Healthy
Conditions
Keywords
Volunteers
Brief summary
Oxytocin is neurohypophysial peptide that acts mainly as a neuromodulator in the brain.The vast majority of basic science studies suggested a large effect of oxytocin in minimizing acute pain.Few studies have demonstrated an association between plasma levels of oxytocin and pain in humans. Since addictive properties of oxytocin have not been described, the drug may have important application in the management of acute and chronic pain. No studies have examined the effect of intranasal oxytocin on pain sensitivity and threshold.
Interventions
PROCEDUREIntervention 1
Each subject will receive nasal spray(s) into each nostril of 4 Units up to 32 units of study drug prior to Thermal Evaluation System Testing on intervention 1 (Day 1).
BEHAVIORALWashout Period
The wash-out period will be between intervention 1 and intervention 2. 13 days in length.
PROCEDUREIntervention 2
Each subject will receive nasal spray(s) into each nostril of 4 Units up to 32 units of study drug prior to Thermal Evaluation System Testing on intervention 2 (Day 14).
Sponsors
Northwestern University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 35 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy males and females volunteers, English speaking
Exclusion criteria
* Pregnancy, lactation, allergy to preservatives, mental disease, any chronic pain and any current use of analgesics, anxiety or depression.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hot and Cold Thermal Sensory Threshold for Pain at Baseline in Degrees Celsius. | Baseline | Thermal Sensory Threshold for Pain at baseline prior to study drug administration. Evaluation of subjects baseline responses of perception of hot and cold stimuli utilizing the Medoc Pathway Pain &Sensory Evaluation System (Medoc Ltd, Israel). The baseline response variable was estimated by averaging the subjects response over three trials, with an interval of 30 seconds. A thermode was attached to the subjects hand and the subject was asked to press a mouse button when they perceive the sensation of heat pain or cold pain. The temperature range was 51C to 0C. |
| Hot and Cold Thermal Sensory Threshold for Pain at 45 Minutes in Degrees Celsius. | 45 minutes | Thermal Sensory Threshold for Pain at 45 minutes after study drug administration. Evaluation of subjects responses of perception of hot and cold stimuli utilizing the Medoc Pathway Pain &Sensory Evaluation System (Medoc Ltd, Israel). The response variable was estimated by averaging the subjects response over three trials, with an interval of 30 seconds. A thermode was attached to the subjects hand and the subject was asked to press a mouse button when they perceive the sensation of heat pain or cold pain. The temperature range was 51C to 0C. |
| Hot and Cold Thermal Sensory Threshold for Pain at 90 Minutes in Degrees Celsius. | 90 minutes | Thermal Sensory Threshold for Pain at 90 minutes after study drug administration. Evaluation of subjects responses of perception of hot and cold stimuli utilizing the Medoc Pathway Pain &Sensory Evaluation System (Medoc Ltd, Israel). The response variable was estimated by averaging the subjects response over three trials, with an interval of 30 seconds. A thermode was attached to the subjects hand and the subject was asked to press a mouse button when they perceive the sensation of heat pain or cold pain. The temperature range was 51C to 0C. |
| Mechanical Pain Threshold for Pain at Baseline in Grams. | Baseline | Mechanical pain threshold for pain at baseline utilizing a digital electrovonfrey anesthesiometer (IITC model Alemo 2290-4; Woodland Hills, CA, USA). The subjects response to painful stimulus was recorded in grams. Each variable was estimated by averaging a participant's responses over 3 trials, with an intertrial interval of 30 s. The lower amount in grams the more sensitive you are to pain. |
