Grob, C.S., Danforth, A.L., Chopra, G.S., Hagerty, M., McKay, C.R., Halberstadt, A.L., & Greer, G.R. (2011). Pilot study of psilocybin treatment for anxiety in patients with advanced-stage cancer. Archives of General Psychiatry, 68, 71–78.
To explore the safety and efficacy of psilocybin in patients with advanced cancer and anxiety
Each participant received two treatment sessions, one with placebo and one with psilocybin, provided in random order. A niacin placebo was used, and psilocybin was given orally at a 0.2 mg/kg dosage. Sessions took six hours, provided in a clinical research unit with direct constant staff observation. Vital signs were measured 30 minutes before drug ingestion and at hourly intervals. All had continuous Holter monitoring. Study instruments were administered the day before each session, the day after the session, two weeks after sessions, and at monthly intervals for the next six months. At the end of each session, participants discussed their experiences. Participants were followed via monthly phone calls.
A within-subjects, double-blind, placebo-controlled study design was used.
All patients completed three months of follow-up, and eight patients completed six months of follow-up. Psilocybin induced a mild but statistically significant elevation of heart rate and diastolic blood pressure compared to the placebo. Heart rate peaked at two hours, with a peak rate of 81.5 on average. Blood pressure also peaked at two hours at a mean of 138.9 systolic, compared to a baseline average of 117. Holter monitor recording showed no significant differences from placebo session results. BDI scores dropped by almost 30% from the first session to one month after the second session (p = 0.05). This difference was sustained for six months (p = 0.03). Improvement in POMs were observed in 11 patients after psilocybin administration. STAI results showed improvement in state anxiety at one month (p = 0.001) and three months (p = 0.03).
As administered here, psilocybin administration was associated with sustained improvement in depression and anxiety, with no serious cardiovascular adverse effects.
Studies done in the 1960s and 1970s showed that hallucinogens had therapeutic benefits for patients with terminal cancer, and this pilot feasibility study shows similar results. As provided here, administration of psilocybin was accomplished in a clinical research unit with constant staff monitoring, which may not be widely practical in terms of cost and manpower. Further research in the use of hallucinogens in patients with anxiety and depression are needed to determine the most appropriate dosages, and whether they can be used in a less controlled setting for therapeutic benefit. The majority of patients had prior experience with hallucinogens; it is not clear if similar results would be seen if patients had no such prior experience.