Who Qualifies for Treatment?

Canada’s Controlled Drugs and Substances Act provides a means whereby the Minister of Health can grant an exemption to the Act that would permit a patient access to treatment using psilocybin in a case where it is medically necessary.

“The Minister may, on any terms and conditions that the Minister considers necessary, exempt from the application of all or any of the provisions of this Act or the regulations any person or class of persons or any controlled substance or precursor or any class of either of them if, in the opinion of the Minister, the exemption is necessary for a medical or scientific purpose or is otherwise in the public interest.” 

Section 56 (1)

This phrase ‘necessary for a medical purpose’ here is important; it is the standard that our prospective patients must satisfy.   We maintain that a medicine may rightfully be considered “necessary for a medical purpose” when:

  1. The patient is suffering ongoing significant pain that is debilitating to quality of life, and will likely continue to suffer without an effective medical intervention;
  2. That medicine shows an evidence-based likelihood that it will be helpful to the patient; and
  3. All other medicines have been tried and have proved to be ineffective; this is the only remaining medicine that offers reasonable hope of relief.

Our program of compassionate treatment focuses on patients having the following four features:

  1. They face a serious and life-threatening illness: cancer. They will likely die soon, so concerns about long-term effects of psilocybin are not relevant;
  2. They suffer from serious end-of-life psychological distress (anxiety/depression) as a result of their disease and diagnosis;
  3. They suffer from end-of-life-distress to the point that it interferes with their other medical treatments;
  4. Their emotional distress has not successfully responded to other treatments;

Clearly, given the strength of the science to date, patients having these characteristics satisfy the three criteria above for medical necessity.   For our target patients, psilocybin is indeed “necessary for a medical treatment”.  And not just possibly necessary or maybe necessary.  Our target patients represent paradigm examples of medical necessity!  If these patients cannot rightfully claim medical necessity, what patients of any kind can?

We supplement our four general criteria (a-d) with some additional detailed medical and psychiatric criteria below.   If you think that you may qualify for treatment with us, show these criteria to the medical professionals working with you, encourage them to read the research articles found on this site, and ask them to conduct a careful initial assessment of your personal situation using these criteria.  Let them know we would be pleased to consult with them.

We are, of course, not able yet to begin offering treatment.  But we are now identifying patients who would like to be candidates for treatment, people who will be the vanguard of a new approach to dealing with the challenges of dying.  We would like to hear from you!

 

Detailed Inclusion Criteria for Compassionate Treatment

 

Below is a comprehensive check-list that sets out our criteria for inclusion in our proposed program of compassionate treatment of end-of-life distress .  We have emulated the Johns Hopkins team’s Inclusion/Exclusion criteria in all clinically significant respects (though we have reformulated the wording of their exclusion criteria to form one master list of inclusion criteria).  The Hopkins criteria originate with the following December 2016 study, and are published as “Supplementary material” accompanying this paper found on page 1 of our Research Bibliography:

Griffiths R, Johnson M, Carducci M, et al. (2016) Psilocybin produces substantial and

            sustained decreases in depression and anxiety in patients with life-threatening

            cancer: A randomized double-blind trial J Psychopharmacology 30(12): 1181-1197.

We have supplemented The Hopkins criteria with two additional criteria of our own (the first two criteria under Psychiatric Inclusion Criteria) to ensure that  our target patients exhibit true medical necessity.

Medical Inclusion Criteria

  • Age: between 21 and 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.
  • 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
    • non-prescription medication,
    • nutritional supplement, or
    • herbal supplement except when approved by the treatment team.

Exceptions will be evaluated by the treatment 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.
  • NO 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 at the study site. No evidence of a focal deficit.
  • NOT in treatment in another clinical trial involving an investigational product for treatment of cancer.
  • No 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

  • No 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
  • No Cardiovascular conditions: uncontrolled hypertension, angina, a clinically significant ECG abnormality (e.g. atrial fibrilation), TIA in the last 6 months, stroke, peripheral or pulmonary vascular disease (no active claudication)
  • No blood pressure exceeding 140 systolic or 90 diastolic
  • No epilepsy with history of seizures
  • No renal insufficiency (creatinine clearance < 40 ml/min using the Cockraft and Gault equation)
  • No Insulin-dependent diabetes; if taking oral hypoglycemic agent, then no history of hypoglycemia
  • Females who are NOT pregnant (positive pregnancy test) or nursing, or are practicing an effective means of birth control
  • NOT 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., odansetron), or
    • medications that are MAO inhibitors.

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.

  • 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.
  • NOT currently using any the following of potent metabolic inducers or inhibitors:

Inducers – Rifamycin (rifampin, rifabutin, rifapentine), anticonvulsants (carbamazepine, phenytoin, phenobarbital), nevirapine, efavirenz, Taxol, dexamethasone), St Johns Wort; Inhibitors – all HIV protease inhibitors, itraconazole, ketoconazole, erythromycin, clarithromycin, troleandomycin.

  • No medical requirement that patient receive any of the following drugs with low therapeutic index within 12 hours after receiving psilocybin: ergot alkaloids, pimozide, midazolam, triazolam, lovastatin, simvastatin, fentanyl.

Psychiatric Inclusion Criteria

  • Patient emotional distress has not successfully responded to other treatments;
  • Patient suffers end-of-life-distress to the point that it interferes with their other medical treatments.
  • Have a high school or equivalent (e.g. GED) level of education. Patients without a high school or equivalent education must demonstrate reading literacy and comprehension sufficient for understanding the consent form and study questionnaires, as evaluated by study staff obtaining consent.
  • Have a DSM-IV psychiatric diagnosis of one or more of the following Axis I psychiatric disorders that is judged to have been precipitated by or exacerbated by the psychological stress of the cancer diagnosis:
    • Generalized Anxiety Disorder;
    • Acute Stress Disorder;
    • Posttraumatic 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.
  • NO severity of depression or anxiety symptoms warranting immediate treatment with antidepressant or daily anxiolytic medication (e.g., due to suicidal ideation). Patients will be interviewed to determine if referral (e.g., to Community Psychiatry) is necessary. For individuals who are consented and screened, we will notify the referring physician as to: 1) whether the individual enrolled in the compassionate treatment program or not, and 2) if disqualified, why the individual was disqualified. If disqualification was based on severe depression or anxiety (e.g., suicidal ideation), this will be included in the information conveyed to the referring physician. Permission for this contact will be obtained from the participant.
  • NO current or past history of meeting DSM-IV criteria for:
    • Schizophrenia,
    • Psychotic Disorder (unless substance-induced or due to a medical condition), or
    • Bipolar I or II Disorder
  • NO first or second degree relative with schizophrenia, psychotic disorder (unless substance induced or due to a medical condition), or bipolar I or II disorder.
  • NO current or past history within the last 5 years of meeting DSM-IV criteria for alcohol or drug dependence (excluding caffeine and nicotine).
  • Does NOT currently meet DSM-IV criteria for
    • Dissociative Disorder,
    • Anorexia Nervosa,
    • Bulimia Nervosa, or
    • other psychiatric conditions judged to be incompatible with establishment of rapport or safe exposure to psilocybin.