Granted Patent B2

US 12,396,981 · App. 18/601,926 · Granted Aug 26, 2025

Inventor: William Shulman (Kentfield, CA)

A61K31/4045A61K9/0043A61K31/135A61K31/5513

Abstract

Claims (52)

1. A method of providing an improved subjective experience of DMT to an individual, comprising administering to the individual:

i. psilacetin, or a pharmaceutically acceptable salt thereof; and

ii. DMT, or a pharmaceutically acceptable salt thereof;

wherein:

iii. administering the psilacetin is at least about 90 minutes prior to administering the DMT;

iv. the DMT is administered by inhalation; and

V. the DMT is administered from 1 to 5 times during the 5 hours following the peak of the psychedelic effects of the psilacetin; and

wherein the method results in, compared to administering an equal amount of DMT alone, any of:

a. a reduction in the intensity of the subjective experience of DMT;

b. a reduction in a physical or psychological side effect of DMT;

c. an increase in the individual's ability to keep their eyes open; and

d. an increase in the individual's sense of control.

2. The method of claim 1 , wherein the psilacetin is administered at a dose of from about 5 to 50 mg, about 10 to 40 mg, about 15 to 30 mg, or about 20 to 25 mg.

3. The method of claim 1 , wherein the DMT is administered about 90 minutes after the administration of the psilacetin.

4. The method of claim 1 , wherein the DMT is administered 2 times during the 2 hours, 3 times during the 3 hours, or 4 times during the 4 hours following the peak of the psychedelic effects of the psilacetin.

5. The method of claim 4 , wherein each dose of DMT is from about 5 to 50 mg, about 10 to 30 mg, or about 15 to 25 mg.

6. The method of claim 1 , further comprising administering to the individual a benzodiazepine, or a pharmaceutically acceptable salt thereof.

7. The method claim 6 , wherein the benzodiazepine is any of alprazolam, bromazepam, chlordiazepoxide, clobazam, clonazepam, clorazepate, diazepam, estazolam, etizolam, flunitrazepam, flurazepam, flutoprazepam, halazepam, ketazolam, loprazolam, lorazepam, lormetazepam, midazolam, nimetazepam, nitrazepam, oxazepam, prazepam, quazepam, temazepam, tetrazepam, and triazolam.

8. The method of claim 7 , wherein the benzodiazepine is lorazepam.

9. The method of claim 8 , wherein the lorazepam is administered at a dose of from about 0.5 to 2 mg.

10. The method of claim 6 , wherein the benzodiazepine is administered prior to the psilacetin.

11. The method of claim 1 , further comprising administering to the individual ketamine, or a pharmaceutically acceptable salt thereof.

12. The method of claim 11 , wherein the ketamine is administered from 1 to 5 times during the 5 hours following administering to the individual the psilacetin.

13. The method of claim 12 , wherein each dose of ketamine is from about 5 to 50 mg, about 10 to 30 mg, or about 15 to 25 mg.

14. The method of claim 11 , wherein the ketamine is administered intranasally.

15. The method of claim 1 , further comprising administering to the individual a long-acting psychedelic, or a pharmaceutically acceptable salt thereof.

16. The method of claim 15 , wherein the long-acting psychedelic is 4-hydroxy-N-methyl-N-ethyltryptamine (4-HO-MET) or 4-hydroxy-N-methyl-N-isopropyltryptamine (4-HO-MiPT).

17. The method of claim 1 , wherein the reduction in a physical or psychological side effect of DMT is determined by individual reporting or data monitoring, and comprises a reduction in any of disorientation, acute anxiety, emotional distress, diarrhea, nausea, vomiting, elevated heart rate, elevated blood pressure, dizziness, agitation, and muscle incoordination, compared to administering an equal amount of DMT alone to the individual.

18. The method of claim 1 , further comprising an increase in a positive effect of DMT, wherein the increase in a positive effect of DMT is determined by individual reporting or data monitoring, and comprises an increase in any of feelings of euphoria, positive mood, internal unity, external unity, transcendence of time and space, ineffability, paradoxicality, sacredness, and noetic quality, compared to administering an equal amount of DMT alone to the individual.

19. The method of claim 1 , further comprising an increase in a positive effect of DMT, wherein the increase in a positive effect of DMT is determined by individual reporting or data monitoring, and comprises an increase in the score of any of the Mystical, Positive Mood, Transcendence of Time and Space, and Ineffability subscales of the 30-item revised Mystical Experience Questionnaire (MEQ30), compared to administering an equal amount of DMT alone to the individual.

20. The method of claim 1 , wherein the reduction in a physical or psychological side effect of DMT is determined by individual reporting or data monitoring, and comprises a reduction in the score of any of the Fear, Grief, Physical Distress, Insanity, Isolation, Death, and Paranoia subscales of the Challenging Experience Questionnaire (CEQ), compared to administering an equal amount of DMT alone to the individual.

21. A method of providing an improved subjective experience of DMT to an individual, comprising administering to the individual:

i. psilacetin, or a pharmaceutically acceptable salt thereof;

ii. DMT, or a pharmaceutically acceptable salt thereof;

iii. lorazepam, or a pharmaceutically acceptable salt thereof; and

iv. ketamine, or a pharmaceutically acceptable salt thereof;

wherein:

iii. administering the psilacetin is at least about 90 minutes prior to administering the DMT;

iv. the DMT is administered by inhalation; and

v. the DMT is administered from 1 to 5 times during the 5 hours following the peak of the psychedelic effects of the psilacetin; and

wherein the method results in, compared to administering an equal amount of DMT alone, any of:

a. a reduction in the intensity of the subjective experience of DMT;

b. a reduction in a physical or psychological side effect of DMT;

c. an increase in the individual's ability to keep their eyes open; and

d. an increase in the individual's sense of control.

22. The method of claim 1 , wherein the reduction in the intensity of the subjective experience of DMT is determined by individual reporting or data monitoring, and comprises a more navigable and controlled experience, compared to administering an equal amount of DMT alone to the individual.

23. The method of claim 1 , wherein the increase in the individual's ability to keep their eyes open is determined by individual reporting or data monitoring, compared to administering an equal amount of DMT alone to the individual.

24. The method of claim 1 , wherein the increase in the individual's sense of control is determined by individual reporting or data monitoring, compared to administering an equal amount of DMT alone to the individual.

25. The method of claim 1 , wherein the method results in, compared to administering an equal amount of DMT alone, a reduction in the intensity of the subjective experience of DMT and a reduction in a physical or psychological side effect of DMT.

26. The method of claim 1 , wherein the method results in, compared to administering an equal amount of DMT alone, an increase in the individual's ability to keep their eyes open and an increase in the individual's sense of control.

27. The method of claim 1 , wherein the method results in, compared to administering an equal amount of DMT alone, a reduction in the intensity of the subjective experience of DMT, a reduction in a physical or psychological side effect of DMT, an increase in the individual's ability to keep their eyes open, and an increase in the individual's sense of control.

28. The method of claim 1 , further comprising determining, by individual reporting or data monitoring, the reduction in the intensity of the subjective experience of DMT, the reduction in a physical or psychological side effect of DMT, the increase in the individual's ability to keep their eyes open, or the increase in the individual's sense of control, compared to administering an equal amount of DMT alone to the individual.

Continuity (2)

References Cited (196)