Maternal BehaviorPhase 2NCT02979093

Oxytocin and Brain Responses in Maternal Addiction

A Phase 2 study testing Oxytocin and Functional MRI scanning in people with Maternal Behavior and Maternal Addiction, run by Lane Strathearn, MBBS PhD at 2 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 18 to 40 years, women onlyHealthy volunteers can take part
Conditions the study is for: Maternal Behavior, Maternal Addiction
What is being tested?: Oxytocin and Functional MRI scanning
Type of treatment: Surgery or procedure
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 59 participants
Where: 2 sitesUnited States
Study dates: 5 May 2017to 17 May 2021
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 18 to 40 years
Women only
Healthy volunteers accepted
Adult

Who may be able to join

Drug-addicted subjects will be English speaking adult women who:
are being evaluated for treatment of their addiction or are currently enrolled in treatment programs;
have an infant <12 months;
meet criteria for substance abuse or dependence in the past year, as assessed by MINI International Neuropsychiatric Interview (MINI);
have a substance abuse history, including use during the most recent pregnancy;
are recommended at intake for drug-treatment services for substance abuse;

Show all 13Show fewer

are 18 years to 40 years old; and
have been speaking English or enrolled in English-speaking school since age 8.
Control subjects will be English-speaking adult women who:
have an infant <12 months of age;
do not meet criteria for past or present drug abuse or dependence;
are 18 years to 40 years old; and
have been speaking English or enrolled in English-speaking school since age 8.

Who cannot join

Potential drug-addicted subjects will be ineligible if they have:
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;
past or present diagnosis of schizophrenia or other psychotic disorders;
metal implants or other contraindications for MRI scanning;
pending legal cases (e.g., outstanding arrest warrants or parental rights hearings) prohibiting them from completing the study;
current pregnancy or plans to become pregnant during the course of the study;

Show all 29Show fewer

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;
infants with birth weight less than 3 lb. 5 oz.;
infants who have significant vision, hearing or motor problems (such as cerebral palsy) that cannot be corrected;
mothers who have significant vision or hearing problems that cannot be corrected;
out-of-home placement of infant for the past month or more than 50% of child's life;
delivered more than one baby during most recent pregnancy (twins, triplets, etc.).
exclusively breastfeeding
Potential control subjects will be ineligible if they have:
positive drug toxicology screen at any point in the study;
drug abuse or dependence based on MINI in the past year or lifetime;
use of tobacco products in the past 2 years;
current hazardous alcohol use as ascertained by AUDIT score > 8;
present or past history of ambulatory detoxification;
severe psychiatric symptoms requiring inpatient psychiatric hospitalization for suicidality, homicidality, grave disability, physiological alcohol or drug withdrawal within the past 30 days;
past or present diagnosis of schizophrenia or other psychotic disorders;
metal implants or other contraindications for MRI scanning;
current pregnancy or plans to become pregnant during the course of the study;
infants with birth weight less than 3 lb. 5 oz.;
infants who have significant vision, hearing or motor problems that cannot be corrected (such as cerebral palsy);
mothers who have significant vision or hearing problems that cannot be corrected;
out-of-home placement of infant for the past month or more than 50% of child's life; and
delivered more than one baby during most recent pregnancy (twins, triplets, etc.).
exclusively breastfeeding

Trial locations and contacts

2 sites in 1 country.

United States2 sites

University of Iowa
Iowa City, Iowa, 52242
Yale Child Study Center
New Haven, Connecticut, 06520-7900

Other trials in United States

About this study

Official title: Oxytocin and Brain Reward and Stress Responses to Infant Cues in Addicted Mothers

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.

Read the detailed description

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.

Conditions: Maternal Behavior, Maternal Addiction
Being tested: Oxytocin, Placebos, Functional MRI scanning
Keywords: maternal drug addiction, mother-infant attachment, intranasal oxytocin, unresolved trauma, maternal brain responses, mother-infant synchrony

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

OxytocinDrug
Also called Pitocin, Syntocinon
All women will receive a nasal spray containing oxytocin.
PlacebosDrug
All women will receive a nasal spray containing a placebo solution.
Functional MRI scanningProcedure or surgery
Study participants undergo two functional MRI scans.

