Trial Outcomes & Findings for The Effect of Intranasal Oxytocin on Pain Sensitivity and Threshold (NCT NCT02550093)

NCT ID: NCT02550093

Last Updated: 2022-05-16

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 20 participants
• Primary outcome timeframe: Baseline
• Results posted on: 2022-05-16

Participant Flow

Cross-over study design

Participant milestones

Measure	Oxytocin, Then Normal Saline Each subject will receive nasal spray(s) into each nostril of 4 Units up to 32 units of Oxytocin prior to Thermal Evaluation System Testing on intervention 1 (day 1). Following a wash-out period of 13 days the same subject will then receive a nasal spray(s) into each nostril of 4 Units up to 32 units of Normal Saline prior to Thermal Evaluation System Testing on intervention 2 (day 14).	Normal Saline, Then Oxytocin Each subject will receive nasal spray(s) into each nostril of 4 Units up to 32 units of Normal Saline prior to Thermal Evaluation System Testing on intervention 1 (day 1). Following a wash-out period of 14 to 15 days the same subject will then receive nasal spray(s) into each nostril of 4 Units up to 32 units of Oxytocin prior to Thermal Evaluation System Testing on intervention 2 (day 14).
Intervention 1 STARTED	10	10
Intervention 1 COMPLETED	10	10
Intervention 1 NOT COMPLETED	0	0
Wash-out Period STARTED	10	10
Wash-out Period COMPLETED	10	10
Wash-out Period NOT COMPLETED	0	0
Intervention 2 STARTED	10	10
Intervention 2 COMPLETED	10	10
Intervention 2 NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Effect of Intranasal Oxytocin on Pain Sensitivity and Threshold

Baseline characteristics by cohort

Measure	All Study Participants n=20 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.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	20 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	24 Years n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Oxytocin n=20 Participants Baseline recording - no study drug administerd prior to Thermal Evaluation System Testing.	Normal Saline n=20 Participants Baseline recording - no study drug administerd prior to Thermal Evaluation System Testing.
Hot and Cold Thermal Sensory Threshold for Pain at Baseline in Degrees Celsius. Heat	43.93 degrees Celsius Standard Deviation 4.18	43.0 degrees Celsius Standard Deviation 4.34
Hot and Cold Thermal Sensory Threshold for Pain at Baseline in Degrees Celsius. Cold	14.81 degrees Celsius Standard Deviation 11.10	13.33 degrees Celsius Standard Deviation 10.51

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Oxytocin n=20 Participants Baseline recording - no study drug administerd prior to Thermal Evaluation System Testing.	Normal Saline n=20 Participants Baseline recording - no study drug administerd prior to Thermal Evaluation System Testing.
Hot and Cold Thermal Sensory Threshold for Pain at 45 Minutes in Degrees Celsius. Heat	43.60 degrees Celsius Standard Deviation 3.68	43.42 degrees Celsius Standard Deviation 3.98
Hot and Cold Thermal Sensory Threshold for Pain at 45 Minutes in Degrees Celsius. Cold	15.68 degrees Celsius Standard Deviation 10.60	15.17 degrees Celsius Standard Deviation 10.88

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Oxytocin n=20 Participants Baseline recording - no study drug administerd prior to Thermal Evaluation System Testing.	Normal Saline n=20 Participants Baseline recording - no study drug administerd prior to Thermal Evaluation System Testing.
Hot and Cold Thermal Sensory Threshold for Pain at 90 Minutes in Degrees Celsius. Heat	43.94 degrees Celsius Standard Deviation 3.97	43.95 degrees Celsius Standard Deviation 3.80
Hot and Cold Thermal Sensory Threshold for Pain at 90 Minutes in Degrees Celsius. Cold	15.41 degrees Celsius Standard Deviation 11.24	12.96 degrees Celsius Standard Deviation 11.38

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Oxytocin n=20 Participants Baseline recording - no study drug administerd prior to Thermal Evaluation System Testing.	Normal Saline n=20 Participants Baseline recording - no study drug administerd prior to Thermal Evaluation System Testing.
Mechanical Pain Threshold for Pain at Baseline in Grams.	194.90 Grams Standard Deviation 117.52	223.31 Grams Standard Deviation 149.56

