- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02799277
A Multinomial Process Model of Moral Judgment (PSY)
November 20, 2018 updated by: University of Texas at Austin
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
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
- Medical Screening Interview: Participants will be asked to answer several questions to identify potential medical and non-medical conditions that would preclude the self-administration of testosterone.
- First Saliva Sample: Participants will be asked provide a saliva sample after they completed the medical screening interview.
- Testosterone Self-Administration: Immediately following the first saliva collection, participants will self-administer spray puffs of either testosterone or placebo.
- Relaxation: Participants will be given the opportunity to relax for 30 minutes.
- Moral Dilemmas Judgments: Participants will be asked to read a set of 24 moral dilemmas that describe situations in which an actor has to make a decision 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.
- Demographics: Participants will be asked to indicate their gender, age, and ethnicity.
- Ear Temperature, heart rate, and blood pressure will be measured before drug administration, and again 20 minutes after drug administration. If temperature changes more than 2 degrees, heart rate changes more than 20bmp, or if blood pressure changes more than 20%, the experiment will be terminated and subjects will be escorted across the street to the University Emergency Room.
Study Type
Interventional
Enrollment (Actual)
220
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
-
Austin, Texas, United States, 78712
- University of Texas at Austin Department of Psychology
-
-
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 and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- must be currently enrolled at The University of Texas at Austin
Exclusion Criteria:
- 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
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
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Testosterone
14mg testosterone will be administered intranasally in a 1milliliter aqueous solution
|
Effect of testosterone on moral decision making
|
PLACEBO_COMPARATOR: Placebo
1ml blank (containing no drug) aqueous solution will be administered intranasally
|
Effect of testosterone on moral decision making
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Moral Dilemma Judgments
Time Frame: 90 minutes
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Robert A Josephs, PhD, Professor
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)
August 30, 2017
Primary Completion (ACTUAL)
May 5, 2018
Study Completion (ACTUAL)
June 1, 2018
Study Registration Dates
First Submitted
June 9, 2016
First Submitted That Met QC Criteria
June 13, 2016
First Posted (ESTIMATE)
June 14, 2016
Study Record Updates
Last Update Posted (ACTUAL)
November 23, 2018
Last Update Submitted That Met QC Criteria
November 20, 2018
Last Verified
November 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2014-12-0010
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
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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