The seventh subject out of 24 has now received their first MDMA-assisted psychotherapy session in our ongoing study of MDMA-assisted psychotherapy for U.S. veterans with chronic, treatment-resistant PTSD. We have expanded the study from 16 to 24 subjects, added the possibility of enrolling local firefighters and police officers with work-related PTSD, and revised and updated the budget to accommodate the study expansion.
This study has been ongoing for the past two years, and has an estimated two additional years before completion. We have incorporated into this budget more precise cost estimates based on a review of the actual costs of treating the initial subjects. The total estimated budget for this study is $1.25 million. We have already $600,000, and are seeking to raise the additional $650,000 to complete this study.
The revised budget for this crucial study represents a further professionalization in MAPS’ clinical research procedures. MAPS Director of Clinical Research Amy Emerson created a new budget template for our clinical studies, based on her extensive experience budgeting and monitoring multi-site clinical studies for Novartis. The updated budget distinguishes between start-up costs, site- and procedure-specific patient costs, and internal MAPS staff costs to enable more accurate budget projections for our larger, multi-site Phase 3 studies. The ability to track expenses on a per-patient, per-procedure basis will allow us to understand the implications of protocol changes on clinical research budgets, and by linking our budget to our outcome data analysis to estimate the impact of budgetary changes on our treatment method and clinical results.