Psychopharmacology of Psilocybin in Cancer Patients

NCT00465595 | Completed Phase 2 Results DMC

• 2 other identifiers: NA_00001390Johns Hopkins IRB5 NA_00001390
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

This research is being done to study the psychological effects of psilocybin in cancer patients. Psilocybin is a naturally occurring substance found in some mushrooms that some cultures have used for centuries in religious practices.

Conditions

Depressive Symptoms; Anxiety; Cancer

Outcome Measures

Primary Outcomes (2)

• GRID-HAM-D-17 -- Structured Interview Guide for the Hamilton Depression Scale.

  The GRID-Hamilton Depression Rating Scale is a 17-item clinician-administered rating scale designed to assess severity of depressive symptoms. The score range for the GRID-HAMD is 0 to 52, with higher score indicating more severe depression. For this clinician-rated measure, a clinically significant response was defined as ⩾50% decrease in measure relative to Baseline; symptom remission was defined as ⩾50% decrease in measure relative to Baseline and a score of ⩽7 on the GRID-HAMD

  Baseline, 5 weeks post session 1 and 2, 6-month follow-up

• HAM-A Assessed With the SIGH-A -- a Structured Interview Guide for the Hamilton Anxiety Rating Scale (SIGH-A).

  The Hamilton Anxiety Rating Scale is a 14-item clinician-administered rating scale designed to assess severity of anxiety symptoms. The score range for the HAM-A is 0 to 56, with higher score indicating more severe anxiety. For this clinician-rated measure, a clinically significant response was defined as ⩾50% decrease in measure relative to Baseline; symptom remission was defined as ⩾50% decrease in measure relative to Baseline and a score of ⩽7 on the GRID-HAM-A

  Baseline, 5 weeks post session 1 and 2, 6-month follow-up

Study Arms (2)

Low Dose First, High Dose Second

EXPERIMENTAL

The Low-Dose-1st Group received the low dose of psilocybin on the first session and the high dose on the second session

Drug: psilocybin

High Dose First, Low Dose Second

EXPERIMENTAL

The High-Dose-1st Group received the high dose of psilocybin on the first session and the low dose on the second session

Drug: psilocybin

Interventions

psilocybin DRUG

The dose of psilocybin received in the two sessions will range anywhere from low to high.

Also known as: O-phosphoryl-4-hydroxy-N,N-dimethyltryptamine

High Dose First, Low Dose Second; Low Dose First, High Dose Second

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Volunteers must:
• Have given written informed consent
• Have a high school level of education
• Be 21 to 80 years old
• Has or has had a cancer diagnosis that is potentially life-threatening. Patients with an active cancer (e.g. stage III or IV with a poor prognosis) or disease progression or recurrence are eligible. Patients who do not have an active cancer or disease progression or disease recurrence are only eligible if at least 1 year has elapsed since their diagnosis.
• Have an ECOG performance status of 0, 1, or 2.
• Have a DSM-IV psychiatric diagnosis, as determined by the SCID, of one or more of the following Axis I psychiatric disorders that is either precipitated by or exacerbated by the psychological stress of the cancer diagnosis: Generalized Anxiety Disorder; Acute Stress Disorder; Post traumatic Stress Disorder; Major Depressive Disorder (mild or moderate severity); Dysthymic Disorder; Adjustment Disorder with Anxiety; Adjustment Disorder with Depressed Mood; Adjustment Disorder with Mixed Anxiety and Depressed Mood; Adjustment Disorder with Disturbance of Conduct; Adjustment Disorder with Disturbance of Emotions and Conduct. Psychiatric diagnosis will be determined by BPRU staff.
• Patients receiving chemotherapy, hormonal therapy, radiation therapy, biologic therapies may participate while receiving those therapies. Continuing hormonal therapy, chemotherapy, or radiation treatment is acceptable if the patient is tolerating the therapy or treatment in a sufficient fashion to allow administration of oral psilocybin.
• Agree that for one week preceding each psilocybin session, he/she will refrain from taking any nonprescription medication, nutritional supplement, or herbal supplement except when approved by the research team. Exceptions will be evaluated by the research team and will include acetaminophen, non-steroidal anti-inflammatory drugs, and common doses of vitamins and minerals.
• Agree not to use nicotine for at least 2 hours before psilocybin administration, and not again until questionnaires have been completed approximately 7 hours after psilocybin administration.
• Agree to consume approximately the same amount of caffeine-containing beverage (e.g., coffee, tea) that he/she consumes on a usual morning, before arriving at the research unit on the mornings of psilocybin session days. If the patient does not routinely consume caffeinated beverages, he or she must agree not to do so on psilocybin session days.
• Agree not to take any PRN medications on the mornings of psilocybin sessions, with the exception of daily opioid pain medication. Non-routine PRN medications for treating breakthrough pain that were taken in the 24 hours before the psilocybin session may result in rescheduling the treatment session, with the decision at the discretion of the investigators.
• Agree to refrain from using any psychoactive drugs, including alcoholic beverages, within 24 hours of each psilocybin administration. As described elsewhere, exceptions include daily use of caffeine, nicotine, and opioid pain medication.

