Clinical trial NCT00957359: Psilocybin Cancer Anxiety Study
Official title: Effects of Psilocybin on Anxiety and Psychosocial Distress in Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Cancer
Keywords: Cancer
Anxiety
Depression
Hallucinogens
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2009-08-12
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Maximum age (years): 76
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The primary objective of this double-blind, placebo-controlled pilot study is to assess the efficacy of psilocybin administration (4-phosphoryloxy-N,N-dimethyltryptamine), a serotonergic psychoactive agent, on psychosocial distress, with the specific primary outcome variable being anxiety associated with cancer. Secondary outcome measures will look at the effect of psilocybin on symptoms of pain perception, depression, existential/psychospiritual distress, attitudes towards disease progression and death, quality of life, and spiritual/mystical states of consciousness. In addition, a secondary objective of the study is to determine the feasibility of administering psilocybin to this patient population, with regards to the following issues: safety, patient recruitment, consent for treatment, and retention. The duration of the proposed investigation will be long enough to administer the drug one time to each of thirty-two patients and to conduct follow-up assessments. This study is separate but similar to a recently completed study at the Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center, run by a psychiatrist, Dr. Charles Grob. Although the outcomes measures would be similar to those used as in the Grob study, the proposed dose of psilocybin is higher at 0.3mg/kg and the total subjects for the study would be 32 instead of 12. The study utilizes a cross-over design at 7 weeks and includes prospective follow-up of 6 months duration. This study has been approved by the Bellevue Psychiatry Research Committee, the NYU Oncology PRMC Committee, the Food and Drug Administration (FDA) through the issuance of an IND (77,138), the New York University School of Medicine Institutional Review Board (NYU IRB), the Health and Hospitals Corporation (HHC)-New York University (NYU) Clinical Translational Science Institute (CTSI), the NYU Bluestone Center for Clinical Research, and the Drug Enforcement Agency (DEA) through the issuance of a schedule I license.

It is hypothesized that a one time experience with psilocybin will occasion dramatic shifts in consciousness and awareness that will lead to short-term (ie hours to days) and long-term (up to 6 months in this study, following the administration of the second dosing, either psilocybin or placebo) improvement in anxiety, depression, and pain associated with advanced cancer. The exact mechanism of action is unclear but based on studies done in the 60's using serotonergic hallucinogens in patients with advanced cancer, improvements in anxiety levels, mood and pain were reported. However, a treatment model developed by the famous British psychiatrist Humphrey Osmond, offers one possibility. In this model, serotonergic hallucinogens' therapeutic mechanism lies in their ability to allow the individual to access novel dimensions of consciousness and their efficacy or lack thereof relies on whether a transcendent and mystical state of awareness is attained. Another possible mechanism relates to what Dobkin de Rios and Grob have described as 'managed altered states of consciousness,' where the power of suggestibility, occurring in a safe setting, allows one to transcend a particular state of consciousness (i.e. anxiety and depression associated with advanced illness) as a means to facilitate emotional discharge and to manage irreconcilable conflict.


Eligibility criteria: Inclusion Criteria:

* Age: 18-76
* Current or historical diagnosis of cancer
* Projected life expectancy of at least one year
* DSM-IV diagnoses: Acute Stress Disorder, Generalized Anxiety Disorder, Anxiety Disorder due to cancer, Adjustment Disorder with anxious features
* Any stage of cancer diagnosis

Exclusion Criteria:

* Epilepsy
* Renal disease
* Diabetes
* Abnormal liver function
* Severe cardiovascular disease
* Malignant Hypertension
* Baseline blood pressure must be less than or equal to 140/90
* Personal history or immediate family members with schizophrenia, bipolar affective disorder, delusional disorder, schizoaffective disorder or other psychotic spectrum illness
* Current substance use disorder
* Medication contraindications: anti-seizures medications, insulin, oral hypoglycemics, clonidine, aldomet, cardiovascular medications, anti-psychotics (first and second generation), anti-depressants and mood stabilizers

