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.
12345Is 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.
23467How 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.
89101112Eligibility 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.
Trial 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)
Participant Groups
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.
2Treatment groups
Experimental Treatment
Active Control
Group I: Modified ABCExperimental Treatment1 Intervention
12-session home visiting intervention designed to increase parental sensitivity and nurturance and decrease parental frightening behavior.
Group II: Modified DEFActive Control1 Intervention
12-session home visiting intervention designed to increase parental playful interactions that stimulate infant cognitive and motor development
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of DelawareNewark, DE
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Who Is Running the Clinical Trial?
University of DelawareLead Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)Collaborator
References
Breastfeeding among Mothers on Opioid Maintenance Treatment: A Literature Review. [2021]Although there is an abundance of interventional studies to increase breastfeeding rates, little is known about how to support and promote breastfeeding among mothers on opioid maintenance treatment (OMT). The studies on maternal OMT mainly focus on medication excreted in breast milk and breastfeeding benefits for infants with neonatal abstinence syndrome (NAS). We aim to review interventions to improve breastfeeding outcomes among mothers on OMT to make recommendations for practice and future research. We searched CINAHL, PubMed, PsycINFO, and the Cochrane Database of Systematic Reviews for articles, preferably experimental/quasi-experimental studies published within the past 10 years, that examined interventions to increase rates of breastfeeding initiation and duration among mothers on OMT. Nine studies met our inclusion criteria, comprising 5 categories: 4 combined obstetric and addiction care, 1 rooming-in, 1 Baby-Friendly hospital, 2 inpatient/outpatient NAS treatment, and 1 divided methadone dose. Breastfeeding rates were relatively higher for divided methadone dose (81% initiated any breastfeeding) and rooming-in (62% initiated any breastfeeding); lower in Baby-Friendly hospital (24%) and inpatient/outpatient NAS treatment (45% and 24%, respectively); and mixed in combined obstetric and addiction care programs (2 studies reported 70% and 76%; 2 studies reported 17% and 28%). Studies that included both methadone and buprenorphine did not specify breastfeeding results by medication. We recommend future research to differentiate breastfeeding types and duration by OMT medication. Qualitative studies are needed to explore maternal view on breastfeeding regarding need, barrier, and motivating factors in order to develop effective interventions to promote breastfeeding among mothers on OMT.
An Integrated Mechanistic Model of Mindfulness-Oriented Recovery Enhancement for Opioid-Exposed Mother-Infant Dyads. [2021]A growing body of neurobiological and psychological research sheds light on the mechanisms underlying the development and maintenance of opioid use disorder and its relation to parenting behavior. Perinatal opioid use is associated with risks for women and children, including increased risk of child maltreatment. Drawing from extant data, here we provide an integrated mechanistic model of perinatal opioid use, parenting behavior, infant attachment, and child well-being to inform the development and adaptation of behavioral interventions for opioid-exposed mother-infant dyads. The model posits that recurrent perinatal opioid use may lead to increased stress sensitivity and reward dysregulation for some mothers, resulting in decreased perceived salience of infant cues, disengaged parenting behavior, disrupted infant attachment, and decreased child well-being. We conclude with a discussion of Mindfulness-Oriented Recovery Enhancement as a means of addressing mechanisms undergirding perinatal opioid use, parenting, and attachment, presenting evidence on the efficacy and therapeutic mechanisms of mindfulness. As perinatal opioid use increases in the United States, empirically informed models can be used to guide treatment development research and address this growing concern.
Adapting an Evidence-Based Home Visiting Intervention for Mothers With Opioid Dependence: Modified Attachment and Biobehavioral Catch-up. [2021]Infants born to mothers who are dependent on opioids often have difficulty regulating behavior and physiology at birth. Without sensitive maternal care, these infants are at risk for ongoing problems with self-regulation. Mothers who are dependent on opioids may experience challenges related to their substance use (e.g., unsupportive and/or risky environment, impulse control and reward system problems) that increase the likelihood of insensitive parenting in the absence of effective intervention. In this paper, we describe a home-visiting intervention we have adapted to enhance sensitive, responsive caregiving tailored to the specific needs of mothers with opioid dependence. The original intervention, Attachment and Biobehavioral Catch-up (ABC), was designed for mothers of infants aged 6-24 months who were exposed to early adversity. ABC has been shown to enhance sensitive parenting as well as children's behavioral and biological functioning, with positive outcomes extending into at least middle childhood. Mothers who are opioid dependent need earlier support than provided by ABC because opioid-exposed infants are often vulnerable at birth. The adapted intervention (modified ABC or mABC) includes one prenatal session and one early postnatal session, followed by 10 sessions every 2-3 weeks. In the initial two sessions in particular, mothers are helped to anticipate the challenges of caring for a baby who may be difficult to soothe while nonetheless providing sensitive care. mABC is intended to help mothers see the importance of responding sensitively so as to help infants overcome the developmental risks associated with opioid exposure. Additionally, mABC is structured to support mothers with the challenges of early parenting, especially if the mother herself was not parented sensitively. Throughout, the focus is on helping the mother nurture the distressed infant, attend to the infant's signals, and avoid behaving in overstimulating or intrusive ways. Case examples are presented that highlight both the challenges of working with this population as well as the gains made by mothers.
