Rapid and sustained symptom reduction following psilocybin treatment for anxiety and depression in patients with life-threatening cancer: a randomized controlled trial

Abstract

Background:Clinically significant anxiety and depression are common in patients with cancer, and are associated with poor psychiatric and medical outcomes. Historical and recent research suggests a role for psilocybin to treat cancer-related anxiety and depression.Methods:In this double-blind, placebo-controlled, crossover trial, 29 patients with cancer-related anxiety and depression were randomly assigned and received treatment with single-dose psilocybin (0.3 mg/kg) or niacin, both in conjunction with psychotherapy. The primary outcomes were anxiety and depression assessed between groups prior to the crossover at 7 weeks.Results:Prior to the crossover, psilocybin produced immediate, substantial, and sustained improvements in anxiety and depression and led to decreases in cancer-related demoralization and hopelessness, improved spiritual wellbeing, and increased quality of life. At the 6.5-month follow-up, psilocybin was associated with enduring anxiolytic and anti-depressant effects (approximately 60–80% of participants continued with clinically significant reductions in depression or anxiety), sustained benefits in existential distress and quality of life, as well as improved attitudes towards death. The psilocybin-induced mystical experience mediated the therapeutic effect of psilocybin on anxiety and depression.Conclusions:In conjunction with psychotherapy, single moderate-dose psilocybin produced rapid, robust and enduring anxiolytic and anti-depressant effects in patients with cancer-related psychological distress.Trial Registration: ClinicalTrials.gov Identifier: NCT00957359

The Therapeutic Potential of Psychedelic Drugs: Past, Present, and Future

“…There are now positive preliminary reports on the safety and tolerability of psilocybin for obsessive compulsive disorder (OCD) (Moreno, Wiegand, Taitano & Delgado, 2006), psilocybin and LSD for end-of-life psychological distress (Gasser et al, 2014b;Griffiths et al, 2016;Grob et al, 2011;Ross et al, 2016), psilocybin for alcohol (Bogenschutz, Forcehimes, Pommy, Wilcox, Barbosa & Strassman, 2015b) and tobacco addiction (Johnson, Garcia-Romeu, Cosimano & Griffiths, 2014) and ayahuasca (Osorio Fde et al, 2015) and psilocybin for major depressive disorder (Carhart-Harris et al, 2016). An important caveat here, is that many of these trials report on small sample sizes and would best be described as 'safety and tolerability' studies by conventional standards (Schunemann et al 2006), and while all of them do report outcomes consistent with potential efficacy, most have not been appropriately designed to demonstrate it conclusively.…”

“…An important caveat here, is that many of these trials report on small sample sizes and would best be described as 'safety and tolerability' studies by conventional standards (Schunemann et al 2006), and while all of them do report outcomes consistent with potential efficacy, most have not been appropriately designed to demonstrate it conclusively. Guy Goodwin critically discusses two of the largest and better designed trials in the next section (Griffiths et al, 2016;Ross et al, 2016).…”

Psychiatry & the psychedelic drugs. Past, present & future

“…Finally, four separate studies have been published on the use of psychedelics in end-of-life anxiety associated with life threatening illness (Gasser et al, 2014;Griffiths et al, 2016;Grob et al, 2011;Ross et al, 2016). Charles Grob and colleagues, working in California, United States, gave 12 subjects (11 women) a moderate (0.2 mg/kg) dose of psilocybin and an active placebo (niacin 250 mg) several weeks apart with psychological support in a double-blind design in which subjects acted as their own control (Grob et al, 2011).…”

“…Two larger, double blind, randomised, placebo-controlled crossover trials investigating the efficacy of psilocybin in the treatment of anxiety and depression in patients with lifethreatening cancer diagnoses were published from two separate groups in the United States in 2016 (Griffiths et al, 2016;Ross et al, 2016).…”

“…To exemplify, modern RCTs with psilocybin have shown large effect sizes in distress associated with life threatening disease (Griffiths et al, 2016;Ross et al, 2016), however in these studies the psychological support provided was extensive. Criticism of these trials reflects this (Sellers and Leiderman, 2017).…”