Anxiety, Cancer, Depressive Symptoms
Conditions
Brief summary
This research is being done to study the psychological effects of psilocybin in cancer patients. Psilocybin is a naturally occurring substance found in some mushrooms that some cultures have used for centuries in religious practices.
Detailed description
This research is being done to study the psychological effects of psilocybin in cancer patients. Psilocybin is a naturally occurring substance found in some mushrooms that some cultures have used for centuries in religious practices. Psilocybin has not been approved for general medical use by the U.S. Food and Drug Administration (FDA). Its use in this study is investigational. Psilocybin is a mood-altering drug with effects similar to other hallucinogens like LSD and mescaline. Mescaline is the main psychoactive component of the peyote cactus used in Native American religious practices. Such substances have been used for centuries in some cultures as a way of inducing non-ordinary states of consciousness for religious and spiritual purposes. An earlier study that was done in our lab with healthy participants found that psilocybin, given in a comfortable and supportive setting, can provide an experience that is personally and spiritually meaningful for the participant. This study is being done to find out if psilocybin can also produce personally and spiritually meaningful experiences in cancer patients. This could be important because spirituality has been associated with increased psychological coping and decreased depression in serious illness. People with a diagnosis of cancer between the ages of 21 and 80 years old and who meet the medical requirements may join. About 44 people are expected to take part in this study.
Interventions
DRUGpsilocybin
The dose of psilocybin received in the two sessions will range anywhere from low to high.
Sponsors
Heffter Research Institute
Johns Hopkins University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
Volunteers must: * Have given written informed consent * Have a high school level of education * Be 21 to 80 years old * Has or has had a cancer diagnosis that is potentially life-threatening. Patients with an active cancer (e.g. stage III or IV with a poor prognosis) or disease progression or recurrence are eligible. Patients who do not have an active cancer or disease progression or disease recurrence are only eligible if at least 1 year has elapsed since their diagnosis. * Have an ECOG performance status of 0, 1, or 2. * Have a DSM-IV psychiatric diagnosis, as determined by the SCID, of one or more of the following Axis I psychiatric disorders that is either precipitated by or exacerbated by the psychological stress of the cancer diagnosis: Generalized Anxiety Disorder; Acute Stress Disorder; Post traumatic Stress Disorder; Major Depressive Disorder (mild or moderate severity); Dysthymic Disorder; Adjustment Disorder with Anxiety; Adjustment Disorder with Depressed Mood; Adjustment Disorder with Mixed Anxiety and Depressed Mood; Adjustment Disorder with Disturbance of Conduct; Adjustment Disorder with Disturbance of Emotions and Conduct. Psychiatric diagnosis will be determined by BPRU staff. * Patients receiving chemotherapy, hormonal therapy, radiation therapy, biologic therapies may participate while receiving those therapies. Continuing hormonal therapy, chemotherapy, or radiation treatment is acceptable if the patient is tolerating the therapy or treatment in a sufficient fashion to allow administration of oral psilocybin. * Agree that for one week preceding each 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 psilocybin administration, and not again until questionnaires have been completed approximately 7 hours after 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 mornings of psilocybin session days. If the patient does not routinely consume caffeinated beverages, he or she must agree not to do so on psilocybin session days. * Agree not to take any PRN medications on the mornings of psilocybin sessions, with the exception of daily opioid pain medication. Non-routine PRN medications for treating breakthrough pain that were taken in the 24 hours before the psilocybin session may result in rescheduling the treatment session, with the decision at the discretion of the investigators. * Agree to refrain from using any psychoactive drugs, including alcoholic beverages, within 24 hours of each psilocybin administration. As described elsewhere, exceptions include daily use of caffeine, nicotine, and opioid pain medication.
Exclusion criteria
General Medical
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| GRID-HAM-D-17 -- Structured Interview Guide for the Hamilton Depression Scale. | Baseline, 5 weeks post session 1 and 2, 6-month follow-up | The GRID-Hamilton Depression Rating Scale is a 17-item clinician-administered rating scale designed to assess severity of depressive symptoms. The score range for the GRID-HAMD is 0 to 52, with higher score indicating more severe depression. For this clinician-rated measure, a clinically significant response was defined as ⩾50% decrease in measure relative to Baseline; symptom remission was defined as ⩾50% decrease in measure relative to Baseline and a score of ⩽7 on the GRID-HAMD |
| HAM-A Assessed With the SIGH-A -- a Structured Interview Guide for the Hamilton Anxiety Rating Scale (SIGH-A). | Baseline, 5 weeks post session 1 and 2, 6-month follow-up | The Hamilton Anxiety Rating Scale is a 14-item clinician-administered rating scale designed to assess severity of anxiety symptoms. The score range for the HAM-A is 0 to 56, with higher score indicating more severe anxiety. For this clinician-rated measure, a clinically significant response was defined as ⩾50% decrease in measure relative to Baseline; symptom remission was defined as ⩾50% decrease in measure relative to Baseline and a score of ⩽7 on the GRID-HAM-A |
Countries
United States
Participant flow
Recruitment details
Participants were recruited through flyers, internet, and physician referral.
