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

NCT ID: NCT01408498

Last Updated: 2012-10-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2012-04-30

Brief Summary

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.

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).

Conditions

Testosterone's Effects on Threat Perception/Response

Keywords

Testosterone; Social psychology; Human behavior

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

Placebo Control

Control group who will not receive exogenous testosterone administration. Will act as a comparison group to the testosterone group.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Testosterone administration group

Experimental group that will receive a single 10 g dose of 1% testosterone topical gel.

Group Type: EXPERIMENTAL

Testosterone

Intervention Type: DRUG

Topical administration of testosterone gel. Participants receive a one-time, single dose of 10 g of 1% testosterone gel.

Interventions

Testosterone

Topical administration of testosterone gel. Participants receive a one-time, single dose of 10 g of 1% testosterone gel.

Intervention Type: DRUG

Other Intervention Names

AngroGel

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Texas at Austin

OTHER

Sponsor Role: lead

Responsible Party

Scott Liening

Graduate Student

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Scott H Liening, B.A.

Role: PRINCIPAL_INVESTIGATOR

University of Texas at Austin

Locations

Seay Building

Austin, Texas, United States

Countries

United States

Other Identifiers

SHL-Diss-1

Identifier Type: -

Identifier Source: org_study_id