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
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
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
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: DrugTreatment
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?
| Utah | 25.0% |
| Florida | 25.0% |
| Colorado | 12.5% |
| Other | 37.5% |
How old are they?
| 65+ | 28.6% |
| 18 - 65 | 71.4% |
What site did they apply to?
| Huntsman Cancer Institute | 100.0% |
What portion of applicants met pre-screening criteria?
| Met criteria | 85.7% |
| Did not meet criteria | 14.3% |
How responsive is this trial?
Typically responds via
| 100.0% | |
Most responsive sites:
- Huntsman Cancer Institute: < 24 hours
Average response time
- < 1 Day