Table of Contents
Cover
1
Aims and Goals
1.1
Specific Hypotheses
2.
Background and Significance
2.1
Previous Clinical Experiences with MDMA
3.
Methods
3.1
Overview
3.2
Subjects
3.2.1
Inclusion Criteria
3.2.2
Exclusion Criteria
3.2.3
Recruitment and Informed Consent
3.2.4
Oncology Assessment and Initial screening
3.2.5
Screening Process
3.3
Study Procedures
3.3.1
Timeline
3.3.2
Measures
3.4
Baseline Assessment
3.5
Non-Experimental Psychotherapy Sessions
3.6
Experimental Sessions
3.6.1
Drugs and Dosing
3.6.2
Measures During Experimental Session
3.6.3
Psychotherapeutic Procedures during Experimental Session
3.7
Post-Session Monitoring and Data Collection
3.7.1
Therapy Follow-Up
3.8
Monitoring for Toxicity
4.
Costs to Participants
5.
Treatment and Compensation of Study-Related Injury
6.
Risks to Participants
6.1
Risks and Discomforts Associated with Drawing Blood
6.2
Risks and Discomforts Associated with Screening Procedure
6.3
Risks and Discomforts Associated with Non-Experimental and Experimental Psychotherapy
6.4
Risks and Discomforts Associated with the Experimental Intervention
6.4.1
Potential Neurotoxicity Associated with Ecstasy Use
7.
Alternative treatments and procedures
8.
Confidentiality of Records
9.
Risk-Benefits Analysis
10.
References
11.
Appendix: Procedures for Treating Serious Adverse Events