Clinical TrialPalliative & End-of-Life DistressPsilocybinPlaceboCompleted

Psilocybin Cancer Anxiety Study

The primary objective of this double-blind, placebo-controlled pilot crossover study (n=29) is to assess the efficacy of a single oral psilocybin dose (0.3 mg/kg) versus niacin (250 mg) on anxiety associated with cancer, with follow-up to 6 months.

Target Enrollment
29 participants
Study Type
Phase I interventional
Design
Randomized, quadruple Blind

Detailed Description

Randomized, double-blind, quadruple-masked crossover trial comparing a single oral dose of psilocybin (0.3 mg/kg) with active niacin control (250 mg) in patients with current or historical cancer-related anxiety; crossover interval ~7 weeks with follow-up assessments to 6 months.

Outcomes include anxiety related to cancer as the primary measure, and secondary measures of pain perception, depression, existential/psychospiritual distress, attitudes toward disease and death, quality of life, and mystical/spiritual states. Study conducted under IND with IRB and DEA approvals.

Study Protocol

Preparation

sessions

Dosing

2 sessions

Integration

sessions

Study Arms & Interventions

Psilocybin

experimental

Psilocybin 0.3 mg/kg oral single dose; crossover design with niacin.

Interventions

  • Psilocybin0.3 mg/kg
    via Oral• single dose• 1 doses total

    Single dose; crossover at 7 weeks; follow-up to 6 months.

Niacin

active comparator

Active niacin control (250 mg) in identical capsule.

Interventions

  • Placebo250 mg
    via Oral• single dose• 1 doses total

    Niacin 250 mg active comparator; identical opaque capsule.

Participants

Ages
18 – 76
Sexes
Male & Female

Inclusion Criteria

  • Inclusion Criteria:
  • Age: 18-76
  • Current or historical diagnosis of cancer
  • Projected life expectancy of at least one year
  • DSM-IV diagnoses: Acute Stress Disorder, Generalized Anxiety Disorder, Anxiety Disorder due to cancer, Adjustment Disorder with anxious features
  • Any stage of cancer diagnosis

Exclusion Criteria

  • Exclusion Criteria:
  • Epilepsy
  • Renal disease
  • Diabetes
  • Abnormal liver function
  • Severe cardiovascular disease
  • Malignant hypertension
  • Baseline blood pressure > 140/90
  • Personal history or immediate family members with schizophrenia, bipolar affective disorder, delusional disorder, schizoaffective disorder or other psychotic spectrum illness
  • Current substance use disorder
  • Medication contraindications: anti-seizure medications, insulin, oral hypoglycemics, clonidine, aldomet, cardiovascular medications, antipsychotics, antidepressants and mood stabilizers

Study Details

Study Team

Sponsors & Collaborators

Locations

NYU College of Dentistry Bluestone Center for Clinical Research — New York, New York, United States

Related Publications

Paywallindividual

Long-term follow-up of psilocybin-assisted psychotherapy for psychiatric and existential distress in patients with life-threatening cancer

In a 3.2–4.5 year follow-up of 15 cancer patients from a prior crossover trial, single-dose psilocybin-assisted psychotherapy produced large, sustained reductions in anxiety, depression, hopelessness, demoralisation and death anxiety, with about 60–80% maintaining clinically significant antidepressant or anxiolytic responses. Participants overwhelmingly reported enduring positive, personally meaningful and spiritually significant life changes, although definitive efficacy conclusions are limited by the parent study’s crossover design.

Published
Journal
Journal of Psychopharmacology
Authors
Agin-Liebes, G. I., Bossis, A. P., Fischer, S., Grigsby, J., Guss, J., Malone, T., Mennenga, S. E., Ponté, K. L., Ross, S., Yalch, M. M.
Open Accessindividual

Patient Experiences of Psilocybin-Assisted Psychotherapy: An Interpretative Phenomenological Analysis

This first qualitative interpretative phenomenological analysis of 13 cancer patients receiving psilocybin-assisted psychotherapy identified consistent themes — relational embeddedness, broadened emotional range, music- and vision-mediated meaning‑making, movement from separateness to interconnectedness, and revised life priorities — alongside transient distress and integration challenges. The findings indicate psilocybin-assisted psychotherapy may be a promising treatment for psychological distress in people with cancer and highlight experiential mechanisms relevant to theory and clinical practice.

Published
Journal
Journal of Humanistic Psychology
Authors
Agin-Liebes, G. I., Belser, A. B., Bossis, A. P., Devenot, N., Friedman, H. L., Guss, J., Ross, S., Swift, T. C.
Paywallindividual

Psilocybin-assisted psychotherapy improves psychiatric symptoms across multiple dimensions in patients with cancer

This pooled analysis of two Phase II RCTs (n=79) evaluates psilocybin-assisted psychotherapy (PAP/PAT) for cancer-related distress. PAT significantly improves anxiety, depression, interpersonal sensitivity, hostility, obsession-compulsion, and somatization without inducing lasting phobia, paranoia, or psychosis.

Published
Journal
Nature Mental Health
Authors
Agin-Liebes, G. I., Bogenschutz, M. P., Griffiths, R. R., Grinband, J., Kinslow, C. J., Petridis, P. D., Ross, S., Zeifman, R. J.
Open Accessindividual

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

In a double-blind, placebo-controlled crossover trial of 29 patients with cancer-related anxiety and depression, a single moderate dose of psilocybin (0.3 mg/kg) given with psychotherapy produced rapid, substantial and sustained reductions in anxiety and depression versus niacin, with around 60–80% of participants maintaining clinically significant improvements at 6.5 months. Psilocybin also reduced demoralisation and hopelessness, improved spiritual wellbeing, quality of life and attitudes to death, and the intensity of the psilocybin-induced mystical experience mediated its therapeutic effects.

Published
Journal
Journal of Psychopharmacology
Authors
Agin-Liebes, G. I., Babb, J., Belser, A. B., Bossis, A. P., Cohen, B., Corby, P., Guss, J., Kalliontzi, K., Malone, T., Mennenga, S. E., Ross, S., Schmidt, B. L., Su, Z.

Your Library