Effects of Psilocybin in Advanced-Stage Cancer Patients With Anxiety

NCT00302744 | Completed Phase 1 DMC

• 1 other identifier: HEFFTER11287-01
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

Psychiatric Research Study For Cancer Patients The Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center is conducting a study designed to measure the effectiveness of the novel psychoactive medication psilocybin on the reduction of anxiety, depression, and physical pain.

Conditions

Anxiety

Keywords

Anxiety; Depression; Mood; Cancer; Quality of Life; Psychiatric; Psilocybin; Alternative; Los Angeles

Outcome Measures

Primary Outcomes (1)

• Anxiety

  State-Trait Anxiety Inventory for Adults - Form Y-2

  6 months

Study Arms (2)

Psilocybin

EXPERIMENTAL

Single, 6-hour treatment with 0.2 mg/kg active psilocybin capsule.

Drug: Psilocybin (drug); Diagnostic Test: MRI

Active Niacin Placebo

ACTIVE COMPARATOR

Each subject functioned as their own control, receiving niacin placebo capsule in a single 6-hour session.

Other: Niacin; Diagnostic Test: MRI

Interventions

Psilocybin (drug) DRUG

Capsule (.2 mg/kg).

Also known as: 4-phosphoryloxy-N,N-dimethyltryptamine

Psilocybin

Niacin OTHER

Active Placebo

Also known as: nicotinamide, vitamin B3

Active Niacin Placebo

MRI DIAGNOSTIC_TEST

MRI required for study inclusion for purpose of ruling out metasteses to brain

Active Niacin Placebo; Psilocybin

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center: lead
• Heffter Research Institute: collaborator

Study Sites (1)

Harbor-UCLA Medical Center

Torrance, California, 90509, United States

Location

Related Publications (1)

• Grob CS, Danforth AL, Chopra GS, Hagerty M, McKay CR, Halberstadt AL, Greer GR. Pilot study of psilocybin treatment for anxiety in patients with advanced-stage cancer. Arch Gen Psychiatry. 2011 Jan;68(1):71-8. doi: 10.1001/archgenpsychiatry.2010.116. Epub 2010 Sep 6.

  PMID: 20819978 RESULT

MeSH Terms

Conditions

Anxiety Disorders; Depression; Neoplasms

Interventions

Psilocybin; Pharmaceutical Preparations; Niacin; Niacinamide

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Tryptamines; Indolizidines; Indolizines; Nicotinic Acids; Acids, Heterocyclic; Pyridines; Heterocyclic Compounds, 1-Ring

Study Officials

• Charles S. Grob, MD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor of psychiatry

Model Details: Within-subject cross-over study. Each participant received active drug and active placebo on separate dates.

Study Record Dates

• First Submitted: March 10, 2006
• First Posted: March 14, 2006
• Study Start: April 1, 2004
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: March 13, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)