Back to resultsHormones and Decision Making
Primary Purpose
Dyssocial Behavior
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
testosterone propionate
0.5% cholorbutanol, saline
Sponsored by
About this trial
This is an interventional basic science trial for Dyssocial Behavior
Eligibility Criteria
Inclusion Criteria:
- males between 18 and 25
Exclusion Criteria:
- recruitment will be limited to male participants between 18 and 25 years who have no current conditions that would preclude the use of testosterone. Specific exclusion criteria are:
- women of all ages
- males younger than 18 years and older than 25 years
- self-report discomfort with ingestion of testosterone for the purpose of this study
- body mass index lower than 18 or higher than 27
- prior diagnosis of major depression, posttraumatic stress disorder, phobia, anxiety disorder, or other psychiatric conditions
- first-degree relatives diagnosed with a psychiatric disorder
- presence of a medical condition that would preclude the use of testosterone
- use of medications that would preclude the use of testosterone
- consumption of more than 5 cigarettes a day
- current use of testosterone enhancing products, such as gels, creams, and injections
Sites / Locations
- Robert Josephs
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
testosterone
placebo
Arm Description
7mg testosterone propionate
125 mg 0.5% cholorbutanol, 50mg saline, pH5
Outcomes
Primary Outcome Measures
Measure of ethical behavior - Cheating rate defined as the Average number of 'heads' coin flips participants claim to have obtained
drug administration following by behavioral outcome. Specifically, participants will have the opportunity to predict the outcome of a series of coin flips. To obtain a measure of ethical behavior, participants will have the opportunity to cheat by over-reporting their prediction accuracy.
Secondary Outcome Measures
Full Information
NCT ID
NCT04865562
First Posted
February 9, 2015
Last Updated
April 28, 2021
Sponsor
University of Texas at Austin
1. Study Identification
Unique Protocol Identification Number
NCT04865562
Brief Title
Hormones and Decision Making
Official Title
Hormones and Decision Making
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
March 1, 2015 (Actual)
Primary Completion Date
May 1, 2016 (Actual)
Study Completion Date
September 1, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Texas at Austin
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
An investigation of the neuropsychological processes underlying ethical decision making.
Detailed Description
This study will investigate the influence of reward sensitivity on cheating behavior via experimental manipulation of reward sensitivity using testosterone.
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
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
testosterone
Arm Type
Experimental
Arm Description
7mg testosterone propionate
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
125 mg 0.5% cholorbutanol, 50mg saline, pH5
Intervention Type
Drug
Intervention Name(s)
testosterone propionate
Other Intervention Name(s)
Testovis
Intervention Description
1mg/0.1mL solution, to be administered intranasally
Intervention Type
Drug
Intervention Name(s)
0.5% cholorbutanol, saline
Intervention Description
125 mg 0.5% cholorbutanol, 50mg saline
Primary Outcome Measure Information:
Title
Measure of ethical behavior - Cheating rate defined as the Average number of 'heads' coin flips participants claim to have obtained
Description
drug administration following by behavioral outcome. Specifically, participants will have the opportunity to predict the outcome of a series of coin flips. To obtain a measure of ethical behavior, participants will have the opportunity to cheat by over-reporting their prediction accuracy.
Time Frame
90 minutes
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
males between 18 and 25
Exclusion Criteria:
recruitment will be limited to male participants between 18 and 25 years who have no current conditions that would preclude the use of testosterone. Specific exclusion criteria are:
women of all ages
males younger than 18 years and older than 25 years
self-report discomfort with ingestion of testosterone for the purpose of this study
body mass index lower than 18 or higher than 27
prior diagnosis of major depression, posttraumatic stress disorder, phobia, anxiety disorder, or other psychiatric conditions
first-degree relatives diagnosed with a psychiatric disorder
presence of a medical condition that would preclude the use of testosterone
use of medications that would preclude the use of testosterone
consumption of more than 5 cigarettes a day
current use of testosterone enhancing products, such as gels, creams, and injections
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert A Josephs, PhD
Organizational Affiliation
University of Texas at Austin
Official's Role
Principal Investigator
Facility Information:
Facility Name
Robert Josephs
City
Austin
State/Province
Texas
ZIP/Postal Code
78712-1050
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Hormones and Decision Making
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