The Effect of Intranasal Oxytocin on Pain Sensitivity and Threshold
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ClinicalTrials.gov Identifier: NCT02550093 |
Recruitment Status : Unknown
Verified September 2016 by David Walega, Northwestern University.
Recruitment status was: Active, not recruiting
First Posted : September 15, 2015
Last Update Posted : September 23, 2016
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Condition or disease | Intervention/treatment | Phase |
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Healthy | Drug: Normal Saline Drug: Oxytocin | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 20 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | The Effect of Intranasal Oxytocin on Pain Sensitivity and Threshold: A Randomized, Double Blinded, Crossover Volunteer Study |
Study Start Date : | April 2015 |
Actual Primary Completion Date : | August 2015 |
Estimated Study Completion Date : | November 2016 |
Arm | Intervention/treatment |
---|---|
Active Comparator: Oxytocin
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.
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Drug: Oxytocin
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.
Other Name: Pitocin |
Placebo Comparator: Normal Saline
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.
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Drug: Normal Saline
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.
Other Name: 0.9% Sodium Chloride |
- Changes from baseline of hot and cold thermal threshold for pain [ Time Frame: up to 2 hrs ]Changes from baseline of hot and cold sensory thermal threshold for pain utilizing the Medoc Pathway Pain &Sensory Evaluation System (Medoc Ltd, Israel) at baseline before drug administration, at 45 minutes and at 90 minutes. Celsius Units.
- Changes from baseline of mechanical pain threshold [ Time Frame: up to 2 hrs ]Using a Visual Analog Scale (VAS) subjects will be asked to rate the painfulness of the stimulus utilizing a digital electrovonfrey anesthesiometer (IITC model Alemo 2290-4; Woodland Hills, CA, USA) at its worst at 30 second intervals. Units in grams
- Changes from baseline of suprathreshold magnitude [ Time Frame: up to 2 hrs ]Changes from baseline of suprathreshold magnitude assessment utilizing the Medoc Pathway System with contact heat evoked potential stimulator (CHEPS) at 30 second intervals. Measured at VAS (0-10).
- Changes from baseline of thermal wind-up pain [ Time Frame: up to 2 hrs ]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 with CHEPS thermode at 30 second intervals. Measured as counts.
- Incidence of side effects [ Time Frame: up to 2 hrs ]Incidence of side effects from oxytocin administration (n, %)

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Ages Eligible for Study: | 20 Years to 35 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02550093
United States, Illinois | |
Northwestern University Feinberg School of Medicine | |
Chicago, Illinois, United States, 60611 |
Principal Investigator: | David R Walega, MD | Northwestern University Feinberg School of Medicine |
Responsible Party: | David Walega, Associate Professor, Chief, Division of Pain Medicine, Northwestern University |
ClinicalTrials.gov Identifier: | NCT02550093 |
Other Study ID Numbers: |
STU86297 |
First Posted: | September 15, 2015 Key Record Dates |
Last Update Posted: | September 23, 2016 |
Last Verified: | September 2016 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Volunteers |
Hypersensitivity Immune System Diseases Oxytocin |
Oxytocics Reproductive Control Agents Physiological Effects of Drugs |