Study of Psilocybin Enhanced Group Psychotherapy in Patients With Cancer

NCT04522804 | Completed Early Phase 1 DMC FDA Drug

• 1 other identifier: HCI131965
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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. 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

Outcome Measures

Primary Outcomes (13)

• 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.

  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.

  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.

  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.

  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.

  8 months

• recruitment of patients with cancer diagnosis or hematologic malignancy

  assess the feasibility to recruit patients with a cancer diagnosis or hematologic malignancy

  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

  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

  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

  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

  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

  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

  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

  8 months

Study Arms (1)

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.

Drug: Psilocybin

Interventions

Psilocybin DRUG

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.

Treatment: all patients

Eligibility Criteria

• Age: 25 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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:

You may not qualify if:

• 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).
• 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

Sponsors & Collaborators

• University of Utah: lead
• Usona Institute: collaborator

Study Sites (1)

Huntsman Cancer Institute

Salt Lake City, Utah, 84112, United States

Location

MeSH Terms

Conditions

Neoplasms

Interventions

Psilocybin

Intervention Hierarchy (Ancestors)

Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Tryptamines; Indolizidines; Indolizines

Study Officials

• Anna Beck, MD

  Huntsman Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2020
• First Posted: August 21, 2020
• Study Start: October 4, 2021
• Primary Completion: June 11, 2022
• Study Completion: December 16, 2022
• Last Updated: March 20, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)