Table of Contents
- Precis page 1
- Introduction page 2
- Background Information page 2
- Research Question and Hypothesis page 5
- Study Design and Methods page 6
- Subject Enrollment page 9
- Inclusion and Exclusion Criteria page 10
- Procedures page 10
- Provision of Care to Research Subjects page 12
- Human Subject Risks and Protections page 14
- Consent and Assent Procedures page 14
- Risk of Study Participation by Phase page 14
- Psychiatric Assessment page 14
- Functional MRI page 14
- Single Dose Use of Stimulant page 15
- Stimulant Free Period page 16
- Procedures for Minimizing Risk page 17
- Benefits of Study Participation page 18
- Investigator Conflicts of Interest page 19
- Privacy and Confidentiality Provisions page 19
- Adverse Event Reporting page 19
- Data and Safety Monitoring Process page 19
- Subject Compensation page 19
- Pharmaceutical, Biologic and/or Device Information page 19