For the past year our research team at Harbor-UCLA Medical Center has been conducting a double-blind, placontrolled investigation of the effects of psilocybin in subjects with advanced, metastatic cancer who have severe existential anxiety. Following up on the encouraging findings of researchers in the 1960s and early 1970s, including Eric Kast, M.D., Walter Pahnke, M.D., and Stanislav Grof, M.D., who studied the effects of psychedelics with terminally ill patients, we have constructed and implemented a protocol using contemporary, state-of-the-art research methodologies.
Following screening and entry into the study, all subjects are admitted on two separate occasions, approximately four weeks apart, to the Harbor-UCLA Medical Center Clinical Research Unit. Each subject receives one placebo session and one session with the experimental medicine, psilocybin, administered in variable order. Subjects are admitted the evening before the morning treatment session, and are allowed to leave following treatment in the late afternoon with a friend or family member driver. In addition to formal psychological data collection, we have also been recording Holter cardiac monitors during the sessions. The research team remains with the subject for the entire duration of the treatment session.
Although the primary variable is anxiety, we are also exploring acute and subsequent mood regulation, pain perception, need for narcotic pain medications and overall function and quality of life calibrated for patients with advanced cancer. Thus far, recruitment of subjects has proceeded at a moderate pace, with four subjects out of the total twelve we are approved for enrolled and completing the treatment study. While it is far too early to break the blind and formally analyze the data, preliminary observations to date have been very encouraging.
A relatively strict set of inclusion/exclusion criteria has been selected for this first approved research investigation of this type in over thirty years. Additional information concerning our methodology and inclusion/exclusion criteria can be seen at www.canceranxietystudy.org.
The approved dose of psilocybin employed is 0.2 mg/kg, sufficient for what has appeared to be a significant psycholytic (more psychoanalytic than mystical) experience in all cases observed thus far. The model employed consists of lying quietly listening through headphones to preselected music and wearing eye shades. We are fortunate to have access on the clinical research unit to the room formerly used for sleep research, which has good sound insulation from outside noise. During treatment sessions subjects are encouraged to lie quietly in bed, listening to the music. At each hour point, we check the blood pressure and ask our subject how he or she is doing. For the first four hours we keep discussion to a minimum, encouraging subjects to lie down again and go deeply into the experience. For the final two hours, we engage in more detailed processing of the experience. Continued processing also occurs in the days, weeks and months following treatment.
After treatment has completed, contact is formally sustained for six months, including detailed follow-up questionnaires and inventories, with informal connection maintained in most cases well beyond the completion of formal data collection. All subjects to date have reported positive experiences during the treatment they believed to involve administration of the active experimental medicine, psilocybin. Each of the subjects also recommended that subsequent protocols should include the opportunity for at least one additional “booster” session.
Valued members of our research team at Harbor-UCLA include Preet Chopra, M.D. and Marycie Hagerty, R.N. Funding for this psilocybin investigation has been provided by the Heffter Research Institute.