Effects of Fast Acting Testosterone Nasal Spray on Anxiety
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- Magnitude of behavioral approach
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Male, 18 years of age or older
排除标准
- •Male breast cancer
- •Obstructive sleep apnea
- •Suspected or diagnosed prostate cancer
- •Male breast cancer
- •Obstructive sleep apnea
- •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
- •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
- •Statins (i.e.., cholesterol lowering drugs)
- •Sleeping pills
- •Drugs to treat hormone disorders
- •Antibiotics in the past 7 days
- •Gastrointestinal disease
- •Pain Killers -
研究组 & 干预措施
Placebo nasal spray
Subjects will inhale approximately 40ml aqueous solution via intranasal route
干预措施: Placebo (Drug)
Testosterone nasal spray
Subjects will inhale approximately 40ml aqueous, testosterone-containing solution via intranasal route
干预措施: Testosterone (Drug)
结局指标
主要结局
Magnitude of behavioral approach
时间窗: 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
次要结局
未报告次要终点
研究者
Robert Josephs
Professor
University of Texas at Austin