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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01939639
Other study ID # OXT_PS_2013
Secondary ID PS_2013
Status Completed
Phase Phase 1
First received August 27, 2013
Last updated September 5, 2013
Start date March 2013
Est. completion date August 2013

Study information

Verified date September 2013
Source University Hospital, Bonn
Contact n/a
Is FDA regulated No
Health authority Germany: Ethics Commission
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date August 2013
Est. primary completion date June 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria:

Healthy male volunteers

Exclusion Criteria:

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

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science


Related Conditions & MeSH terms


Intervention

Drug:
Placebo
intranasal application, sodium chloride solution, 3 puffs per nostril
Oxytocin
24 IU Oxytocin, intranasal application 45 min prior to the experiment

Locations

Country Name City State
Germany Department of Psychiatry, University of Bonn Bonn North Rhine-Westphalia

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Bonn

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Other Saliva oxytocin concentrations 15 minutes before the nasal spray administration and (on average) 10 minutes after the fMRI experiment No
Primary Pleasantness ratings of social touch After each trial, subjects are asked to use a visual analog scale to rate the pleasantness of the administered touch. 30 minutes after the nasal spray administration No
Primary Blood-oxygen-level dependent signal in response to social touch By using functional magnetic resonance imaging we want to examine oxytocin's effects on the neural correlates (BOLD signal) of social touch. 30 minutes after the nasal spray administration No
Secondary Questionnaire measurement of mood (PANAS) and anxiety (STAI). 15 minutes before the nasal spray administration and (on average) 10 minutes after the fMRI experiment No
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