CancerEarly Phase 1NCT00957359
Psilocybin Cancer Anxiety Study
A Early Phase 1 study testing Psilocybin and Niacin in people with Cancer, run by NYU Langone Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 76 years
- Conditions the study is for
- Cancer
- What is being tested?
- Psilocybin and Niacin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2009to 6 Sep 2018
- Phase
- Early Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 76 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Epilepsy
- Renal disease
- Diabetes
- Abnormal liver function
- Severe cardiovascular disease
- Malignant Hypertension
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
NYU College of Dentistry Bluestone Center for Clinical Research
New York, New York, 10010
About this study
Official title: Effects of Psilocybin on Anxiety and Psychosocial Distress in Cancer Patients
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.
- Conditions
- Cancer
- Being tested
- Psilocybin, Niacin
- Keywords
- Cancer, Anxiety, Depression, Hallucinogens
- Medical subject headings
- Neoplasms, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PsilocybinDrug
Also called 4-phosphoryloxy-N,N-dimethyltryptamine
Psilocybin is a serotonergic hallucinogen that will be administered once at a dose of 0.3mg/kg
NiacinDrug
Psilocybin and niacin will be administered in identically appearing opaque, size 0 gelatin capsules with approximately 180ml of water. The niacin dose will be 250mg
| Study group | Role | What they receive |
|---|---|---|
| Psilocybin | Experimental | Drug intervention Receives: Drug: Psilocybin; Drug: Niacin |
| Niacin | Active comparator | Active control Receives: Drug: Psilocybin; Drug: Niacin |
What is being measured
The primary outcome is the main question the study is designed to answer.
HADS Anxiety
Hospital Anxiety and Depression Scale (HADS) used for measuring anxiety; Scored on a scale of 0-21 (higher score more anxiety)
Measured: 2-4 weeks prior to drug administration
HADS Anxiety
Hospital Anxiety and Depression Scale (HADS) used for measuring anxiety; Scored on a scale of 0-21 (higher score more anxiety)
Measured: 1 day prior to drug administration 1
HADS Anxiety
Hospital Anxiety and Depression Scale (HADS) used for measuring anxiety; Scored on a scale of 0-21 (higher score more anxiety)
Measured: 1 day post drug administration 1
HADS Anxiety
Hospital Anxiety and Depression Scale (HADS) used for measuring anxiety; Scored on a scale of 0-21 (higher score more anxiety)
Measured: 6 weeks post drug administration 1
HADS Anxiety
Hospital Anxiety and Depression Scale (HADS) used for measuring anxiety; Scored on a scale of 0-21 (higher score more anxiety)
Measured: 1 day prior to drug administration 2
HADS Anxiety
Hospital Anxiety and Depression Scale (HADS) used for measuring anxiety; Scored on a scale of 0-21 (higher score more anxiety)
Measured: 6 weeks post drug administration 2
HADS Anxiety
Hospital Anxiety and Depression Scale (HADS) used for measuring anxiety; Scored on a scale of 0-21 (higher score more anxiety)
Measured: 26 weeks post drug administration 2
State-Trait Anxiety Inventory (STAI) State
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).
Measured: 2-4 weeks prior to drug administration/ Baseline
STAI State
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).
Measured: 1 day prior to drug administration 1
STAI State
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).
Measured: 1 day post drug administration 1
HADS Depression
0-21 (higher score more depression)
Measured: 2-4 weeks prior to drug administration/ Baseline
STAI State
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).
Measured: 6 weeks post drug administration 1
STAI State
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).
Measured: 1 day prior to drug administration 2
STAI State
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).
Measured: 1 day post drug administration 2
STAI State
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).
Measured: 6 weeks post drug administration 2
STAI State
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).
Measured: 26 weeks post drug administration 2
STAI Trait
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).
Measured: 2-4 weeks prior to drug administration/ Baseline
STAI Trait
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).
