Neuroimaging the Expectancy Versus Pharmacotherapy Effect of Adderall on Cognitive Performance
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Number of Participants Consistently Attending and Completing Four Neuroimaging Sessions
研究概览
简要总结
The purpose of this balanced-placebo design study is to pilot a larger study to further explore the current evidence that stimulant medications are not cognitive enhancers, despite this rampant belief in young adults. While the lack of cognitive enhancement from stimulant medication has been documented in prior research, this study is the first to utilize neuroimaging technology to examine brain regions activated during neurocognitive tasks when participants believe they have been administered stimulant medication or placebo.
详细描述
This is a 2 X 2 within subjects, balanced placebo design and all participants will experience each of the four conditions during four sequential weeks. Medication administered (Adderall vs. placebo) is crossed with instructional set (truth vs. deception) and participants' performance on neurocognitive tasks is compared across these groups. For example, participants are either given stimulant medication or placebo, and are either accurately told or inaccurately told that they received stimulant medication or placebo. Neuroimaging is being utilized to investigate whether participants' expectations regarding the benefits of stimulant medication affects their performance on neurocognitive tasks. The hypothesis of the study is that participants' expectations regarding stimulant medication will affect their performance on neurocognitive tasks, rather than the actual effect of the medication.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Health Services Research
- 盲法
- Double (Participant, Investigator)
盲法说明
This will be a double-blind study. Research assistants will administer capsules, and based on package labeling, tell the participant if they are being administered Adderall or placebo. However, researchers and participants will be blind to which medication is actually being administered.
入排标准
- 年龄范围
- 18 Years 至 24 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age (18-24)
- •College student with at least average IQ
- •Willingness to standardize caffeine intake to 100 mg on day of study
排除标准
- •Attention Deficit/Hyperactivity Disorder (ADHD)
- •First degree relative with ADHD
- •Unwillingness to comply with caffeine specifications
- •Regular use of Adderall
- •Pregnant/breastfeeding
- •History of substance use disorders
- •Illicit stimulant use within the last year
- •Contraindications to stimulants (i.e., tics, Tourette's, cardiac disease, hypertension)
- •Uncontrolled medical illness
- •Active contagious infection
研究组 & 干预措施
Adderall/Truth
Participants will be told they are receiving Adderall and will actually be administered Adderall.
干预措施: Adderall (Drug)
Placebo/Truth
Participants will be told they are receiving placebo and will actually be administered placebo.
干预措施: Placebo (Drug)
Adderall/Deception
Participants will be told they are receiving Adderall and will actually be administered placebo.
干预措施: Placebo (Drug)
Placebo/Deception
Participants will be told they are receiving placebo and will actually be administered Adderall.
干预措施: Adderall (Drug)
结局指标
主要结局
Number of Participants Consistently Attending and Completing Four Neuroimaging Sessions
时间窗: A total of 4 imagining sessions, an average of 60 minutes each
Using a balanced placebo design, participants were either administered mixed amphetamine salts or placebo. Their cognitive performance was assessed in the MRI scanner. The main outcome measure was the feasibility of participants attending four neuroimaging sessions.
次要结局
未报告次要终点
研究者
Karen Cropsey
Principal Investigator
University of Alabama at Birmingham