CancerEarly Phase 1HOPENCT04522804
Study of Psilocybin Enhanced Group Psychotherapy in Patients With Cancer
A Early Phase 1 study testing Psilocybin in people with Cancer, run by University of Utah at 1 site in United States.
Trial summary
This pilot project is an open-label trial that will offer psilocybin in a group format to assess the feasibility of offering psilocybin therapy in a group setting with a decreased therapist to subject ratio. Read more about this study
- Who is it for?
- Ages 25 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- Psilocybin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Oct 2021to 16 Dec 2022
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female subject aged ≥ 25 years old.
- Current diagnosis of cancer and undergoing treatment for their cancer or completed treatment within ≤ 26 weeks of study registration.
- Life expectancy ≥ 3 months.
- Current DSM-V diagnosis of a depression disorder including adjustment disorder with disturbance of mood.
- Not taking regularly scheduled medications to treat depression and/or anxiety, including benzodiazepines, for at least 4 weeks prior to initiation of the study.
- Fluent in English.
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- Have a high school or equivalent (e.g., GED) level of education. Volunteers without a high school or equivalent education must demonstrate reading literacy and comprehension sufficient for understanding the consent form and study questionnaires, as evaluated by study staff obtaining consent.
- Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines.
- ECOG Performance Status ≤ 2.
- Have a support person that would be able to escort the subject home on the evening of the psilocybin dosing session.
- Adequate liver function as defined as:
- Total Bilirubin ≤ 1.5x institutional upper limit of normal (ULN) unless elevated bilirubin is related to Gilbert's Syndrome.
- AST(SGOT)/ALT(SGPT) ≤ 3 × institutional ULN
- For female subjects: Negative pregnancy test and agreement to use highly effective contraception (as described in Section 7.2) or evidence of post-menopausal status. The post-menopausal status will be defined as having been amenorrheic for 12 months without an alternative medical cause. The following age-specific requirements apply:
- Women < 50 years of age:
- Amenorrheic for ≥ 12 months following cessation of exogenous hormonal treatments; and
- Luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution; or
- Underwent surgical sterilization (bilateral oophorectomy or hysterectomy).
- Women ≥ 50 years of age:
- Amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments; or
- Had radiation-induced menopause with last menses >1 year ago; or
- Had chemotherapy-induced menopause with last menses >1 year ago; or underwent surgical sterilization (bilateral oophorectomy, bilateral salpingectomy or hysterectomy).
- Agree to refrain from using any psychoactive drugs, including alcoholic beverages, ondansetron, cannabis, and non-routine PRN medications within 24 hours of each psilocybin administration. Exceptions include daily use of caffeine, nicotine, and opioid pain medication (see Section 6.2.2).
- Agree that for one week preceding the psilocybin session, he/she will refrain from taking any nonprescription medication, nutritional supplement, or herbal supplement except when approved by the research team. Exceptions will be evaluated by the research team and will include acetaminophen, non-steroidal anti-inflammatory drugs, and common doses of vitamins and minerals.
- Agree not to use nicotine for at least 2 hours before the psilocybin administration.
- Agree to consume approximately the same amount of caffeine-containing beverage (e.g., coffee, tea) that he/she consumes on a usual morning, before arriving at the research unit on the morning of the psilocybin session. If the subject does not routinely consume caffeinated beverages, he or she must agree not to do so on the day of psilocybin administration.
- Subjects requiring opioid use for pain are on a stable pain management regimen. Long-acting opioid medications (e.g., oxycodone sustained-release, morphine sustained release) will be allowed if the last dose occurred at least 6 hours before psilocybin administration; such medication will not be taken again until at least 6 hours after psilocybin administration.
Who cannot join
- Positive screening SARS-CoV2 (COVID-19) test, symptoms of COVID-19, or contact with someone who has tested positive for COVID-19.
- Prior systemic antidepressants, anti-psychotic, or anxiolytic medication within four weeks prior to study initiation.
- Personal history or immediate family members with schizophrenia, bipolar affective disorder, delusional disorder, schizoaffective disorder, psychosis, or other psychotic spectrum illness.
- Currently meeting DSM-V criteria for Dissociative Disorder, or other psychiatric conditions judged to be incompatible with the establishment of rapport or safe exposure to psilocybin.
