<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02979093</url>
  </required_header>
  <id_info>
    <org_study_id>201601749</org_study_id>
    <nct_id>NCT02979093</nct_id>
  </id_info>
  <brief_title>Oxytocin and Brain Responses in Maternal Addiction</brief_title>
  <official_title>Oxytocin and Brain Reward and Stress Responses to Infant Cues in Addicted Mothers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Lane Strathearn, MBBS PhD</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Yale University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Iowa</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      A prior study by the principal investigator of this project identified dopamine- and&#xD;
      oxytocin-related brain pathways that showed a diminished response when addicted mothers&#xD;
      viewed the faces of their own vs. unknown infants, compared with non-addicted mothers. These&#xD;
      areas include the hypothalamus, striatum and ventromedial prefrontal cortex. In addition, the&#xD;
      investigators plan to examine activation patterns within the salience network, which includes&#xD;
      the anterior cingulate cortex and the anterior insula. Oxytocin, a neuropeptide with&#xD;
      decreased blood levels seen in addicted mothers, is integrally involved in maternal brain and&#xD;
      behavioral responses. When administered intranasally, the pilot data has shown enhanced&#xD;
      activation of the striatum, prefrontal cortex (PFC) and amygdala.&#xD;
&#xD;
      The purpose of this study is to continue and expand upon the previous investigation of&#xD;
      maternal addiction, by conducting a randomized, double-blinded, placebo controlled, crossover&#xD;
      study of intranasal oxytocin on maternal brain responses. 150 mothers from the University of&#xD;
      Iowa and the Yale Child Study Center will be enrolled (75 with a history of drug addiction&#xD;
      and 75 matched control mothers), along with their 2 to 12-month-old infants, to participate&#xD;
      in four study visits over a two-month period.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Maternal drug addiction constitutes a major public health problem for both women and affected&#xD;
      children, with long lasting consequences on children's social, emotional and cognitive&#xD;
      development. Current treatment strategies tend to focus on the mother and her current&#xD;
      addiction, rather than her relationship with her child, and developmental processes that may&#xD;
      perpetuate the addiction problems, such as unresolved childhood attachment trauma, neglect,&#xD;
      and chronic stress. Unlike mothers who find engaging with their own infant to be a uniquely&#xD;
      rewarding experience, mothers with addictions may be less able to respond appropriately to&#xD;
      their infant's cues, finding them less intrinsically rewarding or salient, and more stress&#xD;
      provoking.&#xD;
&#xD;
      Aim 1: To examine, in addicted mothers compared to non-addicted control mothers, the effect&#xD;
      of intranasal oxytocin (OT) on functional MRI brain responses to reward-related cues: own vs.&#xD;
      unknown happy infant faces.&#xD;
&#xD;
      Aim 2: To examine, in addicted mothers compared to non-addicted control mothers, the effect&#xD;
      of intranasal OT on brain responses to stress-related cues: own vs. unknown sad infant faces&#xD;
      and cries.&#xD;
&#xD;
      Aim 3: To examine the effect of intranasal OT on functional brain connectivity, including the&#xD;
      striatum, PFC and amygdala. Specifically, exploring whether, after receiving intranasal OT&#xD;
      compared to placebo, addicted mothers show increased functional connectivity between the&#xD;
      amygdala and (i) the ventromedial PFC for own-happy infant faces, and (ii) the dorsolateral&#xD;
      PFC and striatum for own-sad faces.&#xD;
&#xD;
      Aim 4: To explore how individual differences in adult attachment and mother-infant synchrony,&#xD;
      sensation-seeking/risk-taking and stress/trauma exposure are associated with OT brain&#xD;
      responses to infant faces.&#xD;
&#xD;
      Aim 5: To examine the effect of intranasal OT on activation of the salience network in&#xD;
      addicted mothers, as well as connectivity patterns between these regions and the amygdala. We&#xD;
      predict that there will be noticeable increase in activity in the salience network (dorsal&#xD;
      anterior cingulate and anterior insula) after administering OT. We predict the addiction&#xD;
      group will have a greater affect from the OT treatment than the control group.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Unable to recruit proposed study sample size due to COVID restrictions.&#xD;
  </why_stopped>
  <start_date type="Actual">May 5, 2017</start_date>
  <completion_date type="Actual">May 17, 2021</completion_date>
  <primary_completion_date type="Actual">May 17, 2021</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Effect of intranasal oxytocin on brain fMRI activation, independent of addiction status</measure>
