Trial Outcomes & Findings for Oxytocin and Affect Processing in Posttraumatic Stress Disorder (NCT NCT02546570)
NCT ID: NCT02546570
Last Updated: 2020-04-08
Results Overview
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.
COMPLETED
PHASE2
11 participants
1 week; fMRI data collected at second and third visits, one week apart
2020-04-08
Participant Flow
Participant milestones
| Measure |
Adults With PTSD (18-55)
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).
Oxytocin: See arm/group descriptions for dosage amount and procedure. Placebo: See arm/group descriptions for dosage amount and procedure.
|
Trauma-exposed/No-PTSD Adults (18-55)
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).
Oxytocin: See arm/group descriptions for dosage amount and procedure. Placebo: See arm/group descriptions for dosage amount and procedure.
|
|---|---|---|
|
Overall Study
STARTED
|
9
|
2
|
|
Overall Study
Crossover Order: Oxytocin, Placebo
|
6
|
2
|
|
Overall Study
Crossover Order: Placebo, Oxytocin
|
3
|
0
|
|
Overall Study
COMPLETED
|
9
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Oxytocin and Affect Processing in Posttraumatic Stress Disorder
Baseline characteristics by cohort
| Measure |
Adults With PTSD (18-55)
n=9 Participants
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).
Oxytocin: See arm/group descriptions for dosage amount and procedure.
Placebo: See arm/group descriptions for dosage amount and procedure.
|
Trauma-exposed/No-PTSD Adults (18-55)
n=2 Participants
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).
Oxytocin: See arm/group descriptions for dosage amount and procedure.
Placebo: See arm/group descriptions for dosage amount and procedure.
|
Total
n=11 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
|
9 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 week; fMRI data collected at second and third visits, one week apartPopulation: Data for all enrolled are summarized.
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.
Outcome measures
| Measure |
Adults With PTSD (18-55): Drug
n=9 Participants
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).
Oxytocin: See arm/group descriptions for dosage amount and procedure.
Placebo: See arm/group descriptions for dosage amount and procedure.
|
Adults With PTSD (18-55): Placebo
n=9 Participants
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).
Oxytocin: See arm/group descriptions for dosage amount and procedure.
Placebo: See arm/group descriptions for dosage amount and procedure.
|
Adults Without PTSD (18-55): Drug
n=2 Participants
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).
Oxytocin: See arm/group descriptions for dosage amount and procedure.
Placebo: See arm/group descriptions for dosage amount and procedure.
|
Adults Without PTSD (18-55): Placebo
n=2 Participants
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).
Oxytocin: See arm/group descriptions for dosage amount and procedure.
Placebo: See arm/group descriptions for dosage amount and procedure.
|
|---|---|---|---|---|
|
fMRI Analysis: Change in Anterior Insula Region
forearm
|
-12.6 percentage of area activation
Interval -39.7 to 14.3
|
-1.6 percentage of area activation
Interval -13.5 to 10.3
|
10.6 percentage of area activation
Interval -100.0 to 100.0
|
-7.8 percentage of area activation
Interval -64.4 to 48.8
|
|
fMRI Analysis: Change in Anterior Insula Region
palm
|
-13.9 percentage of area activation
Interval -39.7 to 11.8
|
3.9 percentage of area activation
Interval -12.9 to 20.9
|
5.9 percentage of area activation
Interval -100.0 to 100.0
|
3.6 percentage of area activation
Interval -100.0 to 100.0
|
PRIMARY outcome
Timeframe: 1 week; fMRI data collected at second and third visits, one week apartPopulation: Data for all enrolled are summarized.
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.
Outcome measures
| Measure |
Adults With PTSD (18-55): Drug
n=9 Participants
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).
Oxytocin: See arm/group descriptions for dosage amount and procedure.
Placebo: See arm/group descriptions for dosage amount and procedure.
|
Adults With PTSD (18-55): Placebo
n=9 Participants
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).
Oxytocin: See arm/group descriptions for dosage amount and procedure.
Placebo: See arm/group descriptions for dosage amount and procedure.
|
Adults Without PTSD (18-55): Drug
n=2 Participants
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).
Oxytocin: See arm/group descriptions for dosage amount and procedure.
Placebo: See arm/group descriptions for dosage amount and procedure.
|
Adults Without PTSD (18-55): Placebo
n=2 Participants
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).
Oxytocin: See arm/group descriptions for dosage amount and procedure.