- Currently meeting DSM-V criteria for Cluster B Personality Disorder.
- Current or history within the last two years of meeting DSM-V criteria of substance use disorder (excluding caffeine and nicotine).
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- Severe depression requiring immediate standard-of-care treatment e,g.,hospitalization.
- Suicidal ideation with active intent or plan to act on suicidal thoughts as assessed by the treating investigator.
- Cancer with known CNS involvement, or other major CNS disease.
- Involvement in another investigational product for the treatment of cancer.
- Known paraneoplastic syndrome or other ectopic hormone production by a tumor.
- The subject has uncontrolled, significant intercurrent or recent illness including, but not limited to, the following conditions:
- Cardiovascular disorders:
- Congestive heart failure New York Heart Association Class III or IV
- Unstable angina pectoris, cardiac hypertrophy, cardiac ischemia, myocardial infarction
- Uncontrolled hypertension at time of enrollment (BP>140 systolic or 90 diastolic), coronary artery disease, artificial heart valve
- Prolonged or congenital long QT syndrome (≥480 ms), serious cardiac arrhythmias, tachycardia, a clinically significant screening ECG abnormality
- Renal insufficiency as defined as creatinine clearance < 40 mL/min calculated by Cockcroft-Gault formula:
- Males: ((140-age)×weight[kg])/(serum creatinine [mg/dL]×72)
- Females: (((140-age)×weight[kg])/(serum creatinine [mg/dL]×72))×0.85
- Hepatic disorders:
- Active infection including hepatitis B (known positive HBV surface antigen (HBsAg) result) or hepatitis C.
- Note: Patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody [anti-HBc] and absence of HBsAg) are eligible. Patients positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA.
- Any other condition that would, in the Investigator's judgment, contraindicate the subject's participation in the clinical study due to safety concerns or compliance with clinical study procedures (e.g., infection/inflammation, intestinal obstruction, unable to swallow medication, [patients may not receive the drug through a feeding tube], social/ psychological issues, etc.)
- Known prior severe hypersensitivity to investigational product or any component in its formulations (NCI CTCAE v5.0 Grade ≥ 3).
- Subjects taking prohibited medications as described in Section 6.3.2. A washout period of prohibited medications for a period of at least five half-lives should occur prior to study registration.
Trial locations and contacts
1 site in 1 country.
United States1 site
Huntsman Cancer Institute
Salt Lake City, Utah, 84112
About this study
Official title: A Pilot Study of Psilocybin Enhanced Group Psychotherapy in Patients With Cancer
This pilot project is an open-label trial that will offer psilocybin in a group format to assess the feasibility of offering psilocybin therapy in a group setting with a decreased therapist to subject ratio. Study intervention will involve a group of six patients with one therapist per subject for a 1:1 ratio, thus significantly reducing the total number of therapist hours per subject compared to standard individual therapy protocols.
Two groups of six will be treated on this trial. After the enrollment and treatment of the first group of six patients, accrual will be placed on hold to ensure subject safety. If stopping rules are not met (Section 11), the next group of six patients will be enrolled and treated on study.
The study intervention will include a total of seven group therapy sessions including three 2-hour preparatory sessions, one 8-hour psilocybin session, and one two-hour integration session. The group therapy sessions will occur on a weekly basis, followed one week later by the psilocybin session. The first integration group session will occur 1-2 days following the psilocybin session.
- Conditions
- Cancer
- Being tested
- Psilocybin
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PsilocybinDrug
Psilocybin is a classic psychedelic of medium duration that is well-tolerated and has a documented safety and efficacy record that makes it uniquely well-suited to the existential issues that arise in this patient population. Psilocybin has been described as an 'existential medicine' given patient testimonials as to its acute and lasting effects on interpersonal connection, ability to more deeply engage with meaningful activities and relationships, dramatic reductions in fear of death, and a renewed sense of well-being.
| Study group | Role | What they receive |
|---|---|---|
| Treatment: all patients | Experimental | 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. Receives: Drug: Psilocybin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of adverse events (AEs) and serious adverse events (SAEs) characterized by severity
assess the safety of psilocybin in patients with a cancer diagnosis or hematologic malignancy.
