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The Influence of Oxytocin on the Processing of Social Contact

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ClinicalTrials.gov Identifier: NCT01939639
Recruitment Status : Completed
First Posted : September 11, 2013
Last Update Posted : September 11, 2013
Sponsor:
Information provided by (Responsible Party):
Rene Hurlemann, University Hospital, Bonn

Tracking Information
First Submitted Date  ICMJE August 27, 2013
First Posted Date  ICMJE September 11, 2013
Last Update Posted Date September 11, 2013
Study Start Date  ICMJE March 2013
Actual Primary Completion Date June 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 5, 2013)
  • Pleasantness ratings of social touch [ Time Frame: 30 minutes after the nasal spray administration ]
    After each trial, subjects are asked to use a visual analog scale to rate the pleasantness of the administered touch.
  • Blood-oxygen-level dependent signal in response to social touch [ Time Frame: 30 minutes after the nasal spray administration ]
    By using functional magnetic resonance imaging we want to examine oxytocin's effects on the neural correlates (BOLD signal) of social touch.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: September 5, 2013)
Questionnaire measurement of mood (PANAS) and anxiety (STAI). [ Time Frame: 15 minutes before the nasal spray administration and (on average) 10 minutes after the fMRI experiment ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: September 5, 2013)
Saliva oxytocin concentrations [ Time Frame: 15 minutes before the nasal spray administration and (on average) 10 minutes after the fMRI experiment ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE The Influence of Oxytocin on the Processing of Social Contact
Official Title  ICMJE Not Provided
Brief Summary Social touch can convey the most potent and salient of socio-emotional signals. While the hypothalamic peptide oxytocin (OXT) has been identified as a key neurochemical mediator of grooming in some other social species, its modulatory influence on human interpersonal touch is unknown. The investigators expect that OXT augments the hedonic value of touch and that this behavioral effect is paralleled at the neural level by an increased response in brain areas mediating rewarding aspects of social touch.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Condition  ICMJE Healthy Male Volunteers
Intervention  ICMJE
  • Drug: Placebo
    intranasal application, sodium chloride solution, 3 puffs per nostril
  • Drug: Oxytocin
    24 IU Oxytocin, intranasal application 45 min prior to the experiment
    Other Name: Syntocinon
Study Arms  ICMJE
  • Experimental: Oxytocin
    24 IU Oxytocin, intranasal application 30 min prior to the experiment
    Intervention: Drug: Oxytocin
  • Placebo Comparator: Placebo
    intranasal application, sodium chloride solution, 3 puffs per nostril
    Intervention: Drug: Placebo
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 Completed
Actual Enrollment  ICMJE
 (submitted: September 5, 2013)
40
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2013
Actual Primary Completion Date June 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

Healthy male volunteers

Exclusion Criteria:

Current or past psychiatric disease Current or past physical illness Psychoactive medication Tobacco smokers

Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01939639
Other Study ID Numbers  ICMJE OXT_PS_2013
PS_2013 ( Other Grant/Funding Number: University of Bonn )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Rene Hurlemann, University Hospital, Bonn
Study Sponsor  ICMJE University Hospital, Bonn
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University Hospital, Bonn
Verification Date September 2013

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