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Effects of Fast Acting Testosterone Nasal Spray on Anxiety

Information source: University of Texas at Austin
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Anxiety

Intervention: Testosterone (Drug)

Phase: N/A

Status: Not yet recruiting

Sponsored by: University of Texas at Austin

Official(s) and/or principal investigator(s):
Robert A Josephs, Phd, Principal Investigator, Affiliation: University of Texas at Austin

Overall contact:
Robert A Josephs, PhD, Phone: 5124719788, Email: bob.josephs@utexas.edu

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.

Clinical Details

Official title: Effects of Fast Acting Testosterone Nasal Spray on Anxiety

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Primary outcome: Magnitude of behavioral approach

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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Male.

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 -

Locations and Contacts

Robert A Josephs, PhD, Phone: 5124719788, Email: bob.josephs@utexas.edu

University of Texas at Austin Department of Psychology, Austin, Texas 78712, United States
Additional Information

Starting date: February 2015
Last updated: February 5, 2015

Page last updated: August 23, 2015

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