Measured: 1 day prior to drug administration 1
STAI Trait
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).
Measured: 1 day post drug administration 1
STAI Trait
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).
Measured: 6 weeks post drug administration 1
STAI Trait
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).
Measured: 1 day prior to drug administration 2
STAI Trait
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).
Measured: 1 day post drug administration 2
STAI Trait
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).
Measured: 6 weeks prior to drug administration 2
STAI Trait
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).
Measured: 6 weeks post drug administration 2
HADS Depression
0-21 (higher score more depression)
Measured: 1 day prior to drug administration 1
HADS Depression
Hospital Anxiety and Depression Scale (HADS) used for measuring depression; Scored on a scale of 0-21 (higher score more depression)
Measured: 1 day post drug administration 1
HADS Depression
Hospital Anxiety and Depression Scale (HADS) used for measuring depression; Scored on a scale of 0-21 (higher score more depression)
Measured: 6 weeks post drug administration 1
HADS Anxiety
0-21 (higher score more anxiety)
Measured: 1 day post drug administration 2
HADS Depression
Hospital Anxiety and Depression Scale (HADS) used for measuring depression; Scored on a scale of 0-21 (higher score more depression)
Measured: 1 day post drug administration 2
HADS Depression
Hospital Anxiety and Depression Scale (HADS) used for measuring depression; Scored on a scale of 0-21 (higher score more depression)
Measured: 6 weeks post drug administration 2
HADS Depression
Hospital Anxiety and Depression Scale (HADS) used for measuring depression; Scored on a scale of 0-21 (higher score more depression)
Measured: 26 weeks post drug administration 2
Secondary outcomes (23)
Death Anxiety Scale
0-15 (higher score more death anxiety)
Measured: 26 weeks post drug administration 2
Death Anxiety Scale
0-15 (higher score more death anxiety)
Measured: 2 weeks post drug administration 1
Death Transcendence Scale
0-60 (higher score more death transcendence)
Measured: 2-4 weeks prior to drug administration/ Baseline
Hopelessness
0-16 (higher score more hopeless)
Measured: Baseline
Death Anxiety Scale
0-15 (higher score more death anxiety)
Measured: 2-4 weeks prior to drug administration/ Baseline
Death Transcendence Scale
0-60 (higher score more death transcendence)
Measured: 2 weeks post drug administration 1
Hopelessness
0-16 (higher score more hopeless)
Measured: 2 weeks post drug administration 1
Hopelessness
0-16 (higher score more hopeless)
Measured: 26 weeks post drug administration 2
Demoralization Scale
0-96 (higher score more demoralized)
Measured: 2-4 weeks prior to drug administration/ Baseline
Demoralization Scale
0-96 (higher score more demoralized)
Measured: 2 weeks post drug administration 1
Demoralization Scale
0-96 (higher score more demoralized)
Measured: 26 weeks post drug administration 2
QoL Physical Health Scale
4-20 (higher score improved quality of life domain)
Measured: 2-4 weeks prior to drug administration/ Baseline
QoL Physical Health Scale
4-20 (higher score improved quality of life domain)
Measured: 2 weeks post drug administration 1
QoL Physical Health Scale
4-20 (higher score improved quality of life domain)
Measured: 26 weeks post drug administration 2
QoL Psychological Scale
4-20 (higher score improved quality of life domain)
Measured: 2-4 weeks prior to drug administration/ Baseline
QoL Psychological Scale
4-20 (higher score improved quality of life domain)
Measured: 2 weeks post drug administration 1
QoL Psychological Scale
4-20 (higher score improved quality of life domain)
Measured: 26 weeks post drug administration 2
QoL Social Relationships Scale
4-20 (higher score improved quality of life domain)
Measured: 2-4 weeks prior to drug administration/ Baseline
QoL Social Relationships Scale
4-20 (higher score improved quality of life domain)
Measured: 2 weeks post drug administration 1
QoL Social Relationships Scale
4-20 (higher score improved quality of life domain)
Measured: 26 weeks post drug administration 2
QoL Environment Scale
4-20 (higher score improved quality of life domain)
Measured: 2-4 weeks prior to drug administration/ Baseline
QoL Environment Scale
4-20 (higher score improved quality of life domain)
Measured: 2 weeks post drug administration 1
QoL Environment Scale
4-20 (higher score improved quality of life domain)
Measured: 26 weeks post drug administration 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2009 (estimated)
- Study startFeb 2009
- Primary completion6 Sep 2018
- Study completion6 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stephen Ross, MD, Principal investigator, NYU Langone HealthAnthony Bossis, PhD, Study chair, Co-Principal Investigator NYU Langone School of MedicineJeffrey Guss, MD, Study director, Co-Principal Investigator NYU Langone School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00957359
- Sponsor's protocol ID
- 06-954
- Status last verified
- Sep 2020
- First submitted
- 11 Aug 2009
- Last updated
- 20 Oct 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
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.
