Dyssocial BehaviorEarly Phase 1NCT02361177
Role of Oxytocin in Telling and Detecting Lies
A Early Phase 1 study testing Oxytocin in people with Dyssocial Behavior, run by University of Texas at Austin.
Trial summary
The investigators are interested in the impact of intranasal oxytocin in unethical behavior. Read more about this study
- Who is it for?
- Ages 18 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Dyssocial Behavior
- What is being tested?
- Oxytocin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jan 2016to Apr 2016
- Phase
- Early 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 30 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male
Who cannot join
- _____ _____BP > 130/85, HRT > 95 (can be included at discretion of study physician/designee)
- _____History of seizures
- _____Neurological Disorder
- _____Current psychiatric disorder
- _____Previous psychiatric disorder (can be included at discretion of PI)
- Date last episode (if > 1 year, include; if <1 year, at discretion of PI)
Show all 28Show fewer
- _____Current use of psychoactive drugs
- _____Previous use of psychoactive drugs (can be included at discretion of PI) _____Date last medicated_____ _____Type of medication___________________________________
- _____Current use of anticoagulants
- _____Current use of corticosteroids
- _____Previous head trauma (can be included at discretion of PI)
- _____Alcoholism or substance abuse
- _____Carcinoma of the breast or prostate
- _____Renal or Hepatic diseases
- _____Chronic lung diseases
- _____Cancer
- _____Liver problems
- _____Hypertension/Cardiac diseases
- _____Cardiovascular Disease
- _____Nephritis
- _____Diabetes (use of insulin) /Obesity
- _____Endocrine disease or malignancy
- _____Asthma (can be included as discretion of study physician/designee, if episodes are infrequent, nonmedicated, and no active problems at time of study)
- Medication
- Frequency of episodes____ _____Date of last episode_____
- _____Migraines(can be included as discretion of study physician/designee, if episodes are infrequent, nonmedicated, and no active problems at time of study)
- Medication _____Frequency of migraines_____ _____Date of last migraine_____
- _____High levels of physical contact with women or children
About this study
The investigators are interested in the impact of intranasal oxytocin in unethical behavior.
Read the detailed description
The objective of this project is to further explore the role of oxytocin in moral judgment and ethical behavior. Oxytocin is a peptide hormone produced in a variety of hypothalamic neurons. It is released into the brain or brought into general circulation through sensory stimuli in a pulsatile fashion. In social psychology research, oxytocin is hypothesized to coordinate both the causes and effects of positive social interactions in a biofeedback loop.
- Conditions
- Dyssocial Behavior
- Being tested
- Oxytocin
- Medical subject headings
- Antisocial Personality Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxytocinDrug
Also called syntocinon
Intranasal oxytocin is hypothesized to amplify the influence of social norms on unethical behavior.
| Study group | Role | What they receive |
|---|---|---|
| oxytocin | Experimental | Intranasal 24 IU oxytocin self-administration. Receives: Drug: Oxytocin |
| placebo | Placebo comparator | Intranasal placebo. 125 mg of 0.5% cholorobutanol to 50 ml saline, with approximately 5 pH. The solution will then be sterilized using a 0.22 micron filter. Receives: Drug: Oxytocin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Unethical behavior
To measure unethical behavior, we will calculate whether participants took more money than they actually earned on a problem-solving task.
Measured: 130 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2015 (estimated)
- Study startJan 2016
- Primary completionApr 2016
- Study completionApr 2016
Why it stopped: Drug not available
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dyssocial BehaviorStudies of the same condition, open and under way.
- More trials run by University of Texas at AustinThe sponsor's other registered studies.
- 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
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas at Austin
- Sponsor type
- University, hospital or other
- Collaborators
- Harvard University
- Responsible party
- Sponsor
- Investigators
- Robert A Josephs, PhD, Principal investigator, utaustin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02361177
- Sponsor's protocol ID
- 2013-11-0033
- Status last verified
- Jun 2016
- First submitted
- 5 Feb 2015
- Last updated
- 13 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Kosfeld M, Heinrichs M, Zak PJ, Fischbacher U, Fehr E. Oxytocin increases trust in humans. Nature. 2005 Jun 2;435(7042):673-6. doi: 10.1038/nature03701.
PubMed 15931222
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Oxytocin in Telling and Detecting Lies
- ClinicalTrials.gov ID
- NCT02361177
- Acronym / sponsor ID
- 2013-11-0033
- Conditions
- Dyssocial Behavior
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Drug not available
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Texas at AustinUniversity, hospital or other
- Collaborators
- Harvard University
- Study start
- Jan 2016
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 11 Feb 2015 (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.
The investigators are interested in the impact of intranasal oxytocin in unethical behavior.
Detailed description
The objective of this project is to further explore the role of oxytocin in moral judgment and ethical behavior. Oxytocin is a peptide hormone produced in a variety of hypothalamic neurons. It is released into the brain or brought into general circulation through sensory stimuli in a pulsatile fashion. In social psychology research, oxytocin is hypothesized to coordinate both the causes and effects of positive social interactions in a biofeedback loop.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| oxytocin | Experimental | Drug: OxytocinIntranasal 24 IU oxytocin self-administration. |
| placebo | Placebo comparator | Drug: OxytocinIntranasal placebo. 125 mg of 0.5% cholorobutanol to 50 ml saline, with approximately 5 pH. The solution will then be sterilized using a 0.22 micron filter. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Male
Key exclusion criteria (28 listed)
- _____ _____BP > 130/85, HRT > 95 (can be included at discretion of study physician/designee)
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 |
|---|---|---|
| OxytocinAlso: syntocinonIntranasal oxytocin is hypothesized to amplify the influence of social norms on unethical behavior. | Drug | oxytocin, placebo |
Primary outcome
Unethical behavior
Time frame: 130 minutes
To measure unethical behavior, we will calculate whether participants took more money than they actually earned on a problem-solving task.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2016.
- Results publication: PubMed 15931222Kosfeld M, Heinrichs M, Zak PJ, Fischbacher U, Fehr E. Oxytocin increases trust in humans. Nature. 2005 Jun 2;435(7042):673-6. doi: 10.1038/nature03701.
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.
Robert A Josephs, PhD principal investigator
utaustin
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Oxytocin in people with Dyssocial Behavior, run by University of Texas at Austin.
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 28 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: withdrawn, as of the sponsor's last update on 13 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 was withdrawn before enrolling participants, so there are no results.
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?
Unethical behavior (time frame: 130 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02361177, which also lists 1 linked publication.
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 13 Jun 2016.