Effects of Fast Acting Testosterone Nasal Spray on Anxiety

Anxiety Clinical Trial

Official title:

Effects of Fast Acting Testosterone Nasal Spray on Anxiety

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02361190
• Other study ID #: 2014-07-0062
• Status: Completed
• Phase: N/A
• Start date: February 2015
• Est. completion date: May 2016

Study information

• Verified date: April 2021
• Source: University of Texas at Austin
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: May 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

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 -

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders

Intervention

Drug:
• Testosterone
Administration of 1ml aqueous nasal spray containing 7mg testosterone propionate
• Placebo
Administration of 1ml aqueous saline spray

Locations

Country	Name	City	State
United States	University of Texas at Austin Department of Psychology	Austin	Texas

Sponsors (1)

Lead Sponsor	Collaborator
University of Texas at Austin

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Magnitude of behavioral approach	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	30 minutes