Opioid Use DisorderNCT05495984
Neuroplasticity in Maternal Opioid Use Disorder (OUD)
A study testing ERPs with electroencephalography (EEG) and MIO in people with Opioid Use Disorder, run by Yale University at 1 site in United States.
Trial summary
Opioid use disorder (OUD) remains a major public health problem particularly for mothers in the perinatal period, for whom stress, relapse rates, and risk for overdose are elevated. The perinatal period is characterized by significant neural reorganization that determines outcomes for mothers and infants. Read more about this study
- Who is it for?
- Ages 21 to 45 years, women only
- Conditions the study is for
- Opioid Use Disorder
- What is being tested?
- ERPs with electroencephalography (EEG) and MIO
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2023to Dec 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Biological mother of infants between 4-months and 12-months of age
- 21-45 years of age at time of recruitment
- Enrolled in substance use treatment and on mediation for opioid use disorder (MOUD).
Who cannot join
- Incapable of giving informed consent
- Child spends less than 50% of time in mother's custody.
- Non-English-speaking
- Unable to complete the study because of pending legal cases or unable to supply two forms of contact for the purpose of follow-up
- Physiological addiction to a substance that requires detoxification, defined as difficulties with physiological withdrawal from substances (e.g. delirium tremens, shaking, nausea).
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale Child Studies Center
New Haven, Connecticut, 06520
About this study
Opioid use disorder (OUD) remains a major public health problem particularly for mothers in the perinatal period, for whom stress, relapse rates, and risk for overdose are elevated. The perinatal period is characterized by significant neural reorganization that determines outcomes for mothers and infants. OUD is also associated with neural reorganization, specifically neural circuitry implicated in stress regulation and reward processes. Interventions should therefore take advantage of this changing perinatal biology to enhance treatment response by targeting the aberrant neural circuitry compromised by maternal OUD. The investigators have developed and refined an evidence-based intervention for mothers with OUD designed to target these neural mechanisms and enhance the reward of caregiving; however, this has yet to be formally tested. Therefore, the investigators will examine maternal neuroplasticity using high-dense array electroencephalography (EEG) in mothers with OUD in response to our intervention. There will be 1 laboratory visit at pre-treatment, followed by 12 sessions of the evidence-based parenting intervention, and 1 laboratory visit at post-treatment. This study will attempt to validate the importance of taking advantage of the neuroplasticity in the perinatal period to optimize outcomes for mothers with OUD.
Read the detailed description
This is a study conducted at the Child Study Center (CSC) in the Yale School of Medicine. It involves mothers in treatment for OUD who are caring for infants who are 4-12 months old.
15 mothers will complete 1 study visit, which will last 2.5 hours. It will start with informed consent and then will include demographics, EEG/ERP, a multidimensional assessment of mentalization (a brief self-report questionnaire, a 5-minute speaking task, and a one-hour interview) and several clinical measures (depression, anxiety, stressful life events).
Participants will then complete 12 treatment (Mothering from the Inside Out (MIO)) visits, and 1 post-treatment data collection visit.
Visits 2-13 (1 hour each) consist of participation in Mothering from the Inside Out (MIO).
Visit 14 (2.5 hours) includes participation in the ERP paradigm and the multidimensional assessment of mentalization (a brief self-report questionnaire, a 5-minute speaking task, and a one-hour interview) and several clinical measures (depression, anxiety, stressful life events).
- Conditions
- Opioid Use Disorder
- Being tested
- ERPs with electroencephalography (EEG), MIO
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ERPs with electroencephalography (EEG)Behavioural
E-Prime 2.0 software will present visual and auditory stimuli in an experimental paradigm lasting approximately 30 minutes (ERPs). Visual stimuli will include photographs of color photographs of unfamiliar infants (aged 5- 10 months) balanced for ethnicity (Black/White) and gender (male/female) displaying happy neutral, and sad affective expressions. Auditory stimuli will include 2-second audio clips of high-distress and low-distress infant cries. Experimental procedure: Trials will consist of a central fixation cross (jittered 400-600ms), stimulus presentation (500ms faces, 2000ms cries), and blank screen (1000ms). Continuous electroencephalography (EEG) will be recorded using Net Station 4.2.1. A 128 Ag/Silver Chloride (AgCl) electrode net will be soaked in a warm potassium chloride solution, and net electrodes will be spaced evenly and symmetrically on each participant's head to cover the scalp.
