A Phase 2 interventional study of Oxytocin and Placebo in Posttraumatic Stress Disorder (PTSD), sponsored by Yale University. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-04-08.
Sponsored by Yale University · Phase 2, Interventional, and Treatment
The investigators will use multiple methods (including Oxytocin intranasal inhalation, neuroimaging, behavioral measures, peripheral hormone measurements) to examine how individuals' behavior, cognition, and brain function is impacted by the neuro-hormone Oxytocin. Specifically, the investigators plan to evaluate the influence of Oxytocin administration on affective processing in non-trauma exposed and trauma-exposed adults (both with and without posttraumatic stress disorder, PTSD).
The investigators will use multiple methods (including Oxytocin intranasal inhalation, neuroimaging, behavioral measures, peripheral hormone measurements) to examine how individuals' behavior, cognition, and brain function is impacted by the neuro-hormone Oxytocin. Specifically, the investigators plan to evaluate the influence of Oxytocin administration on affective processing in non-trauma exposed and trauma-exposed adults (both with and without posttraumatic stress disorder, PTSD). The investigators expect oxytocin (compared to placebo) to positively influence affect processing in healthy subjects, as well as among those diagnosed with PTSD. Given current literature, the investigators expect oxytocin to elevate the processing\perception of positive-related stimuli, and reduce the salience of aversive or un-pleasant cues. The investigators expect oxytocin to impact participants' brain function as measured with functional magnetic resonance imaging (fMRI) while visually processing social and affect-related stimuli, rendering brain function and affective processing to be "more typical" or "adaptive" compared to placebo. Oxytocin's effect on human repertoire is not necessarily direct, but can interact with the individual's socioemotional characteristics, early life environment, and psychiatric symptoms. Therefore, the investigators will incorporate measures that capture the various dimensions that likely shape the effect of oxytocin.
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Exclusion Criteria:
Drug: oxytocin and placebo nasal spray (within-subjects design, blinded and counterbalanced for two lab sessions); dosage=24 international units (IU). Participant inserts nasal spray container 1cm into nostril at angle of 45 degrees and sprays. Will wait 15 seconds then repeat administration to other nostril (alternating between nostrils). Participants will receive 6 puffs in total (3 in each nostril).
Drug: Oxytocin · Drug: Placebo
Drug: oxytocin and placebo nasal spray (within-subjects design, blinded and counterbalanced for two lab sessions); dosage=24 international units (IU). Participant inserts nasal spray container 1cm into nostril at angle of 45 degrees and sprays. Will wait 15 seconds then repeat administration to other nostril (alternating between nostrils). Participants will receive 6 puffs in total (3 in each nostril).
Drug: Oxytocin · Drug: Placebo
Drug: oxytocin and placebo nasal spray (within-subjects design, blinded and counterbalanced for two lab sessions); dosage=24 international units (IU). Participant inserts nasal spray container 1cm into nostril at angle of 45 degrees and sprays. Will wait 15 seconds then repeat administration to other nostril (alternating between nostrils). Participants will receive 6 puffs in total (3 in each nostril).
Drug: Oxytocin · Drug: Placebo
See arm/group descriptions for dosage amount and procedure.
Also known as: Pitocin
See arm/group descriptions for dosage amount and procedure.
Also known as: saline
fMRI Analysis: Change in Anterior Insula Region
Change in blood-oxygen-level dependent (BOLD) contrast signal in regions of interest relevant to fear/threat (e.g., decrease in amygdala activation) and reward processing (increase in ventral striatum activation) in oxytocin versus placebo sessions. Forearm brush stroking targets C-tactile (CT) nerves, which respond to gentle touch and engage the insula and cortical brain regions that mediate social-emotional processing. Palm brush stroking is the control condition, in that CT afferents do not innervate the palm. We contrasted BOLD responses to gentle continuous brushing of the arm vs. palm (4 blocks of 8 trials each), expecting greater oxytocin-related increases in brain reactivity within the insula and other regions in the forearm condition versus the palm condition. The values are % signal change from baseline.
