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NCT00957359 · ClinicalTrials.gov registry record · Early Phase 1
Psilocybin Cancer Anxiety Study
A Early Phase 1 study, sponsored by NYU Langone Health.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 29
- Enrollment target
NCT00957359 is a Early Phase 1 study that has completed, run by NYU Langone Health. The registered enrollment target is 29 participants.
The verdict
NCT00957359, a Early Phase 1 study, has completed, sponsored by NYU Langone Health.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 29 participants
- Enrollment target
Study 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 i
Interventions
- DRUG Niacin
- DRUG Psilocybin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 29 participants |
| Start Date | 2009-02 |
| Est. Completion | 2018-09-06 |
| Phase | Early Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00957359
The ClinicalTrials.gov registry entry for NCT00957359 describes a study currently listed as completed, categorized as Early Phase 1. The registered enrollment target is 29 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is NYU Langone Health, which has 1,164 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Niacin is the first listed.
NCT00957359 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00957359 about?
NCT00957359 is a clinical study titled "Psilocybin Cancer Anxiety Study". 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...
What is the current status of trial NCT00957359?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 29 participants. The study started on 2009-02. Estimated completion is 2018-09-06.
What interventions are being tested in trial NCT00957359?
The interventions under investigation include: Niacin (DRUG), Psilocybin (DRUG).
Who is sponsoring clinical trial NCT00957359?
This trial is sponsored by NYU Langone Health, which has 1,164 total clinical trials registered on ClinicalTrials.gov.
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