Clinical Trials Logo

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
See also
  Status Clinical Trial Phase
Completed NCT05523687 - AME Study of [14C]-PC14586 in Healthy Male Participants Phase 1
Completed NCT02250976 - The Pharmacokinetic Study of the Fixed-dose Combination of Micronized Fenofibrate and Pitavastatin Ca Phase 1
Completed NCT01948011 - Racecadotril Suspension Linearity Study & Comparative Bioavailability Versus Granules Phase 1
Completed NCT04086719 - An Investigational Study to Determine the Drug Level Profile of BMS-986165 in Healthy Male Volunteers Following Transporter Inhibition. Phase 1
Completed NCT03686501 - D1 Receptor Occupancy (RO) Following a Single Dose of PF-06412562 Early Phase 1
Terminated NCT01965301 - First-time-in-man, to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BP1.5375 Phase 1
Completed NCT01005160 - Drug Interaction Between CKD-501 and Metformin Phase 1
Completed NCT04534582 - Pharmacokinetic, Safety and Immunogenicity Phase I Study of HLX14 Versus Prolia® in Healthy Male Subjects Phase 1
Recruiting NCT06159101 - A Study to Compare the PK , Safety, Tolerability, and Immunogenicity of HLX13 With YERVOY in Male Subjects Phase 1
Completed NCT01549743 - The Pharmacokinetic Interaction Between Celecoxib and Rebamipide Phase 1
Completed NCT03532854 - Evaluating a Pharmacokinetic Drug Interaction Between LGEV1801 and LGEV1802 Phase 1
Recruiting NCT03530228 - A Phase 1 Study of Tegoprazan on Healthy Male Volunteers Phase 1
Completed NCT01356043 - CKD-828 Drug Interaction Study (S-amlodipine) Phase 1
Completed NCT04810533 - The Absorption, Metabolism and Excretion of [14C]SH-1028 in Chinese Healthy Male Volunteers Phase 1
Completed NCT03089112 - Pharmacokinetic Drug Interactions Between HGP1607 and HGP1501 Phase 1
Completed NCT01342055 - Pharmacokinetics and Safety Study of Apetrol ES in Healthy Male Volunteers Phase 1
Terminated NCT03863587 - Compare Pharmacokinetic, Safety, Tolerability and Immunogenicity of HLX12 and Ramucirumab in Healthy Male Adult Subjects Phase 1
Completed NCT01382017 - Effects of Lacosamide on Human Motor Cortex Excitability: a Transcranial Magnetic Stimulation Study N/A
Completed NCT01356017 - CKD-828 Drug Interaction Study (Telmisartan) Phase 1
Completed NCT01606462 - Oxytocin and Social Cognition Phase 1

External Links