Study groups in NCT02979093
Study group	Role	What they receive
Addicted	Other	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. Receives: Drug: Oxytocin; Drug: Placebos; Procedure: Functional MRI scanning
Control	Other	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. Receives: Drug: Oxytocin; Drug: Placebos; Procedure: Functional MRI scanning

What is being measured

The primary outcome is the main question the study is designed to answer.

Effect of Intranasal Oxytocin on Brain fMRI Activation, Independent of Addiction Status (Hypotheses 1 and 2A).
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).
Measured: 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)
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).
Measured: 50 minutes after administration of oxytocin or placebo

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

5 May 201717 May 2021

First posted1 Dec 2016 (estimated)
Study start5 May 2017
Primary completion17 May 2021
Study completion17 May 2021

Why it stopped: Unable to recruit proposed study sample size due to COVID restrictions.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (8)Papers the sponsor has linked to this study.
Other trials for Maternal BehaviorStudies of the same condition, open and under way.
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 2
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 59 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02979093
Sponsor's protocol ID: 201601749
Status last verified: Mar 2025
First submitted: 17 Nov 2016
Last updated: 26 Mar 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No: 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.

Publications

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).
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.
PubMed 8734549
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.
PubMed 21779252
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.
PubMed 18595985
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.
PubMed 24635646
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).
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.
PubMed 20201853
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.
PubMed 31780957

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Maternal Behavior trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Oxytocin and Brain Reward and Stress Responses to Infant Cues in Addicted Mothers
ClinicalTrials.gov ID: NCT02979093
Acronym / sponsor ID: 201601749
Conditions: Maternal Behavior, Maternal Addiction
Keywords: maternal drug addiction, mother-infant attachment, intranasal oxytocin, unresolved trauma, maternal brain responses, mother-infant synchrony
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: Unable to recruit proposed study sample size due to COVID restrictions.
Enrolment: 59 participants (actual)
Lead sponsor: Lane Strathearn, MBBS PhDUniversity, hospital or other
Collaborators: Yale University
Study start: 5 May 2017 (actual)
Primary completion: 17 May 2021 (actual)
Study completion: 17 May 2021 (actual)
First posted: 1 Dec 2016 (estimated)
Results: Posted 26 Mar 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Addicted	Other	Drug: Oxytocin, Drug: Placebos, Procedure: Functional MRI scanningThe 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.
Control	Other	Drug: Oxytocin, Drug: Placebos, Procedure: Functional MRI scanningThe 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.

Who may qualify

Ages: 18 to 40 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (13 listed)

are being evaluated for treatment of their addiction or are currently enrolled in treatment programs;
have an infant <12 months;
meet criteria for substance abuse or dependence in the past year, as assessed by MINI International Neuropsychiatric Interview (MINI);
have a substance abuse history, including use during the most recent pregnancy;
are recommended at intake for drug-treatment services for substance abuse;

Key exclusion criteria (29 listed)

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;
past or present diagnosis of schizophrenia or other psychotic disorders;
metal implants or other contraindications for MRI scanning;
pending legal cases (e.g., outstanding arrest warrants or parental rights hearings) prohibiting them from completing the study;
current pregnancy or plans to become pregnant during the course of the study;

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
OxytocinAlso: Pitocin, SyntocinonAll women will receive a nasal spray containing oxytocin.	Drug	Addicted, Control
PlacebosAll women will receive a nasal spray containing a placebo solution.	Drug	Addicted, Control
Functional MRI scanningStudy participants undergo two functional MRI scans.	Procedure or surgery	Addicted, Control

Primary outcome

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
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).
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
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).

