Lung Non-Small Cell Carcinoma, Unipolar Depression
Conditions
Brief summary
This phase II trial tests the safety and side effects of psilocybin in combination with therapy for the treatment of major depressive disorder in patients with non-small cell lung cancer. A cancer diagnosis is life-changing, resulting in significant levels of psychological symptoms, including a combination of depression, anxiety, stress, including feelings of existential distress (i.e., loss of meaning, demoralization, despair). Among all cancer patients, those diagnosed with lung cancer have the highest prevalence of mood disorders, such as depression (up to 40%) leading to profound deterioration in quality of life, prolonged hospital stays, poorer treatment adherence, decreased survival rates, and high rates of suicide (5- and 3-times higher than the general population and other cancer patients, respectively). Psilocybin is substance being studied in the treatment of anxiety or depression in patients with advanced cancer. It is taken from the mushroom Psilocybe mexicana. Psilocybin acts on the brain to cause hallucinations (sights, sounds, smells, tastes, or touches that a person believes to be real but are not real). Psilocybin in combination with therapy may be safe and effective in treating major depressive disorder in patients with non-small cell lung cancer.
Detailed description
PRIMARY OBJECTIVE: I. To determine the safety and acceptability of psilocybin-assisted psychotherapy with non-small cell lung cancer (NSCLC) patients. SECONDARY OBJECTIVE: I. To determine the efficacy of psilocybin-assisted therapy in the reduction of depression and the impact of treatment on quality of life, cancer-related stress, and existential distress. OUTLINE: Patients participate in two preparation therapy sessions over 4 hours each on days 7 and 14, then patients receive psilocybin orally (PO) on day 21 and participate in a single dosing therapy session for over 8-10 hours on study. Patients also complete two post-dosing therapy sessions over 2 hours each on days 22 and 28 on study. Patients additionally undergo blood and urine sample collection throughout the study. After completion of study treatment, patients are followed up at 4 and 12 weeks.
Interventions
PROCEDUREBiospecimen Collection
Undergo blood and urine sample collection
OTHERCounseling
Participate in therapy sessions
OTHERInterview
Ancillary studies
DRUGPsilocybin
Given PO
OTHERSurvey Administration
Ancillary studies
Sponsors
Alan Davis
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Individuals diagnosed with NSCLC, confirmed by pathology report * Have a Karnofsky performance status \>= 60 * Participants receiving chemotherapy, radiation therapy, and biologic therapies may participate while receiving those therapies if they are tolerating the therapy or treatment sufficiently to allow administration of oral psilocybin and if treatments do not result in meeting any of the medical
Exclusion criteria
outlined below * Moderate to severe symptoms of depression (GRID Hamilton Rating Scale for Depression \[GRID-HAMD\] \> 16) * English-speaking * Over the age of 18 * Have given written informed consent * Able to read * Be judged by study team clinicians to be at low risk for suicidality, as defined by a score of =\< 2 on the Columbia- Suicide Severity rating scale (C-SSRS) ideation subscale, 0 on the behavior subscale, and by overall clinical judgment; and * Have limited lifetime use of hallucinogens (the following criteria are preferred: no use in the past 5 years; total hallucinogen use less than 10 times)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ratings of suicidal ideation on the Columbia- Suicide Severity rating scale (C-SSRS) | At baseline, one day post-drug session, and 4 weeks post-drug session | Ratings of suicidal ideation on the C-SSRS will be summarized with means and standard deviations (SD) at baseline, one day post-drug session, and 4 weeks post-drug session. A mixed effects regression model will be fit containing a fixed effect for visit to test for a significant change in ratings of suicidal ideation from baseline to 4 weeks post drug session. Estimated mean differences will be presented with corresponding 95% confidence intervals (CI). An alpha level of 0.05 will be used to determine statistical significance. |
| Incidence of adverse events | At baseline, one day post-drug session, and 4 weeks post-drug session | Descriptive analysis of adverse event reporting logs will be conducted to determine if any serious adverse events have been reported related to psilocybin administration. |
| Acceptability of psilocybin-assisted therapy | At end of visit 3 (7 days prior to drug administration) and 4 weeks post-drug session | The mean (SD) change in Participant/Client Satisfaction Questionnaire levels between end of preparatory session 2 (visit 3; 7 days prior to drug administration) and 4 weeks post-drug session will be presented and a paired t-test will be used to test for a significant increase/decrease in acceptability. The estimated mean change will be presented with corresponding 95% confidence interval (CI). An alpha level of 0.05 will be used to determine statistical significance. |