    <time_frame>50 minutes after administration of oxytocin or placebo</time_frame>
    <description>Specific regions of interests include the striatum and amygdala</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Effect of intranasal oxytocin on brain fMRI activation in addicted vs controls mothers</measure>
    <time_frame>50 minutes after administration of oxytocin or placebo</time_frame>
    <description>Specific region of interest includes the prefrontal cortex</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">73</enrollment>
  <condition>Maternal Behavior</condition>
  <condition>Maternal Addiction</condition>
  <arm_group>
    <arm_group_label>Addicted</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>The addiction group will be scanned twice using functional magnetic resonance imaging (fMRI). Subjects will be randomly assigned to receive either the active comparator (intranasal oxytocin spray) or the placebo comparator before the first scanning session. For the second scan (approximately one month later), the subject will receive the other spray which she did not receive at the time of the first scan.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>The control group will be scanned twice using functional magnetic resonance imaging (fMRI). Subjects will be randomly assigned to receive either the active comparator (intranasal oxytocin spray) or the placebo comparator before the first scanning session. For the second scan (approximately one month later), the subject will receive the other spray which she did not receive at the time of the first scan.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Oxytocin</intervention_name>
    <description>All women will receive a nasal spray containing oxytocin.</description>
    <arm_group_label>Addicted</arm_group_label>
    <arm_group_label>Control</arm_group_label>
    <other_name>Pitocin</other_name>
    <other_name>Syntocinon</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebos</intervention_name>
    <description>All women will receive a nasal spray containing a placebo solution.</description>
    <arm_group_label>Addicted</arm_group_label>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Functional MRI scanning</intervention_name>
    <description>Study participants undergo two functional MRI scans.</description>
    <arm_group_label>Addicted</arm_group_label>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria for addiction sample:&#xD;
&#xD;
        Drug-addicted subjects will be English speaking adult women who:&#xD;
&#xD;
          1. are being evaluated for treatment of their addiction or are currently enrolled in&#xD;
             treatment programs;&#xD;
&#xD;
          2. have an infant &lt;12 months;&#xD;
&#xD;
          3. meet criteria for substance abuse or dependence in the past year, as assessed by MINI&#xD;
             International Neuropsychiatric Interview (MINI);&#xD;
&#xD;
          4. have a substance abuse history, including use during the most recent pregnancy;&#xD;
&#xD;
          5. are recommended at intake for drug-treatment services for substance abuse;&#xD;
&#xD;
          6. are 18 years to 40 years old; and&#xD;
&#xD;
          7. have been speaking English or enrolled in English-speaking school since age 8.&#xD;
&#xD;
        Inclusion Criteria for non-addicted mothers (controls):&#xD;
&#xD;
        Control subjects will be English-speaking adult women who:&#xD;
&#xD;
          1. have an infant &lt;12 months of age;&#xD;
&#xD;
          2. do not meet criteria for past or present drug abuse or dependence;&#xD;
&#xD;
          3. are 18 years to 40 years old; and&#xD;
&#xD;
          4. have been speaking English or enrolled in English-speaking school since age 8.&#xD;
&#xD;
        Exclusion Criteria for addiction sample:&#xD;
&#xD;
        Potential drug-addicted subjects will be ineligible if they have:&#xD;
&#xD;
          1. severe psychiatric or substance-related symptoms requiring in-patient psychiatric&#xD;
             hospitalization or detoxification for suicidality, homicidality, grave disability,&#xD;
             physiological alcohol or drug withdrawal within the last 30 days;&#xD;
&#xD;
          2. past or present diagnosis of schizophrenia or other psychotic disorders;&#xD;
&#xD;
          3. metal implants or other contraindications for MRI scanning;&#xD;
&#xD;
          4. pending legal cases (e.g., outstanding arrest warrants or parental rights hearings)&#xD;
             prohibiting them from completing the study;&#xD;
&#xD;
          5. current pregnancy or plans to become pregnant during the course of the study;&#xD;
&#xD;
          6. infants with clinical evidence of in utero drug effects, such as opiate withdrawal&#xD;
             symptoms during the neonatal period, facial dysmorphism or intrauterine growth&#xD;
             restriction (IUGR) or microcephaly;&#xD;
&#xD;
          7. infants with birth weight less than 3 lb. 5 oz.;&#xD;
&#xD;
          8. infants who have significant vision, hearing or motor problems (such as cerebral&#xD;
