Trial Outcomes & Findings for Oxytocin and Brain Responses in Maternal Addiction (NCT NCT02979093)
NCT ID: NCT02979093
Last Updated: 2025-03-26
Results Overview
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).
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
59 participants
Primary outcome timeframe
50 minutes after administration of oxytocin or placebo
Results posted on
2025-03-26
Participant Flow
59 participant mothers were enrolled in this component of the study. Their infants did not participate in the scanning sessions or receive oxytocin/placebo sprays and were not considered enrolled in this portion of the study. 11 mothers did not participate in scanning session, leaving 48 mothers who participated in the first scanning session. 43 mothers had 74 usable scanning sessions (31 with 2 sessions \[62 sessions\], and 12 with one session).
Unit of analysis: Scans
Participant milestones
| Measure |
ADDICTION: PLACEBO FIRST GROUP
The addiction group participants are scanned twice using functional magnetic resonance imaging (fMRI). These participants receive the placebo comparator before the first scanning session, and the active comparator (intranasal oxytocin spray) before the second scanning session (approximately one month later).
|
ADDICTION: OXYTOCIN FIRST GROUP
The addiction group will be scanned twice using fMRI. These participants receive active comparator (intranasal oxytocin spray) before the first scanning session, and the placebo comparator before the second scanning session (approximately one month later).
|
CONTROL: PLACEBO FIRST GROUP
The control group participants are scanned twice using fMRI. These participants receive the placebo comparator before the first scanning session, and the active comparator (intranasal oxytocin spray) before the second scanning session (approximately one month later).
|
CONTROL: OXYTOCIN FIRST GROUP
The control group will be scanned twice using fMRI. These participants receive active comparator (intranasal oxytocin spray) before the first scanning session, and the placebo comparator before the second scanning session (approximately one month later).
|
|---|---|---|---|---|
|
First Scan Session
STARTED
|
12 12
|
12 12
|
12 12
|
12 12
|
|
First Scan Session
COMPLETED
|
11 11
|
10 10
|
10 10
|
12 12
|
|
First Scan Session
NOT COMPLETED
|
1 1
|
2 2
|
2 2
|
0 0
|
|
Second Scan Session
STARTED
|
9 9
|
7 7
|
11 11
|
11 11
|
|
Second Scan Session
COMPLETED
|
6 6
|
7 7
|
10 10
|
8 8
|
|
Second Scan Session
NOT COMPLETED
|
3 3
|
0 0
|
1 1
|
3 3
|
Reasons for withdrawal
| Measure |
ADDICTION: PLACEBO FIRST GROUP
The addiction group participants are scanned twice using functional magnetic resonance imaging (fMRI). These participants receive the placebo comparator before the first scanning session, and the active comparator (intranasal oxytocin spray) before the second scanning session (approximately one month later).
|
ADDICTION: OXYTOCIN FIRST GROUP
The addiction group will be scanned twice using fMRI. These participants receive active comparator (intranasal oxytocin spray) before the first scanning session, and the placebo comparator before the second scanning session (approximately one month later).
|
CONTROL: PLACEBO FIRST GROUP
The control group participants are scanned twice using fMRI. These participants receive the placebo comparator before the first scanning session, and the active comparator (intranasal oxytocin spray) before the second scanning session (approximately one month later).
|
CONTROL: OXYTOCIN FIRST GROUP
The control group will be scanned twice using fMRI. These participants receive active comparator (intranasal oxytocin spray) before the first scanning session, and the placebo comparator before the second scanning session (approximately one month later).
|
|---|---|---|---|---|
|
First Scan Session
Scanning data problems
|
1
|
2
|
2
|
0
|
|
Second Scan Session
Scanning data problems
|
3
|
0
|
1
|
3
|
Baseline Characteristics
Oxytocin and Brain Responses in Maternal Addiction
Baseline characteristics by cohort
| Measure |
Addicted Mothers
n=29 Participants
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.
Oxytocin: All mothers will receive a nasal spray containing oxytocin.
Placebos: All mothers will receive a nasal spray containing a placebo solution.
Functional MRI scanning: Study mothers undergo two functional MRI scans.
Infants did not participate in scanning sessions, so baseline measures are not reported.
|
Control Mothers
n=30 Participants
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.
Oxytocin: All mothers will receive a nasal spray containing oxytocin.
Placebos: All mothers will receive a nasal spray containing a placebo solution.
Functional MRI scanning: Study mothers undergo two functional MRI scans.
