Cognitive Safety Data from a Randomized, Double‐Blind, Parallel‐Group, Placebo‐Controlled Phase IIb Study of the Effects of a Cannabidiol and Δ9‐Tetrahydrocannabinol Drug on Parkinson's Disease‐Related Motor Symptoms
Background Cannabis is increasingly available worldwide but its impact on cognition in Parkinson's disease (PD) is unknown. Objective Present cognitive safety data from study of an oral high‐dose cannabidiol (CBD; 100 mg) and low‐dose Δ9‐tetrahydocannabinol (THC; 3.3 mg) drug in PD. Methods Ran...
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| Veröffentlicht in: | Movement disorders 2023-07, Vol.38 (7), p.1341-1346 |
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| container_title | Movement disorders |
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| creator | Domen, Christopher H. Sillau, Stefan Liu, Ying Adkins, Michelle Rajkovic, Sarah Bainbridge, Jacquelyn Sempio, Cristina Klawitter, Jost Leehey, Maureen A. |
| description | Background
Cannabis is increasingly available worldwide but its impact on cognition in Parkinson's disease (PD) is unknown.
Objective
Present cognitive safety data from study of an oral high‐dose cannabidiol (CBD; 100 mg) and low‐dose Δ9‐tetrahydocannabinol (THC; 3.3 mg) drug in PD.
Methods
Randomized, double‐blind, parallel‐group, placebo‐controlled study of a CBD/THC drug administered for 16.3 (SD: 4.2) days, with dosage escalating to twice per day. Neuropsychological tests were administered at baseline and 1–1½ hours after final dose; scores were analyzed with longitudinal regression models (alpha = 0.05). Cognitive adverse events were collected.
Results
When adjusted for age and education, the CBD/THC group (n = 29) performed worse than the placebo group (n = 29) on Animal Verbal Fluency. Adverse cognitive events were reported at least twice as often by the CBD/THC than the placebo group.
Conclusion
Data suggest this CBD/THC drug has a small detrimental effect on cognition following acute/short‐term use in PD. © 2023 The Authors. Movement Disorders published by Wiley Periodicals LLC on behalf of International Parkinson and Movement Disorder Society. |
| doi_str_mv | 10.1002/mds.29447 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_cross</sourceid><recordid>TN_cdi_proquest_miscellaneous_2817776882</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>2843042630</sourcerecordid><originalsourceid>FETCH-LOGICAL-c3887-11521858047997519a42d3ab301140a35b895952da79530504a0ada2c8eda60b3</originalsourceid><addsrcrecordid>eNp1kc9u1DAQxiMEotvCgRdAljgAEmn9J06cI-yWslIrqm45R5PY6bo49tZ2isKJR-DAc_EQ8CJ42cIBiZM1Mz9_32i-LHtC8CHBmB4NMhzSuiiqe9mMcEZyQXl1P5thIXjOiOB72X4I1xgTwkn5MNtjFSWUiXKW_Zy7K6ujvlVoBb2KE1pABNR7NyBAF2ClG_RnJV-hhRtbo358-frGaJvqc_BgjDKpc-LduEkdA51qXWrMnY3epalE52sICi2XLVrFUU7I9SiuFTrue9XFsC0BzcFaaLXUzqDkiL5_q5PIpYoe1pP0rtvNbRov_HiFnN26f9Q2OPs8oIUOKpmkLxfKQEymZy46j1bTsIluCI-yBz2YoB7fvQfZh7fHl_N3-en7k-X89WneMSGqPB2HplsJXFR1XXFSQ0Elg5alsxUYGG9FzWtOJVQ1Z5jjAjBIoJ1QEkrcsoPsxU53493NqEJsBh06ZQxY5cbQUEGqqiqFoAl99g967UZv03aJKhguaMlwol7uqM67ELzqm43XA_ipIbjZJt-k5JvfySf26Z3i2A5K_iX_RJ2Aox3wSRs1_V-pOVusdpK_AIBrvm4</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>2843042630</pqid></control><display><type>article</type><title>Cognitive Safety Data from a Randomized, Double‐Blind, Parallel‐Group, Placebo‐Controlled Phase IIb Study of the Effects of a Cannabidiol and Δ9‐Tetrahydrocannabinol Drug on Parkinson's Disease‐Related Motor Symptoms</title><source>MEDLINE</source><source>Wiley Online Library Journals Frontfile Complete</source><creator>Domen, Christopher H. ; Sillau, Stefan ; Liu, Ying ; Adkins, Michelle ; Rajkovic, Sarah ; Bainbridge, Jacquelyn ; Sempio, Cristina ; Klawitter, Jost ; Leehey, Maureen A.</creator><creatorcontrib>Domen, Christopher H. ; Sillau, Stefan ; Liu, Ying ; Adkins, Michelle ; Rajkovic, Sarah ; Bainbridge, Jacquelyn ; Sempio, Cristina ; Klawitter, Jost ; Leehey, Maureen A.</creatorcontrib><description>Background
Cannabis is increasingly available worldwide but its impact on cognition in Parkinson's disease (PD) is unknown.