| Mechanical Pain Threshold for Pain at 45 Minutes in Grams. | 45 minutes | Mechanical pain threshold for pain at 45 minutes utilizing a digital electrovonfrey anesthesiometer (IITC model Alemo 2290-4; Woodland Hills, CA, USA). The subjects response to painful stimulus was recorded in grams. Each variable was estimated by averaging a participant's responses over 3 trials, with an intertrial interval of 30 s. The lower amount in grams the more sensitive you are to pain. |
| Mechanical Pain Threshold for Pain at 90 Minutes in Grams. | 90 minutes | Mechanical pain threshold for pain at 90 minutes utilizing a digital electrovonfrey anesthesiometer (IITC model Alemo 2290-4; Woodland Hills, CA, USA). The subjects response to painful stimulus was recorded in grams. Each variable was estimated by averaging a participant's responses over 3 trials, with an intertrial interval of 30 s. The lower amount in grams the more sensitive you are to pain. |
| Suprathreshold Magnitude for Pain at Baseline Measured in Visual Analog Pain Scores. | Baseline | Supra-threshold magnitude for pain was assessed utilizing the Medoc Pathway System with contact heat evoked potential simulator at 49 degrees Celsius. Visual analog pain score ranges from 0 (no pain) to 10 (worst pain imaginable). |
| Suprathreshold Magnitude for Pain at 45 Minutes Measured in Visual Analog Pain Scores. | 45 minutes | Supra-threshold magnitude for pain was assessed utilizing the Medoc Pathway System with contact heat evoked potential simulator at 49 degrees Celsius. Visual analog pain score ranges from 0 (no pain) to 10 (worst pain imaginable). |
| Suprathreshold Magnitude for Pain at 90 Minutes Measured in Visual Analog Pain Scores. | 90 minutes | Supra-threshold magnitude for pain was assessed utilizing the Medoc Pathway System with contact heat evoked potential simulator at 49 degrees Celsius. Visual analog pain score ranges from 0 (no pain) to 10 (worst pain imaginable). |
| Thermal Wind-up Pain Assessment at Baseline | Baseline | Using a Visual Analog Scale (VAS) subjects will be asked to rate the painfulness of the stimulus for thermal wind-up pain utilizing the medoc pathway system. Each VAS score was recorded over 10 trials, with an interval of 3s. The average VAS score was reported. Visual analog scale ranges from 0 (no pain) to 10 (worst pain imaginable). |
| Thermal Wind-up Pain at 45 Minutes | 45 minutes | Using a Visual Analog Scale (VAS) subjects will be asked to rate the painfulness of the stimulus for thermal wind-up pain utilizing the medoc pathway system. Each VAS score was recorded over 10 trials, with an interval of 3s. The average VAS score was reported. Visual analog scale ranges from 0 (no pain) to 10 (worst pain imaginable). |
| Thermal Wind-up Pain at 90 Minutes | 90 minutes | Using a Visual Analog Scale (VAS) subjects will be asked to rate the painfulness of the stimulus for thermal wind-up pain utilizing the medoc pathway system. Each VAS score was recorded over 10 trials, with an interval of 3s. The average VAS score was reported. Visual analog scale ranges from 0 (no pain) to 10 (worst pain imaginable). |
Countries
United States
Participant flow
Recruitment details
Cross-over study design
Participants by arm
| Arm | Count |
|---|---|
| All Study Participants Each subject will receive nasal spray(s) into each nostril of 4 Units up to 32 units of either Oxytocin then Normal Saline or Normal Saline then Oxytocin prior to Thermal Evaluation System Testing. | 20 |
| Total | 20 |
Baseline characteristics
| Characteristic | All Study Participants |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 20 Participants |
| Age, Continuous | 24 Years |
| Sex: Female, Male Female | 12 Participants |
| Sex: Female, Male Male | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 20 |
| other Total, other adverse events | 0 / 20 | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 |
Outcome results
Primary
Hot and Cold Thermal Sensory Threshold for Pain at 45 Minutes in Degrees Celsius.