MIOBehavioural
A 12-week, manualized, individual parenting psychotherapy developed specifically for mothers with addictions administered by the Principal Investigator. It is designed to foster a mother's capacity for mentalization or reflective functioning (RF). MIO is offered in conjunction with standard addiction treatment.
| Study group | Role | What they receive |
|---|---|---|
| Primary Objective: Event-Related Potentials (ERPs) | Experimental | Use ERPs elicited by unknown infant face and cry stimuli to determine whether neural markers translate to maternal mentalization in mothers with opioid use disorder (OUD) at 4-12 months postpartum Receives: Behavioral: ERPs with electroencephalography (EEG) |
| Secondary Objective: ERPs + Mothering from the Inside Out (MIO) | Experimental | Use Event-Related Potentials (ERPs) elicited by unknown infant face and cry stimuli to determine whether neural response changes with participation in an evidence-based parenting intervention designed specifically for mothers with OUD: Mothering from the Inside Out (MIO). Receives: Behavioral: ERPs with electroencephalography (EEG); Behavioral: MIO |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in mothers' Event-related potentials (ERPs) elicited by unknown infant face and cry stimuli
E-Prime 2.0 software will present visual and auditory stimuli in an experimental paradigm lasting approximately 30 minutes. Continuous electroencephalography (EEG) will be recorded using Net Station 4.2.1. Net Station 4.5 will be used to pre-process EEG data (first be digitally filtered, then segmented into 1-second epochs (100ms pre- and 900ms post-stimulus onset). Net Station artifact detection will be set to detect artifact. Spline interpolation will be used to replace channels with artifacts in more than 40% of trials. Ocular Artifact Removal (OAR), using a blink slope threshold of 14µV/ms, will be applied to data for all participants. EEG data will next be re-referenced to the average reference of all electrodes and baseline corrected to the 100ms interval pre-stimulus onset. Lastly, the EEG data will be averaged across stimulus conditions for each participant. The N170, N100, and P300 will be visually inspected in the grand-averaged data and verified for each participant.
Measured: Week 1 and Week 14
Change in maternal mentalization measured by coding of reflective functioning (RF) on the one-hour Parent Development Interview (PDI)
The PDI is a semi-structured interview with 19 questions eliciting a parent's verbal narrative about common emotionally-challenging aspects of parenting. The interview is recorded, transcribed, and each of the 19 responses is rated on a 10-point scale where: a score of 1 indicates complete absence of recognition of mental states (events are described solely in terms of behavior) and scores above 5 indicate increasingly elaborate and sophisticated understanding of how mental states function and influence behavior. Reliable coders assign an Overall Score to the protocol that represents the parent's modal level of response. The PDI requires approximately 60 minutes to complete.
Measured: Week 1 and Week 14
Change in mothers' reflective functioning assessed using the self-report Parental Reflective Functioning Questionnaire (PRFQ)
The PRFQ is an 18-item self-report questionnaire to quantify levels of 3 key components of parental RF: Interest \& Curiosity surrounding their child's mental states, Certainty in the recognition of their child's mental states, and Pre-Mentalizing or difficulty in considering the child's mental states. Optimal RF is indicated by higher scores on the interest and curiosity subscale, moderate scores on the certainty subscale, and lower scores on the pre-mentalizing subscale. Participants rate their responses on a 7-point likert scale ranging from 1 (strongly disagree) to 7 (strongly agree). The PRFQ requires approximately 10 minutes to complete.
Measured: Week 1 and Week 14
Change in mothers' certainty about mental states assessed using the self-report Certainty about Mental States Questionnaire (CAMSQ)
The CAMSQ is a psychometrically sound 20-item self-report questionnaire. The CAMSQ assesses two maladaptive variants of subjective certainty about mental states that can be linked to hypomentalizing and hypermentalizing. The CAMSQ yields two subscales representing certainty about one's own metal states, and certainty about others' mental states. Items are scored by taking the mean of item responses (never = 1, almost never = 2, sometimes = 3, half of the time = 4, often = 5, almost always = 6, always = 7). The CAMSQ requires approximately 15 minutes to complete.
