Clinical trial · Interventional
Effects of Psilocybin in Advanced-Stage Cancer Patients With Anxiety
NCT00302744CI-TRIAL-00087164completedPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anxiety | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MRI | Diagnostic Test | — | UNRESOLVED |
| Niacin | Other | — | UNRESOLVED |
| Psilocybin (drug) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Psilocybin
- description
- Single, 6-hour treatment with 0.2 mg/kg active psilocybin capsule.
- interventionNames
- Drug: Psilocybin (drug)
- Diagnostic Test: MRI
- type
- ACTIVE_COMPARATOR
- label
- Active Niacin Placebo
- description
- Each subject functioned as their own control, receiving niacin placebo capsule in a single 6-hour session.
- interventionNames
- Other: Niacin
- Diagnostic Test: MRI
Primary outcomes (1)
- measure
- Anxiety
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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: * 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.
References
Publications (1)
- RESULTGrob 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