Participants by arm
| Arm | Count |
|---|---|
| Low-Dose First The Low-Dose-1st Group received the low dose of psilocybin on the first session and the high dose on the second session. | 25 |
| High-Dose First The High-Dose-1st Group received the high dose on the first session and the low dose on the second session. | 26 |
| Total | 51 |
Baseline characteristics
| Characteristic | High-Dose First | Total | Low-Dose First |
|---|---|---|---|
| Age, Continuous | 56.5 years STANDARD_DEVIATION 9.18 | 56.3 years STANDARD_DEVIATION 9.99 | 56.1 years STANDARD_DEVIATION 11.5 |
| Education College | 15 Participants | 23 Participants | 8 Participants |
| Education High School | 0 Participants | 1 Participants | 1 Participants |
| Education Post-graduate | 11 Participants | 27 Participants | 16 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 25 Participants | 48 Participants | 23 Participants |
| Sex: Female, Male Female | 13 Participants | 25 Participants | 12 Participants |
| Sex: Female, Male Male | 13 Participants | 26 Participants | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 10 / 56 | 23 / 56 |
| serious Total, serious adverse events | 0 / 56 | 0 / 56 |
Outcome results
Primary
GRID-HAM-D-17 -- Structured Interview Guide for the Hamilton Depression Scale.
The GRID-Hamilton Depression Rating Scale is a 17-item clinician-administered rating scale designed to assess severity of depressive symptoms. The score range for the GRID-HAMD is 0 to 52, with higher score indicating more severe depression. For this clinician-rated measure, a clinically significant response was defined as ⩾50% decrease in measure relative to Baseline; symptom remission was defined as ⩾50% decrease in measure relative to Baseline and a score of ⩽7 on the GRID-HAMD
Time frame: Baseline, 5 weeks post session 1 and 2, 6-month follow-up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Low-Dose First Baseline | GRID-HAM-D-17 -- Structured Interview Guide for the Hamilton Depression Scale. | 22.32 units on a scale | Standard Error 0.88 |
| Low-Dose First Post Session 1 | GRID-HAM-D-17 -- Structured Interview Guide for the Hamilton Depression Scale. | 14.8 units on a scale | Standard Error 1.45 |
| Low-Dose First Post Session 2 | GRID-HAM-D-17 -- Structured Interview Guide for the Hamilton Depression Scale. | 6.5 units on a scale | Standard Error 0.86 |
| Low-Dose First 6 Month | GRID-HAM-D-17 -- Structured Interview Guide for the Hamilton Depression Scale. | 6.95 units on a scale | Standard Error 1.24 |
| High-Dose First Baseline | GRID-HAM-D-17 -- Structured Interview Guide for the Hamilton Depression Scale. | 22.84 units on a scale | Standard Error 0.97 |
| High-Dose First Post Session 1 | GRID-HAM-D-17 -- Structured Interview Guide for the Hamilton Depression Scale. | 6.64 units on a scale | Standard Error 1.04 |
| High-Dose First Post Session 2 | GRID-HAM-D-17 -- Structured Interview Guide for the Hamilton Depression Scale. | 6.52 units on a scale | Standard Error 1.44 |
| High-Dose First 6 Month | GRID-HAM-D-17 -- Structured Interview Guide for the Hamilton Depression Scale. | 6.23 units on a scale | Standard Error 1.3 |
Primary
HAM-A Assessed With the SIGH-A -- a Structured Interview Guide for the Hamilton Anxiety Rating Scale (SIGH-A).
The Hamilton Anxiety Rating Scale is a 14-item clinician-administered rating scale designed to assess severity of anxiety symptoms. The score range for the HAM-A is 0 to 56, with higher score indicating more severe anxiety. For this clinician-rated measure, a clinically significant response was defined as ⩾50% decrease in measure relative to Baseline; symptom remission was defined as ⩾50% decrease in measure relative to Baseline and a score of ⩽7 on the GRID-HAM-A
Time frame: Baseline, 5 weeks post session 1 and 2, 6-month follow-up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Low-Dose First Baseline | HAM-A Assessed With the SIGH-A -- a Structured Interview Guide for the Hamilton Anxiety Rating Scale (SIGH-A). | 25.68 units on a scale | Standard Error 0.89 |
| Low-Dose First Post Session 1 | HAM-A Assessed With the SIGH-A -- a Structured Interview Guide for the Hamilton Anxiety Rating Scale (SIGH-A). | 16.64 units on a scale | Standard Error 1.53 |
| Low-Dose First Post Session 2 | HAM-A Assessed With the SIGH-A -- a Structured Interview Guide for the Hamilton Anxiety Rating Scale (SIGH-A). | 8.92 units on a scale | Standard Error 1.14 |
| Low-Dose First 6 Month | HAM-A Assessed With the SIGH-A -- a Structured Interview Guide for the Hamilton Anxiety Rating Scale (SIGH-A). | 7.95 units on a scale | Standard Error 1.19 |
| High-Dose First Baseline | HAM-A Assessed With the SIGH-A -- a Structured Interview Guide for the Hamilton Anxiety Rating Scale (SIGH-A). | 25.73 units on a scale | Standard Error 1.11 |
| High-Dose First Post Session 1 | HAM-A Assessed With the SIGH-A -- a Structured Interview Guide for the Hamilton Anxiety Rating Scale (SIGH-A). | 8.48 units on a scale | Standard Error 1.16 |
| High-Dose First Post Session 2 | HAM-A Assessed With the SIGH-A -- a Structured Interview Guide for the Hamilton Anxiety Rating Scale (SIGH-A). | 7.52 units on a scale | Standard Error 1.27 |
| High-Dose First 6 Month | HAM-A Assessed With the SIGH-A -- a Structured Interview Guide for the Hamilton Anxiety Rating Scale (SIGH-A). | 7.04 units on a scale | Standard Error 1.17 |