Thermal Sensory Threshold for Pain at 45 minutes after study drug administration. Evaluation of subjects responses of perception of hot and cold stimuli utilizing the Medoc Pathway Pain &Sensory Evaluation System (Medoc Ltd, Israel). The response variable was estimated by averaging the subjects response over three trials, with an interval of 30 seconds. A thermode was attached to the subjects hand and the subject was asked to press a mouse button when they perceive the sensation of heat pain or cold pain. The temperature range was 51C to 0C.
Time frame: 45 minutes
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Oxytocin | Hot and Cold Thermal Sensory Threshold for Pain at 45 Minutes in Degrees Celsius. | Heat | 43.60 degrees Celsius | Standard Deviation 3.68 |
| Oxytocin | Hot and Cold Thermal Sensory Threshold for Pain at 45 Minutes in Degrees Celsius. | Cold | 15.68 degrees Celsius | Standard Deviation 10.6 |
| Normal Saline | Hot and Cold Thermal Sensory Threshold for Pain at 45 Minutes in Degrees Celsius. | Heat | 43.42 degrees Celsius | Standard Deviation 3.98 |
| Normal Saline | Hot and Cold Thermal Sensory Threshold for Pain at 45 Minutes in Degrees Celsius. | Cold | 15.17 degrees Celsius | Standard Deviation 10.88 |
Comparison: HEATp-value: 0.84Wilcoxon (Mann-Whitney)
Comparison: COLDp-value: 0.95Wilcoxon (Mann-Whitney)
Primary
Hot and Cold Thermal Sensory Threshold for Pain at 90 Minutes in Degrees Celsius.
Thermal Sensory Threshold for Pain at 90 minutes after study drug administration. Evaluation of subjects responses of perception of hot and cold stimuli utilizing the Medoc Pathway Pain &Sensory Evaluation System (Medoc Ltd, Israel). The response variable was estimated by averaging the subjects response over three trials, with an interval of 30 seconds. A thermode was attached to the subjects hand and the subject was asked to press a mouse button when they perceive the sensation of heat pain or cold pain. The temperature range was 51C to 0C.
Time frame: 90 minutes
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Oxytocin | Hot and Cold Thermal Sensory Threshold for Pain at 90 Minutes in Degrees Celsius. | Heat | 43.94 degrees Celsius | Standard Deviation 3.97 |
| Oxytocin | Hot and Cold Thermal Sensory Threshold for Pain at 90 Minutes in Degrees Celsius. | Cold | 15.41 degrees Celsius | Standard Deviation 11.24 |
| Normal Saline | Hot and Cold Thermal Sensory Threshold for Pain at 90 Minutes in Degrees Celsius. | Heat | 43.95 degrees Celsius | Standard Deviation 3.8 |
| Normal Saline | Hot and Cold Thermal Sensory Threshold for Pain at 90 Minutes in Degrees Celsius. | Cold | 12.96 degrees Celsius | Standard Deviation 11.38 |
Comparison: HEATp-value: 0.92Wilcoxon (Mann-Whitney)
Comparison: COLDp-value: 0.63Wilcoxon (Mann-Whitney)
Primary
Hot and Cold Thermal Sensory Threshold for Pain at Baseline in Degrees Celsius.
Thermal Sensory Threshold for Pain at baseline prior to study drug administration. Evaluation of subjects baseline responses of perception of hot and cold stimuli utilizing the Medoc Pathway Pain &Sensory Evaluation System (Medoc Ltd, Israel). The baseline response variable was estimated by averaging the subjects response over three trials, with an interval of 30 seconds. A thermode was attached to the subjects hand and the subject was asked to press a mouse button when they perceive the sensation of heat pain or cold pain. The temperature range was 51C to 0C.