Time frame: 1 week; fMRI data collected at second and third visits, one week apart
fMRI Analysis: Change in Accumbens Region
Change in blood-oxygen-level dependent (BOLD) contrast signal in regions of interest relevant to fear/threat (e.g., decrease in amygdala activation) and reward processing (increase in ventral striatum activation) in oxytocin versus placebo sessions. Forearm brush stroking targets C-tactile (CT) nerves, which respond to gentle touch and engage the insula and cortical brain regions that mediate social-emotional processing. Palm brush stroking is the control condition, in that CT afferents do not innervate the palm. We contrasted BOLD responses to gentle continuous brushing of the arm vs. palm (4 blocks of 8 trials each), expecting greater oxytocin-related increases in brain reactivity within the insula and other regions in the forearm condition versus the palm condition. The values are % signal change from baseline.
Time frame: 1 week; fMRI data collected at second and third visits, one week apart
fMRI Analysis: Change in Amygdala Region
Change in blood-oxygen-level dependent (BOLD) contrast signal in regions of interest relevant to fear/threat (e.g., decrease in amygdala activation) and reward processing (increase in ventral striatum activation) in oxytocin versus placebo sessions. Forearm brush stroking targets C-tactile (CT) nerves, which respond to gentle touch and engage the insula and cortical brain regions that mediate social-emotional processing. Palm brush stroking is the control condition, in that CT afferents do not innervate the palm. We contrasted BOLD responses to gentle continuous brushing of the arm vs. palm (4 blocks of 8 trials each), expecting greater oxytocin-related increases in brain reactivity within the insula and other regions in the forearm condition versus the palm condition. The values are % signal change from baseline.
Time frame: 1 week; fMRI data collected at second and third visits, one week apart
fMRI Analysis: Change in dACC Region
Change in blood-oxygen-level dependent (BOLD) contrast signal in regions of interest relevant to fear/threat (e.g., decrease in amygdala activation) and reward processing (increase in ventral striatum activation) in oxytocin versus placebo sessions. Forearm brush stroking targets C-tactile (CT) nerves, which respond to gentle touch and engage the insula and cortical brain regions that mediate social-emotional processing. Palm brush stroking is the control condition, in that CT afferents do not innervate the palm. We contrasted BOLD responses to gentle continuous brushing of the arm vs. palm (4 blocks of 8 trials each), expecting greater oxytocin-related increases in brain reactivity within the insula and other regions in the forearm condition versus the palm condition. The values are % signal change from baseline.
Time frame: 1 week; fMRI data collected at second and third visits, one week apart
fMRI Analysis: Change in mOFC Region
Change in blood-oxygen-level dependent (BOLD) contrast signal in regions of interest relevant to fear/threat (e.g., decrease in amygdala activation) and reward processing (increase in ventral striatum activation) in oxytocin versus placebo sessions. Forearm brush stroking targets C-tactile (CT) nerves, which respond to gentle touch and engage the insula and cortical brain regions that mediate social-emotional processing. Palm brush stroking is the control condition, in that CT afferents do not innervate the palm. We contrasted BOLD responses to gentle continuous brushing of the arm vs. palm (4 blocks of 8 trials each), expecting greater oxytocin-related increases in brain reactivity within the insula and other regions in the forearm condition versus the palm condition. The values are % signal change from baseline.
Time frame: 1 week; fMRI data collected at second and third visits, one week apart
fMRI Analysis: Change in rACC Region
Change in blood-oxygen-level dependent (BOLD) contrast signal in regions of interest relevant to fear/threat (e.g., decrease in amygdala activation) and reward processing (increase in ventral striatum activation) in oxytocin versus placebo sessions. Forearm brush stroking targets C-tactile (CT) nerves, which respond to gentle touch and engage the insula and cortical brain regions that mediate social-emotional processing. Palm brush stroking is the control condition, in that CT afferents do not innervate the palm. We contrasted BOLD responses to gentle continuous brushing of the arm vs. palm (4 blocks of 8 trials each), expecting greater oxytocin-related increases in brain reactivity within the insula and other regions in the forearm condition versus the palm condition. The values are % signal change from baseline.
