Ketamine-Assisted PsychoTherapy ViAbility in Treating Cancer-related Emotional Distress
Stopped: Study team is not moving forward with protocol
0Started 2023-10-31
Plain-language summary
The present study will investigate if ketamine-assisted psychotherapy during palliative radiation therapy is safe, feasible, and effective at reducing psychological distress.
Who can participate
Age range21 Years – 65 Years
SexALL
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Inclusion Criteria:
* Subject have provided informed consent
* Male or female ≥ 21 to ≤ 65years 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 (Appendix 1) 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 ameno…
What they're measuring
1
Percentage of population completing at least one KAP session.
Timeframe: Within 6 months from completion of radiation therapy