- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04865562
Hormones and Decision Making
April 28, 2021 updated by: Robert Josephs, University of Texas at Austin
An investigation of the neuropsychological processes underlying ethical decision making.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This study will investigate the influence of reward sensitivity on cheating behavior via experimental manipulation of reward sensitivity using testosterone.
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Texas
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Austin, Texas, United States, 78712-1050
- Robert Josephs
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 25 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: testosterone
7mg testosterone propionate
|
1mg/0.1mL solution, to be administered intranasally
Other Names:
|
|
Placebo Comparator: placebo
125 mg 0.5% cholorbutanol, 50mg saline, pH5
|
125 mg 0.5% cholorbutanol, 50mg saline
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Measure of ethical behavior - Cheating rate defined as the Average number of 'heads' coin flips participants claim to have obtained
Time Frame: 90 minutes
|
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.
|
90 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Robert A Josephs, PhD, University of Texas at Austin
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 1, 2015
Primary Completion (Actual)
May 1, 2016
Study Completion (Actual)
September 1, 2016
Study Registration Dates
First Submitted
February 9, 2015
First Submitted That Met QC Criteria
April 28, 2021
First Posted (Actual)
April 29, 2021
Study Record Updates
Last Update Posted (Actual)
April 29, 2021
Last Update Submitted That Met QC Criteria
April 28, 2021
Last Verified
April 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Personality Disorders
- Antisocial Personality Disorder
- Physiological Effects of Drugs
- Antineoplastic Agents
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Androgens
- Anabolic Agents
- Testosterone
- Methyltestosterone
- Testosterone undecanoate
- Testosterone enanthate
- Testosterone 17 beta-cypionate
Other Study ID Numbers
- 2015-02-0011
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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