treatment

Exclusion Criteria

Not applicable.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-intervention

Baseline assessments including maternal parasympathetic nervous system activity and maternal methylation of oxytocin receptor gene

3rd trimester

1 visit (in-person)

Intervention

Participants receive either the modified ABC or DEF intervention, consisting of 12 home visiting sessions

12 weeks

12 visits (in-person)

Follow-up

Participants are monitored for outcomes such as infant methylation, maternal sensitivity, and infant attachment

12 months

Multiple visits (in-person and virtual)

What Are the Treatments Tested in This Trial?

Interventions

• mABC
• mDEF

Trial Overview The study is testing the effectiveness of a parenting intervention called modified Attachment and Biobehavioral Catch-Up (mABC) for mothers with opioid use disorder. It aims to improve nurturing behavior and emotional regulation in both mothers and infants compared to a control group receiving standard care.

How Is the Trial Designed?

Group I: Modified ABC Experimental Treatment 1 Intervention

12-session home visiting intervention designed to increase parental sensitivity and nurturance and decrease parental frightening behavior.

Group II: Modified DEF Active Control 1 Intervention

12-session home visiting intervention designed to increase parental playful interactions that stimulate infant cognitive and motor development

Who Is Running the Clinical Trial?

University of Delaware

Lead Sponsor

Trials

167

Recruited

25,700+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials

2,103

Recruited

2,760,000+

Published Research Related to This Trial

Interventions to support breastfeeding among mothers on opioid maintenance treatment (OMT) show varying success, with higher initiation rates observed in studies using divided methadone doses (81%) and rooming-in practices (62%).

There is a need for more research to differentiate breastfeeding outcomes based on the type of OMT medication (methadone vs. buprenorphine) and to understand the barriers and motivators for mothers on OMT to improve breastfeeding rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Breastfeeding among Mothers on Opioid Maintenance Treatment: A Literature Review. Tsai, LC., Doan, TJ.[2021]

In a 6-month trial involving 306 opioid-dependent patients, long-term treatment with naltrexone did not lead to increased levels of anxiety, depression, or craving for opioids, addressing concerns about its psychological effects.

Patients who remained in treatment experienced a gradual reduction in symptoms of anhedonia, depression, anxiety, and craving within the first 1-2 months, suggesting that naltrexone can be safely used without exacerbating these issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Anhedonia, depression, anxiety, and craving in opioid dependent patients stabilized on oral naltrexone or naltrexone implant]. Krupitsky, EM., Zvartau, EE., Blokhina, EA., et al.[2019]

The modified Attachment and Biobehavioral Catch-up (mABC) intervention is designed to support mothers with opioid dependence by enhancing sensitive caregiving, starting with prenatal and early postnatal sessions to address the unique challenges of caring for opioid-exposed infants.

This intervention aims to improve maternal responsiveness and help infants regulate their behavior and physiology, potentially reducing the long-term developmental risks associated with opioid exposure at birth.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adapting an Evidence-Based Home Visiting Intervention for Mothers With Opioid Dependence: Modified Attachment and Biobehavioral Catch-up. Labella, MH., Eiden, RD., Roben, CKP., et al.[2021]

A pilot randomized trial involving 21 mothers in residential substance-abuse treatment showed that those who participated in the attachment-based parenting program exhibited more supportive parenting behaviors compared to the control group.

The intervention consisted of 10 home-based sessions of the Attachment and Biobehavioral Catch-up (ABC) program, indicating that such programs can be feasibly integrated into substance-abuse treatment for new mothers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Promoting supportive parenting in new mothers with substance-use problems: a pilot randomized trial of residential treatment plus an attachment-based parenting program. Berlin, LJ., Shanahan, M., Appleyard Carmody, K.[2018]

Buprenorphine substitution therapy during pregnancy appears to be safe, with no reported teratogenic effects, and results in neonatal abstinence syndrome (NAS) in 85% of infants, which is generally less severe and shorter in duration compared to methadone.

Most infants showed normal neurodevelopmental outcomes, although some experienced transient motor issues like hypertonia and jitteriness, which resolved completely in 85% of cases by the time of follow-up.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Buprenorphine withdrawal syndrome in newborns: a report of 13 cases. Kayemba-Kay's, S., Laclyde, JP.[2019]

A study involving 32 detoxified heroin-dependent individuals used fMRI to explore the neural correlates of adherence to injectable extended-release naltrexone (XRNTX), revealing that brain activity in the medial prefrontal cortex predicted how many XRNTX injections participants received.

Despite varying adherence levels, the incidence of opioid-positive urine tests was low during XRNTX treatment, suggesting that XRNTX is effective in reducing opioid use, although concurrent use of other substances like tobacco and cocaine may complicate treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neural correlates of adherence to extended-release naltrexone pharmacotherapy in heroin dependence. Wang, AL., Elman, I., Lowen, SB., et al.[2021]

In a study involving 15 patients with protracted abstinence from opioid use disorder (OUD), 33 patients receiving methadone treatment, and 23 healthy controls, it was found that those in protracted abstinence showed incomplete recovery of brain function in the nucleus accumbens, particularly in response to negative events, which may contribute to their high relapse rates.