Relational Psychotherapy Mothers' Group: a developmentally informed intervention for at-risk mothers. [2022]The Relational Psychotherapy Mothers' Group (RPMG), a developmentally informed, supportive psychotherapy designed to serve heroin-addicted mothers with children up to 16 years of age, aims at addressing psychosocial vulnerabilities, and facilitating optimal parenting, among at-risk mothers. We present preliminary evidence on the efficacy of RPMG as an "add on" treatment in comparison with standard methadone counseling alone. At the end of the 24-week treatment period, mothers receiving RPMG plus standard methadone counseling demonstrated lower levels of risk for child maltreatment, greater involvement with their children, and more positive psychosocial adjustment than women who received methadone counseling alone. Children of RPMG participants also reflected fewer problems in multiple areas. At 6 months posttreatment, RPMG recipients continued to be at a relative advantage, although the magnitude of group differences was often attenuated. Notably, urinalyses indicated that RPMG mothers showed greater improvements in levels of opioid use over time than comparison mothers.
Promoting supportive parenting in new mothers with substance-use problems: a pilot randomized trial of residential treatment plus an attachment-based parenting program. [2018]This pilot randomized trial tested the feasibility and efficacy of supplementing residential substance-abuse treatment for new mothers with a brief, yet rigorous, attachment-based parenting program. Twenty-one predominantly (86%) White mothers and their infants living together in residential substance-abuse treatment were randomly assigned to the program (n = 11) or control (n = 10) group. Program mothers received 10 home-based sessions of Dozier's Attachment and Biobehavioral Catch-up (ABC) intervention. Postintervention observations revealed more supportive parenting behaviors among the randomly assigned ABC mothers.
Prenatal methadone exposure and neonatal neurobehavioral functioning. [2022]Opioid-exposed infants display a wide and variable range of dysregulated neurobehavioral functioning, but the regulatory difficulties experienced by these infants outside the defined clusters of neonatal abstinence syndrome (NAS) have not been well described and may have implications for the infant's developmental course. This study describes the neurobehavioral functioning of neonates prenatally exposed to methadone, using the NICU Network Neurobehavioral Scale (NNNS), and explores the relationships between maternal factors and infant functioning. The relationship between NNNS measures, NAS severity, and need for pharmacotherapy for NAS was also evaluated. Infants who required pharmacologic treatment for NAS showed more dysregulated behavior and signs of stress and abstinence as indicated by NNNS scores, but NNNS scores were not significantly correlated with maternal methadone dose. The determination of the range of the methadone-exposed infant's neurobehavioral repertoire could guide the optimal treatment of all such infants, particularly those requiring only nonpharmacologic care.
Buprenorphine withdrawal syndrome in newborns: a report of 13 cases. [2019]To assess neonatal abstinence syndrome (NAS) and neurodevelopmental outcome in infants born to addicted mothers under buprenorphine substitution therapy.
Neural correlates of adherence to extended-release naltrexone pharmacotherapy in heroin dependence. [2021]Injectable extended-release naltrexone (XRNTX) presents an effective therapeutic strategy for opioid addiction, however its utility could be hampered by poor adherence. To gain a better insight into this phenomenon, we utilized blood oxygenation level-dependent functional magnetic resonance imaging (fMRI) in conjunction with a validated cue-induced craving procedure to examine neural correlates of XRNTX adherence. We operationalized treatment adherence as the number of monthly XRNTX injections (range: 0-3) administered to a group of fully detoxified heroin-dependent subjects (n=32). Additional outcomes included urine toxicology screening and self-reported tobacco use. The presented heroin-related visual cues reliably elicited heroin craving in all tested subjects. Nine, five, three and 15 of the participants, respectively, received zero, one, two and three XRNTX injections, predicted by the individual baseline fMRI signal change in response to the cues in the medial prefrontal cortex, a brain region involved in inhibitory self-control and emotional appraisal. The incidence of opioid-positive urines during the XRNTX therapy was low and remained about half the pre-treatment rate after the XRNTX ended. During the treatment, cigarette smoking behaviors followed patterns of opioid use, while cocaine consumption was increased with reductions in opioid use. The present data support the hypothesis that medial prefrontal cortex functions are involved in adherence to opioid antagonist therapy. A potential role of concurrent non-opioid addictive substances consumption during the XRNTX pharmacotherapy warrants further investigation. Our findings set the stage for further bio-behavioral investigations of the mechanisms of relapse prevention in opioid dependence.
