Psilocybin-Assisted Psychotherapy in Patients With Advanced Cancer on Maintenance Therapy
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age25+
SponsorM.D. Anderson Cancer Center
About this trial
To learn about the feasibility, safety, and effects of psilocybin-assisted psychotherapy on depression and/or anxiety in participants who are being treated for advanced cancer.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Participants must have one of the following histology documented tumor types: non-small cell lung carcinoma, renal cell carcinoma, urothelial carcinoma, prostate cancer, head and neck squamous cell carcinoma, ovarian cancer, breast cancer, gastric/GEJ cancer, cervical, anal, or MSI-high
Documentation of locally advanced, recurrent, or metastatic incurable malignancy that has partially responded or progressed after at least 1 available standard therapy and disease is stable (no progression of disease for 3 months or more on current treatment regimen)
No prior grade 3 AEs on current standard of care cancer treatment regimen;
Age ≥ 25 years; as by the age of 25 brain is fully developed.
Disqualifiers
History of depression prior to cancer diagnosis.
History of bipolar disorder, psychosis (of any nature), and seizures.
Functionally limiting comorbid conditions such as second primary malignancies in CNS or chest, and history of total laryngectomy or total .glossectomy.
ECG with QTc > 450.
Trial design
Design model
Parallel
Treatments tested in this trial
Psilocybin
DrugGiven by PO
Niacin
Other interventionGiven by PO
Treatment groups
48 Participants
are divided into 2 treatment groupsGroup A: Arm AExperimental treatment 1 intervention
Group B: Arm BPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Safety and adverse events (AEs)
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Time frame
Through study completion; an average of 1 year.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
M.D. Anderson Cancer Center
Lead sponsor
Gateway for Cancer Research
Collaborator
Source ClinicalTrials.gov