Role of Oxytocin in Telling and Detecting Lies
Primary Purpose
Dyssocial Behavior
Status
Withdrawn
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
Oxytocin
Sponsored by
About this trial
This is an interventional basic science trial for Dyssocial Behavior
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
oxytocin
placebo
Arm Description
Intranasal 24 IU oxytocin self-administration.
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.
Outcomes
Primary Outcome Measures
Unethical behavior
To measure unethical behavior, we will calculate whether participants took more money than they actually earned on a problem-solving task.
Secondary Outcome Measures
Full Information
NCT ID
NCT02361177
First Posted
February 5, 2015
Last Updated
June 9, 2016
Sponsor
University of Texas at Austin
Collaborators
Harvard University
1. Study Identification
Unique Protocol Identification Number
NCT02361177
Brief Title
Role of Oxytocin in Telling and Detecting Lies
Official Title
Role of Oxytocin in Telling and Detecting Lies
Study Type
Interventional
2. Study Status
Record Verification Date
June 2016
Overall Recruitment Status
Withdrawn
Why Stopped
Drug not available
Study Start Date
January 2016 (undefined)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
April 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Texas at Austin
Collaborators
Harvard University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dyssocial Behavior
7. Study Design
Primary Purpose
Basic Science
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
oxytocin
Arm Type
Experimental
Arm Description
Intranasal 24 IU oxytocin self-administration.
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Oxytocin
Other Intervention Name(s)
syntocinon
Intervention Description
Intranasal oxytocin is hypothesized to amplify the influence of social norms on unethical behavior.
Primary Outcome Measure Information:
Title
Unethical behavior
Description
To measure unethical behavior, we will calculate whether participants took more money than they actually earned on a problem-solving task.
Time Frame
130 minutes
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert A Josephs, PhD
Organizational Affiliation
utaustin
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
15931222
Citation
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.
Results Reference
result
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Role of Oxytocin in Telling and Detecting Lies
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