Measured: Week 1 and Week 14
Change in mothers' mind-mindedness assessed using the Five-Minute Speech Sample (MM)
On the five-minute speech sample, mothers will be asked to describe their child for five minutes; responses will be recorded, transcribed, and coded using the representational MM coding manual. Descriptions that refer to mental states (e.g., cognitions, emotions, desires, interests) are identified as mind-minded. The frequency of mind-minded comments will be calculated, as will the proportion of mind-minded to non- mind-minded comments, to control for verbosity.
Measured: Week 1 and Week 14
Secondary outcomes (9)
Mothers' baseline substance use assessed using the Addiction Severity Index (ASI-Lite)
This interview characterizes mothers' recent (past 30 day) and lifetime substance use. Seven potential problem areas are assessed: Medical, Employment/Support Status, Alcohol, Drug, Legal, Family/Social, and Psychological. For each area, mothers will be asked to rate the impact of their substance use, using the following scale: (0) Not at all; (1) Slightly; (2) Moderately; (3) Considerably; (4) Extremely. The ASI-Lite requires approximately 15 minutes to complete.
Measured: Week 1
Change in mothers' depression assessed using the Edinburgh Postnatal Depression Scale (EPDS)
The EPDS is a 10-item questionnaire that uses a 4-point Likert scale. Participants are asked to rate the extent to which in the past 7 days they have experienced symptoms such as feeling unhappy, panicky, sad, or tearful. Scores range from 0 to 30, and the threshold for the presence of possible depression is 10. The EPDS requires approximately 5 minutes to complete.
Measured: Week 1 and Week 14
Change in mothers' depression assessed using the Patient Health Questionnaire-2 (PHQ-2)
The PHQ-2 is a brief, 2-item screening tool that asks on a 4-point Likert scale how often over the past two weeks participants have been bothered by little interest or pleasure in doing things and feeling down/depressed/hopeless. Scores range from 0 to 8. The PHQ-2 requires approximately 1 minute to complete.
Measured: Week 1 and Week 14
Change in mothers' anxiety assessed using the Generalized Anxiety Disorder-7 (GAD-7)
The GAD-7 is a brief, 7-item screening tool that asks on a 4-point Likert scale how often over the past two weeks participants have been bothered by symptoms of generalized anxiety (e.g., feeling nervous, worry, difficulty relaxing, restlessness, irritability, etc.) Scores range from 0 to 21. The GAD-7 requires approximately 5 minutes to complete.
Measured: Week 1 and Week 14
Change in mothers' stress assessed using the Parenting Stress Index- Short Form (PSI-SF)
The PSI-SF is a 36-item self-report questionnaire for parents of children who are younger than 12 years of age. Parents are asked to rate their agreement with statements on a 5-point likert scale ranging from 1 (strongly disagree) to 5 (strongly agree). The PSI-SF yields a Total Stress score, as well as 3 subscales (each consisting of 12 items): Parental Distress, Parent-Child Dysfunctional Interaction, and Difficult Child. Responses from each item are summed for each subscale and all items are included in the Total Stress score, with higher scores representing higher levels of parenting stress. The PSI-SF requires approximately 15 minutes to complete.
Measured: Week 1 and Week 14
Mothers' experience of childhood maltreatment assessed using the Childhood Trauma Questionnaire (CTQ)
The CTQ is a 28-item self-report questionnaire asking parents to indicate the frequency of their traumatic experiences on a 5-point Likert scale ranging from 1 (never true) to 5 (very often true). The CTQ yields 5 subscales: emotional abuse, physical abuse, sexual abuse, emotional neglect, and physical neglect. Each subscale consists of 5 questions and scores can thus range from 5 to 25. The remaining 3 questions are used to assess participants minimization or denial of their experiences, which would suggest an underreporting of traumatic experiences. The CTQ requires approximately 15 minutes to complete.
Measured: Week 1
Mothers' experience of childhood adversity assessed using the Adverse Childhood Experiences Scale (ACES)
The ACES is a 10-item questionnaire that assesses exposure to various adversities before the age of 18. Participants are asked to indicate whether or not they experienced 10 different kinds of adversities in a dichotomous no/yes format. Scores can thus range from 0 to 10, with higher scores representing exposure to a greater number of types of adversity. The ACES requires approximately 5 minutes to complete.