Measured: 8 months
Number of adverse events (AEs) and serious adverse events (SAEs) characterized by duration
assess the safety of psilocybin in patients with a cancer diagnosis or hematologic malignancy.
Measured: 8 months
Number of adverse events (AEs) and serious adverse events (SAEs) characterized by relationship to study treatment.
assess the safety of psilocybin in patients with a cancer diagnosis or hematologic malignancy.
Measured: 8 months
Number of adverse events (AEs) and serious adverse events (SAEs) characterized by seriousness
assess the safety of psilocybin in patients with a cancer diagnosis or hematologic malignancy.
Measured: 8 months
Number of adverse events (AEs) and serious adverse events (SAEs) characterized by type
assess the safety of psilocybin in patients with a cancer diagnosis or hematologic malignancy.
Measured: 8 months
recruitment of patients with cancer diagnosis or hematologic malignancy
assess the feasibility to recruit patients with a cancer diagnosis or hematologic malignancy
Measured: 18 months
Enrollment of patients with a cancer diagnosis or hematologic malignancy
assess the feasibility to enroll patients with a cancer diagnosis or hematologic malignancy
Measured: 18 months
Consent of patients with a cancer diagnosis or hematologic malignancy
assess the feasibility to consent patients with a cancer diagnosis or hematologic malignancy
Measured: 18 months
Number of adverse events (AEs) and serious adverse events (SAEs) characterized by severity
assess the tolerability of psilocybin in patients with a cancer diagnosis or
Measured: 8 months
Number of adverse events (AEs) and serious adverse events (SAEs) characterized by relationship to study treatment.
assess the tolerability of psilocybin in patients with a cancer diagnosis or
Measured: 8 months
Number of adverse events (AEs) and serious adverse events (SAEs) characterized by duration.
assess the tolerability of psilocybin in patients with a cancer diagnosis or
Measured: 8 months
Number of adverse events (AEs) and serious adverse events (SAEs) characterized by seriousness.
assess the tolerability of psilocybin in patients with a cancer diagnosis or
Measured: 8 months
Number of adverse events (AEs) and serious adverse events (SAEs) characterized by type.
assess the tolerability of psilocybin in patients with a cancer diagnosis or
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2020
- Study start4 Oct 2021
- Primary completion11 Jun 2022
- Study completion16 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by University of UtahThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Collaborators
- Usona Institute
- Responsible party
- Sponsor
- Investigators
- Anna Beck, MD, Principal investigator, Huntsman Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04522804
- Sponsor's protocol ID
- HCI131965
- Acronym
- HOPE
- Status last verified
- Mar 2024
- First submitted
- 18 Aug 2020
- Last updated
- 20 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Psilocybin Enhanced Group Psychotherapy in Patients With Cancer
- ClinicalTrials.gov ID
- NCT04522804
- Acronym / sponsor ID
- HOPE / HCI131965
- Conditions
- Cancer
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Collaborators
- Usona Institute
- Study start
- 4 Oct 2021 (actual)
- Primary completion
- 11 Jun 2022 (actual)
- Study completion
- 16 Dec 2022 (actual)
- First posted
- 21 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This pilot project is an open-label trial that will offer psilocybin in a group format to assess the feasibility of offering psilocybin therapy in a group setting with a decreased therapist to subject ratio. Study intervention will involve a group of six patients with one therapist per subject for a 1:1 ratio, thus significantly reducing the total number of therapist hours per subject compared to standard individual therapy protocols.
Two groups of six will be treated on this trial. After the enrollment and treatment of the first group of six patients, accrual will be placed on hold to ensure subject safety. If stopping rules are not met (Section 11), the next group of six patients will be enrolled and treated on study.
The study intervention will include a total of seven group therapy sessions including three 2-hour preparatory sessions, one 8-hour psilocybin session, and one two-hour integration session. The group therapy sessions will occur on a weekly basis, followed one week later by the psilocybin session. The first integration group session will occur 1-2 days following the psilocybin session.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment: all patients | Experimental | Drug: PsilocybinSubjects 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. |
Who may qualify
- Ages
- 25 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (27 listed)
- Male or female subject aged ≥ 25 years old.
- Current diagnosis of cancer and undergoing treatment for their cancer or completed treatment within ≤ 26 weeks of study registration.
- Life expectancy ≥ 3 months.
- Current DSM-V diagnosis of a depression disorder including adjustment disorder with disturbance of mood.
- Not taking regularly scheduled medications to treat depression and/or anxiety, including benzodiazepines, for at least 4 weeks prior to initiation of the study.
Key exclusion criteria (26 listed)
- Positive screening SARS-CoV2 (COVID-19) test, symptoms of COVID-19, or contact with someone who has tested positive for COVID-19.
- Prior systemic antidepressants, anti-psychotic, or anxiolytic medication within four weeks prior to study initiation.
- Personal history or immediate family members with schizophrenia, bipolar affective disorder, delusional disorder, schizoaffective disorder, psychosis, or other psychotic spectrum illness.
- Currently meeting DSM-V criteria for Dissociative Disorder, or other psychiatric conditions judged to be incompatible with the establishment of rapport or safe exposure to psilocybin.
- Currently meeting DSM-V criteria for Cluster B Personality Disorder.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PsilocybinPsilocybin is a classic psychedelic of medium duration that is well-tolerated and has a documented safety and efficacy record that makes it uniquely well-suited to the existential issues that arise in this patient population. Psilocybin has been described as an 'existential medicine' given patient testimonials as to its acute and lasting effects on interpersonal connection, ability to more deeply engage with meaningful activities and relationships, dramatic reductions in fear of death, and a renewed sense of well-being. | Drug | Treatment: all patients |
Primary outcome
Number of adverse events (AEs) and serious adverse events (SAEs) characterized by severity
Time frame: 8 months
assess the safety of psilocybin in patients with a cancer diagnosis or hematologic malignancy.
Number of adverse events (AEs) and serious adverse events (SAEs) characterized by duration
Time frame: 8 months
assess the safety of psilocybin in patients with a cancer diagnosis or hematologic malignancy.
Number of adverse events (AEs) and serious adverse events (SAEs) characterized by relationship to study treatment.
Time frame: 8 months
assess the safety of psilocybin in patients with a cancer diagnosis or hematologic malignancy.
Number of adverse events (AEs) and serious adverse events (SAEs) characterized by seriousness
Time frame: 8 months
assess the safety of psilocybin in patients with a cancer diagnosis or hematologic malignancy.
Number of adverse events (AEs) and serious adverse events (SAEs) characterized by type
Time frame: 8 months
assess the safety of psilocybin in patients with a cancer diagnosis or hematologic malignancy.
recruitment of patients with cancer diagnosis or hematologic malignancy
Time frame: 18 months
assess the feasibility to recruit patients with a cancer diagnosis or hematologic malignancy
Enrollment of patients with a cancer diagnosis or hematologic malignancy
Time frame: 18 months
assess the feasibility to enroll patients with a cancer diagnosis or hematologic malignancy
Consent of patients with a cancer diagnosis or hematologic malignancy
Time frame: 18 months
assess the feasibility to consent patients with a cancer diagnosis or hematologic malignancy
Number of adverse events (AEs) and serious adverse events (SAEs) characterized by severity
Time frame: 8 months
assess the tolerability of psilocybin in patients with a cancer diagnosis or
Number of adverse events (AEs) and serious adverse events (SAEs) characterized by relationship to study treatment.
Time frame: 8 months
assess the tolerability of psilocybin in patients with a cancer diagnosis or
Number of adverse events (AEs) and serious adverse events (SAEs) characterized by duration.
Time frame: 8 months
assess the tolerability of psilocybin in patients with a cancer diagnosis or
Number of adverse events (AEs) and serious adverse events (SAEs) characterized by seriousness.
Time frame: 8 months
assess the tolerability of psilocybin in patients with a cancer diagnosis or
Number of adverse events (AEs) and serious adverse events (SAEs) characterized by type.
Time frame: 8 months
assess the tolerability of psilocybin in patients with a cancer diagnosis or
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anna Beck, MD principal investigator
Huntsman Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Psilocybin in people with Cancer, run by University of Utah at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 27 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of adverse events (AEs) and serious adverse events (SAEs) characterized by severity (time frame: 8 months). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2024.