PubMed 31916890Ross 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.
PubMed 27909164
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Psilocybin on Anxiety and Psychosocial Distress in Cancer Patients
- ClinicalTrials.gov ID
- NCT00957359
- Acronym / sponsor ID
- 06-954
- Conditions
- Cancer
- Keywords
- Cancer, Anxiety, Depression, Hallucinogens
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- Feb 2009 (actual)
- Primary completion
- 6 Sep 2018 (actual)
- Study completion
- 6 Sep 2018 (actual)
- First posted
- 12 Aug 2009 (estimated)
- Results
- Posted 3 Oct 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Psilocybin | Experimental | Drug: Psilocybin, Drug: NiacinDrug intervention |
| Niacin | Active comparator | Drug: Psilocybin, Drug: NiacinActive control |
Who may qualify
- Ages
- 18 to 76 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- Epilepsy
- Renal disease
- Diabetes
- Abnormal liver function
- Severe cardiovascular disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PsilocybinAlso: 4-phosphoryloxy-N,N-dimethyltryptaminePsilocybin is a serotonergic hallucinogen that will be administered once at a dose of 0.3mg/kg | Drug | Niacin, Psilocybin |
| NiacinPsilocybin and niacin will be administered in identically appearing opaque, size 0 gelatin capsules with approximately 180ml of water. The niacin dose will be 250mg | Drug | Niacin, Psilocybin |
Primary outcome
HADS Anxiety
Time frame: 2-4 weeks prior to drug administration
Hospital Anxiety and Depression Scale (HADS) used for measuring anxiety; Scored on a scale of 0-21 (higher score more anxiety)
HADS Anxiety
Time frame: 1 day prior to drug administration 1
Hospital Anxiety and Depression Scale (HADS) used for measuring anxiety; Scored on a scale of 0-21 (higher score more anxiety)
HADS Anxiety
Time frame: 1 day post drug administration 1
Hospital Anxiety and Depression Scale (HADS) used for measuring anxiety; Scored on a scale of 0-21 (higher score more anxiety)
HADS Anxiety
Time frame: 6 weeks post drug administration 1
Hospital Anxiety and Depression Scale (HADS) used for measuring anxiety; Scored on a scale of 0-21 (higher score more anxiety)
HADS Anxiety
Time frame: 1 day prior to drug administration 2
Hospital Anxiety and Depression Scale (HADS) used for measuring anxiety; Scored on a scale of 0-21 (higher score more anxiety)
HADS Anxiety
Time frame: 6 weeks post drug administration 2
Hospital Anxiety and Depression Scale (HADS) used for measuring anxiety; Scored on a scale of 0-21 (higher score more anxiety)
HADS Anxiety
Time frame: 26 weeks post drug administration 2
Hospital Anxiety and Depression Scale (HADS) used for measuring anxiety; Scored on a scale of 0-21 (higher score more anxiety)
State-Trait Anxiety Inventory (STAI) State
Time frame: 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).