Measured: Week 1
Change in mothers' internalized stigma assessed using the Brief Opioid Stigma Scale (BOSS)
The BOSS is a 7-item self-report questionnaire that assesses internalized stigma experienced by individuals with an opioid use disorder. Participants respond using a 5-point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree). The BOSS yields 3 subscales: Aware (i.e., awareness of stereotypes), Agree (i.e., agreement with stereotypes), and Harm (i.e., negative impact to self-esteem), with higher scores representing higher levels of internalized stigma. The BOSS requires approximately 5 minutes to complete.
Measured: Week 1 and Week 14
Change in mothers' internalized stigma assessed using the Substance Use Stigma Mechanism Scale (SU-SMS)
The SU-SMS is an 18-item self-report questionnaire that assesses enacted stigma (i.e., experiences of discrimination from others), anticipated stigma (expectations of experiencing discrimination), and internalized stigma (the application of negative beliefs about people with substance use disorders to onesself). Participants respond on a 5-point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree). Each subscale yields a score that can range from 6 to 30, with higher scores representing higher levels of stigma. The SU-SMS requires approximately 10 minutes to complete.
Measured: Week 1 and Week 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2022
- Study start1 Jan 2023
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Why it stopped: PI in transition, assessing feasibility of study continuation
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid Use DisorderStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- All participants (n=15) will complete Study Visit 1 for the Primary Objective, and Study Visits 2-14 for the Secondary Objective.
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- Alkermes, Inc.
- Responsible party
- Sponsor
- Investigators
- Amanda Lowell, Ph.D., Principal investigator, Yale UniversityHelena Rutherford, PhD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05495984
- Sponsor's protocol ID
- 2000033065
- Status last verified
- Sep 2026
- First submitted
- 8 Aug 2022
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuroplasticity in Maternal Opioid Use Disorder (OUD)
- ClinicalTrials.gov ID
- NCT05495984
- Acronym / sponsor ID
- 2000033065
- Conditions
- Opioid Use Disorder
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: PI in transition, assessing feasibility of study continuation
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- Alkermes, Inc.
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 10 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Opioid use disorder (OUD) remains a major public health problem particularly for mothers in the perinatal period, for whom stress, relapse rates, and risk for overdose are elevated. The perinatal period is characterized by significant neural reorganization that determines outcomes for mothers and infants. OUD is also associated with neural reorganization, specifically neural circuitry implicated in stress regulation and reward processes. Interventions should therefore take advantage of this changing perinatal biology to enhance treatment response by targeting the aberrant neural circuitry compromised by maternal OUD. The investigators have developed and refined an evidence-based intervention for mothers with OUD designed to target these neural mechanisms and enhance the reward of caregiving; however, this has yet to be formally tested. Therefore, the investigators will examine maternal neuroplasticity using high-dense array electroencephalography (EEG) in mothers with OUD in response to our intervention. There will be 1 laboratory visit at pre-treatment, followed by 12 sessions of the evidence-based parenting intervention, and 1 laboratory visit at post-treatment. This study will attempt to validate the importance of taking advantage of the neuroplasticity in the perinatal period to optimize outcomes for mothers with OUD.
Detailed description
This is a study conducted at the Child Study Center (CSC) in the Yale School of Medicine. It involves mothers in treatment for OUD who are caring for infants who are 4-12 months old.
15 mothers will complete 1 study visit, which will last 2.5 hours. It will start with informed consent and then will include demographics, EEG/ERP, a multidimensional assessment of mentalization (a brief self-report questionnaire, a 5-minute speaking task, and a one-hour interview) and several clinical measures (depression, anxiety, stressful life events).
Participants will then complete 12 treatment (Mothering from the Inside Out (MIO)) visits, and 1 post-treatment data collection visit.
Visits 2-13 (1 hour each) consist of participation in Mothering from the Inside Out (MIO).