Placebo: See arm/group descriptions for dosage amount and procedure.
|
|---|---|---|---|---|
|
fMRI Analysis: Change in Accumbens Region
forearm
|
7.6 percentage of area activation
Interval -5.4 to 20.7
|
-7.9 percentage of area activation
Interval -17.3 to 1.5
|
-17.2 percentage of area activation
Interval -100.0 to 100.0
|
-12.7 percentage of area activation
Interval -70.6 to 45.1
|
|
fMRI Analysis: Change in Accumbens Region
palm
|
-14.8 percentage of area activation
Interval -25.8 to -3.9
|
-8.0 percentage of area activation
Interval -25.4 to 9.3
|
-8.5 percentage of area activation
Interval -87.8 to 70.7
|
1.2 percentage of area activation
Interval -100.0 to 100.0
|
PRIMARY outcome
Timeframe: 1 week; fMRI data collected at second and third visits, one week apartPopulation: Data for all enrolled are summarized.
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.
Outcome measures
| Measure |
Adults With PTSD (18-55): Drug
n=9 Participants
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).
Oxytocin: See arm/group descriptions for dosage amount and procedure.
Placebo: See arm/group descriptions for dosage amount and procedure.
|
Adults With PTSD (18-55): Placebo
n=9 Participants
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).
Oxytocin: See arm/group descriptions for dosage amount and procedure.
Placebo: See arm/group descriptions for dosage amount and procedure.
|
Adults Without PTSD (18-55): Drug
n=2 Participants
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).
Oxytocin: See arm/group descriptions for dosage amount and procedure.
Placebo: See arm/group descriptions for dosage amount and procedure.
|
Adults Without PTSD (18-55): Placebo
n=2 Participants
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).
Oxytocin: See arm/group descriptions for dosage amount and procedure.
Placebo: See arm/group descriptions for dosage amount and procedure.
|
|---|---|---|---|---|
|
fMRI Analysis: Change in Amygdala Region
forearm
|
-3.8 percentage of area activation
Interval -13.7 to 6.1
|
-9.1 percentage of area activation
Interval -20.6 to 2.3
|
14.5 percentage of area activation
Interval -24.9 to 54.1
|
-6.7 percentage of area activation
Interval -74.8 to 61.3
|
|
fMRI Analysis: Change in Amygdala Region
palm
|
-4.2 percentage of area activation
Interval -13.6 to 5.2
|
.58 percentage of area activation
Interval -11.0 to 12.2
|
16.7 percentage of area activation
Interval -100.0 to 100.0
|
-.45 percentage of area activation
Interval -90.2 to 89.4
|
PRIMARY outcome
Timeframe: 1 week; fMRI data collected at second and third visits, one week apartPopulation: Data for all enrolled are summarized.
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.
Outcome measures
| Measure |
Adults With PTSD (18-55): Drug
n=9 Participants
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).
Oxytocin: See arm/group descriptions for dosage amount and procedure.
Placebo: See arm/group descriptions for dosage amount and procedure.
|
Adults With PTSD (18-55): Placebo
n=9 Participants
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).
Oxytocin: See arm/group descriptions for dosage amount and procedure.
Placebo: See arm/group descriptions for dosage amount and procedure.
|
Adults Without PTSD (18-55): Drug
n=2 Participants
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).
Oxytocin: See arm/group descriptions for dosage amount and procedure.
Placebo: See arm/group descriptions for dosage amount and procedure.
|
Adults Without PTSD (18-55): Placebo
n=2 Participants
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).
Oxytocin: See arm/group descriptions for dosage amount and procedure.
Placebo: See arm/group descriptions for dosage amount and procedure.
|
|---|---|---|---|---|
|
fMRI Analysis: Change in dACC Region
forearm
|
-20.9 percentage of area activation
Interval -52.6 to 10.7
|
-16.4 percentage of area activation
Interval -28.2 to -4.6
|
-4.8 percentage of area activation
Interval -6.6 to -3.0
|
-30.2 percentage of area activation
Interval -62.3 to 1.8
|
|
fMRI Analysis: Change in dACC Region
palm
|
-23.8 percentage of area activation
Interval -48.3 to 0.5
|
-7.5 percentage of area activation
Interval -25.0 to 9.9
|
-10.9 percentage of area activation
Interval -100.0 to 100.0
|
-12.7 percentage of area activation
Interval -65.7 to 40.3
|
PRIMARY outcome
Timeframe: 1 week; fMRI data collected at second and third visits, one week apartPopulation: Data for all enrolled are summarized.
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.
Outcome measures
| Measure |
Adults With PTSD (18-55): Drug
n=9 Participants
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).
Oxytocin: See arm/group descriptions for dosage amount and procedure.
Placebo: See arm/group descriptions for dosage amount and procedure.
|
Adults With PTSD (18-55): Placebo
n=9 Participants
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).
Oxytocin: See arm/group descriptions for dosage amount and procedure.
Placebo: See arm/group descriptions for dosage amount and procedure.
|
Adults Without PTSD (18-55): Drug
n=2 Participants
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).
Oxytocin: See arm/group descriptions for dosage amount and procedure.
Placebo: See arm/group descriptions for dosage amount and procedure.
|
Adults Without PTSD (18-55): Placebo
n=2 Participants
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).
Oxytocin: See arm/group descriptions for dosage amount and procedure.