Primary outcomes:
measure: HADS Anxiety
timeFrame: 2-4 weeks prior to drug administration
measure: HADS Anxiety
timeFrame: 1 day prior to drug administration 1
measure: HADS Anxiety
timeFrame: 1 day post drug administration 1
measure: HADS Anxiety
timeFrame: 6 weeks post drug administration 1
measure: HADS Anxiety
timeFrame: 1 day prior to drug administration 2
measure: HADS Anxiety
timeFrame: 6 weeks post drug administration 2
measure: HADS Anxiety
timeFrame: 26 weeks post drug administration 2
measure: State-Trait Anxiety Inventory (STAI) State
timeFrame: 2-4 weeks prior to drug administration/ Baseline
measure: STAI State
timeFrame: 1 day prior to drug administration 1
measure: STAI State
timeFrame: 1 day post drug administration 1
measure: HADS Depression
timeFrame: 2-4 weeks prior to drug administration/ Baseline
measure: STAI State
timeFrame: 6 weeks post drug administration 1
measure: STAI State
timeFrame: 1 day prior to drug administration 2
measure: STAI State
timeFrame: 1 day post drug administration 2
measure: STAI State
timeFrame: 6 weeks post drug administration 2
measure: STAI State
timeFrame: 26 weeks post drug administration 2
measure: STAI Trait
timeFrame: 2-4 weeks prior to drug administration/ Baseline
measure: STAI Trait
timeFrame: 1 day prior to drug administration 1
measure: STAI Trait
timeFrame: 1 day post drug administration 1
measure: STAI Trait
timeFrame: 6 weeks post drug administration 1
measure: STAI Trait
timeFrame: 1 day prior to drug administration 2
measure: STAI Trait
timeFrame: 1 day post drug administration 2
measure: STAI Trait
timeFrame: 6 weeks prior to drug administration 2
measure: STAI Trait
timeFrame: 6 weeks post drug administration 2
measure: HADS Depression
timeFrame: 1 day prior to drug administration 1
measure: HADS Depression
timeFrame: 1 day post drug administration 1
measure: HADS Depression
timeFrame: 6 weeks post drug administration 1
measure: HADS Anxiety
timeFrame: 1 day post drug administration 2
measure: HADS Depression
timeFrame: 1 day post drug administration 2
measure: HADS Depression
timeFrame: 6 weeks post drug administration 2
measure: HADS Depression
timeFrame: 26 weeks post drug administration 2
Secondary outcomes:
measure: Death Anxiety Scale
timeFrame: 26 weeks post drug administration 2
measure: Death Anxiety Scale
timeFrame: 2 weeks post drug administration 1
measure: Death Transcendence Scale
timeFrame: 2-4 weeks prior to drug administration/ Baseline
measure: Hopelessness
timeFrame: Baseline
measure: Death Anxiety Scale
timeFrame: 2-4 weeks prior to drug administration/ Baseline
measure: Death Transcendence Scale
timeFrame: 2 weeks post drug administration 1
measure: Hopelessness
timeFrame: 2 weeks post drug administration 1
measure: Hopelessness
timeFrame: 26 weeks post drug administration 2
measure: Demoralization Scale
timeFrame: 2-4 weeks prior to drug administration/ Baseline
measure: Demoralization Scale
timeFrame: 2 weeks post drug administration 1
measure: Demoralization Scale
timeFrame: 26 weeks post drug administration 2
measure: QoL Physical Health Scale
timeFrame: 2-4 weeks prior to drug administration/ Baseline
measure: QoL Physical Health Scale
timeFrame: 2 weeks post drug administration 1
measure: QoL Physical Health Scale
timeFrame: 26 weeks post drug administration 2
measure: QoL Psychological Scale
timeFrame: 2-4 weeks prior to drug administration/ Baseline
measure: QoL Psychological Scale
timeFrame: 2 weeks post drug administration 1
measure: QoL Psychological Scale
timeFrame: 26 weeks post drug administration 2
measure: QoL Social Relationships Scale
timeFrame: 2-4 weeks prior to drug administration/ Baseline
measure: QoL Social Relationships Scale
timeFrame: 2 weeks post drug administration 1
measure: QoL Social Relationships Scale
timeFrame: 26 weeks post drug administration 2
measure: QoL Environment Scale
timeFrame: 2-4 weeks prior to drug administration/ Baseline
measure: QoL Environment Scale
timeFrame: 2 weeks post drug administration 1
measure: QoL Environment Scale
timeFrame: 26 weeks post drug administration 2
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU College of Dentistry Bluestone Center for Clinical Research
state: New York
Study officials:
affiliation: NYU Langone Health
name: Stephen Ross, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Co-Principal Investigator NYU Langone School of Medicine
name: Anthony Bossis, PhD
role: STUDY_CHAIR
affiliation: Co-Principal Investigator NYU Langone School of Medicine
name: Jeffrey Guss, MD
role: STUDY_DIRECTOR
References:
citation: Agin-Liebes GI, Malone T, Yalch MM, Mennenga SE, Ponte KL, Guss J, Bossis AP, Grigsby J, Fischer S, Ross S. Long-term follow-up of psilocybin-assisted psychotherapy for psychiatric and existential distress in patients with life-threatening cancer. J Psychopharmacol. 2020 Feb;34(2):155-166. doi: 10.1177/0269881119897615. Epub 2020 Jan 9.
citation: Ross S, Bossis A, Guss J, Agin-Liebes G, Malone T, Cohen B, Mennenga SE, Belser A, Kalliontzi K, Babb J, Su Z, Corby P, Schmidt BL. Rapid and sustained symptom reduction following psilocybin treatment for anxiety and depression in patients with life-threatening cancer: a randomized controlled trial. J Psychopharmacol. 2016 Dec;30(12):1165-1180. doi: 10.1177/0269881116675512.