Methods and compositions for treating cannabis use disorder and mitigating cannabinoid withdrawal
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Publication Number
US-12268659-B2
Publication Date
2025-04-08
Expiration Date
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.
Core Innovation
The disclosure describes methods and compositions for treating cannabis use disorder and cannabis withdrawal syndrome by administering therapeutically effective daily doses of nabilone and gabapentin to a patient in need thereof. The treatment is configured to improve sleep quality, sleep duration or quantity, sleep depth, or to reduce sleep difficulty during cannabis withdrawal syndrome.
The described approach mitigates cannabinoid withdrawal by giving nabilone together with gabapentin, where 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. The daily doses are administered for a period of time between two to seven days.
The disclosure further includes clinical evaluation of nabilone and gabapentin, including a Phase 1 randomized placebo-controlled crossover study (PP-01: nabilone+gabapentin), assessing withdrawal outcomes and sleep outcomes. The described study reports statistically significant reductions in cannabis withdrawal symptom scores and improvements in sleep quality, with physiological markers consistent with reduced withdrawal stress.
Claims Coverage
The document includes one independent claim. The independent claim is centered on a dual-active regimen combining nabilone with gabapentin at specified daily dose ranges over a short 2 to 7 day period, with sleep-related improvement and/or sleep difficulty reduction as the claimed treatment outcome.
Treating cannabis withdrawal syndrome with combined nabilone and gabapentin for 2 to 7 days
A method of treating cannabis withdrawal syndrome by administering to a patient in need thereof therapeutically effective daily doses of nabilone and gabapentin, where the daily doses are administered for a period of time between two to seven days.
Specified nabilone and gabapentin daily dose ranges to improve sleep
Administer therapeutically effective daily doses of nabilone at 5 to 7 mg per day and gabapentin at 50 to 700 mg per day.
Improving sleep quality, sleep duration or quantity, sleep depth, or reducing sleep difficulty
Where the treatment improves sleep quality, sleep duration or quantity, sleep depth or reduces sleep difficulty.
Overall claim coverage is focused on a short-course, combined nabilone plus gabapentin dosing regimen with specified daily dose ranges (nabilone 5 to 7 mg/day; gabapentin 50 to 700 mg/day) administered for 2 to 7 days, where the claimed result is improvement in sleep outcomes and/or reduction of sleep difficulty.
Stated Advantages
Improves sleep quality, sleep duration or quantity, sleep depth, and/or reduces sleep difficulty.
Documented Applications
Treating cannabis withdrawal syndrome using nabilone and gabapentin with claimed sleep-related benefits during cannabis withdrawal syndrome.
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