Ketamine-Assisted PsychoTherapy ViAbility in... — Clinical Trial Details

Open-label, single-group early-phase study evaluating safety, feasibility, and preliminary effectiveness of three ketamine-assisted psychotherapy (KAP) sessions in patients receiving palliative radiation therapy with moderate–severe cancer-related anxiety or depression.

Each participant receives a preparatory session, three IM KAP sessions (individualised Ketalar dosing ≤60 mg or 1 mg/kg; ~3 hours per session) with a psychotherapist, and integration sessions the day after each KAP and one month after the final session.

Outcome measures include repeated assessments of depression, anxiety, and existential distress (GRID-HAM-D17, HAM-A) and feasibility/safety endpoints during and after the treatment package.

Participants

Ages

21 – 65

Sexes

Male & Female

BMI

Psychosis History

Excluded

Inclusion Criteria

Inclusion Criteria:
Subject have provided informed consent
Male or female ≥ 21 to ≤ 65 years of age at signing of informed consent
Moderate-severe anxiety or depression related to cancer as measured by the GRID-HAM-D17 (depression) or the HAM-A (anxiety)
Prescribed a radiation therapy course with palliative intent. Radiation therapy will be given priority with respect to scheduling and delivery over appointments related to KAP. Patients may begin the KAP process as soon as they are able after enrollment as long as it does not interfere with or delay receipt of radiation therapy. The timing of KAP/ RT can be either concurrent or sequential with RT coming first based on convenience to the patient and treatment teams, although completing the treatment expediently will be encouraged. Total treatment package time should be less than 3 months from CT simulation.
A female subject of childbearing potential who is sexually active with a non-sterilized male partner must agree to consistently and correctly use a highly effective method of contraception with a failure rate of < 1% per year during the study and for at least 90 days after study drug administration. If a hormonal contraceptive is used, it must have been initiated at least 1 month before dosing.
Negative pregnancy test (women only)
Female subject of non-childbearing potential must be either: surgically sterile (hysterectomy, tubal ligation, or bilateral oophorectomy), or post-menopausal with amenorrhea for at least 2 years and documented follicle-stimulating hormone (FSH) levels ≥30 mIU/mL, or must use a medically accepted double-barrier contraceptive method during the study and for at least 90 days after study drug administration.
Male subject must agree to use prophylactic contraception
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 intramuscular ketamine
Agree that for one week preceding each KAP 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 KAP administration, and not again until questionnaires have been completed approximately 7 hours after KAP 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 KAP session days. If the patient does not routinely consume caffeinated beverages, he or she must agree not to do so on KAP session days.
Agree not to take any PRN medications on the mornings of KAP 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 KAP 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 KAP administration. As described elsewhere, exceptions include daily use of caffeine, nicotine, and opioid pain medication.
Willingness to not driving for 24 hours following study drug administration
English proficiency
Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria

Exclusion Criteria:
Karnofsky Performance Scale (KPS) index of 60 or less
Patients will be excluded if they are in treatment in another clinical trial involving an investigational product for treatment of cancer.
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 fibrilation), TIA in the last 6 months, stroke, peripheral or pulmonary vascular disease (no active claudication)
Systolic blood pressure >140 mmHG or < 85 mmHg or diastolic blood pressure >90mmHg or heart rate of > 110 beat per minutes. Pulse oximetry of 94% or less.
Epilepsy with history of seizures
Renal insufficiency (creatinine clearance < 40 ml/min using the Cockcroft and Gault equation)
Uncontrolled hyperthyroidism (low thyroid stimulating hormone with high T3 or T4)
Insulin-dependent diabetes; if taking oral hypoglycemic agent, then no history of hypoglycemia
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 12 hours before KAP administration; such medication will not be taken again until at least 6 hours after KAP administration.
Current or history of schizophrenia, psychotic disorder, bipolar disorder, delusional disorder, paranoid personality disorder, substance use disorder, schizoaffective disorder, or borderline personality disorder, as assessed by medical history. Patients who have bipolar disorder but are not currently in a manic state may be included based on judgement of investigators.
Patients with first or second-degree relatives with schizophrenia, non-substance induced psychotic disorder, or bipolar disorder
Increased risk of intracranial pressure:
- Recent ischemic or hemorrhagic cerebral vascular accident in the last 1 month.
- Brain tumors with symptoms and signs of increased intracranial pressure.

Company

Product

Legal

Ketamine-Assisted PsychoTherapy ViAbility in Treating Cancer-related Emotional Distress

Detailed Description

Study Protocol

Preparation

Locations

Dosing

Integration

Therapeutic Protocol

Study Arms & Interventions