Effects of Psilocybin on Anxiety and Psychosocial Distress in Cancer Patients
Phase 1/Phase 2
18 Years
76 Years
18 Years
76 Years
Open (Enrolling)
Both
Cancer
Both
Cancer
Trial Information
Effects of Psilocybin on Anxiety and Psychosocial Distress in Cancer Patients
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Outcome Measure:
anxiety
Outcome Time Frame:
2-4 weeks prior to drug administration
Safety Issue:
Yes
Principal Investigator
Stephen Ross, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
New York University School of Medicine
Authority:
United States: Food and Drug Administration
Study ID:
06-954
NCT ID:
NCT00957359
Start Date:
February 2009
Completion Date:
July 2014
Related Keywords:
- Cancer
- Cancer
- Anxiety
- Depression
- Hallucinogens
- Anxiety Disorders
Name | Location |
|---|---|
| NYU College of Dentistry Bluestone Center for Clinical Research | New York, New York 10010 |