Objective
Present cognitive safety data from study of an oral high‐dose cannabidiol (CBD; 100 mg) and low‐dose Δ9‐tetrahydocannabinol (THC; 3.3 mg) drug in PD.
Methods
Randomized, double‐blind, parallel‐group, placebo‐controlled study of a CBD/THC drug administered for 16.3 (SD: 4.2) days, with dosage escalating to twice per day. Neuropsychological tests were administered at baseline and 1–1½ hours after final dose; scores were analyzed with longitudinal regression models (alpha = 0.05). Cognitive adverse events were collected.
Results
When adjusted for age and education, the CBD/THC group (n = 29) performed worse than the placebo group (n = 29) on Animal Verbal Fluency. Adverse cognitive events were reported at least twice as often by the CBD/THC than the placebo group.
Conclusion
Data suggest this CBD/THC drug has a small detrimental effect on cognition following acute/short‐term use in PD. © 2023 The Authors. Movement Disorders published by Wiley Periodicals LLC on behalf of International Parkinson and Movement Disorder Society.</description><identifier>ISSN: 0885-3185</identifier><identifier>EISSN: 1531-8257</identifier><identifier>DOI: 10.1002/mds.29447</identifier><identifier>PMID: 37212386</identifier><language>eng</language><publisher>Hoboken, USA: John Wiley & Sons, Inc</publisher><subject>Cannabidiol ; Cannabidiol - adverse effects ; Cannabinoids ; Cannabis ; cognition ; Cognition & reasoning ; Cognition - drug effects ; Cognitive ability ; Double-Blind Method ; Double-blind studies ; Dronabinol - adverse effects ; Drug dosages ; Humans ; Movement disorders ; Neurodegenerative diseases ; Parkinson Disease - drug therapy ; Parkinson's disease ; Placebos ; Regression analysis ; Tetrahydrocannabinol ; THC ; Δ9‐tetrahydrocannabinol</subject><ispartof>Movement disorders, 2023-07, Vol.38 (7), p.1341-1346</ispartof><rights>2023 The Authors. published by Wiley Periodicals LLC on behalf of International Parkinson and Movement Disorder Society.</rights><rights>2023 The Authors. Movement Disorders published by Wiley Periodicals LLC on behalf of International Parkinson and Movement Disorder Society.</rights><rights>2023. This article is published under http://creativecommons.org/licenses/by-nc-nd/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c3887-11521858047997519a42d3ab301140a35b895952da79530504a0ada2c8eda60b3</citedby><cites>FETCH-LOGICAL-c3887-11521858047997519a42d3ab301140a35b895952da79530504a0ada2c8eda60b3</cites><orcidid>0000-0003-1075-5389 ; 0000-0002-9878-766X</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://onlinelibrary.wiley.com/doi/pdf/10.1002%2Fmds.29447$$EPDF$$P50$$Gwiley$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1002%2Fmds.29447$$EHTML$$P50$$Gwiley$$Hfree_for_read</linktohtml><link.rule.ids>314,776,780,1411,27901,27902,45550,45551</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/37212386$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Domen, Christopher H.</creatorcontrib><creatorcontrib>Sillau, Stefan</creatorcontrib><creatorcontrib>Liu, Ying</creatorcontrib><creatorcontrib>Adkins, Michelle</creatorcontrib><creatorcontrib>Rajkovic, Sarah</creatorcontrib><creatorcontrib>Bainbridge, Jacquelyn</creatorcontrib><creatorcontrib>Sempio, Cristina</creatorcontrib><creatorcontrib>Klawitter, Jost</creatorcontrib><creatorcontrib>Leehey, Maureen A.</creatorcontrib><title>Cognitive Safety Data from a Randomized, Double‐Blind, Parallel‐Group, Placebo‐Controlled Phase IIb Study of the Effects of a Cannabidiol and Δ9‐Tetrahydrocannabinol Drug on Parkinson's Disease‐Related Motor Symptoms</title><title>Movement disorders</title><addtitle>Mov Disord</addtitle><description>Background
Cannabis is increasingly available worldwide but its impact on cognition in Parkinson's disease (PD) is unknown.
Objective
Present cognitive safety data from study of an oral high‐dose cannabidiol (CBD; 100 mg) and low‐dose Δ9‐tetrahydocannabinol (THC; 3.3 mg) drug in PD.