Visit 14 (2.5 hours) includes participation in the ERP paradigm and the multidimensional assessment of mentalization (a brief self-report questionnaire, a 5-minute speaking task, and a one-hour interview) and several clinical measures (depression, anxiety, stressful life events).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- All participants (n=15) will complete Study Visit 1 for the Primary Objective, and Study Visits 2-14 for the Secondary Objective.
| Arm | Type | Receives |
|---|---|---|
| Primary Objective: Event-Related Potentials (ERPs) | Experimental | Behavioral: ERPs with electroencephalography (EEG)Use ERPs elicited by unknown infant face and cry stimuli to determine whether neural markers translate to maternal mentalization in mothers with opioid use disorder (OUD) at 4-12 months postpartum |
| Secondary Objective: ERPs + Mothering from the Inside Out (MIO) | Experimental | Behavioral: ERPs with electroencephalography (EEG), Behavioral: MIOUse Event-Related Potentials (ERPs) elicited by unknown infant face and cry stimuli to determine whether neural response changes with participation in an evidence-based parenting intervention designed specifically for mothers with OUD: Mothering from the Inside Out (MIO). |
Who may qualify
- Ages
- 21 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Biological mother of infants between 4-months and 12-months of age
- 21-45 years of age at time of recruitment
- Enrolled in substance use treatment and on mediation for opioid use disorder (MOUD).
Key exclusion criteria (5 listed)
- Incapable of giving informed consent
- Child spends less than 50% of time in mother's custody.
- Non-English-speaking
- Unable to complete the study because of pending legal cases or unable to supply two forms of contact for the purpose of follow-up
- Physiological addiction to a substance that requires detoxification, defined as difficulties with physiological withdrawal from substances (e.g. delirium tremens, shaking, nausea).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ERPs with electroencephalography (EEG)E-Prime 2.0 software will present visual and auditory stimuli in an experimental paradigm lasting approximately 30 minutes (ERPs). Visual stimuli will include photographs of color photographs of unfamiliar infants (aged 5- 10 months) balanced for ethnicity (Black/White) and gender (male/female) displaying happy neutral, and sad affective expressions. Auditory stimuli will include 2-second audio clips of high-distress and low-distress infant cries. Experimental procedure: Trials will consist of a central fixation cross (jittered 400-600ms), stimulus presentation (500ms faces, 2000ms cries), and blank screen (1000ms). Continuous electroencephalography (EEG) will be recorded using Net Station 4.2.1. A 128 Ag/Silver Chloride (AgCl) electrode net will be soaked in a warm potassium chloride solution, and net electrodes will be spaced evenly and symmetrically on each participant's head to cover the scalp. | Behavioural | Primary Objective: Event-Related Potentials (ERPs), Secondary Objective: ERPs + Mothering from the Inside Out (MIO) |
| MIOA 12-week, manualized, individual parenting psychotherapy developed specifically for mothers with addictions administered by the Principal Investigator. It is designed to foster a mother's capacity for mentalization or reflective functioning (RF). MIO is offered in conjunction with standard addiction treatment. | Behavioural | Secondary Objective: ERPs + Mothering from the Inside Out (MIO) |
Primary outcome
Change in mothers' Event-related potentials (ERPs) elicited by unknown infant face and cry stimuli
Time frame: Week 1 and Week 14
E-Prime 2.0 software will present visual and auditory stimuli in an experimental paradigm lasting approximately 30 minutes. Continuous electroencephalography (EEG) will be recorded using Net Station 4.2.1. Net Station 4.5 will be used to pre-process EEG data (first be digitally filtered, then segmented into 1-second epochs (100ms pre- and 900ms post-stimulus onset). Net Station artifact detection will be set to detect artifact. Spline interpolation will be used to replace channels with artifacts in more than 40% of trials. Ocular Artifact Removal (OAR), using a blink slope threshold of 14µV/ms, will be applied to data for all participants. EEG data will next be re-referenced to the average reference of all electrodes and baseline corrected to the 100ms interval pre-stimulus onset. Lastly, the EEG data will be averaged across stimulus conditions for each participant. The N170, N100, and P300 will be visually inspected in the grand-averaged data and verified for each participant.
Change in maternal mentalization measured by coding of reflective functioning (RF) on the one-hour Parent Development Interview (PDI)
Time frame: Week 1 and Week 14
The PDI is a semi-structured interview with 19 questions eliciting a parent's verbal narrative about common emotionally-challenging aspects of parenting. The interview is recorded, transcribed, and each of the 19 responses is rated on a 10-point scale where: a score of 1 indicates complete absence of recognition of mental states (events are described solely in terms of behavior) and scores above 5 indicate increasingly elaborate and sophisticated understanding of how mental states function and influence behavior. Reliable coders assign an Overall Score to the protocol that represents the parent's modal level of response. The PDI requires approximately 60 minutes to complete.
