Effect of Intranasal Oxytocin on Brain fMRI Activation, Independent of Addiction Status (Hypotheses 1 and 2A).
| Group | Value (BOLD signal) | Spread |
|---|---|---|
| Oxytocin | -.33 | .16 |
| Placebo | .00678 | .14 |
Trial · Interventional
TerminatedPhase 2Results postedRegistry dataThis trial was stopped early.
Reason given at the registry: Unable to recruit proposed study sample size due to COVID restrictions.
Results were posted for this trial.
United States
1 trial · 1 stopped early · 1 with posted results
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.
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.
Outcomes the sponsor listed as primary.
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).
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
| Group | Value (BOLD signal) | Spread |
|---|---|---|
| Oxytocin | -.33 | .16 |
| Placebo | .00678 | .14 |
| Group | Value (BOLD signal) | Spread |
|---|---|---|
| Addicted - Oxytocin Condition | .00266 | 0.20 |
| Control - Oxytocin Condition | -0.30 | 0.18 |
| Addicted - Placebo Condition | 0.20 | 0.18 |
| Control - Placebo Condition | -0.11 | 0.18 |
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| ADDICTION: PLACEBOThis arm includes the addiction group during the scanning session under the placebo condition. | 0 / 17 | 0 / 17 | 0 / 17 |
| ADDICTION: OXYTOCINThis arm includes the addiction group during the scanning session under the oxytocin condition. | 0 / 17 | 0 / 17 | 0 / 17 |
| CONTROL: PLACEBOThis arm includes the control group during the scanning session under the placebo condition. | 0 / 20 | 0 / 20 | 0 / 20 |
| CONTROL: OXYTOCINThis arm includes the control group during the scanning session under the oxytocin condition. | 0 / 20 | 0 / 20 | 0 / 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
Studies that cite this trial.
2 studies on this page
Indexing hint: Review · 2019
Strathearn et al. 2019Frontiers in psychiatrycited by 45
PMID 31780957PMC6857543DOI 10.3389/fpsyt.2019.00737PUB-31780957
Indexing hint: Review · 2010
Strathearn et al. 2010Annals of the New York Academy of Sciencescited by 54
PMID 20201853PMC3016156DOI 10.1111/j.1749-6632.2009.05142.xPUB-20201853
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