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Psychedelic
Psilocybin Therapy for Cancer-Related Anxiety
Phase 1 & 2
Recruiting
Led By Anthony Back
Research Sponsored by University of Washington
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from 14 days before the psilocybin session to 28 days (4 weeks) after the psilocybin session
Awards & highlights
Study Summary
This trial tests if psilocybin, from a mushroom, can help reduce anxiety in advanced cancer patients when combined with therapy. It is being studied for safety and side effects.
Who is the study for?
This trial is for adults aged 18-80 with metastatic cancer experiencing anxiety or depression, not on certain psychiatric meds, and without severe medical conditions like heart failure. Participants must be off SSRIs for a specific period, willing to use contraception if applicable, and able to attend therapy sessions.Check my eligibility
What is being tested?
The trial tests psilocybin-assisted therapy's safety and side effects in treating cancer-related anxiety/depression. Psilocybin activates brain serotonin receptors which may alter perceptions and reduce anxiety.See study design
What are the potential side effects?
Potential side effects of psilocybin may include changes in perception, mood swings, dizziness, nausea, headaches, increased heart rate or blood pressure. Psychological distress or intensified emotions could also occur during the experience.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from 14 days before the psilocybin session to 28 days (4 weeks) after the psilocybin session
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from 14 days before the psilocybin session to 28 days (4 weeks) after the psilocybin session
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of instances of potentially unattended psilocybin-related distress during psilocybin sessions.
Secondary outcome measures
Change in measured anxiety and depression: Hospital Anxiety and Depression Scale (HADS)
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (psilocybin, therapy)Experimental Treatment3 Interventions
Patients receive psilocybin PO and participate in group and individual therapy sessions on trial.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Psilocybin
2021
Completed Phase 2
~730
Find a Location
Who is running the clinical trial?
Steven & Alexandra Cohen FoundationOTHER
6 Previous Clinical Trials
168 Total Patients Enrolled
University of WashingtonLead Sponsor
1,741 Previous Clinical Trials
1,847,704 Total Patients Enrolled
Steven and Alexandra Cohen FoundationUNKNOWN
1 Previous Clinical Trials
20 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had any number of chemotherapy treatments.I am not using any MAOI medication and I am not allergic to psilocybin.I am between 18 and 85 years old.My doctor has diagnosed me with an incurable cancer that has spread.I am not taking any medications that affect my heart's rhythm.I have risk factors for irregular heartbeats.I haven't taken SSRIs for their full half-life plus 2 weeks.I am on medication that cannot be stopped or reduced.I will not start new psychiatric medications during the study.I do not have any illnesses that could stop me from following the trial's requirements.It has been over 4 weeks since my last surgery or radiotherapy.I do not need to have measurable signs of my disease.I am willing to join and actively participate in a group study.I have brain metastases that have not been treated.I can take care of myself and am up and about more than 50% of my waking hours.I do not have any unstable neurological or medical conditions.I can provide an adult contact for daily check-ins.I am currently taking tramadol.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (psilocybin, therapy)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Cancer Patient Testimony for trial: Trial Name: NCT05847686 — Phase 1 & 2
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Am I eligible to take part in this clinical trial?
"Patients with certain blood cancers that are aged between 18 and 80 can be accepted into this medical trial, which is seeking to enrol approximately 56 individuals."
Answered by AI
Is the age qualification for this medical experiment limited to those older than sixty?
"As specified in the inclusion criteria, participants must be within 18 and 80 years old. Moreover, there are 345 studies available for minors and 2843 trials targeting senior citizens."
Answered by AI
Are there any vacancies available in this investigation?
"According to the clinicaltrials.gov database, this trial is not presently accepting participants: it was first published on September 1st 2023 and last edited on May 5th 2023. Nevertheless, there are 3055 other medical studies that are currently enrolling patients."
Answered by AI
Who else is applying?
What state do they live in?
Washington
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0
What site did they apply to?
Fred Hutch/University of Washington Cancer Consortium
Why did patients apply to this trial?
I have a long psychiatric history. When I was 16 my psychopathic mother had me committed to Fairfax and she hired an RN to abuse me for her, who said she was a counselor - SHE WAS NOT! And was just as abusive as my mother with criticism, degradation, disrespect, etc. I ve seen 10 counselors and 10 psychiatrists and was diagnosed with 8 different mental disorders - I never had enough symptoms of any of them to be considered a person with any disorder. I didn t realize I had been an abuse survivor until I was 50. I Don t believe in Psychiatry any more. I ve had depression and anxiety all my life and I was terrorized all my life by my mother and sister. It was cruel and unusual punishment. I ve had problems with addictions.
PatientReceived no prior treatments
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