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CLINICAL STUDY PROTOCOL Psilocybin-Assisted Psychotherapy

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CLINICAL STUDY PROTOCOL Psilocybin-Assisted Psychotherapy CLINICAL STUDY PROTOCOL Psilocybin-assisted Psychotherapy in the Management of Anxiety Associated With Stage IV Melanoma. Version: Final IND: [79,321] SPONSOR Multidisciplinary Association for Psychedelic PRINCIPAL INVESTIGATOR Sameet Kumar Ph.D. MEDICAL MONITOR Michael C. Mithoefer MD. STUDY PERSONNEL XXXXXXXXXXXXX XXXXXXXXXXXXX XXXXXXXXXXXXX STUDY MONITOR [CRA] Valerie Mojeiko IRB Study Site IRB Sponsor Signatory Rick Doblin Ph.D. Study Period 2008 For trial related emergencies please contact: Dr. Michael Mithoefer MAPS: S Kumar PI Clinical Study Protocol PCA1 Final December 1, 2007 Confidential Page 2 of 83 Table of Contents Introduction......................................................................................................................... 4 Background..................................................................................................................... 4 Disease History and Related Research ........................................................................... 5 Rationale ......................................................................................................................... 7 Summary......................................................................................................................... 7 Ethics................................................................................................................................... 8 Informed Consent of Subject .......................................................................................... 9 Recruitment and Screening............................................................................................. 9 Study Objectives ............................................................................................................... 10 Primary Efficacy and Safety Objectives....................................................................... 10 Secondary Objectives.................................................................................................... 10 General Investigational Plan............................................................................................. 11 Drug Description and Doses ......................................................................................... 11 Sample Population and Subjects................................................................................... 12 Inclusion Criteria ...................................................................................................... 12 Exclusion Criteria ..................................................................................................... 12 Planned Duration of the Study...................................................................................... 13 Method .......................................................................................................................... 13 Time and Events ........................................................................................................... 15 Assessments and Measures........................................................................................... 18 Visit Descriptions: Psychotherapy and Assessment ......................................................... 19 Subject Numbering ....................................................................................................... 19 Screening and Baseline evaluation (Visits #1 to #3) .................................................... 20 Randomized blinded Study phase................................................................................. 20 Randomization .......................................................................................................... 20 Introductory Psychotherapy Session (Visits #4 and #4.5)........................................ 20 Psilocybin-Assisted Psychotherapy (Visit #5, Visit #8)........................................... 21 Integrative Non-Drug Psychotherapy (Visits #6, #7 and #9) ................................... 23 Final Evaluation in Randomized Phase (Visit #10).................................................. 23 Unblinding and Opportunity to Enter the Open-Label Study Segment or Two-Month Follow-up (Visit 10) ..................................................................................................... 24 Open-Label Study Phase (Visits #11-18) ..................................................................... 24 Two-Month Follow-up (Follow-up Screening and Follow Up 1) ................................ 25 Visit by Visit Description ............................................................................................. 26 Removal of Subjects from Therapy or Assessment...................................................... 30 Premature Discontinuation of the Study....................................................................... 30 Data Analysis................................................................................................................ 30 Statistical Power............................................................................................................ 32 Monitoring for Risks......................................................................................................... 32 Acute Psychological Distress........................................................................................ 33 Medical Emergencies.................................................................................................... 34 Serious Adverse Events ................................................................................................ 35 Adverse Event Collection ............................................................................................. 36 Collection of Concomitant Medications ....................................................................... 37 MAPS: S Kumar PI Clinical Study Protocol PCA1 Final December 1, 2007 Confidential Page 3 of 83 Laboratory Assessments ............................................................................................... 37 Study Monitoring, Auditing and Documentation ......................................................... 37 Risks to Participants.......................................................................................................... 37 Risks and Discomforts Related to Screening and Baseline Examination..................... 37 Risks and Discomforts of Psychotherapy ..................................................................... 38 Risk of the Experimental Drug (psilocybin)................................................................. 38 Panic attacks, severe generalized anxiety, or persisting insomnia............................ 39 Reckless or self-injurious behavior........................................................................... 39 Psychosis, suicidal thoughts or impulses.................................................................. 40 Chronic neuropsychological effects.......................................................................... 40 Reproductive and Developmental Risks....................................................................... 41 Potential for Drug/ Drug Interactions ....................................................................... 41 Abuse Liability.......................................................................................................... 42 Risks of Active Placebo dose of Psilocybin ................................................................. 42 Alternative Treatments and Procedures ............................................................................ 42 Confidentiality .................................................................................................................. 43 Costs to Participants.......................................................................................................... 43 Risk/Benefits Analysis...................................................................................................... 43 Patient’s Rights/Insurance ................................................................................................ 44 Record Retention .......................................................................................................... 45 Chemistry, Manufacturing and Control Information........................................................ 45 Pharmacokinetics and Pharmacodynamics....................................................................... 45 Primary Pharmacology.................................................................................................. 45 Primary Pharmacodynamics ......................................................................................... 46 Drug Activity Related to Proposed Action ............................................................... 46 Secondary Pharmacology.............................................................................................. 47 Safety Pharmacology ................................................................................................ 47 Common side effects................................................................................................. 48 Acute Adverse Effects .............................................................................................. 49 Abuse Liability.......................................................................................................... 50 Pharmacokinetics/Toxicokinetics ................................................................................. 51 Absorption, Distribution,
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