Effects of Fast Acting Testosterone Nasal Spray on Anxiety

NCT ID: NCT02361190

Last Updated: 2021-04-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 96 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-02-28
• Study Completion Date: 2016-05-31

Brief 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.

Detailed 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.

Conditions

Anxiety

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: TRIPLE

Study Groups

Placebo nasal spray

Subjects will inhale approximately 40ml aqueous solution via intranasal route

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Administration of 1ml aqueous saline spray

Testosterone nasal spray

Subjects will inhale approximately 40ml aqueous, testosterone-containing solution via intranasal route

Group Type: EXPERIMENTAL

Testosterone

Intervention Type: DRUG

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

Interventions

Testosterone

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

Intervention Type: DRUG

Placebo

Administration of 1ml aqueous saline spray

Intervention Type: DRUG

Other Intervention Names

Testosterone propionate; saline

Eligibility Criteria

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 -

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

Sponsors

University of Texas at Austin

OTHER

Sponsor Role: lead

Responsible Party

Robert Josephs

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Robert A Josephs, Phd

Role: PRINCIPAL_INVESTIGATOR

University of Texas at Austin

Locations

University of Texas at Austin Department of Psychology

Austin, Texas, United States

Countries

United States

Other Identifiers

2014-07-0062

Identifier Type: -

Identifier Source: org_study_id