Protracted abstinence in males with an opioid use disorder: partial recovery of nucleus accumbens function. [2022]Opioid use disorder (OUD) affects more than 27 million people globally accounting for more than 300,000 deaths annually. Protracted abstinence among individuals with OUD is rare due to a high relapse rate among those not receiving medications for OUD. Extensive preclinical studies form the basis of the allostasis theory, which proposes long-lasting functional brain abnormalities that persist after opioid withdrawal and contribute to relapse. Few studies have tested the allostasis theory in humans using neuroimaging. Here, we used fMRI and an instrumental learning task to test allostasis theory predictions (ATP) of functional abnormalities in both positive valence (PVS) and negative valence (NVS) accumbens systems in OUD patients with protracted abstinence (n = 15), comparing them with OUD patients receiving methadone treatment (MT) (n = 33), and with healthy controls (n = 23). As hypothesized, protracted abstinence OUD patients showed incomplete recovery of nucleus accumbens function, as evidenced by the blunted response to aversive events (NVS) during negative reinforcement, as observed in MT patients. In contrast, their accumbens response to rewarding events (PVS) during positive reinforcement was similar to that of controls and different from that in MT patients whose response was blunted. Protracted abstinence OUD patients also showed improvements in depression symptoms compared to MT patients. Residual depressive symptoms and pre-MT intravenous drug measures were associated with worse accumbens function in protracted abstinence. These results support the ATP of long-lasting dysfunction of NVS after withdrawal and show preliminary evidence of recovery of PVS function with protracted withdrawal. Therapeutic strategies that target NVS may facilitate recovery.
The role of withdrawal in mesocorticolimbic drug cue reactivity in opioid use disorder. [2021]Opioid use disorder (OUD) is characterized by heightened cognitive, physiological, and neural responses to opioid-related cues that are mediated by mesocorticolimbic brain pathways. Craving and withdrawal are key symptoms of addiction that persist during physiological abstinence. The present study evaluated the relationship between the brain response to drug cues in OUD and baseline levels of craving and withdrawal. We used functional magnetic resonance imaging (fMRI) to examine brain responses to opioid-related pictures and control pictures in 29 OUD patients. Baseline measures of drug use severity, opioid craving, and withdrawal symptoms were assessed prior to cue exposure and correlated with subsequent brain responses to drug cues. Mediation analysis was conducted to test the indirect effect of drug use severity on brain cue reactivity through craving and withdrawal symptoms. We found that baseline drug use severity and opioid withdrawal symptoms, but not craving, were positively associated with the neural response to drug cues in the nucleus accumbens, orbitofrontal cortex, and amygdala. Withdrawal, but not craving, mediated the effect of drug use severity on the nucleus accumbens' response to drug cues. We did not find similar effects for the neural responses to stimuli unrelated to drugs. Our findings emphasize the central role of withdrawal symptoms as the mediator between the clinical severity of OUD and the brain correlates of sensitization to opioid-related cues. They suggest that in OUD, baseline withdrawal symptoms signal a high vulnerability to drug cues.
[Anhedonia, depression, anxiety, and craving in opioid dependent patients stabilized on oral naltrexone or naltrexone implant]. [2019]To assess the relationship between long-term naltrexone treatment and anxiety, depression and craving in opioid dependent individuals.
Time-dependent neuronal changes associated with craving in opioid dependence: an fMRI study. [2022]Relapse after initially successful treatment is a significant problem facing the treatment of opioid dependence. Evidence suggests craving elicited by re-exposure to drug cues may precipitate relapse. Attempts to identify neural biomarkers of cue-elicited craving have yielded inconsistent findings. We aimed to apply a novel continuous functional magnetic resonance imaging technique to follow the minute-to-minute evolution of brain responses, which correlate with the waxing and waning of craving. Newly detoxified male opioid-dependent patients and healthy control participants attended two separate, counterbalanced, functional magnetic resonance imaging scanning sessions during which they viewed a 10-minute video (drug cue or neutral cue) followed by 5 minutes of fixation. Participants rated the intensity of their craving throughout each session. We hypothesized that subcortical/ventral prefrontal cortex (PFC) regions and dorsal PFC regions would show different associations with craving reflecting their putative roles in appetitive processing versus cognitive control. Compared with controls, drug cue (minus neutral cue) video recruited the left amygdala and was temporally correlated with craving. In contrast, dorsal anterior cingulate blood-oxygen-level-dependent signal time course was higher than controls only during a period after cue exposure when craving levels were declining. Against expectations, neither the ventral striatum nor ventral PFC was significantly recruited by drug cue exposure. Findings suggest that the amygdala has a central role in craving, whereas the dorsal anterior cingulate may control craving in treatment-seeking patients. Time course analysis yielded new insights into the neural substrates of craving that could objectively validate development of psychological and pharmacological approaches to sustained abstinence.