Placebo: See arm/group descriptions for dosage amount and procedure.
|
|---|---|---|---|---|
|
fMRI Analysis: Change in mOFC Region
forearm
|
1.5 percentage of area activation
Interval -6.8 to 9.8
|
2.5 percentage of area activation
Interval -6.8 to 22.7
|
1.7 percentage of area activation
Interval -92.6 to 96.2
|
-8.1 percentage of area activation
Interval -100.0 to 100.0
|
|
fMRI Analysis: Change in mOFC Region
palm
|
-4.9 percentage of area activation
Interval -18.2 to 8.2
|
12.3 percentage of area activation
Interval 2.0 to 22.7
|
4.2 percentage of area activation
Interval -46.3 to 54.9
|
10.3 percentage of area activation
Interval -21.6 to 23.7
|
PRIMARY outcome
Timeframe: 1 week; fMRI data collected at second and third visits, one week apartPopulation: Data for all enrolled are summarized.
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.
Outcome measures
| Measure |
Adults With PTSD (18-55): Drug
n=9 Participants
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).
Oxytocin: See arm/group descriptions for dosage amount and procedure.
Placebo: See arm/group descriptions for dosage amount and procedure.
|
Adults With PTSD (18-55): Placebo
n=9 Participants
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).
Oxytocin: See arm/group descriptions for dosage amount and procedure.
Placebo: See arm/group descriptions for dosage amount and procedure.
|
Adults Without PTSD (18-55): Drug
n=2 Participants
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).
Oxytocin: See arm/group descriptions for dosage amount and procedure.
Placebo: See arm/group descriptions for dosage amount and procedure.
|
Adults Without PTSD (18-55): Placebo
n=2 Participants
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).
Oxytocin: See arm/group descriptions for dosage amount and procedure.
Placebo: See arm/group descriptions for dosage amount and procedure.
|
|---|---|---|---|---|
|
fMRI Analysis: Change in rACC Region
forearm
|
-5.9 percentage of area activation
Interval -16.0 to 4.0
|
-4.4 percentage of area activation
Interval -12.0 to 3.0
|
-0.2 percentage of area activation
Interval -15.2 to 14.8
|
-16.3 percentage of area activation
Interval -36.7 to 4.1
|
|
fMRI Analysis: Change in rACC Region
palm
|
-9.2 percentage of area activation
Interval -21.9 to 3.4
|
0.7 percentage of area activation
Interval -7.7 to 9.3
|
-1.6 percentage of area activation
Interval -100.0 to 100.0
|
-7.6 percentage of area activation
Interval -100.0 to 100.0
|
PRIMARY outcome
Timeframe: 1 week; fMRI data collected at second and third visits, one week apartPopulation: Data for all enrolled are summarized.
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.
Outcome measures
| Measure |
Adults With PTSD (18-55): Drug
n=9 Participants
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).
Oxytocin: See arm/group descriptions for dosage amount and procedure.
Placebo: See arm/group descriptions for dosage amount and procedure.
|
Adults With PTSD (18-55): Placebo
n=9 Participants
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).
Oxytocin: See arm/group descriptions for dosage amount and procedure.
Placebo: See arm/group descriptions for dosage amount and procedure.
|
Adults Without PTSD (18-55): Drug
n=2 Participants
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).
Oxytocin: See arm/group descriptions for dosage amount and procedure.
Placebo: See arm/group descriptions for dosage amount and procedure.
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Adults Without PTSD (18-55): Placebo
n=2 Participants
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).
Oxytocin: See arm/group descriptions for dosage amount and procedure.
Placebo: See arm/group descriptions for dosage amount and procedure.
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|---|---|---|---|---|
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fMRI Analysis: Change in vmPFC Region
forearm
|
-3.8 percentage of area activation
Interval -10.5 to 2.7
|
-6.8 percentage of area activation
Interval -13.0 to -0.6
|
-3.3 percentage of area activation
Interval -24.8 to 18.0
|
-16.0 percentage of area activation
Interval -96.7 to 64.6
|
|
fMRI Analysis: Change in vmPFC Region
palm
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-12.0 percentage of area activation
Interval -26.6 to 2.5
|
2.4 percentage of area activation
Interval -7.4 to 12.4
|
-2.8 percentage of area activation
Interval -67.5 to 61.7
|
-10.4 percentage of area activation
Interval -100.0 to 100.0
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SECONDARY outcome
Timeframe: 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 apartPopulation: Saliva samples were collected as outlined. The research team attempted to analyze them. However, despite best efforts, and assurances from the manufacturer, the assay performance remained unacceptable primarily in regards to inadequate sensitivity and significant variability in sample duplicates. Therefore, there are no results to report.
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).
Outcome measures
Outcome data not reported
Adverse Events
Adults With PTSD (18-55)
Trauma-exposed/No-PTSD Adults (18-55)
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