Role of Oxytocin in Telling and Detecting Lies | NCT02361177

Studies
Role of Oxytocin in Telling and Detecting Lies

NCT02361177

Sponsor

University of Texas at Austin

Status

Withdrawn

Last Update Posted

Jun 13, 2016Estimated

Enrollment

0Actual

Phase

Early Phase 1

Conditions

Dyssocial Behavior

Interventions

Oxytocin

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2016

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Drug not available

Expanded Access Info

Start Date

Jan 2016

Primary Completion Date

Apr 2016Actual

Completion Date

Apr 2016Actual

First Submitted Date

Feb 5, 2015

First Submission Date that Met QC Criteria

Feb 10, 2015

First Posted Date

Feb 11, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 9, 2016

Last Update Posted Date

Jun 13, 2016Estimated

Name	Class
Harvard University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Early Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
oxytocin	Experimental	Intranasal 24 IU oxytocin self-administration.	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.	Drug: Oxytocin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Oxytocin	Drug	Intranasal oxytocin is hypothesized to amplify the influence of social norms on unethical behavior.	oxytocin placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Unethical behavior	To measure unethical behavior, we will calculate whether participants took more money than they actually earned on a problem-solving task.	130 minutes

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male

Exclusion Criteria:

_____ _____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)
- _____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

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

30 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D010554	Personality Disorders
D001523	Mental Disorders

ID	Term
D010909	Pituitary Hormones, Posterior
D010907	Pituitary Hormones
D036361	Peptide Hormones
D006728	Hormones