Effects of Fast Acting Testosterone Nasal Spray on Anxiety

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effects of Fast Acting Testosterone Nasal Spray on Anxiety

Conditions
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Anxiety

Intervention / Treatment
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* Drug: Testosterone
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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 -

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo nasal spray<br>Subjects will inhale approximately 40ml aqueous solution via intranasal route | Drug: Placebo<br>* Administration of 1ml aqueous saline spray<br>* Other names: saline;|
| Experimental: Testosterone nasal spray<br>Subjects will inhale approximately 40ml aqueous, testosterone-containing solution via intranasal route | Drug: Testosterone<br>* Administration of 1ml aqueous nasal spray containing 7mg testosterone propionate<br>* Other names: Testosterone propionate;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |