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Psychedelic
Psilocybin Therapy for Cancer (HOPE Trial)
Phase < 1
Waitlist Available
Led By Anna Beck, MD
Research Sponsored by University of Utah
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 18 months
Awards & highlights
HOPE Trial 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.
Who is the study for?
This trial is for cancer patients aged 25 or older with a high school education level or equivalent, currently treated for cancer or within 26 weeks post-treatment, and expected to live at least another 3 months. They must have depression related to their condition but not be on antidepressants recently. Participants need good liver function, non-pregnant females must use contraception, and all must have support after psilocybin sessions.Check my eligibility
What is being tested?
The study tests the feasibility of group psychotherapy enhanced by psilocybin (a psychedelic compound) in a reduced therapist-to-patient setting. It includes seven therapy sessions: three preparatory, one main session with psilocybin lasting eight hours, followed by integration sessions to discuss experiences.See study design
What are the potential side effects?
While specific side effects are not listed here, typical reactions to psilocybin can include changes in perception, mood swings, nausea, disorientation or confusion during the immediate period following its administration.
HOPE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 18 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~18 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Consent of patients with a cancer diagnosis or hematologic malignancy
Enrollment of patients with a cancer diagnosis or hematologic malignancy
Number of adverse events (AEs) and serious adverse events (SAEs) characterized by duration
+8 moreSide effects data
From 2021 Phase 2 trial • 95 Patients • NCT020612939%
Nausea
7%
Pain
7%
Viral upper resp. tract infection
7%
Back pain
7%
Bronchitis
4%
Suicidal Ideation
4%
Oropharyngeal pain
4%
Insomnia
4%
Influenza
4%
Depression
4%
Diarrhea
4%
Headache
4%
Sinus headache
4%
Depressed mood
4%
Lower resp. tract congestion
4%
Alcohol withdrawal syndrome
2%
Restlessness
2%
Fungal infection
2%
Rhinorrhea
2%
Pyrexia
2%
Hypoesthesia
2%
Oedema
2%
Vomiting
2%
Musculoskeletal pain
2%
Peripheral swelling
2%
Thrombocytosis
2%
Eye infection
2%
Constipation
2%
Dermatitis contact
2%
Bronchitis bacterial
2%
Traumatic lung injury
2%
Hyponatremia
2%
Arthralgia
2%
Pain in extremity
2%
Dizziness
2%
Migraine
2%
Sedation
2%
Anger
2%
Anxiety
2%
Cough
2%
Sexual abuse
2%
Sinus congestion
2%
Malignant melanoma
2%
Endodontic procedure
2%
Mallory-Weiss Syndrom
2%
Anemia
2%
Influenza like Illness
2%
Gingivitis
2%
Arthoscopic surgery
100%
80%
60%
40%
20%
0%
Study treatment Arm
Diphenhydramine
Psilocybin
HOPE Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment: all patientsExperimental Treatment1 Intervention
Subjects will participate in a total of seven group sessions. There will be 4 or 6 subjects per group and one therapist will be assigned to each subject for a total of 4 or 6 therapists. In addition, there will be one Group Leader that will facilitate the group sessions. Group sessions will occur once per week for approximately five weeks. The first three sessions are "Preparatory" sessions followed by three "Integration" sessions. During the week following the third Preparatory session and prior to the first Integration session, participants will participate in a psilocybin session.
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?
University of UtahLead Sponsor
1,099 Previous Clinical Trials
1,778,710 Total Patients Enrolled
Usona InstituteOTHER
12 Previous Clinical Trials
746 Total Patients Enrolled
Anna Beck, MDPrincipal InvestigatorHuntsman Cancer Institute
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a psychological condition that may make it unsafe for you to take psilocybin or make it difficult for you to establish a trusting relationship with the study team.You must not use nicotine for at least two hours before taking the psilocybin.You have cancer that has spread to your brain or have any other major brain disease.You are currently participating in another study for a cancer treatment.You have a tumor that is producing hormones in the wrong place in your body.You have a heart condition.You have heart problems that are unstable or could become worse, such as chest pain, an enlarged heart, heart disease caused by poor blood flow, or a recent heart attack.You have high blood pressure that is not well-controlled (blood pressure higher than 140 over 90), or you have coronary artery disease, or you have an artificial heart valve.You went through menopause caused by radiation therapy over a year ago.You have to stop taking medications for depression or anxiety, including benzodiazepines, for at least 4 weeks before starting the study.You need to drink the same amount of coffee or tea that you normally do on the morning of the psilocybin session. If you don't usually drink caffeine, you can't have any on the day of the session.If you need to take opioids for pain relief, you must have already been taking them regularly before the study. If you take long-acting opioid medications, you need to stop taking them at least 6 hours before receiving psilocybin and cannot take them again until at least 6 hours after receiving psilocybin.You, or someone in your immediate family, has a history of severe mental health disorders like schizophrenia, bipolar disorder, or psychosis.You currently have a Cluster B Personality Disorder diagnosis according to the DSM-V.You have expressed thoughts about wanting to harm yourself, and have a plan to do so.Your doctor thinks that participating in the study could be risky for your health or you may have difficulty following the study procedures due to certain medical or personal reasons.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment: all patients
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Who else is applying?
What state do they live in?
South Carolina
Utah
Other
Florida
How old are they?
65+
18 - 65
What site did they apply to?
Huntsman Cancer Institute
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
3+
How responsive is this trial?
Typically responds via
Email
Average response time
- < 1 Day
Most responsive sites:
- Huntsman Cancer Institute: < 24 hours
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