U.S. Veterans Study: IRB Approves 2nd Amendment

Today the second amendment to our study protocol was approved by the IRB. On Sept. 30, we submitted that amendment and our revised investigator’s brochure to the FDA. The amendment returned the NEO personality inventory test to the protocol, and added the Mystical States of Consciousness Questionnaire, video recording of the Clinician Administered Posttraumatic Stress Disorder Scale (CAPS) interview, and the Posttraumatic Growth Inventory (PGI).

The personality test was in our first study, and measures if there are any changes to a subject’s personality as a result of the treatment. Johns Hopkins’ researcher William Richards, Ph.D, developed the Mystical States of Consciousness Questionnaire. We will administer it right after treatment sessions to track any correlation between mystical experiences and overcoming PTSD. Our hypothesis is there will not be a correlation, since some subjects don’t have mystical experiences and yet still benefit from the treatment. We added the PGI measure, which assesses whether people experience significant life improvements as a result of the treatment. Similar to a quality-of-life measure, which was already in the protocol, the PGI measure tracks personal growth, for example when a subject returns to work after participating in our study. In our last study, we gathered anecdotal reports of growth, but could not quantifiably report it to the FDA.

We’ve also added video recording of the CAPS interviews to help us develop training materials for our independent raters.

*MDMA Ad Text.pdf *Beck Depression Inventory Real Time Report.pdf *Consent Quiz Answers.pdf *Original Investigation: Psilocybin.pdf *Investigator’s Brochure.pdf *12-MONTH FOLLOW-UP MEMORY AID CARD.pdf