Psilocybin With Psychotherapy for Improving Chronic Pain in Cancer Patients Requiring Opioids
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorRoswell Park Cancer Institute
About this trial
This phase II trial studies whether psilocybin with psychotherapy is safe and if it works for improving chronic pain in cancer patients who require opioids to manage their pain. Psilocybin is taken from the mushroom Psilocybe mexicana. Psilocybin acts on the brain to cause hallucinations (sights, sounds, smells, tastes, or touches that a person believes to be real but are not real). This may impact a patient's "total pain", a view that accounts for the psychological, spiritual, and social factors that contribute to their experience of pain. Psychotherapy uses methods such as discussion, listening, and counseling to help patients change the way they react to environmental triggers that may cause a negative reaction. Giving psilocybin with psychotherapy may be safe and helpful for improving chronic pain in cancer patients who require opioids to manage their pain.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 18 and ≤ 75 years old
Diagnosis of active cancer, any stage
Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
Estimated prognosis of ≥ 3 months at the time of enrollment, determined by participant's primary oncologist or palliative physician
Disqualifiers
Participants who are pregnant or breast-feeding
Participants of childbearing potential who decline to use a highly effective dual contraceptive method for the duration of the study
Participants with a condition impairing oral intake or digestive absorption
Cognitive impairment as defined by Montreal Cognitive Assessment (MOCA) score < 23
Trial design
Design model
Single group
Treatments tested in this trial
Biospecimen Collection
Procedure/SurgeryUndergo collection of blood and urine samples
Functional Magnetic Resonance Imaging
Procedure/SurgeryUndergo fMRI
Interview
Other interventionAncillary studies
Psilocybine
DrugGiven PO
Psychotherapy
BehavioralAttend psychotherapy sessions
Questionnaire Administration
Other interventionAncillary studies
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: Supportive care (psychotherapy, psilocybin)Experimental treatment 6 interventions
Trial outcomes
Primary outcomes
1
Incidence of adverse events (AEs)
AE assessments will be performed at each treatment session and all subsequent in-person and virtual visits. This will be clinician-observed events. These evaluations will utilize the established Common Terminology Criteria for Adverse Events version 5.0. AEs will be summarized by attribution and grade using frequencies and relative frequencies, where the grade 3+ AE rate will be estimated with 90% credible regions obtained by Jeffrey's prior method. Additionally, a continual safety monitoring plan will be utilized to ensure study suspension should the AE rates exceed pre-defined thresholds.
Time frame
From start date of intervention to 30 days after the last intervention2
Change in Vital signs
Continuous Vital signs will be assessed and summarized by timepoint using the appropriate descriptive statistics. The change in these measures will be modeled as a function of time and a random subject effect using linear mixed models, where tests about the appropriate contrasts of model estimates will be used to identify significant changes relative to pre-treatment levels. All model assumptions will be verified graphically.
Time frame
Up to baseline, dosing sessions 1 and 2 up to day 843
Incidence of clinically important changes in ICG parameters
To assess any changes in EKG records from baseline EKG to day 28 EKG
Time frame
At baseline and day 284
Change in risk for suicide
Will be assessed using the Columbia-Suicide Severity Rating Scale. Will be summarized by timepoint using the appropriate descriptive statistics. The change will be modeled as a function of time and a random subject effect using linear mixed models, where tests about the appropriate contrasts of model estimates will be used to identify significant changes relative to pre-treatment levels. All model assumptions will be verified graphically.
Time frame
At baseline, dosing sessions 1, 2, 3, 5, and 7, and days 28, 56, and 84Secondary outcomes
1
Change in average pain intensity
The reported average pain will be assessed via the Brief Pain Inventory-Short Form, which includes multiple pain-related questions using an 11-point Numerical Rating Scale. A decrease by 30% or 2 points is regarded as clinically meaningful. Will be summarized by timepoint (baseline and by micro-dose session) using the appropriate descriptive statistics and graphical summaries. The log of each outcome will be modeled as a function of timepoint and a random subject effect using a linear mixed model. Tests about the appropriate contrasts of model estimates will be used to evaluate changes of interest. All model assumptions will be verified graphically.
Time frame
At baseline and days 3, 7, 28, 56, and 842
Change in rescue opioid requirement
Will be measured in Oral Morphine Equivalents. Will be assessed via participant self-report with medication log and further verified with pill count. Will be summarized by timepoint (baseline and by micro-dose session) using the appropriate descriptive statistics and graphical summaries. The log of each outcome will be modeled as a function of timepoint and a random subject effect using a linear mixed model. Tests about the appropriate contrasts of model estimates will be used to evaluate changes of interest. All model assumptions will be verified graphically.
Time frame
At baseline and days 3, 7, 28, 56, and 84Sponsors and contacts
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Source ClinicalTrials.gov
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