Treatment of opioid use disorder, opioid withdrawal symptoms, and chronic pain
Inventors
HEINZERLING, Keith G. • BRIONES, Marisa S. • DEYOUNG, Dustin Z.
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Assignees
University of California San Diego UCSD
University of California, San Diego (UCSD)The University of California, San Diego (UCSD) is a leading public research university located in La Jolla, California. Known for its innovative and interdisciplinary approach, UCSD offers a wide range of undergraduate, graduate, and professional programs across various fields. The university is committed to fostering a diverse and inclusive community, promoting sustainability, and driving social mobility through education, research, and public service. UCSD is recognized for its contributions to research and innovation, particularly in areas such as climate science, health innovation, and artificial intelligence.
The University of California, San Diego (UCSD) is a leading public research university located in La Jolla, California. Known for its innovative and interdisciplinary approach, UCSD offers a wide range of undergraduate, graduate, and professional programs across various fields. The university is committed to fostering a diverse and inclusive community, promoting sustainability, and driving social mobility through education, research, and public service. UCSD is recognized for its contributions to research and innovation, particularly in areas such as climate science, health innovation, and artificial intelligence.
Publication Number
US-12364668-B2
Publication Date
2025-07-22
Expiration Date
2038-11-15
Abstract
The current methods and compositions provide for a novel and effective therapeutic method for treating opioid use disorder, opioid withdrawal symptoms and/or chronic pain. Accordingly, certain aspects of the disclosure relate to a method for treating opioid use disorder, opioid withdrawal symptoms and/or chronic pain in a subject, the method comprising administering at least one purified cannabinoid compound and a partial opioid agonist. In some embodiments, the method comprises administering a composition comprising cannabidiol and buprenorphine.
Core Innovation
The invention provides novel therapeutic compositions and methods for treating opioid use disorder, opioid withdrawal symptoms, and chronic pain by administering at least one purified cannabinoid compound and a partial opioid agonist. In particular, the method involves administering cannabidiol and a partial opioid agonist such as buprenorphine, optionally together in the same composition, where these agents produce synergistic effects greater than either compound alone. This approach addresses both analgesic needs and anxiety symptoms related to opioid use and withdrawal.
The problem being solved relates to the public health crisis caused by the epidemic of opioid abuse and overdose deaths associated with chronic pain management, opioid use disorder, and opioid withdrawal symptoms. Existing treatments, such as buprenorphine alone, have limitations including risks of overdose especially when combined with sedatives, and challenges in managing associated anxiety and pain catastrophizing. There is a severe need for safe, effective alternative therapies that better address these conditions and reduce associated risks.
Claims Coverage
The patent claims encompass methods of treatment and pharmaceutical compositions involving cannabidiol and a partial opioid agonist, focusing on their synergistic administration and specific dosing forms and ratios.
Method of treating opioid-related disorders with cannabidiol and partial opioid agonist at synergistic ratios
A method for treating opioid use disorder, opioid withdrawal symptoms, and/or chronic pain by administering cannabidiol and a partial opioid agonist at a synergistically effective ratio of about 700:1 to 4,000:1, with sublingual administration.
Administration of cannabidiol including its pharmaceutically acceptable derivatives and homologues
Use of cannabidiol comprising purified cannabidiol or its pharmaceutically acceptable derivatives, salts, prodrugs, solvates, metabolites, metabolic precursors, or homologues in treatment methods.
Use of specific partial opioid agonists
Partial opioid agonists comprising buprenorphine, mitragynine, or 7-hydroxymitragynine are used in the treatment method.
Temporal co-administration of cannabidiol and partial opioid agonist
Administration of cannabidiol and the partial opioid agonist between about 30 minutes and 24 hours of each other, including simultaneous administration or combined composition.
Optional co-administration of an opioid antagonist
In combination with cannabidiol and the partial opioid agonist, administering an opioid antagonist such as naloxone, its oxymorphol analog, naloxone salt, naloxone dihydrate, or naltrexone.
Specific cannabinoid and partial opioid agonist dosages
Administering cannabidiol in doses from about 2 mg to 900 mg, including 7 mg to 200 mg, and partial opioid agonist doses from about 0.005 mg to 50 mg, optionally from 0.1 mg to 1 mg.
Multiple administrations over a treatment course
Administering cannabidiol and the partial opioid agonist multiple times over at least one week to treat opioid-related conditions.
Pharmaceutical compositions formulated for sublingual administration
Pharmaceutical compositions comprising cannabidiol and a partial opioid agonist at the synergistic ratio of about 700:1 to 4,000:1, formulated for sublingual delivery, optionally including an opioid antagonist.
Specific composition with buprenorphine and naloxone
Pharmaceutical composition comprising about 10 mg to 30 mg cannabidiol, about 0.5 mg buprenorphine, and optionally naloxone.
The claims collectively cover synergistic combination methods and compositions of cannabidiol and partial opioid agonists, notably buprenorphine, administered sublingually in specified ratios and dosages, optionally with opioid antagonists, for treating opioid use disorder, withdrawal symptoms, and chronic pain.
Stated Advantages
The combination of cannabidiol and partial opioid agonists is safer and more effective than individual compounds alone due to synergistic effects enhancing anxiolytic and analgesic benefits.
Concomitant administration may reduce buprenorphine metabolism, achieving analgesic effects with lower, safer doses of buprenorphine.
Reduction in anxiety through the combination may decrease opioid relapse, misuse, overdose rates, and associated risks from co-use of sedatives like benzodiazepines.
A combination sublingual formulation may improve treatment adherence compared to separate administration or non-approved medical marijuana products.
Documented Applications
Treatment of opioid use disorder, including preventing relapse and opioid abuse.
Treatment and reduction of opioid withdrawal symptoms including alleviation of anxiety and other withdrawal-related symptoms.
Management and treatment of chronic pain.
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