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Psilocybin Cancer Anxiety Study

Ní féidir ach le húsáideoirí cláraithe ailt a aistriú
Logáil Isteach / Cláraigh
Sábháiltear an nasc chuig an gearrthaisce
StádasCríochnaithe
Urraitheoirí
NYU Langone Health

Keywords

Coimriú

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.

Dátaí

Fíoraithe Deireanach: 08/31/2020
Cuireadh isteach den chéad uair: 08/10/2009
Clárú Measta Curtha isteach: 08/10/2009
Arna chur suas ar dtús: 08/11/2009
Nuashonrú Deireanach Curtha isteach: 09/28/2020
Nuashonrú Deireanach Postáilte: 10/19/2020
Dáta na gcéad torthaí a cuireadh isteach: 02/18/2019
Dáta na dtorthaí QC a cuireadh isteach den chéad uair: 10/01/2019
Dáta na gcéad torthaí a cuireadh sa phost: 10/02/2019
Dáta Tosaigh an Staidéir Iarbhír: 01/31/2009
Dáta Críochnaithe Bunscoile Measta: 09/05/2018
Dáta Críochnaithe an Staid Mheasta: 09/05/2018

Coinníoll nó galar

Cancer

Idirghabháil / cóireáil

Drug: Psilocybin

Drug: Niacin

Céim

-

Grúpaí Láimhe

LámhIdirghabháil / cóireáil
Experimental: Psilocybin
Drug intervention
Active Comparator: Niacin
Active control

Critéir Incháilitheachta

Aois Incháilithe le haghaidh Staidéir 18 Years Chun 18 Years
Gnéas Incháilithe le haghaidh StaidéirAll
Glacann Oibrithe Deonacha SláintiúlaSea
Critéir

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

Toradh

Bearta Toraidh Príomhúla

1. HADS Anxiety [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)

2. HADS Anxiety [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)

3. HADS Anxiety [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)

4. HADS Anxiety [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)

5. HADS Anxiety [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)

6. HADS Anxiety [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)

7. HADS Anxiety [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)

8. 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).

9. STAI State [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).

10. STAI State [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).

11. HADS Depression [2-4 weeks prior to drug administration/ Baseline]

0-21 (higher score more depression)

12. STAI State [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).

13. STAI State [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).

14. STAI State [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).

15. STAI State [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).

16. 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).

17. STAI Trait [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).

18. STAI Trait [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).

19. STAI Trait [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).

20. STAI Trait [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).

21. STAI Trait [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).

22. STAI Trait [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).

23. STAI Trait [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).

24. 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).

25. HADS Depression [1 day prior to drug administration 1]

0-21 (higher score more depression)

26. HADS Depression [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)

27. HADS Depression [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)

28. HADS Anxiety [1 day post drug administration 2]

0-21 (higher score more anxiety)

29. HADS Depression [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)

30. HADS Depression [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)

31. 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)

Bearta Torthaí Tánaisteacha

1. Death Anxiety Scale [26 weeks post drug administration 2]

0-15 (higher score more death anxiety)

2. Death Anxiety Scale [2 weeks post drug administration 1]

0-15 (higher score more death anxiety)

3. Death Transcendence Scale [2-4 weeks prior to drug administration/ Baseline]

0-60 (higher score more death transcendence)

4. Hopelessness [Baseline]

0-16 (higher score more hopeless)

5. Death Anxiety Scale [2-4 weeks prior to drug administration/ Baseline]

0-15 (higher score more death anxiety)

6. Death Transcendence Scale [2 weeks post drug administration 1]

0-60 (higher score more death transcendence)

7. Hopelessness [2 weeks post drug administration 1]

0-16 (higher score more hopeless)

8. Hopelessness [26 weeks post drug administration 2]

0-16 (higher score more hopeless)

9. Demoralization Scale [2-4 weeks prior to drug administration/ Baseline]

0-96 (higher score more demoralized)

10. Demoralization Scale [2 weeks post drug administration 1]

0-96 (higher score more demoralized)

11. Demoralization Scale [26 weeks post drug administration 2]

0-96 (higher score more demoralized)

12. QoL Physical Health Scale [2-4 weeks prior to drug administration/ Baseline]

4-20 (higher score improved quality of life domain)

13. QoL Physical Health Scale [2 weeks post drug administration 1]

4-20 (higher score improved quality of life domain)

14. QoL Physical Health Scale [26 weeks post drug administration 2]

4-20 (higher score improved quality of life domain)

15. QoL Psychological Scale [2-4 weeks prior to drug administration/ Baseline]

4-20 (higher score improved quality of life domain)

16. QoL Psychological Scale [2 weeks post drug administration 1]

4-20 (higher score improved quality of life domain)

17. QoL Psychological Scale [26 weeks post drug administration 2]

4-20 (higher score improved quality of life domain)

18. QoL Social Relationships Scale [2-4 weeks prior to drug administration/ Baseline]

4-20 (higher score improved quality of life domain)

19. QoL Social Relationships Scale [2 weeks post drug administration 1]

4-20 (higher score improved quality of life domain)

20. QoL Social Relationships Scale [26 weeks post drug administration 2]

4-20 (higher score improved quality of life domain)

21. QoL Environment Scale [2-4 weeks prior to drug administration/ Baseline]

4-20 (higher score improved quality of life domain)

22. QoL Environment Scale [2 weeks post drug administration 1]

4-20 (higher score improved quality of life domain)

23. QoL Environment Scale [26 weeks post drug administration 2]

4-20 (higher score improved quality of life domain)

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