Time frame: 1 week; fMRI data collected at second and third visits, one week apart
fMRI Analysis: Change in vmPFC Region
Change in blood-oxygen-level dependent (BOLD) contrast signal in regions of interest relevant to fear/threat (e.g., decrease in amygdala activation) and reward processing (increase in ventral striatum activation) in oxytocin versus placebo sessions. Forearm brush stroking targets C-tactile (CT) nerves, which respond to gentle touch and engage the insula and cortical brain regions that mediate social-emotional processing. Palm brush stroking is the control condition, in that CT afferents do not innervate the palm. We contrasted BOLD responses to gentle continuous brushing of the arm vs. palm (4 blocks of 8 trials each), expecting greater oxytocin-related increases in brain reactivity within the insula and other regions in the forearm condition versus the palm condition. The values are % signal change from baseline.
Time frame: 1 week; fMRI data collected at second and third visits, one week apart
Salivary Oxytocin
Expect within-session (30 min) increase in peripheral salivary oxytocin level during OT sessions (within-session), and higher OT levels in oxytocin administration vs. placebo sessions. Peripheral OT levels measured with Salivettes (sterile cotton participants will be asked to chew on for 1 minutes).
Time frame: Within session (30 min) and between sessions (1 week); saliva samples collected twice (before and after OT administration) at both second and third visits, one week apart
| Milestone | Adults With PTSD (18-55) | Trauma-exposed/No-PTSD Adults (18-55) |
|---|---|---|
| Started | 9 | 2 |
| Crossover order: oxytocin, placebo | 6 | 2 |
| Crossover order: placebo, oxytocin | 3 | 0 |
| Completed | 9 | 2 |
| Not completed | 0 | 0 |
Change in blood-oxygen-level dependent (BOLD) contrast signal in regions of interest relevant to fear/threat (e.g., decrease in amygdala activation) and reward processing (increase in ventral striatum activation) in oxytocin versus placebo sessions. Forearm brush stroking targets C-tactile (CT) nerves, which respond to gentle touch and engage the insula and cortical brain regions that mediate social-emotional processing. Palm brush stroking is the control condition, in that CT afferents do not innervate the palm. We contrasted BOLD responses to gentle continuous brushing of the arm vs. palm (4 blocks of 8 trials each), expecting greater oxytocin-related increases in brain reactivity within the insula and other regions in the forearm condition versus the palm condition. The values are % signal change from baseline.
| percentage of area activation | Adults With PTSD (18-55): Drug | Adults With PTSD (18-55): Placebo | Adults Without PTSD (18-55): Drug | Adults Without PTSD (18-55): Placebo |
|---|---|---|---|---|
| forearm | -12.6 (-39.7 to 14.3) | -1.6 (-13.5 to 10.3) | 10.6 (-100 to 100) | -7.8 (-64.4 to 48.8) |
| palm | -13.9 (-39.7 to 11.8) | 3.9 (-12.9 to 20.9) | 5.9 (-100 to 100) | 3.6 (-100 to 100) |
Change in blood-oxygen-level dependent (BOLD) contrast signal in regions of interest relevant to fear/threat (e.g., decrease in amygdala activation) and reward processing (increase in ventral striatum activation) in oxytocin versus placebo sessions. Forearm brush stroking targets C-tactile (CT) nerves, which respond to gentle touch and engage the insula and cortical brain regions that mediate social-emotional processing. Palm brush stroking is the control condition, in that CT afferents do not innervate the palm. We contrasted BOLD responses to gentle continuous brushing of the arm vs. palm (4 blocks of 8 trials each), expecting greater oxytocin-related increases in brain reactivity within the insula and other regions in the forearm condition versus the palm condition. The values are % signal change from baseline.
