IP Library › Granted Patent US 12,268,659
Granted Patent B2
US 12,268,659 · App. 17/461,540 · Granted Apr 8, 2025

Methods and compositions for treating cannabis use disorder and mitigating cannabinoid withdrawal

Inventor: Ginger D. Constantine (Malvern, PA)
Assignee: Pleopharma, Inc.
A61K31/196A61K31/352A61P25/30
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Quick Facts
Patent No.
US 12,268,659
App. No.
17/461,540
Granted
Apr 8, 2025
Kind
B2
Abstract

The present invention provides methods of treating cannabis withdrawal syndrome and other cannabis related conditions, including cannabis use disorder, in a subject, comprising administering to the subject in need thereof an effective amount of a cannabinoid or an effective amount of a cannabinoid and an effective amount of a second active agent, such as gabapentin or a gabapentin analog.

Claims (24)

1. A method of treating cannabis withdrawal syndrome, comprising administering to a patient in need thereof therapeutically effective daily doses of nabilone and gabapentin, wherein the nabilone daily dose is from 5 to 7 mg per day and the gabapentin daily dose is from 50 to 700 mg per day and wherein the daily doses are administered for a period of time of between two to seven days, where said treatment improves sleep quality, sleep duration or quantity, sleep depth or reduces sleep difficulty.

2. The method of claim 1 , wherein subsequent daily doses of nabilone and gabapentin are administered for a second period of time, wherein the nabilone daily dose is from 4 to 6 mg per day and the gabapentin daily dose is from 300 to 1000 mg per day and wherein the daily doses are administered for a second period of time of between two to seven days.

3. The method of claim 2 , wherein subsequent daily doses of nabilone and gabapentin are administered for a third period of time, wherein the nabilone daily dose is from 3 to 5 mg per day and the gabapentin daily dose is from 300 to 1200 mg per day and wherein the daily doses are administered for a third period of time of between two to seven days.

4. The method of claim 3 , wherein subsequent daily doses of nabilone and gabapentin are administered for a fourth period of time, wherein the nabilone daily dose is from 2 to 4 mg per day and the gabapentin daily dose is from 300 to 1200 mg per day and wherein the daily doses are administered for a fourth period of time of between two to seven days.

5. The method of claim 4 , wherein subsequent doses of nabilone and gabapentin are administered for a fifth period of time, wherein the nabilone daily dose is from 1 to 3 mg per day and the gabapentin daily dose is from 300 to 1200 mg per day and wherein the daily doses are administered for a fifth period of time of between two to seven days.

6. The method of claim 5 , wherein subsequent doses of nabilone and gabapentin are administered for a sixth period of time, wherein the nabilone daily dose is from 0.5 to 2 mg per day and the gabapentin daily dose is from 300 to 1200 mg per day and wherein the daily doses are administered for a sixth period of time of between two to seven days.

7. The method of claim 6 , wherein subsequent doses of nabilone and gabapentin are administered for a seventh period of time, wherein the nabilone daily dose is from 0.25 to 1 mg per day and the gabapentin daily dose is from 300 to 1000 mg per day and wherein the daily doses are administered for a seventh period of time of between two to seven days.

8. The method of claim 7 , wherein subsequent doses of nabilone and gabapentin are administered for an eighth period of time, wherein the nabilone daily dose is from 0.0 to 0.5 mg per day and the gabapentin daily dose is from 300 to 1000 mg per day and wherein the daily doses are administered for an eighth period of time of between two to seven days.

9. The method of claim 1 , wherein sleep duration is improved at least about 0.5 hours of additional sleep per day or 24 hour period.

10. The method of claim 1 , wherein sleep duration is improved by at least 0.75 hours of additional sleep per day or 24 hour period.

11. The method of claim 1 , wherein sleep duration is improved by at least 1.0 hours of additional sleep per day or 24 hour period.

12. The method of claim 1 , wherein sleep duration is improved by at least 1.25 hours of additional sleep per day or 24 hour period.

13. The method of claim 1 , wherein sleep duration is improved by at least 1.5 hours of additional sleep per day or 24 hour period.

14. The method of claim 7 , wherein sleep duration is improved by at least 0.5 hours of additional sleep per day or 24 hour period.

15. The method of claim 7 , wherein sleep duration is improved by at least 0.75 hours of additional sleep per day or 24 hour period.

16. The method of claim 7 , wherein sleep duration is improved by at least 1.0 hours of additional sleep per day or 24 hour period.

17. The method of claim 7 , wherein sleep duration is improved by at least 1.25 hours of additional sleep per day or 24 hour period.

18. The method of claim 7 , wherein sleep duration is improved by at least 1.5 hours of additional sleep per day or 24 hour period.

19. The method of claim 1 , wherein the treatment results in improvement in sleep quality.

20. The method of claim 1 , wherein the treatment results in improvement in sleep depth.

21. The method of claim 1 , wherein the treatment results in a reduction in sleep difficulty.

22. The method of claim 7 , wherein the treatment results in improvement in sleep quality.

23. The method of claim 7 , wherein the treatment results in improvement in sleep depth.

24. The method of claim 7 , wherein the treatment results in a reduction in sleep difficulty.

Assignments (2)
CHANGE OF NAME Recorded Nov 14, 2022
From: PLEOPHARMA, L.L.C.
To: PLEOPHARMA, INC.
Reel/Frame 061935/0211 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Nov 1, 2021
From: CONSTANTINE, GINGER D.
To: PLEOPHARMA L.L.C.
Reel/Frame 057981/0970 →
Continuity (4)
Continuation In Part 17244585 · Apr 29, 2021
Continuation In Part PCTUS2021020921 · Mar 4, 2021
Provisional Application 62985097 · Mar 4, 2020
Related Publication 20220079904A1 · Mar 17, 2022
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