Healthy Male VolunteersPhase 1NCT01939639
The Influence of Oxytocin on the Processing of Social Contact
A Phase 1 study testing Oxytocin in people with Healthy Male Volunteers, run by University Hospital, Bonn at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Male Volunteers
- What is being tested?
- Oxytocin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2013to Aug 2013
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male volunteers
Who cannot join
- Current or past psychiatric disease Current or past physical illness Psychoactive medication Tobacco smokers
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Psychiatry, University of Bonn
Bonn, North Rhine-Westphalia, 53105
About this study
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.
- Conditions
- Healthy Male Volunteers
- Being tested
- Placebo, Oxytocin
- Keywords
- Oxytocin, fMRI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
intranasal application, sodium chloride solution, 3 puffs per nostril
OxytocinDrug
Also called Syntocinon
24 IU Oxytocin, intranasal application 45 min prior to the experiment
| Study group | Role | What they receive |
|---|---|---|
| Oxytocin | Experimental | 24 IU Oxytocin, intranasal application 30 min prior to the experiment Receives: Drug: Oxytocin |
| Placebo | Placebo comparator | intranasal application, sodium chloride solution, 3 puffs per nostril Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 30 minutes after the nasal spray administration
Secondary outcomes (1)
Questionnaire measurement of mood (PANAS) and anxiety (STAI).
Measured: 15 minutes before the nasal spray administration and (on average) 10 minutes after the fMRI experiment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2013 (estimated)
- Study startMar 2013
- Primary completionJun 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Male VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bonn
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rene Hurlemann, University Hospital, Bonn
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01939639
- Sponsor's protocol ID
- OXT_PS_2013
- Other IDs
- PS_2013
- Status last verified
- Sep 2013
- First submitted
- 27 Aug 2013
- Last updated
- 11 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Oxytocin on the Processing of Social Contact
- ClinicalTrials.gov ID
- NCT01939639
- Acronym / sponsor ID
- OXT_PS_2013
- Conditions
- Healthy Male Volunteers
- Keywords
- Oxytocin, fMRI
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University Hospital, BonnUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Jun 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 11 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oxytocin | Experimental | Drug: Oxytocin24 IU Oxytocin, intranasal application 30 min prior to the experiment |
| Placebo | Placebo comparator | Drug: Placebointranasal application, sodium chloride solution, 3 puffs per nostril |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy male volunteers
Key exclusion criteria (1 listed)
- Current or past psychiatric disease Current or past physical illness Psychoactive medication Tobacco smokers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placebointranasal application, sodium chloride solution, 3 puffs per nostril | Drug | Placebo |
| OxytocinAlso: Syntocinon24 IU Oxytocin, intranasal application 45 min prior to the experiment | Drug | Oxytocin |
Primary outcome
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.
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2013.
- Related InfoLink provided by the sponsor.
Related trials for Healthy Male Volunteers
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
Not yet recruitingPhase 2
Effects of Meal Macronutrients on Postprandial Lipids
Nephrotic Syndrome, Lipodystrophy
RecruitingPhase 1
The Mass Balance Recovery, Metabolite Profile and Metabolite Identification of [14C]OD-001 in Healthy Male Participants
Health Volunteers
RecruitingPhase 1
A Randomized, Double-Blind, Positive-Controlled, Parallel Pharmacokinetic Phase I Clinical Study of Cetuximab Injection Versus Erbitux in Healthy Male Subjects
Cetuximab, Bioequivalence
RecruitingObservational study
Kidney Stiffness Measured by Ultrasound in Patients With High Blood Pressure and Healthy Volunteers
Arterial Hypertension, Chronic Kidney Disease, Primary Aldosteronism
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Oxytocin in people with Healthy Male Volunteers, run by University Hospital, Bonn at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pleasantness ratings of social touch (time frame: 30 minutes after the nasal spray administration). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2013.