NCT01939639

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Mar 2013

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2013

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

August 27, 2013

Completed
15 days until next milestone

First Posted

Study publicly available on registry

September 11, 2013

Completed
Last Updated

September 11, 2013

Status Verified

September 1, 2013

Enrollment Period

3 months

First QC Date

August 27, 2013

Last Update Submit

September 5, 2013

Conditions

Keywords

OxytocinfMRI

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Secondary Outcomes (1)

  • Questionnaire measurement of mood (PANAS) and anxiety (STAI).

    15 minutes before the nasal spray administration and (on average) 10 minutes after the fMRI experiment

Other Outcomes (1)

  • Saliva oxytocin concentrations

    15 minutes before the nasal spray administration and (on average) 10 minutes after the fMRI experiment

Study Arms (2)

Oxytocin

EXPERIMENTAL

24 IU Oxytocin, intranasal application 30 min prior to the experiment

Drug: Oxytocin

Placebo

PLACEBO COMPARATOR

intranasal application, sodium chloride solution, 3 puffs per nostril

Drug: Placebo

Interventions

intranasal application, sodium chloride solution, 3 puffs per nostril

Placebo

24 IU Oxytocin, intranasal application 45 min prior to the experiment

Also known as: Syntocinon
Oxytocin

Eligibility Criteria

Age18 Years - 60 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy male volunteers

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Psychiatry, University of Bonn

Bonn, North Rhine-Westphalia, 53105, Germany

Location

Related Links

MeSH Terms

Interventions

Oxytocin

Intervention Hierarchy (Ancestors)

Pituitary Hormones, PosteriorPituitary HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD PhD M.Sc.

Study Record Dates

First Submitted

August 27, 2013

First Posted

September 11, 2013

Study Start

March 1, 2013

Primary Completion

June 1, 2013

Study Completion

August 1, 2013

Last Updated

September 11, 2013

Record last verified: 2013-09

Locations