| percentage of area activation | Adults With PTSD (18-55): Drug | Adults With PTSD (18-55): Placebo | Adults Without PTSD (18-55): Drug | Adults Without PTSD (18-55): Placebo |
|---|---|---|---|---|
| forearm | 7.6 (-5.4 to 20.7) | -7.9 (-17.3 to 1.5) | -17.2 (-100 to 100) | -12.7 (-70.6 to 45.1) |
| palm | -14.8 (-25.8 to -3.9) | -8.0 (-25.4 to 9.3) | -8.5 (-87.8 to 70.7) | 1.2 (-100 to 100) |
Change in blood-oxygen-level dependent (BOLD) contrast signal in regions of interest relevant to fear/threat (e.g., decrease in amygdala activation) and reward processing (increase in ventral striatum activation) in oxytocin versus placebo sessions. Forearm brush stroking targets C-tactile (CT) nerves, which respond to gentle touch and engage the insula and cortical brain regions that mediate social-emotional processing. Palm brush stroking is the control condition, in that CT afferents do not innervate the palm. We contrasted BOLD responses to gentle continuous brushing of the arm vs. palm (4 blocks of 8 trials each), expecting greater oxytocin-related increases in brain reactivity within the insula and other regions in the forearm condition versus the palm condition. The values are % signal change from baseline.
| percentage of area activation | Adults With PTSD (18-55): Drug | Adults With PTSD (18-55): Placebo | Adults Without PTSD (18-55): Drug | Adults Without PTSD (18-55): Placebo |
|---|---|---|---|---|
| forearm | -3.8 (-13.7 to 6.1) | -9.1 (-20.6 to 2.3) | 14.5 (-24.9 to 54.1) | -6.7 (-74.8 to 61.3) |
| palm | -4.2 (-13.6 to 5.2) | .58 (-11.0 to 12.2) | 16.7 (-100 to 100) | -.45 (-90.2 to 89.4) |
Change in blood-oxygen-level dependent (BOLD) contrast signal in regions of interest relevant to fear/threat (e.g., decrease in amygdala activation) and reward processing (increase in ventral striatum activation) in oxytocin versus placebo sessions. Forearm brush stroking targets C-tactile (CT) nerves, which respond to gentle touch and engage the insula and cortical brain regions that mediate social-emotional processing. Palm brush stroking is the control condition, in that CT afferents do not innervate the palm. We contrasted BOLD responses to gentle continuous brushing of the arm vs. palm (4 blocks of 8 trials each), expecting greater oxytocin-related increases in brain reactivity within the insula and other regions in the forearm condition versus the palm condition. The values are % signal change from baseline.
| percentage of area activation | Adults With and Without PTSD (18-55): Drug | Adults With and Without PTSD (18-55): Placebo | Adults Without PTSD (18-55): Drug | Adults Without PTSD (18-55): Placebo |
|---|---|---|---|---|
| forearm | -20.9 (-52.6 to 10.7) | -16.4 (-28.2 to -4.6) | -4.8 (-6.6 to -3.0) | -30.2 (-62.3 to 1.8) |
| palm | -23.8 (-48.3 to 0.5) | -7.5 (-25.0 to 9.9) | -10.9 (-100 to 100) | -12.7 (-65.7 to 40.3) |
Change in blood-oxygen-level dependent (BOLD) contrast signal in regions of interest relevant to fear/threat (e.g., decrease in amygdala activation) and reward processing (increase in ventral striatum activation) in oxytocin versus placebo sessions. Forearm brush stroking targets C-tactile (CT) nerves, which respond to gentle touch and engage the insula and cortical brain regions that mediate social-emotional processing. Palm brush stroking is the control condition, in that CT afferents do not innervate the palm. We contrasted BOLD responses to gentle continuous brushing of the arm vs. palm (4 blocks of 8 trials each), expecting greater oxytocin-related increases in brain reactivity within the insula and other regions in the forearm condition versus the palm condition. The values are % signal change from baseline.
