Psilocybin

To examine the effect of two psilocybin doses on symptoms of anxiety and depression among patients with advanced cancer

Participants were assigned to two groups: one received low-dose psyilocybin in the first session and high-dose psyilocybin in a second session. The other group received psilocybin doses in reverse order. The first session was done about one month after study entry, and the second session was five weeks later. Study measures were obtained at baseline, during, and at the end of each session, and approximately six months later. Session monitors met with patients prior to sessions to establish rapport and prepare the patient for the sessions. Drug session were done in a living room-like environment with two monitors present.

• N: 56 (46 at 6 months)   
• MEAN AGE: 56.3 years (SD = 1.4)
• MALES: 51%  
• FEMALES: 49%
• CURRENT TREATMENT: Not applicable
• KEY DISEASE CHARACTERISTICS: All had life-threatening cancer diagnoses and DSM-IV diagnoses of anxiety or mood symptoms  Various tumor types
• OTHER KEY SAMPLE CHARACTERISTICS: 69% married, 47% used cannabinoids, 51% had prior medication for anxiety or depression.  Almost all had at least a college education

• SITE: Single site   
• SETTING TYPE: Outpatient    
• LOCATION: Johns Hopkins, Maryland

• PHASE OF CARE: End-of-life care
• APPLICATIONS: Palliative care

Crossover, double blind, randomized study

• Cardiovascular monitoring during sessions
• Session monitor ratings of participant behaviors and mood throughout session
• Hallucinogen Rating Scale
• 5 Dimension Altered States of Consciousness
• Mysticism Scale
• States of Consciousness Questionnaire
• Mystical Experience Questionnaire
• GRID-HAM-D-17 (for depression)
• HAM_A (for anxiety)
• Beck Depression Inventory
• Hospital Anxiety and Depression Scale 
• POMS 
• Spiritual Religious Outcomes Scale
• STAI State trait anxiety

There were no serious adverse effects of the intervention. There were transient moderate increases in blood pressure after psilocybin. Transient psychological distress was seen in some patients with high-dose psilocybin. All measures of depression, anxiety, and total mood disturbance showed significant improvement with high dose (p < 0.001). Death acceptance and optimism also were increased with high-dose intervention (p < 0.01). These changes were maintained at 6 months.

High-dose psilocybin under supportive conditions was shown to decrease symptoms of depression and anxiety, and improve mood, optimism, acceptance of death and spirituality. These effects were generally maintained for months after drug use.

• Small sample (< 100)
• Risk of bias (no control group)
• Measurement validity/reliability questionable
• Intervention expensive, impractical, or training needs
• Other limitations/explanation: Subjects took a large battery of tests repeatedly raising the question of possible testing affect and subject fatigue. The intervention was provided in a controlled supportive environment

Administration of psilocybin under controlled supportive conditions was shown to have multiple benefits for patients with terminal cancers. Further confirmatory research is warranted, and research comparing outcomes with psilocybin to other appropriate interventions would be helpful.