Hormones and Decision Making

NCT04865562 | Completed Phase 4

• 1 other identifier: 2015-02-0011
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

An investigation of the neuropsychological processes underlying ethical decision making.

Conditions

Dyssocial Behavior

Outcome Measures

Primary Outcomes (1)

• 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.

  90 minutes

Study Arms (2)

testosterone

EXPERIMENTAL

7mg testosterone propionate

Drug: testosterone propionate

placebo

PLACEBO COMPARATOR

125 mg 0.5% cholorbutanol, 50mg saline, pH5

Drug: 0.5% cholorbutanol, saline

Interventions

testosterone propionate DRUG

1mg/0.1mL solution, to be administered intranasally

Also known as: Testovis

testosterone

0.5% cholorbutanol, saline DRUG

125 mg 0.5% cholorbutanol, 50mg saline

placebo

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• males between 18 and 25

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Texas at Austin: lead

Study Sites (1)

Robert Josephs

Austin, Texas, 78712-1050, United States

Location

MeSH Terms

Conditions

Antisocial Personality Disorder

Interventions

Testosterone Propionate; Sodium Chloride

Condition Hierarchy (Ancestors)

Personality Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Testosterone; Androstenols; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Testosterone Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Robert A Josephs, PhD

  University of Texas at Austin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 9, 2015
• First Posted: April 29, 2021
• Study Start: March 1, 2015
• Primary Completion: May 1, 2016
• Study Completion: September 1, 2016
• Last Updated: April 29, 2021

Record last verified: 2021-04

Locations

US (1)