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Oxytocin n=20 Participants Baseline recording - no study drug administerd prior to Thermal Evaluation System Testing.	Normal Saline n=20 Participants Baseline recording - no study drug administerd prior to Thermal Evaluation System Testing.
Mechanical Pain Threshold for Pain at 45 Minutes in Grams.	195.07 Grams Standard Deviation 145.41	197.49 Grams Standard Deviation 124.71

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Oxytocin n=20 Participants Baseline recording - no study drug administerd prior to Thermal Evaluation System Testing.	Normal Saline n=20 Participants Baseline recording - no study drug administerd prior to Thermal Evaluation System Testing.
Mechanical Pain Threshold for Pain at 90 Minutes in Grams.	198.76 Grams Standard Deviation 141.41	208.77 Grams Standard Deviation 124.97

PRIMARY outcome

Timeframe: 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).

Outcome measures

Measure	Oxytocin n=20 Participants Baseline recording - no study drug administerd prior to Thermal Evaluation System Testing.	Normal Saline n=20 Participants Baseline recording - no study drug administerd prior to Thermal Evaluation System Testing.
Suprathreshold Magnitude for Pain at Baseline Measured in Visual Analog Pain Scores.	2.90 scores on a scale Standard Deviation 1.65	3.02 scores on a scale Standard Deviation 1.88

PRIMARY outcome

Timeframe: 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).

Outcome measures

Measure	Oxytocin n=20 Participants Baseline recording - no study drug administerd prior to Thermal Evaluation System Testing.	Normal Saline n=20 Participants Baseline recording - no study drug administerd prior to Thermal Evaluation System Testing.
Suprathreshold Magnitude for Pain at 45 Minutes Measured in Visual Analog Pain Scores.	2.58 scores on a scale Standard Deviation 1.37	2.67 scores on a scale Standard Deviation 1.59

PRIMARY outcome

Timeframe: 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).

Outcome measures

Measure	Oxytocin n=20 Participants Baseline recording - no study drug administerd prior to Thermal Evaluation System Testing.	Normal Saline n=20 Participants Baseline recording - no study drug administerd prior to Thermal Evaluation System Testing.
Suprathreshold Magnitude for Pain at 90 Minutes Measured in Visual Analog Pain Scores.	2.53 scores on a scale Standard Deviation 1.58	2.29 scores on a scale Standard Deviation 1.51

PRIMARY outcome

Timeframe: 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).

Outcome measures

Measure	Oxytocin n=20 Participants Baseline recording - no study drug administerd prior to Thermal Evaluation System Testing.	Normal Saline n=20 Participants Baseline recording - no study drug administerd prior to Thermal Evaluation System Testing.
Thermal Wind-up Pain Assessment at Baseline	3.59 scores on a scale Standard Deviation 2.09	3.15 scores on a scale Standard Deviation 1.90

PRIMARY outcome

Timeframe: 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).

Outcome measures

Measure	Oxytocin n=20 Participants Baseline recording - no study drug administerd prior to Thermal Evaluation System Testing.	Normal Saline n=20 Participants Baseline recording - no study drug administerd prior to Thermal Evaluation System Testing.
Thermal Wind-up Pain at 45 Minutes	2.99 scores on a scale Standard Deviation 1.71	2.85 scores on a scale Standard Deviation 1.92

PRIMARY outcome

Timeframe: 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).

Outcome measures

Measure	Oxytocin n=20 Participants Baseline recording - no study drug administerd prior to Thermal Evaluation System Testing.	Normal Saline n=20 Participants Baseline recording - no study drug administerd prior to Thermal Evaluation System Testing.
Thermal Wind-up Pain at 90 Minutes	2.82 scores on a scale Standard Deviation 1.63	2.63 scores on a scale Standard Deviation 1.66

Adverse Events

Oxytocin

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Normal Saline

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

David Walega, MD

Northwestern University, Feinberg School of Medicine

Phone: 312-695-2500

Email: d-walega@northwestern.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place