Table of Contents

Cover

Introductory Statement and General Investigational Plan

The Investigator's Brochure

The Protocol

Study Objectives

Background and Significance

Previous Clinical Experiences with MDMA-Assisted Therapy

Investigators and Institutional Review Board

Subjects

Methods

Drugs and Dosage

Assessment/Measures

Monitoring for toxicity

Chemistry, Manufacturing and Control Information

Drug Substance

Drug Product

Environmental Analysis Requirements

Pharmacology And Toxicology

Primary Pharmacodynamics

Drug Activity Related to Proposed Action

Secondary Pharmacodynamics

Safety Pharmacology

Abuse Liability

Pharmacokinetics/Toxicokinetics

Toxicology

Previous Human Experience

Additional Information

Drug Dependence and Abuse Potential

References

Appendix A: Investigator Curriculum Vitae