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

Locations

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

Your Library