Skip to content

Trial · Interventional

TerminatedPhase 2Results postedRegistry data

Oxytocin and Brain Responses in Maternal Addiction

Overview

Status
Terminated
Phase
Phase 2
Enrollment
59 participants (actual)
Sponsor
Lane Strathearn, MBBS PhD · Other
Design
Randomized · Double masking
Countries
1 country

United States

Start
5 May 2017
Primary completion
17 May 2021
Completion
17 May 2021
First posted
1 Dec 2016 (estimated)
Last update posted
26 Mar 2025
Conditions
Maternal Behavior · Maternal Addiction

Timeline

1 trial · 1 stopped early · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201720182019202020212022
  1. Ph 2

    Oxytocin and Brain Responses in Maternal Addiction

    NCT02979093

    5 May 2017 to 17 May 2021

    Terminated

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • OxytocinDrug
  • PlacebosDrug
  • Functional MRI scanningProcedure

Arms2

  • Other

    Addicted

    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.

  • Other

    Control

    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.

Primary outcomes2

Outcomes the sponsor listed as primary.

  1. Effect of Intranasal Oxytocin on Brain fMRI Activation, Independent of Addiction Status (Hypotheses 1 and 2A).

    Time frame · 50 minutes after administration of oxytocin or placebo

    Registry description

    Brain activation (blood-oxygen level dependent \[BOLD\] signal) in response to reward-related cues (own \[O\] vs. unknown \[U\] infant happy faces). Brain activation (BOLD signal) in response to stress-related cues (own \[O\] vs. unknown \[U\] infant sad faces). Specific regions of interests include the striatum and amygdala (for both happy and sad faces).

  2. Effect of Intranasal Oxytocin on Brain fMRI Activation in Addicted vs Controls Mothers (Hypotheses 1 and 2B)

    Time frame · 50 minutes after administration of oxytocin or placebo

    Registry description

    Brain activation (BOLD signal) in response to reward-related cues (own \[O\] vs. unknown \[U\] infant happy faces). Specific region of interest includes the ventromedial prefrontal cortex (vmPFC) (interaction effect). Brain activation (BOLD signal) in response to stress-related cues (own vs. unknown infant sad faces). Specific region of interest includes the dorsolateral prefrontal cortex (dlPFC) (interaction effect).

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeLeast squares mean· 50 minutes after administration of oxytocin or placebo

Effect of Intranasal Oxytocin on Brain fMRI Activation, Independent of Addiction Status (Hypotheses 1 and 2A).

GroupValue (BOLD signal)Spread
Oxytocin-.33.16
Placebo.00678.14
Primary outcomeLeast squares mean· 50 minutes after administration of oxytocin or placebo

Effect of Intranasal Oxytocin on Brain fMRI Activation in Addicted vs Controls Mothers (Hypotheses 1 and 2B)

GroupValue (BOLD signal)Spread
Addicted - Oxytocin Condition.002660.20
Control - Oxytocin Condition-0.300.18
Addicted - Placebo Condition0.200.18
Control - Placebo Condition-0.110.18

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
ADDICTION: PLACEBOThis arm includes the addiction group during the scanning session under the placebo condition.0 / 170 / 170 / 17
ADDICTION: OXYTOCINThis arm includes the addiction group during the scanning session under the oxytocin condition.0 / 170 / 170 / 17
CONTROL: PLACEBOThis arm includes the control group during the scanning session under the placebo condition.0 / 200 / 200 / 20
CONTROL: OXYTOCINThis arm includes the control group during the scanning session under the oxytocin condition.0 / 200 / 200 / 20

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies2

Studies that cite this trial.

More studies

2 studies on this page

Indexing hint: Review · 2019

Pathways Relating the Neurobiology of Attachment to Drug Addiction.

Strathearn et al. 2019Frontiers in psychiatrycited by 45

PMID 31780957PMC6857543DOI 10.3389/fpsyt.2019.00737PUB-31780957

CC BY
Download PDF

Indexing hint: Review · 2010

Cocaine addiction in mothers: potential effects on maternal care and infant development.

Strathearn et al. 2010Annals of the New York Academy of Sciencescited by 54

PMID 20201853PMC3016156DOI 10.1111/j.1749-6632.2009.05142.xPUB-20201853

Rights unknown
Source link

Eligibility

Who could join, as posted.

Sex
Female
Age
from 18 Years up to 40 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria for addiction sample: Drug-addicted subjects will be English speaking adult women who: 1. are being evaluated for treatment of their addiction or are currently enrolled in treatment programs; 2. have an infant \<12 months; 3. meet criteria for substance abuse or dependence in the past year, as assessed by MINI International Neuropsychiatric Interview (MINI); 4. have a substance abuse history, including use during the most recent pregnancy; 5. are recommended at intake for drug-treatment services for substance abuse; 6. are 18 years to 40 years old; and 7. have been speaking English or enrolled in English-speaking school since age 8. Inclusion Criteria for non-addicted mothers (controls): Control subjects will be English-speaking adult women who: 1. have an infant \<12 months of age; 2. do not meet criteria for past or present drug abuse or dependence; 3. are 18 years to 40 years old; and 4. have been speaking English or enrolled in English-speaking school since age 8. Exclusion Criteria for addiction sample: Potential drug-addicted subjects will be ineligible if they have: 1. severe psychiatric or substance-related symptoms requiring in-patient psychiatric hospitalization or detoxification for suicidality, homicidality, grave disability, physiological alcohol or drug withdrawal within the last 30 days; 2. past or present diagnosis of schizophrenia or other psychotic disorders; 3. metal implants or other contraindications for MRI scanning; 4. pending legal cases (e.g., outstanding arrest warrants or parental rights hearings) prohibiting them from completing the study; 5. current pregnancy or plans to become pregnant during the course of the study; 6. infants with clinical evidence of in utero drug effects, such as opiate withdrawal symptoms during the neonatal period, facial dysmorphism or intrauterine growth restriction (IUGR) or microcephaly; 7. infants with birth weight less than 3 lb. 5 oz.; 8. infants who have significant vision, hearing or motor problems (such as cerebral palsy) that cannot be corrected; 9. mothers who have significant vision or hearing problems that cannot be corrected; 10. out-of-home placement of infant for the past month or more than 50% of child's life; 11. delivered more than one baby during most recent pregnancy (twins, triplets, etc.). 12. exclusively breastfeeding Exclusion criteria for non-addicted mothers: Potential control subjects will be ineligible if they have: 1. positive drug toxicology screen at any point in the study; 2. drug abuse or dependence based on MINI in the past year or lifetime; 3. use of tobacco products in the past 2 years; 4. current hazardous alcohol use as ascertained by AUDIT score \> 8; 5. present or past history of ambulatory detoxification; 6. severe psychiatric symptoms requiring inpatient psychiatric hospitalization for suicidality, homicidality, grave disability, physiological alcohol or drug withdrawal within the past 30 days; 7. past or present diagnosis of schizophrenia or other psychotic disorders; 8. metal implants or other contraindications for MRI scanning; 9. current pregnancy or plans to become pregnant during the course of the study; 10. infants with birth weight less than 3 lb. 5 oz.; 11. infants who have significant vision, hearing or motor problems that cannot be corrected (such as cerebral palsy); 12. mothers who have significant vision or hearing problems that cannot be corrected; 13. out-of-home placement of infant for the past month or more than 50% of child's life; and 14. delivered more than one baby during most recent pregnancy (twins, triplets, etc.). 15. exclusively breastfeeding

PepBank is a research reference. Talk to a doctor before you use any peptide.