             palsy) that cannot be corrected;&#xD;
&#xD;
          9. mothers who have significant vision or hearing problems that cannot be corrected;&#xD;
&#xD;
         10. out-of-home placement of infant for the past month or more than 50% of child's life;&#xD;
&#xD;
         11. delivered more than one baby during most recent pregnancy (twins, triplets, etc.).&#xD;
&#xD;
         12. exclusively breastfeeding&#xD;
&#xD;
        Exclusion criteria for non-addicted mothers:&#xD;
&#xD;
        Potential control subjects will be ineligible if they have:&#xD;
&#xD;
          1. positive drug toxicology screen at any point in the study;&#xD;
&#xD;
          2. drug abuse or dependence based on MINI in the past year or lifetime;&#xD;
&#xD;
          3. use of tobacco products in the past 2 years;&#xD;
&#xD;
          4. current hazardous alcohol use as ascertained by AUDIT score &gt; 8;&#xD;
&#xD;
          5. present or past history of ambulatory detoxification;&#xD;
&#xD;
          6. severe psychiatric symptoms requiring inpatient psychiatric hospitalization for&#xD;
             suicidality, homicidality, grave disability, physiological alcohol or drug withdrawal&#xD;
             within the past 30 days;&#xD;
&#xD;
          7. past or present diagnosis of schizophrenia or other psychotic disorders;&#xD;
&#xD;
          8. metal implants or other contraindications for MRI scanning;&#xD;
&#xD;
          9. current pregnancy or plans to become pregnant during the course of the study;&#xD;
&#xD;
         10. infants with birth weight less than 3 lb. 5 oz.;&#xD;
&#xD;
         11. infants who have significant vision, hearing or motor problems that cannot be&#xD;
             corrected (such as cerebral palsy);&#xD;
&#xD;
         12. mothers who have significant vision or hearing problems that cannot be corrected;&#xD;
&#xD;
         13. out-of-home placement of infant for the past month or more than 50% of child's life;&#xD;
             and&#xD;
&#xD;
         14. delivered more than one baby during most recent pregnancy (twins, triplets, etc.).&#xD;
&#xD;
         15. exclusively breastfeeding&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lane Strathearn, MBBS PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Iowa</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Linda Mayes, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Yale University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Helena Rutherford, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Yale University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Yale Child Study Center</name>
      <address>
        <city>New Haven</city>
        <state>Connecticut</state>
        <zip>06520-7900</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Iowa</name>
      <address>
        <city>Iowa City</city>
        <state>Iowa</state>
        <zip>52242</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>SAMHSA, &quot;Results from the 2011 National Survey on Drug Use and Health: Summary of National Findings&quot; (Substance Abuse and Mental Health Services Administration, Rockville, MD, 2012).</citation>
  </reference>
  <reference>
    <citation>Chaffin M, Kelleher K, Hollenberg J. Onset of physical abuse and neglect: psychiatric, substance abuse, and social risk factors from prospective community data. Child Abuse Negl. 1996 Mar;20(3):191-203. doi: 10.1016/s0145-2134(95)00144-1.</citation>
    <PMID>8734549</PMID>
  </reference>
  <reference>
    <citation>Rutherford HJ, Williams SK, Moy S, Mayes LC, Johns JM. Disruption of maternal parenting circuitry by addictive process: rewiring of reward and stress systems. Front Psychiatry. 2011 Jul 6;2:37. doi: 10.3389/fpsyt.2011.00037. eCollection 2011.</citation>
    <PMID>21779252</PMID>
  </reference>
  <reference>
    <citation>Strathearn L, Li J, Fonagy P, Montague PR. What's in a smile? Maternal brain responses to infant facial cues. Pediatrics. 2008 Jul;122(1):40-51. doi: 10.1542/peds.2007-1566. Erratum In: Pediatrics. 2008 Sep;122(3):689.</citation>
    <PMID>18595985</PMID>
  </reference>
  <reference>
    <citation>Kim S, Fonagy P, Allen J, Strathearn L. Mothers' unresolved trauma blunts amygdala response to infant distress. Soc Neurosci. 2014;9(4):352-63. doi: 10.1080/17470919.2014.896287. Epub 2014 Mar 17.</citation>
    <PMID>24635646</PMID>
  </reference>
  <reference>
    <citation>L. C. Mayes, R. Feldman, R. Granger, The effects of polydrug use with and without cocaine on mother infant interaction at 3 and 6 months. Infant behavior &amp; development 20, 489 (1997).</citation>
  </reference>
  <reference>
    <citation>Strathearn L, Mayes LC. Cocaine addiction in mothers: potential effects on maternal care and infant development. Ann N Y Acad Sci. 2010 Feb;1187:172-83. doi: 10.1111/j.1749-6632.2009.05142.x.</citation>
    <PMID>20201853</PMID>
  </reference>
  <reference>
    <citation>Strathearn L, Mertens CE, Mayes L, Rutherford H, Rajhans P, Xu G, Potenza MN, Kim S. Pathways Relating the Neurobiology of Attachment to Drug Addiction. Front Psychiatry. 2019 Nov 8;10:737. doi: 10.3389/fpsyt.2019.00737. eCollection 2019.</citation>
