Psilocybin Cancer Anxiety Study
Raktažodžiai
Santrauka
Datos
| Paskutinį kartą patikrinta: | 08/31/2020 |
| Pirmasis pateikimas: | 08/10/2009 |
| Numatytas registravimas pateiktas: | 08/10/2009 |
| Pirmas paskelbtas: | 08/11/2009 |
| Paskutinis atnaujinimas pateiktas: | 09/28/2020 |
| Paskutinis atnaujinimas paskelbtas: | 10/19/2020 |
| Pirmųjų rezultatų pateikimo data: | 02/18/2019 |
| Pirmojo QC rezultatų pateikimo data: | 10/01/2019 |
| Pirmųjų paskelbtų rezultatų data: | 10/02/2019 |
| Faktinė studijų pradžios data: | 01/31/2009 |
| Numatoma pirminio užbaigimo data: | 09/05/2018 |
| Numatoma studijų užbaigimo data: | 09/05/2018 |
Būklė ar liga
Intervencija / gydymas
Drug: Psilocybin
Drug: Niacin
Fazė
Rankų grupės
| Ranka | Intervencija / gydymas |
|---|---|
| Experimental: Psilocybin Drug intervention | |
| Active Comparator: Niacin Active control |
Tinkamumo kriterijai
| Amžius, tinkami studijuoti | 18 Years Į 18 Years |
| Tinkamos studijoms lytys | All |
| Priima sveikus savanorius | Taip |
| Kriterijai | 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 |
Rezultatas
Pirminės rezultatų priemonės
1. HADS Anxiety [2-4 weeks prior to drug administration]
2. HADS Anxiety [1 day prior to drug administration 1]
3. HADS Anxiety [1 day post drug administration 1]
4. HADS Anxiety [6 weeks post drug administration 1]
5. HADS Anxiety [1 day prior to drug administration 2]
6. HADS Anxiety [6 weeks post drug administration 2]
7. HADS Anxiety [26 weeks post drug administration 2]
8. State-Trait Anxiety Inventory (STAI) State [2-4 weeks prior to drug administration/ Baseline]
9. STAI State [1 day prior to drug administration 1]
10. STAI State [1 day post drug administration 1]
11. HADS Depression [2-4 weeks prior to drug administration/ Baseline]
12. STAI State [6 weeks post drug administration 1]
13. STAI State [1 day prior to drug administration 2]
14. STAI State [1 day post drug administration 2]
15. STAI State [6 weeks post drug administration 2]
16. STAI State [26 weeks post drug administration 2]
17. STAI Trait [2-4 weeks prior to drug administration/ Baseline]
18. STAI Trait [1 day prior to drug administration 1]
19. STAI Trait [1 day post drug administration 1]
20. STAI Trait [6 weeks post drug administration 1]
21. STAI Trait [1 day prior to drug administration 2]
22. STAI Trait [1 day post drug administration 2]
23. STAI Trait [6 weeks prior to drug administration 2]
24. STAI Trait [6 weeks post drug administration 2]
25. HADS Depression [1 day prior to drug administration 1]
26. HADS Depression [1 day post drug administration 1]
27. HADS Depression [6 weeks post drug administration 1]
28. HADS Anxiety [1 day post drug administration 2]
29. HADS Depression [1 day post drug administration 2]
30. HADS Depression [6 weeks post drug administration 2]
31. HADS Depression [26 weeks post drug administration 2]
Antrinės rezultatų priemonės
1. Death Anxiety Scale [26 weeks post drug administration 2]
2. Death Anxiety Scale [2 weeks post drug administration 1]
3. Death Transcendence Scale [2-4 weeks prior to drug administration/ Baseline]
4. Hopelessness [Baseline]
5. Death Anxiety Scale [2-4 weeks prior to drug administration/ Baseline]
6. Death Transcendence Scale [2 weeks post drug administration 1]
7. Hopelessness [2 weeks post drug administration 1]
8. Hopelessness [26 weeks post drug administration 2]
9. Demoralization Scale [2-4 weeks prior to drug administration/ Baseline]
10. Demoralization Scale [2 weeks post drug administration 1]
11. Demoralization Scale [26 weeks post drug administration 2]
12. QoL Physical Health Scale [2-4 weeks prior to drug administration/ Baseline]
13. QoL Physical Health Scale [2 weeks post drug administration 1]
14. QoL Physical Health Scale [26 weeks post drug administration 2]
15. QoL Psychological Scale [2-4 weeks prior to drug administration/ Baseline]
16. QoL Psychological Scale [2 weeks post drug administration 1]
17. QoL Psychological Scale [26 weeks post drug administration 2]
18. QoL Social Relationships Scale [2-4 weeks prior to drug administration/ Baseline]
19. QoL Social Relationships Scale [2 weeks post drug administration 1]
20. QoL Social Relationships Scale [26 weeks post drug administration 2]
21. QoL Environment Scale [2-4 weeks prior to drug administration/ Baseline]
22. QoL Environment Scale [2 weeks post drug administration 1]
23. QoL Environment Scale [26 weeks post drug administration 2]
