Psilocybin Cancer Anxiety Study
- Registration Number
- NCT00957359
- Lead Sponsor
- NYU Langone Health
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 29
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Niacin Psilocybin Active control Niacin Niacin Active control Psilocybin Psilocybin Drug intervention Psilocybin Niacin Drug intervention
- Primary Outcome Measures
Name Time Method HADS Anxiety 1 day post drug administration 2 0-21 (higher score more anxiety)
HADS Depression 26 weeks post drug administration 2 Hospital Anxiety and Depression Scale (HADS) used for measuring depression; Scored on a scale of 0-21 (higher score more depression)
STAI State 26 weeks post drug administration 2 STAI scores 20-80 (higher score more anxiety). Commonly classified as "no or low anxiety" (20-37), "moderate anxiety" (38-44), and "high anxiety" (45-80).
STAI Trait 6 weeks post drug administration 2 STAI scores 20-80 (higher score more anxiety). Commonly classified as "no or low anxiety" (20-37), "moderate anxiety" (38-44), and "high anxiety" (45-80).
State-Trait Anxiety Inventory (STAI) State 2-4 weeks prior to drug administration/ Baseline STAI scores 20-80 (higher score more anxiety). Commonly classified as "no or low anxiety" (20-37), "moderate anxiety" (38-44), and "high anxiety" (45-80).
- Secondary Outcome Measures
Name Time Method Hopelessness 26 weeks post drug administration 2 0-16 (higher score more hopeless)
QoL Physical Health Scale 26 weeks post drug administration 2 4-20 (higher score improved quality of life domain)
Death Anxiety Scale 2-4 weeks prior to drug administration/ Baseline 0-15 (higher score more death anxiety)
Death Transcendence Scale 2 weeks post drug administration 1 0-60 (higher score more death transcendence)
Demoralization Scale 26 weeks post drug administration 2 0-96 (higher score more demoralized)
QoL Psychological Scale 26 weeks post drug administration 2 4-20 (higher score improved quality of life domain)
QoL Social Relationships Scale 26 weeks post drug administration 2 4-20 (higher score improved quality of life domain)
QoL Environment Scale 26 weeks post drug administration 2 4-20 (higher score improved quality of life domain)
Trial Locations
- Locations (1)
NYU College of Dentistry Bluestone Center for Clinical Research
🇺🇸New York, New York, United States