MDMA Assisted Psychotherapy for Anxiety due to Life Threatening Illness—A MAPS Sponsored, FDA Approved Phase 2 Study
Philip E Wolfson MD Principal Investigator
ph: 877-372-2692 firstname.lastname@example.org is our email
From Science to the Prescription Pad
I am honored to have been designated the Principle Investigator for the first Bay Area MDMA study sponsored by MAPS–The Multidisciplinary Association for Psychedelic Studies. Our extensive protocol has been approved by the FDA, the relevant Institutional Review Boards (IRBs), and the DEA—MDMA is a Schedule I medicine. We are now beginning subject selection and if you are a health care professional, I request that you consider making referrals to the study, with various criteria for enrollment as specified in our FDA protocol. Or if you are a potential subject please consider contacting us as below.
The study follows upon what has been learned in the several PTSD studies that MAPS created and continues to conduct as we move towards the possibility of a Phase 3 study that would precede approval for medical use as a prescription drug—and in the case of MDMA, ‘a prescription process’ for which therapists will be trained in its use. As an empathogen, MDMA has been encompassed within an intense psychotherapeutic process. In our new study, MDMA’s impact on anxiety, depression, symptoms of PTSD, mindfulness, and death acceptance for individuals living with life threatening illnesses will be assessed in a double-blind placebo controlled protocol with randomization. Embedding our sessions within a thoughtful, compassionate, and healing process, we will also be involving family members and significant others—this without placebo or medication
The study will be conducted at my office for the frequent hour to hour and a half sessions and at a comfortable Marin County site for the overnight sessions, will be video recorded, and extensively documented. To be qualified for the study, subjects will be screened for a life expectancy of at least nine months duration, must not be hypertensive, or diabetic, and willing to taper psychiatric medications for the duration of the study–all of this to be discussed with me. The emotional qualification to be enrolled will be anxiety about having a life threatening illness and related feelings and concerns about relapse, recurrence, and potential death. After being accepted into the study, there will be an intense period for participation of at least twelve weeks duration–—with day long placebo and drug sessions occurring two to three weeks apart. There is a strong possibility that additional weeks will be required. Follow up will continue with assessments at six and 12 months time after the last session. It is important to consider if you are able to attend given the intensive frequency and therefore local Bay Area residency may be necessary.
We are forming a ‘Friends’ of the study group to include practitioners and interested persons from the wider Bay Area who wish to contribute expertise, referrals, volunteer, and stay aware of the process of this work.
I will be posting blog updates at regular intervals about the study on this website. Information is also available on the MAPS site: www.maps.org. We look forward to your interest and inquiry.
Philip E. Wolfson MD
email@example.com is our email