Psilocybin for Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Huntsman Cancer Institute, Salt Lake City, UTCancerPsilocybin - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial will offer psilocybin therapy in a group setting with a decreased therapist to subject ratio in order to assess feasibility. Seven group therapy sessions will include prep, psilocybin, and integration sessions occurring on a weekly basis.

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

11 Primary · 0 Secondary · Reporting Duration: 18 months

18 months
Consent of patients with a cancer diagnosis or hematologic malignancy
Enrollment of patients with a cancer diagnosis or hematologic malignancy
recruitment of patients with cancer diagnosis or hematologic malignancy
8 months
Number of adverse events (AEs) and serious adverse events (SAEs) characterized by duration
Number of adverse events (AEs) and serious adverse events (SAEs) characterized by duration.
Number of adverse events (AEs) and serious adverse events (SAEs) characterized by relationship to study treatment.
Number of adverse events (AEs) and serious adverse events (SAEs) characterized by seriousness
Number of adverse events (AEs) and serious adverse events (SAEs) characterized by seriousness.
Number of adverse events (AEs) and serious adverse events (SAEs) characterized by severity
Number of adverse events (AEs) and serious adverse events (SAEs) characterized by type
Number of adverse events (AEs) and serious adverse events (SAEs) characterized by type.

Trial Safety

Safety Progress

1 of 3

Side Effects for

Diphenhydramine
9%Nausea
7%Pain
7%Bronchitis
7%Viral upper resp. tract infection
7%Back pain
4%Depression
4%Insomnia
4%Oropharyngeal pain
4%Diarrhea
4%Influenza
4%Suicidal Ideation
4%Headache
4%Sinus headache
4%Alcohol withdrawal syndrome
4%Depressed mood
4%Lower resp. tract congestion
2%Endodontic procedure
2%Anemia
2%Thrombocytosis
2%Gingivitis
2%Fungal infection
2%Dermatitis contact
2%Restlessness
2%Pyrexia
2%Hyponatremia
2%Rhinorrhea
2%Sinus congestion
2%Constipation
2%Vomiting
2%Sexual abuse
2%Arthoscopic surgery
2%Oedema
2%Peripheral swelling
2%Bronchitis bacterial
2%Eye infection
2%Arthralgia
2%Musculoskeletal pain
2%Sedation
2%Mallory-Weiss Syndrom
2%Influenza like Illness
2%Traumatic lung injury
2%Pain in extremity
2%Malignant melanoma
2%Dizziness
2%Hypoesthesia
2%Migraine
2%Anger
2%Anxiety
2%Cough
This histogram enumerates side effects from a completed 2021 Phase 2 trial (NCT02061293) in the Diphenhydramine ARM group. Side effects include: Nausea with 9%, Pain with 7%, Bronchitis with 7%, Viral upper resp. tract infection with 7%, Back pain with 7%.

Trial Design

1 Treatment Group

Treatment: all patients
1 of 1

Experimental Treatment

12 Total Participants · 1 Treatment Group

Primary Treatment: Psilocybin · No Placebo Group · Phase < 1

Treatment: all patients
Drug
Experimental Group · 1 Intervention: Psilocybin · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Psilocybin
Not yet FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 18 months

Who is running the clinical trial?

University of UtahLead Sponsor
1,008 Previous Clinical Trials
1,787,370 Total Patients Enrolled
Usona InstituteOTHER
11 Previous Clinical Trials
482 Total Patients Enrolled
Anna Beck, MDPrincipal InvestigatorHuntsman Cancer Institute

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
I can speak English fluently.
The patient has a very good performance status.
Volunteers must have a high school or equivalent level of education in order to participate in the study
A person aged ≥ 25 years old, either male or female.
Someone who has been diagnosed with cancer and is currently undergoing treatment or has completed treatment within the last 26 weeks is eligible to participate in this study.
Your pet has a life expectancy of 3 months or more.
The subject should have a support person to escort them home after taking psilocybin.
The subject is able to provide consent and is willing to sign an approved consent form.
A depression disorder, including an adjustment disorder with disturbance of mood, is currently diagnosed using DSM-V.
Not taking medication to treat depression and/or anxiety for at least 4 weeks prior to initiation of the study.

Who else is applying?

What state do they live in?
Utah25.0%
Florida25.0%
Colorado12.5%
Other37.5%
How old are they?
65+28.6%
18 - 6571.4%
What site did they apply to?
Huntsman Cancer Institute100.0%
What portion of applicants met pre-screening criteria?
Met criteria85.7%
Did not meet criteria14.3%

How responsive is this trial?

Typically responds via
Email100.0%
Most responsive sites:
  1. Huntsman Cancer Institute: < 24 hours
Average response time
  • < 1 Day