NCT02799277

Brief Summary

The main goal of this project to investigate the psychological processes underlying moral judgments in social dilemmas. We will examine neuroendocrine determinants of moral judgment by investigating the effects of exogenous testosterone

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
220

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Aug 2017

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 9, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 14, 2016

Completed
1.2 years until next milestone

Study Start

First participant enrolled

August 30, 2017

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 5, 2018

Completed
27 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

November 23, 2018

Status Verified

November 1, 2018

Enrollment Period

8 months

First QC Date

June 9, 2016

Last Update Submit

November 20, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • Moral Dilemma Judgments

    Subjects will decide on whether or not to engage in a particular action (e.g., sacrifice the well-being of one person to protect the well-being of several others). Participants will be asked to indicate whether they consider the described action acceptable or unacceptable.

    90 minutes

Study Arms (2)

Testosterone

EXPERIMENTAL

14mg testosterone will be administered intranasally in a 1milliliter aqueous solution

Drug: Testosterone

Placebo

PLACEBO COMPARATOR

1ml blank (containing no drug) aqueous solution will be administered intranasally

Drug: Placebo

Interventions

Effect of testosterone on moral decision making

Testosterone

Effect of testosterone on moral decision making

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • must be currently enrolled at The University of Texas at Austin

You may not qualify if:

  • not comfortable with the self-administration of testosterone for the purpose of our study less than 18 years old BMI less than 18 or above 27 suffer from any of the physical health conditions listed on the pre-screen questionnaire (I will not ask about mental health because our study is not about mental health) take any of the medications listed on the pre-screen questionnaire currently pregnant (females) irregular cycle in the past 6 months (females) smoke more than 5 cigarettes/day use cocaine more than once/month (\*\*or should I exclude all those who use any drugs recreationally more than once/month?\*\*) drink more than 10 alcoholic beverages/week

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas at Austin Department of Psychology

Austin, Texas, 78712, United States

Location

MeSH Terms

Interventions

Testosterone

Intervention Hierarchy (Ancestors)

AndrostenolsAndrostenesAndrostanesSteroidsFused-Ring CompoundsPolycyclic CompoundsTestosterone CongenersGonadal Steroid HormonesGonadal HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

  • Robert A Josephs, PhD

    Professor

    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
SPONSOR

Study Record Dates

First Submitted

June 9, 2016

First Posted

June 14, 2016

Study Start

August 30, 2017

Primary Completion

May 5, 2018

Study Completion

June 1, 2018

Last Updated

November 23, 2018

Record last verified: 2018-11

Data Sharing

IPD Sharing
Will not share

Locations