{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,30]],"date-time":"2026-06-30T11:44:41Z","timestamp":1782819881328,"version":"3.54.5"},"reference-count":31,"publisher":"Ubiquity Press, Ltd.","license":[{"start":{"date-parts":[[2025,4,14]],"date-time":"2025-04-14T00:00:00Z","timestamp":1744588800000},"content-version":"unspecified","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"funder":[{"DOI":"10.13039\/100000002","name":"National Institutes of Health (NIH)","doi-asserted-by":"crossref","award":["UL1TR001442"],"award-info":[{"award-number":["UL1TR001442"]}],"id":[{"id":"10.13039\/100000002","id-type":"DOI","asserted-by":"crossref"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["TOHM"],"abstract":"<jats:p>Background: Essential tremor (ET) is characterized by often disabling action tremors. No pharmacological agent has been developed specifically for symptomatic treatment. Anecdotal reports describe tremor improvement with cannabis, but no evidence exists to support these claims. We conducted a phase Ib\/II double-blind, placebo-controlled, crossover pilot trial in participants with ET to investigate tolerability, safety, and efficacy of Tilray TN-CT120 LM, an oral pharmaceutical-grade formulation containing tetrahydrocannabinol (THC) 5 mg and cannabidiol (CBD) 100 mg. Our objectives were to determine if short-term THC\/CBD exposure improved tremor amplitude and was tolerated.\nMethods: Participants with ET were randomized (1:1) to receive either TN-CT120 LM or placebo. Dose titration, driven by tolerability, was attempted every 2\u20133 days to three capsules daily maximum. Participants remained on the highest tolerated dose for two weeks before returning to complete assessments. After completing the first arm, participants titrated off the agent, underwent a three-week washout, and then returned for the same procedures with the alternate compound. The primary endpoint was tremor amplitude change from baseline using digital spiral assessment. Secondary endpoints explored safety and tolerability.\nResults: Among thirteen participants screened, seven were eligible and enrolled. Five completed all visits; one withdrew following a serious adverse event, and another did not tolerate the lowest dose. Intent-to-treat analyses performed for six participants did not reveal significant effects on primary or secondary endpoints.\nConclusions: This pilot trial did not detect any signals of efficacy of THC\/CBD in ET. Although preliminary due to the small sample size, our data do not support anecdotal reports of cannabinoid effectiveness for ET.\nHighlights\nThis double-blind, randomized, placebo-controlled efficacy and tolerability pilot trial did not detect any signals of efficacy of oral cannabidiol and tetrahydrocannabinol in reducing essential tremor amplitude using either digital outcome measures or clinical rating scales. The oral cannabinoids were well-tolerated by most (five out of seven) participants.<\/jats:p>","DOI":"10.5334\/tohm.1005","type":"journal-article","created":{"date-parts":[[2025,4,14]],"date-time":"2025-04-14T08:28:18Z","timestamp":1744619298000},"page":"13","source":"Crossref","is-referenced-by-count":0,"title":["Double-Blind, Randomized, Placebo-Controlled, Crossover Study of Oral Cannabidiol and Tetrahydrocannabinol for Essential Tremor"],"prefix":"10.5334","volume":"15","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-5479-2590","authenticated-orcid":false,"given":"Katherine","family":"Longardner","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5637-4720","authenticated-orcid":false,"given":"Qian","family":"Shen","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9192-9437","authenticated-orcid":false,"given":"Francisco X.","family":"Castellanos","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bin","family":"Tang","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0003-9922-787X","authenticated-orcid":false,"given":"Rhea","family":"Gandhi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0825-6524","authenticated-orcid":false,"given":"Brenton A.","family":"Wright","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3154-6685","authenticated-orcid":false,"given":"Jeremiah D.","family":"Momper","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2452-4939","authenticated-orcid":false,"given":"Fatta B.","family":"Nahab","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"3285","published-online":{"date-parts":[[2025,4,14]]},"reference":[{"issue":"1","key":"key20250414122804_B1","doi-asserted-by":"crossref","first-page":"28","DOI":"10.5334\/tohm.632","article-title":"How Common is Essential Tremor? 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Montreal Cognitive Assessment [Internet]. American Psychological Association; 2014 [cited 2023 Mar 29]. Available from: http:\/\/doi.apa.org\/getdoi.cfm?doi=10.1037\/t27279-000."},{"issue":"4","key":"key20250414122804_B7","doi-asserted-by":"crossref","first-page":"34","DOI":"10.29245\/2572.942X\/2016\/4.1038","article-title":"The Essential Tremor Rating Assessment Scale","volume":"1","year":"2016","journal-title":"J Neurol Neuromedicine"},{"key":"key20250414122804_B8","author":"Diagnostic and statistical manual of mental disorders: DSM-5","year":"2013","edition":"5th ed."},{"issue":"2","key":"key20250414122804_B9","doi-asserted-by":"crossref","first-page":"167","DOI":"10.1016\/j.jpainsymman.2009.06.008","article-title":"Multicenter, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study of the Efficacy, Safety, and Tolerability of THC:CBD Extract and THC Extract in Patients with Intractable Cancer-Related Pain","volume":"39","year":"2010","journal-title":"Journal of Pain and Symptom 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Movements"],"original-title":[],"link":[{"URL":"https:\/\/account.tremorjournal.org\/index.php\/up-j-tohm\/article\/download\/1005\/1982","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/account.tremorjournal.org\/index.php\/up-j-tohm\/article\/download\/1005\/1983","content-type":"text\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/account.tremorjournal.org\/index.php\/up-j-tohm\/article\/download\/1005\/1984","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/account.tremorjournal.org\/index.php\/up-j-tohm\/article\/download\/1005\/1985","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/account.tremorjournal.org\/index.php\/up-j-tohm\/article\/download\/1005\/1986","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/account.tremorjournal.org\/index.php\/up-j-tohm\/article\/download\/1005\/1982","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,6,30]],"date-time":"2026-06-30T10:49:13Z","timestamp":1782816553000},"score":1,"resource":{"primary":{"URL":"https:\/\/account.tremorjournal.org\/index.php\/up-j-tohm\/article\/view\/1005"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,4,14]]},"references-count":31,"URL":"https:\/\/doi.org\/10.5334\/tohm.1005","relation":{},"ISSN":["2160-8288"],"issn-type":[{"value":"2160-8288","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,4,14]]}}}