Cardiovascular Effects of Adderall in Healthy Adults. A Randomized Clinical Trial.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Systolic Blood Pressure
研究概览
简要总结
This study is designed to investigate the cardiovascular response (blood pressure, heart rate, electrocardiographic response and blood vessel reactivity response) to taking Adderall in healthy adults.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults 18 years of age and older
- •Healthy subjects without known cardiovascular disease, thyroid disease or documented mental health illness
- •Subjects who are on no medications
- •Subjects with no prior history of regular amphetamine use, and non-prescription stimulants
- •Exclusion Criteria
- •Subjects with known cardiovascular disease, thyroid disease
- •Subjects with history of psychotic disorders/mental health illness, including but not limited to anxiety, depression, bipolar disorder; history of substance abuse or dependence
- •Subjects currently taking medications
- •Prior history of regular amphetamine use, or non-prescription stimulants
- •Pregnant subjects
- •Known lactose intolerance (due to presence of lactose in the prepared medication)
- •Family history of sudden cardiac death
排除标准
- 未提供
研究组 & 干预措施
Adderall first, then Placebo
Participants will receive an Adderall capsule at the first study visit, then a Placebo capsule at the second study visit.
干预措施: Adderall capsule (Drug)
Adderall first, then Placebo
Participants will receive an Adderall capsule at the first study visit, then a Placebo capsule at the second study visit.
干预措施: Placebo capsule (Drug)
Placebo first, then Adderall
Participants will receive a Placebo capsule at the first study visit, then an Adderall capsule at the second study visit.
干预措施: Adderall capsule (Drug)
Placebo first, then Adderall
Participants will receive a Placebo capsule at the first study visit, then an Adderall capsule at the second study visit.
干预措施: Placebo capsule (Drug)
结局指标
主要结局
Systolic Blood Pressure
时间窗: Baseline and 3 hours
Systolic blood pressure (top number of blood pressure reading)
Heart Rate
时间窗: Baseline and 3 hours
Number of beats per minute
Diastolic Blood Pressure
时间窗: Baseline and 3 hours
Diastolic blood pressure (bottom number of blood pressure reading)
Mean Arterial Pressure (MAP)
时间窗: Baseline and 3 hours
Mean arterial pressure (MAP) is a measure of the average blood pressure in the large arteries. It accounts for the blood flow and resistance. Measured in millimeters of mercury (mmHg)
次要结局
- Plasma Norepinephrine(baseline and 3 hours)
研究者
Anna Svatikova
Principal Investigator
Mayo Clinic