Change in mothers' reflective functioning assessed using the self-report Parental Reflective Functioning Questionnaire (PRFQ)
Time frame: Week 1 and Week 14
The PRFQ is an 18-item self-report questionnaire to quantify levels of 3 key components of parental RF: Interest \& Curiosity surrounding their child's mental states, Certainty in the recognition of their child's mental states, and Pre-Mentalizing or difficulty in considering the child's mental states. Optimal RF is indicated by higher scores on the interest and curiosity subscale, moderate scores on the certainty subscale, and lower scores on the pre-mentalizing subscale. Participants rate their responses on a 7-point likert scale ranging from 1 (strongly disagree) to 7 (strongly agree). The PRFQ requires approximately 10 minutes to complete.
Change in mothers' certainty about mental states assessed using the self-report Certainty about Mental States Questionnaire (CAMSQ)
Time frame: Week 1 and Week 14
The CAMSQ is a psychometrically sound 20-item self-report questionnaire. The CAMSQ assesses two maladaptive variants of subjective certainty about mental states that can be linked to hypomentalizing and hypermentalizing. The CAMSQ yields two subscales representing certainty about one's own metal states, and certainty about others' mental states. Items are scored by taking the mean of item responses (never = 1, almost never = 2, sometimes = 3, half of the time = 4, often = 5, almost always = 6, always = 7). The CAMSQ requires approximately 15 minutes to complete.
Change in mothers' mind-mindedness assessed using the Five-Minute Speech Sample (MM)
Time frame: Week 1 and Week 14
On the five-minute speech sample, mothers will be asked to describe their child for five minutes; responses will be recorded, transcribed, and coded using the representational MM coding manual. Descriptions that refer to mental states (e.g., cognitions, emotions, desires, interests) are identified as mind-minded. The frequency of mind-minded comments will be calculated, as will the proportion of mind-minded to non- mind-minded comments, to control for verbosity.
9 secondary outcomes
Mothers' baseline substance use assessed using the Addiction Severity Index (ASI-Lite)
Time frame: Week 1
Change in mothers' depression assessed using the Edinburgh Postnatal Depression Scale (EPDS)
Time frame: Week 1 and Week 14
Change in mothers' depression assessed using the Patient Health Questionnaire-2 (PHQ-2)
Time frame: Week 1 and Week 14
Change in mothers' anxiety assessed using the Generalized Anxiety Disorder-7 (GAD-7)
Time frame: Week 1 and Week 14
Change in mothers' stress assessed using the Parenting Stress Index- Short Form (PSI-SF)
Time frame: Week 1 and Week 14
Mothers' experience of childhood maltreatment assessed using the Childhood Trauma Questionnaire (CTQ)
Time frame: Week 1
Mothers' experience of childhood adversity assessed using the Adverse Childhood Experiences Scale (ACES)
Time frame: Week 1
Change in mothers' internalized stigma assessed using the Brief Opioid Stigma Scale (BOSS)
Time frame: Week 1 and Week 14
Change in mothers' internalized stigma assessed using the Substance Use Stigma Mechanism Scale (SU-SMS)
Time frame: Week 1 and Week 14
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Opioid Use Disorder
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Enrolling by invitationObservational study
Development of an Interview-Informed Timeline Follow-Back (TLFB) for Opioid Use in the Era of Fentanyl
Substance Use Disorders (SUDs)
Not yet recruiting
Comprehensive Opioid Management and Breathing During Sleep
Sleep-Disordered Breathing, Chronic Opioid Use
Active, not recruitingPhase 2
Wellcome Leap Psilocybin for OUD
Opioid Use Disorder
Recruiting
Opioid and Pain Treatment in Indigenous Communities (OPTIC) Trial
Opioid Use Disorder, Opioid Misuse
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amanda Lowell, Ph.D. principal investigator
Yale University
Helena Rutherford, PhD principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ERPs with electroencephalography (EEG) and MIO in people with Opioid Use Disorder, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in mothers' Event-related potentials (ERPs) elicited by unknown infant face and cry stimuli (time frame: Week 1 and Week 14). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2026.