Effects of Fast Acting Testosterone Nasal Spray on Anxiety

The proposed study will test the effects of a fast-acting testosterone nasal spray on the fear reactions of young men to two distinct anxiety challenges (social and nonsocial) using a double-blind randomized experimental design.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Anxiety Anxiety Disorders Mental Disorders

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

University of Texas at Austin Department of Psychology

Austin, Texas, 78712, United States

About this study

Aim 1: Test the hypothesis that men administered testosterone nasal spray will result in lower levels of anxiety (anticipatory and situational) and greater levels of approach behavior in response to two distinct (social and nonsocial) anxiety challenges relative to men administered placebo spray.

Aim 2: Test the hypothesis that anxiety challenge type (social versus nonsocial) will moderate the effects of testosterone administration on subjects' responses to challenge.

Aim 3: Test the hypothesis that rejection sensitivity - heightened sensitivity to evaluative threat - will moderate the effects of drug condition on response to the two anxiety challenge tests.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Male, 18 years of age or older

Exclusion criteria

Male breast cancer
Obstructive sleep apnea
Suspected or diagnosed prostate cancer
Male breast cancer
Obstructive sleep apnea
Diabetes
Heart Disease
Liver disease (e.g., hepatitis)
Kidney disease
Thyroid disease
Tuberculosis or history if positive TB test
Infection or fever in the past 7 days
Surgeries within the last 6 weeks
Anemia
Gastrointestinal disease
Respiratory disease (e.g., asthma or chronic bronchitis)
Other (Please list)
Reynaud's Disease
Type 2 diabetes
Diagnosed hypersensitivity to cold
Warfarin (Coumadin) for thinning blood
Insulin or any oral drugs for diabetes
Propranolol (Inderal)
Oxyphenbutazone
Imipramine
Any kind of corticosteroid drug
Insulin
Steroids
Statins (i.e.., cholesterol lowering drugs)
Sleeping pills
Drugs to treat hormone disorders
Antibiotics in the past 7 days
Gastrointestinal disease
Pain Killers -

Treatment and study plan

Testosterone

Drug

Administration of 1ml aqueous nasal spray containing 7mg testosterone propionate

Other names: Testosterone propionate

Placebo

Drug

Administration of 1ml aqueous saline spray

Other names: saline

Primary outcomes

Magnitude of behavioral approach

Time frame: 30 minutes

Subjects will be asked to approach a fearful object. Approach will be measured as number of steps (out of 18) the subject completes, with each step bringing the subject closer to the target object

Sponsors and collaborators

Lead sponsor

University of Texas at Austin

Other

Registry information

Important dates

Study start: 2015
Primary completion: 2016
Study completion: 2016
First posted: Feb 11, 2015
Registry last updated: Apr 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed