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| ID | Type | Description | Link |
|---|---|---|---|
| PR#202143H | Other Identifier | Research Advisory Panel - California | |
| 156917 | Other Identifier | FDA |
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| Name | Class |
|---|---|
| Filament Health Corp. | INDUSTRY |
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To compare the physiological and psychological effects of psilocin taken orally by pill or sublingually by dissolving a tablet under the tongue to those of psilocybin taken by pill in healthy adults.
The primary goal of this study is to compare the physiological and psychological effects of psilocin taken orally by pill or sublingually dissolved under the tongue to those of psilocybin taken by pill. Twenty participants, ages 25 to 50, with one previous experience with psychedelics, and who meet all other inclusion and exclusion criteria at screening will be enrolled. After baseline assessments, participants will engage in preparatory visits with trained facilitators, followed by drug administration, supervised by the facilitators and a clinician who will conduct safety monitoring throughout. Participants will then complete assessment and integration sessions with the facilitators in order to help process the experience. The same preparation, procedures, integration, and supervision will be repeated up to three more times with each participant.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oral & Sublingual Psilocin, & Oral Psilocybin | Active Comparator | Every participant will be administered Oral Psilocin, Sublingual Psilocin, and oral psilocybin in a randomized order. |
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| Sublingual Psilocin | Active Comparator | Depending on a number of factors, participants may complete a fourth session where they receive sublingual psilocin for the second time. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Psilocin | Drug | 17.5mg oral psilocin with psychological support and physiological monitoring |
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| Measure | Description | Time Frame |
|---|---|---|
| Physiological Effects | blood pressure | Baseline to 8 hours following drug delivery |
| Physiological Effects | heart rate | Baseline to 8 hours following drug delivery |
| Psychological Effects | - Peak psychedelic intensity ratings will be measured using Likert scale (0-10 rating scale, 0=not intense at all, 10=highest intensity imaginable) | Baseline to 4 weeks after drug delivery |
| Psychological Effects | - Peak psychological effects will be measured by the Altered States of Consciousness (5D-ASC) questionnaire at the end of each dosing session | Baseline to 4 weeks after drug delivery |
| Psychological Effects | - Peak psychological effects will be measured by the Challenging Experiences Questionnaire at the end of each dosing session | Baseline to 4 weeks after drug delivery |
| Psychological Effects | - Persistent changes in attitude, mood, and behavior will be assessed using Persisting Effects Questionnaire, administered 4 weeks after each dosing session | Baseline to 4 weeks after drug delivery |
| Psychological Effects | - Personality profiles will be measured using the Big Five Inventory at baseline and 4 weeks after each dosing session | Baseline to 4 weeks after drug delivery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joshua Woolley, MD/PhD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Francisco | San Francisco | California | 94143 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25784600 | Background | Bogenschutz MP, Johnson MW. Classic hallucinogens in the treatment of addictions. Prog Neuropsychopharmacol Biol Psychiatry. 2016 Jan 4;64:250-8. doi: 10.1016/j.pnpbp.2015.03.002. Epub 2015 Mar 14. | |
| 9781409 | Background | Benet-Martinez V, John OP. Los Cinco Grandes across cultures and ethnic groups: multitrait multimethod analyses of the Big Five in Spanish and English. J Pers Soc Psychol. 1998 Sep;75(3):729-50. doi: 10.1037//0022-3514.75.3.729. |
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| ID | Term |
|---|---|
| C009105 | psilocin |
| D011562 | Psilocybin |
| ID | Term |
|---|---|
| D026121 | Indole Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D007211 | Indoles |
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| Psilocybin | Drug | 25mg oral psilocybin with psychological support and physiological monitoring |
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| Sublingual Psilocin | Drug | 2.18mg - 4.36mg sublingual psilocin with psychological support and physiological monitoring |
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| Adverse Effects |
| Baseline to 24 hours after dosing session |
| 28353056 | Background | Brown RT, Nicholas CR, Cozzi NV, Gassman MC, Cooper KM, Muller D, Thomas CD, Hetzel SJ, Henriquez KM, Ribaudo AS, Hutson PR. Pharmacokinetics of Escalating Doses of Oral Psilocybin in Healthy Adults. Clin Pharmacokinet. 2017 Dec;56(12):1543-1554. doi: 10.1007/s40262-017-0540-6. |
| 27856683 | Background | Barrett FS, Bradstreet MP, Leoutsakos JS, Johnson MW, Griffiths RR. The Challenging Experience Questionnaire: Characterization of challenging experiences with psilocybin mushrooms. J Psychopharmacol. 2016 Dec;30(12):1279-1295. doi: 10.1177/0269881116678781. Epub 2016 Nov 17. |
| 33150319 | Background | Anderson BT, Danforth A, Daroff PR, Stauffer C, Ekman E, Agin-Liebes G, Trope A, Boden MT, Dilley PJ, Mitchell J, Woolley J. Psilocybin-assisted group therapy for demoralized older long-term AIDS survivor men: An open-label safety and feasibility pilot study. EClinicalMedicine. 2020 Sep 24;27:100538. doi: 10.1016/j.eclinm.2020.100538. eCollection 2020 Oct. |
| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D014363 | Tryptamines |
| D054836 | Indolizidines |
| D007212 | Indolizines |