    <PMID>31780957</PMID>
  </reference>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>November 17, 2016</study_first_submitted>
  <study_first_submitted_qc>November 28, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 1, 2016</study_first_posted>
  <disposition_first_submitted>January 11, 2022</disposition_first_submitted>
  <disposition_first_submitted_qc>November 18, 2022</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">November 28, 2022</disposition_first_posted>
  <last_update_submitted>November 25, 2022</last_update_submitted>
  <last_update_submitted_qc>November 25, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 29, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of Iowa</investigator_affiliation>
    <investigator_full_name>Lane Strathearn, MBBS PhD</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>maternal drug addiction</keyword>
  <keyword>mother-infant attachment</keyword>
  <keyword>intranasal oxytocin</keyword>
  <keyword>unresolved trauma</keyword>
  <keyword>maternal brain responses</keyword>
  <keyword>mother-infant synchrony</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Behavior, Addictive</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Oxytocin</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>The University of Iowa and Yale will compile data from both sites for data analysis purposes only. There is no plan to make individual participant data available.</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted, but a results disposition has been submitted           -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02979093
org study id: 201601749
nct id: NCT02979093
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
A prior study by the principal investigator of this project identified dopamine- and
      oxytocin-related brain pathways that showed a diminished response when addicted mothers
      viewed the faces of their own vs. unknown infants, compared with non-addicted mothers. These
      areas include the hypothalamus, striatum and ventromedial prefrontal cortex. In addition, the
      investigators plan to examine activation patterns within the salience network, which includes
      the anterior cingulate cortex and the anterior insula. Oxytocin, a neuropeptide with
      decreased blood levels seen in addicted mothers, is integrally involved in maternal brain and
      behavioral responses. When administered intranasally, the pilot data has shown enhanced
      activation of the striatum, prefrontal cortex (PFC) and amygdala.

      The purpose of this study is to continue and expand upon the previous investigation of
      maternal addiction, by conducting a randomized, double-blinded, placebo controlled, crossover
      study of intranasal oxytocin on maternal brain responses. 150 mothers from the University of
      Iowa and the Yale Child Study Center will be enrolled (75 with a history of drug addiction
      and 75 matched control mothers), along with their 2 to 12-month-old infants, to participate
      in four study visits over a two-month period.
Maternal drug addiction constitutes a major public health problem for both women and affected
      children, with long lasting consequences on children's social, emotional and cognitive
      development. Current treatment strategies tend to focus on the mother and her current
      addiction, rather than her relationship with her child, and developmental processes that may
      perpetuate the addiction problems, such as unresolved childhood attachment trauma, neglect,
      and chronic stress. Unlike mothers who find engaging with their own infant to be a uniquely
      rewarding experience, mothers with addictions may be less able to respond appropriately to
      their infant's cues, finding them less intrinsically rewarding or salient, and more stress
      provoking.

      Aim 1: To examine, in addicted mothers compared to non-addicted control mothers, the effect
      of intranasal oxytocin (OT) on functional MRI brain responses to reward-related cues: own vs.
      unknown happy infant faces.

      Aim 2: To examine, in addicted mothers compared to non-addicted control mothers, the effect
      of intranasal OT on brain responses to stress-related cues: own vs. unknown sad infant faces
      and cries.

      Aim 3: To examine the effect of intranasal OT on functional brain connectivity, including the
      striatum, PFC and amygdala. Specifically, exploring whether, after receiving intranasal OT
      compared to placebo, addicted mothers show increased functional connectivity between the
      amygdala and (i) the ventromedial PFC for own-happy infant faces, and (ii) the dorsolateral
      PFC and striatum for own-sad faces.

      Aim 4: To explore how individual differences in adult attachment and mother-infant synchrony,
      sensation-seeking/risk-taking and stress/trauma exposure are associated with OT brain
      responses to infant faces.