Results and safety

Results posted to the registry on 26 Mar 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
ADDICTION: PLACEBO FIRST GROUP	12	11
ADDICTION: OXYTOCIN FIRST GROUP	12	10
CONTROL: PLACEBO FIRST GROUP	12	10
CONTROL: OXYTOCIN FIRST GROUP	12	12

Primary outcome: 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. Least squares mean (Standard Error). Unit: BOLD signal

Measure	Oxytocin n = 34	Placebo n = 40
Happy faces (O>U): Striatum	-.33 (.16)	.00678 (.14)
Happy faces (O>U): Amygdala	-.25 (.16)	.16 (.15)
Sad faces (O>U): Striatum	.34 (.14)	.04 (.13)
Sad faces (O>U): Amygdala	.36 (.14)	.04 (.13)

Oxytocin vs Placebo: Mean Difference (Final Values): 0.1697, p = 0.106, Mixed Models Analysis
Oxytocin vs Placebo: Mean Difference (Final Values): 0.20458, p = 0.0709, Mixed Models Analysis
Oxytocin vs Placebo: Mean Difference (Final Values): -0.14559, p = 0.0964, Mixed Models Analysis

Population analysed: Sample consists of both mothers with addiction and mothers who have no history of addiction, with one or two scanning sessions. Individuals with movement artifact or preprocessing problems removed. As pre-specified in the study protocol and similar to most functional MRI studies, the contrasts between two stimuli are reported (e.g., own vs unknown baby faces).

Primary outcome: 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. Least squares mean (Standard Error). Unit: BOLD signal

Measure	Addicted - Oxytocin Condition n = 15	Control - Oxytocin Condition n = 19	Addicted - Placebo Condition n = 19	Control - Placebo Condition n = 21
Happy faces (O>U): vmPFC	.00266 (0.20)	-0.30 (0.18)	0.20 (0.18)	-0.11 (0.18)
Sad faces (O>U): dlPFC	0.48 (0.20)	0.39 (0.19)	0.06 (0.19)	-0.02 (0.18)

Addicted - Oxytocin Condition vs Control - Oxytocin Condition vs Addicted - Placebo Condition vs Control - Placebo Condition: Mean Difference (Final Values): 0.09778, p = 0.319, Mixed Models Analysis
Addicted - Oxytocin Condition vs Control - Oxytocin Condition vs Addicted - Placebo Condition vs Control - Placebo Condition: Mean Difference (Final Values): -0.15289, p = 0.171, Mixed Models Analysis
Addicted - Oxytocin Condition vs Control - Oxytocin Condition vs Addicted - Placebo Condition vs Control - Placebo Condition: Mean Difference (Final Values): -0.20839, p = 0.0179, Mixed Models Analysis

Population analysed: The fMRI data was obtained from 43 participant mothers (21 in the Addiction group and 22 in the Control group), each of whom provided one or two valid scanning session, totaling 74 sessions. Of the 21 Addiction mothers, 15 contributed scanning data in the Oxytocin condition, and 19 in the Placebo condition. Of the 22 Control mothers, 19 contributed data in the Oxytocin condition, and 21 in the Placebo condition. As pre-specified in the protocol, the contrasts between two stimuli are reported.

Adverse events

Time frame: Approximately 4-6 months.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
ADDICTION: PLACEBO	0 of 17 (0%)	0 of 17 (0%)	0 of 17
ADDICTION: OXYTOCIN	0 of 17 (0%)	0 of 17 (0%)	0 of 17
CONTROL: PLACEBO	0 of 20 (0%)	0 of 20 (0%)	0 of 20
CONTROL: OXYTOCIN	0 of 20 (0%)	0 of 20 (0%)	0 of 20

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
BackgroundSAMHSA, "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).
Background: PubMed 8734549Chaffin 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.
Background: PubMed 21779252Rutherford 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.
Background: PubMed 18595985Strathearn 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.
Background: PubMed 24635646Kim 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.
BackgroundL. 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).
Background: PubMed 20201853Strathearn 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.
Background: PubMed 31780957Strathearn 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.
Individual participant dataSharing planned: No. 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.

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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.

Lane Strathearn, MBBS PhD principal investigator

University of Iowa

Linda Mayes, MD principal investigator

Yale University

Helena Rutherford, PhD principal investigator

Yale University

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Oxytocin and Functional MRI scanning in people with Maternal Behavior and Maternal Addiction, run by Lane Strathearn, MBBS PhD at 2 sites 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 13 inclusion and 29 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: stopped early, as of the sponsor's last update on 26 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02979093, which also lists 8 linked publications.

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 26 Mar 2025.