STAI State
Time frame: 1 day prior to drug administration 1
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 State
Time frame: 1 day post drug administration 1
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).
HADS Depression
Time frame: 2-4 weeks prior to drug administration/ Baseline
0-21 (higher score more depression)
STAI State
Time frame: 6 weeks post drug administration 1
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 State
Time frame: 1 day prior to 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 State
Time frame: 1 day 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 State
Time frame: 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).
STAI State
Time frame: 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
Time frame: 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).
STAI Trait
Time frame: 1 day prior to drug administration 1
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
Time frame: 1 day post drug administration 1
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
Time frame: 6 weeks post drug administration 1
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
Time frame: 1 day prior to 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
Time frame: 1 day 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
Time frame: 6 weeks prior to 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
Time frame: 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).
HADS Depression
Time frame: 1 day prior to drug administration 1
0-21 (higher score more depression)
HADS Depression
Time frame: 1 day post drug administration 1
Hospital Anxiety and Depression Scale (HADS) used for measuring depression; Scored on a scale of 0-21 (higher score more depression)
HADS Depression
Time frame: 6 weeks post drug administration 1
Hospital Anxiety and Depression Scale (HADS) used for measuring depression; Scored on a scale of 0-21 (higher score more depression)
HADS Anxiety
Time frame: 1 day post drug administration 2
0-21 (higher score more anxiety)
HADS Depression
Time frame: 1 day 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)
HADS Depression
Time frame: 6 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)
HADS Depression
Time frame: 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)
23 secondary outcomes
Death Anxiety Scale
Time frame: 26 weeks post drug administration 2
Death Anxiety Scale
Time frame: 2 weeks post drug administration 1
Death Transcendence Scale
Time frame: 2-4 weeks prior to drug administration/ Baseline
Hopelessness
Time frame: Baseline
Death Anxiety Scale
Time frame: 2-4 weeks prior to drug administration/ Baseline
Death Transcendence Scale
Time frame: 2 weeks post drug administration 1
Hopelessness
Time frame: 2 weeks post drug administration 1
Hopelessness
Time frame: 26 weeks post drug administration 2
Demoralization Scale
Time frame: 2-4 weeks prior to drug administration/ Baseline
Demoralization Scale
Time frame: 2 weeks post drug administration 1
Demoralization Scale
Time frame: 26 weeks post drug administration 2
QoL Physical Health Scale
Time frame: 2-4 weeks prior to drug administration/ Baseline
QoL Physical Health Scale
Time frame: 2 weeks post drug administration 1
QoL Physical Health Scale
Time frame: 26 weeks post drug administration 2
QoL Psychological Scale
Time frame: 2-4 weeks prior to drug administration/ Baseline
QoL Psychological Scale
Time frame: 2 weeks post drug administration 1
QoL Psychological Scale
Time frame: 26 weeks post drug administration 2
QoL Social Relationships Scale
Time frame: 2-4 weeks prior to drug administration/ Baseline
QoL Social Relationships Scale
Time frame: 2 weeks post drug administration 1
QoL Social Relationships Scale
Time frame: 26 weeks post drug administration 2
QoL Environment Scale
Time frame: 2-4 weeks prior to drug administration/ Baseline
QoL Environment Scale
Time frame: 2 weeks post drug administration 1
QoL Environment Scale
Time frame: 26 weeks post drug administration 2
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 31916890Agin-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.
- Derived from this study: PubMed 27909164Ross 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.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen Ross, MD principal investigator
NYU Langone Health
Anthony Bossis, PhD study chair
Co-Principal Investigator NYU Langone School of Medicine
Jeffrey Guss, MD study director
Co-Principal Investigator NYU Langone School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Psilocybin and Niacin in people with Cancer, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Oct 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HADS Anxiety (time frame: 2-4 weeks prior to drug administration). The study lists 31 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00957359, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2020.