Study on the Effects of Exogenous Testosterone on Threat Perception and Behavioral Avoidance

The study aims to establish a clear causal link between testosterone and threat perception and behavioral responses to threat. Namely, the study focuses whether high levels of testosterone will cause an individual to exhibit increased physiological responses to threat (e.g., increased blood pressure, heart rate, and endocrine responses) and a decreased behavioral response (e.g., ignoring the threat, avoiding the threat, and postponing dealing with the threat). The threat in this study is a social threat involving public speaking, and is an outgrowth of previous research on the avoidance of health threats.

Study Overview

• Status: Completed
• Conditions: Testosterone's Effects on Threat Perception/Response
• Intervention / Treatment: Drug: Testosterone

Detailed Description

Participants in the study will receive either a single dose of 10g 1% testosterone topical gel or placebo the day prior to participating in the study. The day of the study, participants will provide saliva samples throughout the study to track testosterone and cortisol levels. Participants will be asked to complete the Trier Social Stressor Task, which includes having to give a 5 minute speech to a panel of judges. Participants will be given the opportunity to postpone giving their speech to an unspecified date. The study will focus on two types of responses to the threat of public speaking: behavioral and physiological. The behavior of interest will be participants desire to postpone dealing with the threat (it is hypothesized that those in the testosterone administration group will have an increased desire to postpone). The physiological responses include increased levels of cortisol and increased cardiovascular tone (it is hypothesized that the testosterone administration group will show an increased physiological response compared to the placebo group).

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Austin, Texas, United States, 78712
      • Seay Building

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• Male
• In good health
• Aged 18-35

Exclusion Criteria:

• Female
• Known carcinoma of the breast or prostate
• Known sensitivity to alcohol or soy products
• Preexisting cardiac, renal, or hepatic diseases
• Obesity
• Chronic lung diseases
• Cancer
• Use of anticoagulants
• Use of insulin or a history of diabetes
• Use of corticosteroids
• High levels of physical contact with women or children
• Preexisting liver problems

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
NO_INTERVENTION: Placebo Control; Control group who will not receive exogenous testosterone administration. Will act as a comparison group to the testosterone group.
EXPERIMENTAL: Testosterone administration group; Experimental group that will receive a single 10 g dose of 1% testosterone topical gel.	Drug: Testosterone; Topical administration of testosterone gel. Participants receive a one-time, single dose of 10 g of 1% testosterone gel.; Other Names: AngroGel

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Behavioral response	Participants will be asked to give a public speech, but will be given the opportunity to postpone the speech to a future date. Postponement is considered an avoidance-oriented behavioral response to a perceived social threat.	16 hours post testosterone administration
Physiological response	Participants will have cortisol and cardiovascular tone tracked during the social threat protocol. Prior to, during, and after being asked, preparing, and giving a public speech, participants' physiological stress markers will be assessed.	16 hours post testosterone administration

Collaborators and Investigators

• Sponsor: University of Texas at Austin
• Investigators: Principal Investigator: Scott H Liening, B.A., University of Texas at Austin

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (ACTUAL): April 1, 2012
• Study Completion (ACTUAL): April 1, 2012

Study Registration Dates

• First Submitted: August 2, 2011
• First Submitted That Met QC Criteria: August 2, 2011
• First Posted (ESTIMATE): August 3, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): October 16, 2012
• Last Update Submitted That Met QC Criteria: October 12, 2012
• Last Verified: October 1, 2012

More Information

Terms related to this study

• Keywords: Testosterone; Social psychology; Human behavior
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Androgens; Testosterone
• Other Study ID Numbers: SHL-Diss-1