Patients in protracted abstinence exhibited similar responses to rewarding events as healthy controls, suggesting some recovery in positive valence systems, and they also reported improvements in depression symptoms compared to those on methadone, indicating potential avenues for therapeutic strategies targeting negative valence systems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Protracted abstinence in males with an opioid use disorder: partial recovery of nucleus accumbens function. Tolomeo, S., Baldacchino, A., Volkow, ND., et al.[2022]

In a study of 29 patients with opioid use disorder (OUD), it was found that withdrawal symptoms, rather than craving, significantly influenced brain responses to opioid-related cues, particularly in areas like the nucleus accumbens and orbitofrontal cortex.

The research indicates that higher baseline withdrawal symptoms are linked to increased neural sensitivity to drug cues, suggesting that these symptoms may signal a greater vulnerability to relapse in individuals with OUD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of withdrawal in mesocorticolimbic drug cue reactivity in opioid use disorder. Shi, Z., Jagannathan, K., Padley, JH., et al.[2021]

Infants exposed to methadone during pregnancy exhibit a wide range of neurobehavioral issues, which can affect their development, as assessed by the NICU Network Neurobehavioral Scale (NNNS).

Those requiring medication for neonatal abstinence syndrome (NAS) displayed more severe dysregulated behaviors, but their NNNS scores did not correlate with the mother's methadone dosage, suggesting that individualized care strategies are essential for managing these infants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prenatal methadone exposure and neonatal neurobehavioral functioning. Velez, ML., Jansson, LM., Schroeder, J., et al.[2022]

Perinatal opioid use can negatively impact parenting behaviors and child well-being by increasing stress sensitivity and disrupting infant attachment, which may lead to child maltreatment.

Mindfulness-Oriented Recovery Enhancement is proposed as an effective intervention to address the underlying issues of perinatal opioid use, with evidence supporting its efficacy in improving parenting and attachment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Integrated Mechanistic Model of Mindfulness-Oriented Recovery Enhancement for Opioid-Exposed Mother-Infant Dyads. Reese, SE., Conradt, E., Riquino, MR., et al.[2021]

The Relational Psychotherapy Mothers' Group (RPMG) significantly improved outcomes for heroin-addicted mothers, showing lower risk for child maltreatment and better parenting involvement compared to standard methadone counseling alone over a 24-week treatment period.

Mothers in the RPMG group also demonstrated greater reductions in opioid use, and these benefits were still evident 6 months after treatment, although some differences diminished over time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Relational Psychotherapy Mothers' Group: a developmentally informed intervention for at-risk mothers. Luthar, SS., Suchman, NE.[2022]

In a study involving newly detoxified male opioid-dependent patients, the left amygdala was found to be significantly activated in response to drug cues, indicating its central role in eliciting craving for opioids.

The dorsal anterior cingulate showed increased activity after exposure to drug cues, suggesting it may help regulate craving levels as they decline, highlighting its potential role in craving control during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Time-dependent neuronal changes associated with craving in opioid dependence: an fMRI study. Murphy, A., Lubman, DI., McKie, S., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04454645

Intervening With Opioid-Dependent MothersMothers and ... This study will assess the efficacy of the modified Attachment and Biobehavioral Catch-Up (mABC) Intervention, adapted for use with peripartum mothers ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8418066/

Adapting an Evidence-Based Home Visiting Intervention for ... In this paper, we describe a home-visiting intervention we have adapted to enhance sensitive, responsive caregiving tailored to the specific needs of mothers ...

3. withpower.com withpower.com/trial/mabc-intervention-for-opioid-addiction-b938e

mABC Intervention for Opioid Addiction (mABC Trial) The modified Attachment and Biobehavioral Catch-up (mABC) intervention has been adapted to support mothers with opioid dependence and their infants, focusing on ...

4. trialx.com trialx.com/clinical-trials/listings/267409/intervening-with-opioid-dependent-mothersmothers-and-infants/?&geo_lat=39.6349&geo_lng=-75.6993&radius=10&place=Newark&user_country=United%20States

Intervening With Opioid-Dependent MothersMothers and Infants This study will assess the efficacy of the modified Attachment and Biobehavioral Catch-Up (mABC) Intervention, adapted for use with peripartum mothers ...

5. ctv.veeva.com ctv.veeva.com/study/intervening-with-opioid-dependent-mothersmothers-and-infants

Intervening With Opioid-Dependent MothersMothers and Infants This study will assess the efficacy of the modified Attachment and Biobehavioral Catch-Up (mABC) Intervention, adapted for use with ...