Infants did not participate in scanning sessions, so baseline measures are not reported.
|
Total
n=59 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
29 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
59 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
29.3 years
STANDARD_DEVIATION 6.8 • n=5 Participants
|
29.0 years
STANDARD_DEVIATION 4.8 • n=7 Participants
|
29.1 years
STANDARD_DEVIATION 5.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
59 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
27 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
25 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
29 participants
n=5 Participants
|
30 participants
n=7 Participants
|
59 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 50 minutes after administration of oxytocin or placeboPopulation: 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).
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).
Outcome measures
| Measure |
Oxytocin
n=34 Number of Scanning sessions
Each participant 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.
Oxytocin: All women will receive a nasal spray containing oxytocin.
Placebos: All women will receive a nasal spray containing a placebo solution.
Functional MRI scanning: Study participants undergo two functional MRI scans.
|
Placebo
n=40 Number of Scanning sessions
Each participant 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.
Oxytocin: All women will receive a nasal spray containing oxytocin.
Placebos: All women will receive a nasal spray containing a placebo solution.
Functional MRI scanning: Study participants undergo two functional MRI scans.
|
Addicted - Placebo Condition
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.
Placebo: All women will receive a nasal spray containing placebo.
Functional MRI scanning: Study participants undergo two functional MRI scans.
|
Control - Placebo Condition
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.
Placebos: All women will receive a nasal spray containing a placebo solution.
Functional MRI scanning: Study participants undergo two functional MRI scans.
|
|---|---|---|---|---|
|
Effect of Intranasal Oxytocin on Brain fMRI Activation, Independent of Addiction Status (Hypotheses 1 and 2A).
Happy faces (O>U): Striatum
|
-.33 BOLD signal
Standard Error .16
|
.00678 BOLD signal
Standard Error .14
|
—
|
—
|
|
Effect of Intranasal Oxytocin on Brain fMRI Activation, Independent of Addiction Status (Hypotheses 1 and 2A).
Happy faces (O>U): Amygdala
|
-.25 BOLD signal
Standard Error .16
|
.16 BOLD signal
Standard Error .15
|
—
|
—
|
|
Effect of Intranasal Oxytocin on Brain fMRI Activation, Independent of Addiction Status (Hypotheses 1 and 2A).
Sad faces (O>U): Striatum
|
.34 BOLD signal
Standard Error .14
|
.04 BOLD signal
Standard Error .13
|
—
|
—
|
|
Effect of Intranasal Oxytocin on Brain fMRI Activation, Independent of Addiction Status (Hypotheses 1 and 2A).
Sad faces (O>U): Amygdala
|
.36 BOLD signal
Standard Error .14
|
.04 BOLD signal
Standard Error .13
|
—
|
—
|
PRIMARY outcome
Timeframe: 50 minutes after administration of oxytocin or placeboPopulation: 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.
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).
Outcome measures
| Measure |
Oxytocin
n=15 Scanning session
Each participant 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.
Oxytocin: All women will receive a nasal spray containing oxytocin.
Placebos: All women will receive a nasal spray containing a placebo solution.
Functional MRI scanning: Study participants undergo two functional MRI scans.
|
Placebo
n=19 Scanning session
Each participant 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.
Oxytocin: All women will receive a nasal spray containing oxytocin.
Placebos: All women will receive a nasal spray containing a placebo solution.
Functional MRI scanning: Study participants undergo two functional MRI scans.
|
Addicted - Placebo Condition
n=19 Scanning session
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.
Placebo: All women will receive a nasal spray containing placebo.
Functional MRI scanning: Study participants undergo two functional MRI scans.
|
Control - Placebo Condition
n=21 Scanning session
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.
Placebos: All women will receive a nasal spray containing a placebo solution.
Functional MRI scanning: Study participants undergo two functional MRI scans.
|
|---|---|---|---|---|
|
Effect of Intranasal Oxytocin on Brain fMRI Activation in Addicted vs Controls Mothers (Hypotheses 1 and 2B)
Happy faces (O>U): vmPFC
|
.00266 BOLD signal
Standard Error 0.20
|
-0.30 BOLD signal
Standard Error 0.18
|
0.20 BOLD signal
Standard Error 0.18
|
-0.11 BOLD signal
Standard Error 0.18
|
|
Effect of Intranasal Oxytocin on Brain fMRI Activation in Addicted vs Controls Mothers (Hypotheses 1 and 2B)
Sad faces (O>U): dlPFC
|
0.48 BOLD signal
Standard Error 0.20
|
0.39 BOLD signal
Standard Error 0.19
|
0.06 BOLD signal
Standard Error 0.19
|
-0.02 BOLD signal
Standard Error 0.18
|
Adverse Events
ADDICTION: PLACEBO
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
ADDICTION: OXYTOCIN
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
CONTROL: PLACEBO
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
CONTROL: OXYTOCIN
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place