The MDMA protocol in progress involves one experimental group and two matched control groups. The subjects will be terminal cancer patients with an estimated remaining life span of less than four years and more than six months. The volunteers will be patients suffering from clinically diagnosed anxiety and depression who are in significant physical pain. The experimental group wil receive four MDMA-assisted psychotherapy treatment sessions and one session with an inactive placebo. The setting will be relaxed, with the patient listening to music with eyes closed, intermittently interacting with the therapists. One control group will receive no MDMA, but will receive five music therapy sessions lasting the same length of time as the MDMA-assisted psychotherapy sessions. The other control group will be a no-treatment group. These patients will be encouraged to seek treatment from whomever they choose. All patients will be evaluated and followed up in an identical manner.
The protocol is not designed as a double blind study. In part this is because following such a methodology would have required administering stressful spinal taps and tryptophan challenge tests even to seriously ill subjects who did not receive MDMA. In addition, the double-blind probably would not fool either the patients or physicians about who received either the placebo or the MDMA.
The protocol now has five separate sections
1. For the investigation of neurotoxic risk to the serotonin system, volunteers wil be administered both a spinal tap and a tryptophan challenge test. Drs. George Ricaurte and Lewis Seiden have been asked to review this aspect of the protocol to ensure that our methodology wil be state of the art.
2. Research into the effect of MDMA on the immune system will be conducted as part of the risk analysis and also in order to determine whether positive cathartic experiences are associated with improved functioning of the immune system. This research will help determine of imagery work conducted under the influence of MDMA can assist in a holistic approach to the treatment of cancer. Information will also be gathered about the risk of MDMA-assisted psychotherapy in AIDS patients, where some preliminary reports suggest that productive psychotherapeutic work can be conducted.
Preliminary contacts have been made with officials of the Fetzer Foundation and with Dr. George Gellert, a researcher funded by the Fetzer Foundation to investigate the survival rates of some patients in Dr. Bernie Siegel’s Exceptional Cancer Patients program. Dr. Gellert has met several tiems with Charles Grob and is interested in assisting with protocol design. If all goes well, this aspect of the protocol may help to attract some financial support and will provide excellent data on the remarkable mind/body interaction that MDMA can facilitate.
3. Another aspect of the protocol involves the investigation of the effect of MDMA-assisted psychotherapy on physical pain. We will monitor amounts of pain-killing anesthetic drugs needed and will also conduct a seried of pain sensitivity tests before, during and after the sessions.
4. An attempt will be made to describe the effect of MDMA on the psychological functioning of the volunteers during the acute period of MDMA’s action. We are hypothesizing that MDMA may be an effective adjunct to psychotherapy due to its ability to strengthen the therapeutic alliance, deepen the experience of emotion, reduce anxiety and fear, and promote a heightened sensitivity for non-habitual thinking. We will try to measure some of these concepts through non-intrusive ratings of tape and possibly video recordings of the sessions, scored by independent raters. We will also try to gather some direct information through short questionnaires and tests. David Lukoff, coauthor of an excellent review of psychedelic research in the late 1990 issue of the Journal of Transpersonal Psychology, has already helped suggest some tests. Additional consultants will soon be contacted.
5. We will also seek to determine if volunteers experience a lifting of the anxiety and depression related to their terminal status. We will be using a variety of standard measures to evaluate psychotherapy outcome, quality of life, and an index of spirituality.