      Aim 5: To examine the effect of intranasal OT on activation of the salience network in
      addicted mothers, as well as connectivity patterns between these regions and the amygdala. We
      predict that there will be noticeable increase in activity in the salience network (dorsal
      anterior cingulate and anterior insula) after administering OT. We predict the addiction
      group will have a greater affect from the OT treatment than the control group.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: Double (Participant, Investigator)
measure: Effect of intranasal oxytocin on brain fMRI activation, independent of addiction status
time frame: 50 minutes after administration of oxytocin or placebo
description: Specific regions of interests include the striatum and amygdala
measure: Effect of intranasal oxytocin on brain fMRI activation in addicted vs controls mothers
time frame: 50 minutes after administration of oxytocin or placebo
description: Specific region of interest includes the prefrontal cortex
arm group label: Addicted
arm group type: Other
description: The addiction group will be scanned twice using functional magnetic resonance imaging (fMRI). Subjects will be randomly assigned to receive either the active comparator (intranasal oxytocin spray) or the placebo comparator before the first scanning session. For the second scan (approximately one month later), the subject will receive the other spray which she did not receive at the time of the first scan.
arm group label: Control
arm group type: Other
description: The control group will be scanned twice using functional magnetic resonance imaging (fMRI). Subjects will be randomly assigned to receive either the active comparator (intranasal oxytocin spray) or the placebo comparator before the first scanning session. For the second scan (approximately one month later), the subject will receive the other spray which she did not receive at the time of the first scan.
intervention type: Drug
intervention name: Oxytocin
description: All women will receive a nasal spray containing oxytocin.
arm group label: Addicted
arm group label: Control
other name: Pitocin
other name: Syntocinon
intervention type: Drug
intervention name: Placebos
description: All women will receive a nasal spray containing a placebo solution.
arm group label: Addicted
arm group label: Control
intervention type: Procedure
intervention name: Functional MRI scanning
description: Study participants undergo two functional MRI scans.
arm group label: Addicted
arm group label: Control
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Lane Strathearn, MBBS PhD
role: Principal Investigator
affiliation: University of Iowa
last name: Linda Mayes, MD
role: Principal Investigator
affiliation: Yale University
last name: Helena Rutherford, PhD
role: Principal Investigator
affiliation: Yale University
facility: 
facility: 
country: United States
citation: SAMHSA, "Results from the 2011 National Survey on Drug Use and Health: Summary of National Findings" (Substance Abuse and Mental Health Services Administration, Rockville, MD, 2012).
citation: Chaffin M, Kelleher K, Hollenberg J. Onset of physical abuse and neglect: psychiatric, substance abuse, and social risk factors from prospective community data. Child Abuse Negl. 1996 Mar;20(3):191-203. doi: 10.1016/s0145-2134(95)00144-1.
PMID: 8734549
citation: Rutherford HJ, Williams SK, Moy S, Mayes LC, Johns JM. Disruption of maternal parenting circuitry by addictive process: rewiring of reward and stress systems. Front Psychiatry. 2011 Jul 6;2:37. doi: 10.3389/fpsyt.2011.00037. eCollection 2011.
PMID: 21779252
citation: Strathearn L, Li J, Fonagy P, Montague PR. What's in a smile? Maternal brain responses to infant facial cues. Pediatrics. 2008 Jul;122(1):40-51. doi: 10.1542/peds.2007-1566. Erratum In: Pediatrics. 2008 Sep;122(3):689.
PMID: 18595985
citation: Kim S, Fonagy P, Allen J, Strathearn L. Mothers' unresolved trauma blunts amygdala response to infant distress. Soc Neurosci. 2014;9(4):352-63. doi: 10.1080/17470919.2014.896287. Epub 2014 Mar 17.
PMID: 24635646
citation: L. C. Mayes, R. Feldman, R. Granger, The effects of polydrug use with and without cocaine on mother infant interaction at 3 and 6 months. Infant behavior & development 20, 489 (1997).
citation: Strathearn L, Mayes LC. Cocaine addiction in mothers: potential effects on maternal care and infant development. Ann N Y Acad Sci. 2010 Feb;1187:172-83. doi: 10.1111/j.1749-6632.2009.05142.x.
PMID: 20201853
citation: Strathearn L, Mertens CE, Mayes L, Rutherford H, Rajhans P, Xu G, Potenza MN, Kim S. Pathways Relating the Neurobiology of Attachment to Drug Addiction. Front Psychiatry. 2019 Nov 8;10:737. doi: 10.3389/fpsyt.2019.00737. eCollection 2019.
PMID: 31780957
responsible party type: Sponsor-Investigator
investigator affiliation: University of Iowa
investigator full name: Lane Strathearn, MBBS PhD
investigator title: Professor
mesh term: Behavior, Addictive
mesh term: Oxytocin
sharing ipd: No
ipd description: The University of Iowa and Yale will compile data from both sites for data analysis purposes only. There is no plan to make individual participant data available.