Time frame: Baseline
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Oxytocin | Hot and Cold Thermal Sensory Threshold for Pain at Baseline in Degrees Celsius. | Heat | 43.93 degrees Celsius | Standard Deviation 4.18 |
| Oxytocin | Hot and Cold Thermal Sensory Threshold for Pain at Baseline in Degrees Celsius. | Cold | 14.81 degrees Celsius | Standard Deviation 11.1 |
| Normal Saline | Hot and Cold Thermal Sensory Threshold for Pain at Baseline in Degrees Celsius. | Heat | 43.0 degrees Celsius | Standard Deviation 4.34 |
| Normal Saline | Hot and Cold Thermal Sensory Threshold for Pain at Baseline in Degrees Celsius. | Cold | 13.33 degrees Celsius | Standard Deviation 10.51 |
Comparison: HEATp-value: 0.47Wilcoxon (Mann-Whitney)
Comparison: COLDp-value: 0.7Wilcoxon (Mann-Whitney)
Primary
Mechanical Pain Threshold for Pain at 45 Minutes in Grams.
Mechanical pain threshold for pain at 45 minutes utilizing a digital electrovonfrey anesthesiometer (IITC model Alemo 2290-4; Woodland Hills, CA, USA). The subjects response to painful stimulus was recorded in grams. Each variable was estimated by averaging a participant's responses over 3 trials, with an intertrial interval of 30 s. The lower amount in grams the more sensitive you are to pain.
Time frame: 45 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oxytocin | Mechanical Pain Threshold for Pain at 45 Minutes in Grams. | 195.07 Grams | Standard Deviation 145.41 |
| Normal Saline | Mechanical Pain Threshold for Pain at 45 Minutes in Grams. | 197.49 Grams | Standard Deviation 124.71 |
p-value: 0.68Wilcoxon (Mann-Whitney)
Primary
Mechanical Pain Threshold for Pain at 90 Minutes in Grams.
Mechanical pain threshold for pain at 90 minutes utilizing a digital electrovonfrey anesthesiometer (IITC model Alemo 2290-4; Woodland Hills, CA, USA). The subjects response to painful stimulus was recorded in grams. Each variable was estimated by averaging a participant's responses over 3 trials, with an intertrial interval of 30 s. The lower amount in grams the more sensitive you are to pain.
Time frame: 90 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oxytocin | Mechanical Pain Threshold for Pain at 90 Minutes in Grams. | 198.76 Grams | Standard Deviation 141.41 |
| Normal Saline | Mechanical Pain Threshold for Pain at 90 Minutes in Grams. | 208.77 Grams | Standard Deviation 124.97 |
p-value: 0.62Wilcoxon (Mann-Whitney)
Primary
Mechanical Pain Threshold for Pain at Baseline in Grams.
Mechanical pain threshold for pain at baseline utilizing a digital electrovonfrey anesthesiometer (IITC model Alemo 2290-4; Woodland Hills, CA, USA). The subjects response to painful stimulus was recorded in grams. Each variable was estimated by averaging a participant's responses over 3 trials, with an intertrial interval of 30 s. The lower amount in grams the more sensitive you are to pain.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oxytocin | Mechanical Pain Threshold for Pain at Baseline in Grams. | 194.90 Grams | Standard Deviation 117.52 |
| Normal Saline | Mechanical Pain Threshold for Pain at Baseline in Grams. | 223.31 Grams | Standard Deviation 149.56 |
p-value: 0.6Wilcoxon (Mann-Whitney)
Primary
Suprathreshold Magnitude for Pain at 45 Minutes Measured in Visual Analog Pain Scores.
Supra-threshold magnitude for pain was assessed utilizing the Medoc Pathway System with contact heat evoked potential simulator at 49 degrees Celsius. Visual analog pain score ranges from 0 (no pain) to 10 (worst pain imaginable).
Time frame: 45 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oxytocin | Suprathreshold Magnitude for Pain at 45 Minutes Measured in Visual Analog Pain Scores. | 2.58 scores on a scale | Standard Deviation 1.37 |
| Normal Saline | Suprathreshold Magnitude for Pain at 45 Minutes Measured in Visual Analog Pain Scores. | 2.67 scores on a scale | Standard Deviation 1.59 |
p-value: 0.97Wilcoxon (Mann-Whitney)
Primary
Suprathreshold Magnitude for Pain at 90 Minutes Measured in Visual Analog Pain Scores.
