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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
Sponsor:
Information provided by (Responsible Party):
David Walega, Northwestern University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Healthy Drug: Normal Saline Drug: Oxytocin Phase 4

Study Design
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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy
Drug Information available for: Oxytocin

Arms and Interventions
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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.
 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.
 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


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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

  3. 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).

  4. 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.


Secondary Outcome Measures :
  1. Incidence of side effects [ Time Frame: up to 2 hrs ]
    Incidence of side effects from oxytocin administration (n, %)


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   20 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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United States, Illinois
Northwestern University Feinberg School of Medicine
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
Investigators
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Principal Investigator: David R Walega, MD Northwestern University Feinberg School of Medicine
More Information
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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
Keywords provided by David Walega, Northwestern University:
Volunteers
Additional relevant MeSH terms:
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Hypersensitivity
Immune System Diseases
Oxytocin
 Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs