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

Trial Summary

What is the purpose of this trial?

This study will assess the efficacy of the modified Attachment and Biobehavioral Catch-Up (mABC) Intervention, adapted for use with peripartum mothers receiving medication-assisted treatment for opioid use disorder. The investigators expect that mothers who receive the modified Attachment and Biobehavioral Catch-up Intervention will show more nurturing and sensitive parenting and more adaptive physiological regulation than parents who receive a control intervention. The investigators expect that infants whose mothers receive the modified Attachment and Biobehavioral Catch-up will show better outcomes in attachment, behavior, and physiological regulation than infants of parents who receive the control intervention.

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 data supports the effectiveness of the mABC treatment for opioid addiction?

The mABC treatment is adapted from the original ABC intervention, which has been shown to improve sensitive parenting and children's behavioral and biological functioning. Additionally, similar attachment-based programs have demonstrated more supportive parenting behaviors among mothers with substance-use problems. ^{1 2 3 4 5}

Is the mABC intervention for opioid addiction safe for humans?

The modified Attachment and Biobehavioral Catch-up (mABC) intervention has been adapted to support mothers with opioid dependence and their infants, focusing on enhancing sensitive caregiving. While specific safety data for mABC is not detailed, the original ABC intervention has shown positive outcomes in children's behavioral and biological functioning, suggesting it is generally safe for use in humans. ^{2 3 4 6 7}

How is the mABC Intervention for Opioid Addiction different from other treatments?

The mABC Intervention is unique because it focuses on improving the attachment and behavioral interactions between opioid-dependent mothers and their children, which is different from standard drug-based treatments that primarily target the biological aspects of addiction. ^{8 9 10 11 12}

Research Team

Mary Dozier, PhD

Principal Investigator

University of Delaware

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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]

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Breastfeeding among Mothers on Opioid Maintenance Treatment: A Literature Review. [2021]

2. Switzerland pubmed.ncbi.nlm.nih.gov

An Integrated Mechanistic Model of Mindfulness-Oriented Recovery Enhancement for Opioid-Exposed Mother-Infant Dyads. [2021]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Adapting an Evidence-Based Home Visiting Intervention for Mothers With Opioid Dependence: Modified Attachment and Biobehavioral Catch-up. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Relational Psychotherapy Mothers' Group: a developmentally informed intervention for at-risk mothers. [2022]

5. United States 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. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

Prenatal methadone exposure and neonatal neurobehavioral functioning. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Buprenorphine withdrawal syndrome in newborns: a report of 13 cases. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Neural correlates of adherence to extended-release naltrexone pharmacotherapy in heroin dependence. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Protracted abstinence in males with an opioid use disorder: partial recovery of nucleus accumbens function. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

The role of withdrawal in mesocorticolimbic drug cue reactivity in opioid use disorder. [2021]

11. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Anhedonia, depression, anxiety, and craving in opioid dependent patients stabilized on oral naltrexone or naltrexone implant]. [2019]

12. United States pubmed.ncbi.nlm.nih.gov

Time-dependent neuronal changes associated with craving in opioid dependence: an fMRI study. [2022]