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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

Tracking Information
First Submitted Date  ICMJE April 16, 2015
First Posted Date  ICMJE September 15, 2015
Last Update Posted Date September 23, 2016
Study Start Date  ICMJE April 2015
Actual Primary Completion Date August 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 11, 2015)
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 11, 2015)
Incidence of side effects [ Time Frame: up to 2 hrs ]
Incidence of side effects from oxytocin administration (n, %)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of Intranasal Oxytocin on Pain Sensitivity and Threshold
Official Title  ICMJE The Effect of Intranasal Oxytocin on Pain Sensitivity and Threshold: A Randomized, Double Blinded, Crossover Volunteer Study
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Healthy
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Oxytocin
  • 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.
    Intervention: Drug: Normal Saline
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: September 11, 2015)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 2016
Actual Primary Completion Date August 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 35 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02550093
Other Study ID Numbers  ICMJE STU86297
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party David Walega, Northwestern University
Study Sponsor  ICMJE Northwestern University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: David R Walega, MD Northwestern University Feinberg School of Medicine
PRS Account Northwestern University
Verification Date September 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP