Clinical TrialAnxiety DisordersPsilocybinPlaceboCompleted

Effects of Psilocybin in Advanced-Stage Cancer Patients With Anxiety

This double-blind cross-over trial (n=12) investigates the effects of psilocybin (14 mg/70 kg; 0.2 mg/kg) versus active niacin placebo on anxiety in advanced-stage cancer patients.

Target Enrollment
12 participants
Study Type
Phase I/II interventional
Design
Randomized, quadruple Blind

Detailed Description

A randomised, double-blind, within-subject crossover pilot (n=12) tests single oral psilocybin sessions (0.2 mg/kg) versus an active niacin placebo in people with advanced cancer and clinically significant anxiety.

Each participant undergoes two overnight admissions three to six weeks apart; sessions are approximately six hours. MRI is performed prior to admission to exclude CNS involvement.

Outcomes include measures of anxiety, depression and physical pain; at least two preparatory psychotherapy meetings are provided before dosing, with safety screening including labs, ECG and pregnancy testing where applicable.

Study Protocol

Preparation

2 sessions

Dosing

2 sessions
360 min each

Integration

sessions

Therapeutic Protocol

Manualized psychotherapy included

Study Arms & Interventions

Psilocybin

experimental

Single 6-hour psilocybin session (0.2 mg/kg).

Interventions

  • Psilocybin0.2 mg/kg
    via Oral• single dose• 1 doses total

    Capsule; 6-hour monitored session.

Active Niacin Placebo

active comparator

Single 6-hour active-niacin placebo session.

Interventions

  • Placebo
    via Oral• single dose• 1 doses total

    Niacin active placebo capsule.

Participants

Ages
18 – 70
Sexes
Male & Female

Inclusion Criteria

  • Inclusion Criteria:
  • Have advanced-stage cancer and anxiety.
  • Be between the ages of 18 - 70.
  • Note: The location for the two treatment sessions is Los Angeles, California. Treatment sessions are scheduled three to six weeks apart, and they include one overnight hospital stay both times.

Exclusion Criteria

  • Exclusion Criteria:
  • Not have cancer that affects the central nervous system or brain function.
  • Have no history of major psychiatric disorder.
  • Have no kidney disease, abnormal liver functions, epilepsy, or cardiovascular disease, including untreated hypertension.
  • Not be taking insulin, oral hypoglycemic, anti-seizure, or cardiovascular medications (except anti-hypertensive drugs).
  • May take PRN benzodiazepines up to 3 days before the session.
  • No Prozac for the previous 5 weeks.
  • No medications the day of and the day after treatment sessions, except may take ongoing adjuvant chemotherapy as prescribed, prescribed or over-the-counter non-narcotic pain medication at any time, and narcotic pain medications up to eight hours before administration of psilocybin and six hours after administration.
  • No alcohol consumption the day before, the day of, and the day after a session.
  • Female subjects of childbearing potential must have a negative pregnancy test and agree to use an effective form of birth control.

Study Details

  • Status
    Completed
  • Phase
    Phase IPhase II
  • Type
    interventional
  • Design
    Randomizedquadruple Blind
  • Target Enrollment12 participants
  • Timeline
    Start: 2004-04-01
    End: 2008-12-01
  • Compounds
    PsilocybinPlacebo
  • Topic
    Anxiety Disorders

Locations

Harbor-UCLA Medical Center — Torrance, California, United States

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