| Satisfaction of psilocybin-assisted therapy | At end of visit 3 (7 days prior to drug administration) and 4 weeks post-drug session | The mean (SD) change in Participant/Client Satisfaction Questionnaire levels between end of preparatory session 2 (visit 3; 7 days prior to drug administration) and 4 weeks post-drug session will be presented and a paired t-test will be used to test for a significant increase/decrease in satisfaction. The estimated mean change will be presented with corresponding 95% confidence interval (CI). An alpha level of 0.05 will be used to determine statistical significance. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Depression symptom severity | At baseline, end of visit 3 (7 days prior to drug administration), and 4 weeks post-drug session. | Mean (SD) ratings of depression symptom severity will be presented from baseline, end of preparatory session 2 (visit 3; 7 days prior to drug administration), and 4 weeks post-drug session. A mixed effects regression model will be fit containing a fixed effect for visit to test for a significant change in ratings of depressive symptom severity from baseline to 4 weeks post drug session. Estimated mean differences will be presented with corresponding 95% confidence intervals (CI). An alpha level of 0.05 will be used to determine statistical significance. |
| Quality of life (Medical Outcomes Study-Short Form-12) | AT baseline, preparatory session 2, and 4 weeks post-drug session | The Medical Outcomes Study-Short Form-12 (SF-12) is a 12-item self-report measure assessing health- related quality of life during the past month.184 The SF-12 assesses eight aspects of quality of life including physical functioning, role functioning physical, general health perceptions, vitality, social functioning, role functioning emotion, and mental health. Scores from the eight are weighted and summed for two scores: physical component summary (PCS) and mental component summary (MCS) score. Mean (SD) ratings for each of the quality of life measures will be presented. |
| Quality of Life (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13) | At baseline, preparatory session 2, and 4 weeks post-drug session | The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13) is a common, validated measure assessing the frequency of common symptoms of lung cancer and lung cancer treatments.The EORTC QLQ-LC 13 contains nine items that assess individual symptoms (e.g., pain, coughing) and one three-item symptom scale that assesses dyspnea. Patients rated the extent to which each symptom was experienced in the past week on a 4-point Likert scale (1=not at all to 4=very much). Each item is transformed to a score ranging 0-100, with lower scores indicating better health-related quality of life and lower symptoms. Mean (SD) ratings for each of the quality of life measures will be presented. |
| Quality of Life (Impact of Events Scale-Revised) | At baseline, preparatory session 2, and 4 weeks post-drug session | The Impact of Events Scale-Revised is a 22-item expansion of the original 15-item IES which assesses subjective distress caused by any specific life event.The items and 3 subscales (Intrusion, Avoidance, and Hyperarousal) correspond closely with the symptoms associated with a DSM-IV diagnosis of PTSD. Items are rated on a 5-point scale ranging from 0 ("not at all") to 4 ("extremely") to yield a total score (ranging from 0 to 88). Mean (SD) ratings for each of the quality of life measures will be presented. |
| Quality of Life (Demoralization Scale) | At baseline, preparatory session 2, and 4 weeks post-drug session | The Demoralization Scale (DEM) is a 24-item self-report questionnaire which was developed to measure demoralization in patients with advanced cancer. It covers 5 dimensions of demoralization: loss of meaning and purpose (five items), dysphoria (five items), disheartenment (six items), helplessness (four items), and sense of failure (four items). Items are rated on five-point Likert scales ranging from 0 (never) to 4 (all the time). A total score is obtained by summing up the single scale scores. Mean (SD) ratings for each of the quality of life measures will be presented. |
| Quality of Life (NIH Healing Experience of All Life Stressors) | At baseline, preparatory session 2, and 4 weeks post-drug session | The NIH Healing Experience of All Life Stressors (NIH-HEALS)is a 35-item self-report questionnaire developed by the NIH Clinical Center Pain and Palliative Care Service as a psycho-social-spiritual measure of healing that assesses positive transformation in response to challenging life events.The scale has a three-factor structure (Connection, Reflection \& Introspection, and Trust \& Acceptance), and items are rated on a 5-point scale (1, "strongly disagree" to 5 "strongly agree"). Mean (SD) ratings for each of the quality of life measures will be presented. |
Countries
United States
Contacts
CONTACTOhio State University Comprehensive Cancer Center
CONTACTMichelle Pham, M.S.
PRINCIPAL_INVESTIGATORAlan K Davis, PhD
Ohio State University Comprehensive Cancer Center
Outcome results
None listed