You may not qualify if:

• Cancer with known CNS involvement, or other major CNS disease. In addition to diagnostic results provided by the referring physician, patients will undergo a neurological exam performed by our BPRU internist. Any patient with evidence of a focal deficit will be excluded.
• Hepatic dysfunction as indicated by the following values:
• GGT \> 3 x ULN (upper limit of norm)
• AST \> 3 x ULN
• ALT \> 3 x ULN
• Tot Bili \> 3.0 mg/dl
• Known paraneoplastic syndrome or "ectopic" hormone production by the primary tumor such as the patient could have or be at risk for hypercalcemia, Cushing's syndrome, hypoglycemia, syndrome of inappropriate antidiuretic hormone secretion, or carcinoid syndrome
• Cardiovascular conditions: uncontrolled hypertension, angina, a clinically significant ECG abnormality (e.g. atrial fibrillation), TIA in the last 6 months, stroke, peripheral or pulmonary vascular disease (no active claudication)
• Blood pressure exceeding screening criteria described below
• Epilepsy with history of seizures
• Renal disease (creatinine clearance \< 40 ml/min using the Cockcroft and Gault equation)
• Insulin-dependent diabetes; if taking oral hypoglycemic agent, then no history of hypoglycemia
• Females who are pregnant (positive pregnancy test) or nursing, or are not practicing an effective means of birth control
• Currently taking on a regular (e.g., daily) basis: investigational agents, psychoactive prescription medications (e.g., benzodiazepines), medications having a primary pharmacological effect on serotonin neurons (e.g., ondansetron), or medications that are MAO inhibitors. Long-acting opioid pain medications (e.g. oxycodone sustained release, morphine sustained release -- which are usually taken at 12 hour intervals) will be allowed if the last dose occurred at least 6 hours before psilocybin administration; such medication will not be taken again until at least 6 hours after psilocybin administration.
• For individuals who have intermittent or PRN use of investigational agents, psychoactive prescription medications, medications having a primary pharmacological effect on serotonin neurons, or medications that are MAO inhibitors, psilocybin sessions will not be conducted until at least 5 half-lives of the agent have elapsed after the last dose.

Sponsors & Collaborators

• Johns Hopkins University: lead
• Heffter Research Institute: collaborator

Study Sites (1)

Behavioral Pharmacology Research Unit, Johns Hopkins Bayview Campus

Baltimore, Maryland, 21224, United States

Location

Related Publications (1)

• Griffiths RR, Johnson MW, Carducci MA, Umbricht A, Richards WA, Richards BD, Cosimano MP, Klinedinst MA. Psilocybin produces substantial and sustained decreases in depression and anxiety in patients with life-threatening cancer: A randomized double-blind trial. J Psychopharmacol. 2016 Dec;30(12):1181-1197. doi: 10.1177/0269881116675513.

  PMID: 27909165 RESULT

MeSH Terms

Conditions

Depression; Anxiety Disorders; Neoplasms

Interventions

Psilocybin

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Intervention Hierarchy (Ancestors)

Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Tryptamines; Indolizidines; Indolizines

Results Point of Contact

• Title: Roland R. Griffiths, Ph.D., Principal Investigator
• Organization: Johns Hopkins University School of Medicine

rgriff@jhmi.edu

4105500034

Study Officials

• Roland R Griffiths, Ph.D.

  Johns Hopkins School of Medicine, Psychiatry Dept.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2007
• First Posted: April 25, 2007
• Study Start: April 1, 2007
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2016
• Last Updated: July 19, 2018
• Results First Posted: July 19, 2018

Record last verified: 2018-06

Locations

US (1)