| percentage of area activation | Adults With PTSD (18-55): Drug | Adults With PTSD (18-55): Placebo | Adults Without PTSD (18-55): Drug | Adults Without PTSD (18-55): Placebo |
|---|---|---|---|---|
| forearm | 1.5 (-6.8 to 9.8) | 2.5 (-6.8 to 22.7) | 1.7 (-92.6 to 96.2) | -8.1 (-100 to 100) |
| palm | -4.9 (-18.2 to 8.2) | 12.3 (2.0 to 22.7) | 4.2 (-46.3 to 54.9) | 10.3 (-21.6 to 23.7) |
Change in blood-oxygen-level dependent (BOLD) contrast signal in regions of interest relevant to fear/threat (e.g., decrease in amygdala activation) and reward processing (increase in ventral striatum activation) in oxytocin versus placebo sessions. Forearm brush stroking targets C-tactile (CT) nerves, which respond to gentle touch and engage the insula and cortical brain regions that mediate social-emotional processing. Palm brush stroking is the control condition, in that CT afferents do not innervate the palm. We contrasted BOLD responses to gentle continuous brushing of the arm vs. palm (4 blocks of 8 trials each), expecting greater oxytocin-related increases in brain reactivity within the insula and other regions in the forearm condition versus the palm condition. The values are % signal change from baseline.
| percentage of area activation | Adults With PTSD (18-55): Drug | Adults With PTSD (18-55): Placebo | Adults Without PTSD (18-55): Drug | Adults Without PTSD (18-55): Placebo |
|---|---|---|---|---|
| forearm | -5.9 (-16.0 to 4.0) | -4.4 (-12.0 to 3.0) | -0.2 (-15.2 to 14.8) | -16.3 (-36.7 to 4.1) |
| palm | -9.2 (-21.9 to 3.4) | 0.7 (-7.7 to 9.3) | -1.6 (-100 to 100) | -7.6 (-100 to 100) |
Change in blood-oxygen-level dependent (BOLD) contrast signal in regions of interest relevant to fear/threat (e.g., decrease in amygdala activation) and reward processing (increase in ventral striatum activation) in oxytocin versus placebo sessions. Forearm brush stroking targets C-tactile (CT) nerves, which respond to gentle touch and engage the insula and cortical brain regions that mediate social-emotional processing. Palm brush stroking is the control condition, in that CT afferents do not innervate the palm. We contrasted BOLD responses to gentle continuous brushing of the arm vs. palm (4 blocks of 8 trials each), expecting greater oxytocin-related increases in brain reactivity within the insula and other regions in the forearm condition versus the palm condition. The values are % signal change from baseline.
| percentage of area activation | Adults With and Without PTSD (18-55): Drug | Adults With and Without PTSD (18-55): Placebo | Adults Without PTSD (18-55): Drug | Adults Without PTSD (18-55): Placebo |
|---|---|---|---|---|
| forearm | -3.8 (-10.5 to 2.7) | -6.8 (-13.0 to -0.6) | -3.3 (-24.8 to 18.0) | -16.0 (-96.7 to 64.6) |
| palm | -12.0 (-26.6 to 2.5) | 2.4 (-7.4 to 12.4) | -2.8 (-67.5 to 61.7) | -10.4 (-100 to 100) |
Expect within-session (30 min) increase in peripheral salivary oxytocin level during OT sessions (within-session), and higher OT levels in oxytocin administration vs. placebo sessions. Peripheral OT levels measured with Salivettes (sterile cotton participants will be asked to chew on for 1 minutes).
No measurements were reported for this outcome.
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Adults With PTSD (18-55) | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) |
| Trauma-exposed/No-PTSD Adults (18-55) | 0/2 (0%) | 0/2 (0%) | 0/2 (0%) |
Combat Veterans
| Age, Categorical(Participants) | Adults With PTSD (18-55) | Trauma-exposed/No-PTSD Adults (18-55) | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 9 | 2 | 11 |
| >=65 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Adults With PTSD (18-55) | Trauma-exposed/No-PTSD Adults (18-55) | Total |
|---|---|---|---|
| Female | 0 | 0 | 0 |
| Male | 9 | 2 | 11 |
Plan to share: Undecided
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Studies of the drug tested here: Oxytocin
Stress Disorders, Post-Traumatic →