Supra-threshold magnitude for pain was assessed utilizing the Medoc Pathway System with contact heat evoked potential simulator at 49 degrees Celsius. Visual analog pain score ranges from 0 (no pain) to 10 (worst pain imaginable).
Time frame: 90 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oxytocin | Suprathreshold Magnitude for Pain at 90 Minutes Measured in Visual Analog Pain Scores. | 2.53 scores on a scale | Standard Deviation 1.58 |
| Normal Saline | Suprathreshold Magnitude for Pain at 90 Minutes Measured in Visual Analog Pain Scores. | 2.29 scores on a scale | Standard Deviation 1.51 |
p-value: 0.61Wilcoxon (Mann-Whitney)
Primary
Suprathreshold Magnitude for Pain at Baseline Measured in Visual Analog Pain Scores.
Supra-threshold magnitude for pain was assessed utilizing the Medoc Pathway System with contact heat evoked potential simulator at 49 degrees Celsius. Visual analog pain score ranges from 0 (no pain) to 10 (worst pain imaginable).
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oxytocin | Suprathreshold Magnitude for Pain at Baseline Measured in Visual Analog Pain Scores. | 2.90 scores on a scale | Standard Deviation 1.65 |
| Normal Saline | Suprathreshold Magnitude for Pain at Baseline Measured in Visual Analog Pain Scores. | 3.02 scores on a scale | Standard Deviation 1.88 |
p-value: 0.97Wilcoxon (Mann-Whitney)
Primary
Thermal Wind-up Pain Assessment at Baseline
Using a Visual Analog Scale (VAS) subjects will be asked to rate the painfulness of the stimulus for thermal wind-up pain utilizing the medoc pathway system. Each VAS score was recorded over 10 trials, with an interval of 3s. The average VAS score was reported. Visual analog scale ranges from 0 (no pain) to 10 (worst pain imaginable).
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oxytocin | Thermal Wind-up Pain Assessment at Baseline | 3.59 scores on a scale | Standard Deviation 2.09 |
| Normal Saline | Thermal Wind-up Pain Assessment at Baseline | 3.15 scores on a scale | Standard Deviation 1.9 |
p-value: 0.71Wilcoxon (Mann-Whitney)
Primary
Thermal Wind-up Pain at 45 Minutes
Using a Visual Analog Scale (VAS) subjects will be asked to rate the painfulness of the stimulus for thermal wind-up pain utilizing the medoc pathway system. Each VAS score was recorded over 10 trials, with an interval of 3s. The average VAS score was reported. Visual analog scale ranges from 0 (no pain) to 10 (worst pain imaginable).
Time frame: 45 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oxytocin | Thermal Wind-up Pain at 45 Minutes | 2.99 scores on a scale | Standard Deviation 1.71 |
| Normal Saline | Thermal Wind-up Pain at 45 Minutes | 2.85 scores on a scale | Standard Deviation 1.92 |
p-value: 0.74Wilcoxon (Mann-Whitney)
Primary
Thermal Wind-up Pain at 90 Minutes
Using a Visual Analog Scale (VAS) subjects will be asked to rate the painfulness of the stimulus for thermal wind-up pain utilizing the medoc pathway system. Each VAS score was recorded over 10 trials, with an interval of 3s. The average VAS score was reported. Visual analog scale ranges from 0 (no pain) to 10 (worst pain imaginable).
Time frame: 90 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oxytocin | Thermal Wind-up Pain at 90 Minutes | 2.82 scores on a scale | Standard Deviation 1.63 |
| Normal Saline | Thermal Wind-up Pain at 90 Minutes | 2.63 scores on a scale | Standard Deviation 1.66 |
p-value: 0.75Wilcoxon (Mann-Whitney)