Methods
Randomized, double‐blind, parallel‐group, placebo‐controlled study of a CBD/THC drug administered for 16.3 (SD: 4.2) days, with dosage escalating to twice per day. Neuropsychological tests were administered at baseline and 1–1½ hours after final dose; scores were analyzed with longitudinal regression models (alpha = 0.05). Cognitive adverse events were collected.
Results
When adjusted for age and education, the CBD/THC group (n = 29) performed worse than the placebo group (n = 29) on Animal Verbal Fluency. Adverse cognitive events were reported at least twice as often by the CBD/THC than the placebo group.
Conclusion
Data suggest this CBD/THC drug has a small detrimental effect on cognition following acute/short‐term use in PD. © 2023 The Authors. Movement Disorders published by Wiley Periodicals LLC on behalf of International Parkinson and Movement Disorder Society.</description><subject>Cannabidiol</subject><subject>Cannabidiol - adverse effects</subject><subject>Cannabinoids</subject><subject>Cannabis</subject><subject>cognition</subject><subject>Cognition & reasoning</subject><subject>Cognition - drug effects</subject><subject>Cognitive ability</subject><subject>Double-Blind Method</subject><subject>Double-blind studies</subject><subject>Dronabinol - adverse effects</subject><subject>Drug dosages</subject><subject>Humans</subject><subject>Movement disorders</subject><subject>Neurodegenerative diseases</subject><subject>Parkinson Disease - drug therapy</subject><subject>Parkinson's disease</subject><subject>Placebos</subject><subject>Regression analysis</subject><subject>Tetrahydrocannabinol</subject><subject>THC</subject><subject>Δ9‐tetrahydrocannabinol</subject><issn>0885-3185</issn><issn>1531-8257</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2023</creationdate><recordtype>article</recordtype><sourceid>24P</sourceid><sourceid>EIF</sourceid><recordid>eNp1kc9u1DAQxiMEotvCgRdAljgAEmn9J06cI-yWslIrqm45R5PY6bo49tZ2isKJR-DAc_EQ8CJ42cIBiZM1Mz9_32i-LHtC8CHBmB4NMhzSuiiqe9mMcEZyQXl1P5thIXjOiOB72X4I1xgTwkn5MNtjFSWUiXKW_Zy7K6ujvlVoBb2KE1pABNR7NyBAF2ClG_RnJV-hhRtbo358-frGaJvqc_BgjDKpc-LduEkdA51qXWrMnY3epalE52sICi2XLVrFUU7I9SiuFTrue9XFsC0BzcFaaLXUzqDkiL5_q5PIpYoe1pP0rtvNbRov_HiFnN26f9Q2OPs8oIUOKpmkLxfKQEymZy46j1bTsIluCI-yBz2YoB7fvQfZh7fHl_N3-en7k-X89WneMSGqPB2HplsJXFR1XXFSQ0Elg5alsxUYGG9FzWtOJVQ1Z5jjAjBIoJ1QEkrcsoPsxU53493NqEJsBh06ZQxY5cbQUEGqqiqFoAl99g967UZv03aJKhguaMlwol7uqM67ELzqm43XA_ipIbjZJt-k5JvfySf26Z3i2A5K_iX_RJ2Aox3wSRs1_V-pOVusdpK_AIBrvm4</recordid><startdate>202307</startdate><enddate>202307</enddate><creator>Domen, Christopher H.</creator><creator>Sillau, Stefan</creator><creator>Liu, Ying</creator><creator>Adkins, Michelle</creator><creator>Rajkovic, Sarah</creator><creator>Bainbridge, Jacquelyn</creator><creator>Sempio, Cristina</creator><creator>Klawitter, Jost</creator><creator>Leehey, Maureen A.</creator><general>John Wiley & Sons, Inc</general><general>Wiley Subscription Services, Inc</general><scope>24P</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7TK</scope><scope>8FD</scope><scope>FR3</scope><scope>K9.</scope><scope>NAPCQ</scope><scope>P64</scope><scope>RC3</scope><scope>7X8</scope><orcidid>https://orcid.org/0000-0003-1075-5389</orcidid><orcidid>https://orcid.org/0000-0002-9878-766X</orcidid></search><sort><creationdate>202307</creationdate><title>Cognitive Safety Data from a Randomized, Double‐Blind, Parallel‐Group, Placebo‐Controlled Phase IIb Study of the Effects of a Cannabidiol and Δ9‐Tetrahydrocannabinol Drug on Parkinson's Disease‐Related Motor Symptoms</title><author>Domen, Christopher H. ; Sillau, Stefan ; Liu, Ying ; Adkins, Michelle ; Rajkovic, Sarah ; Bainbridge, Jacquelyn ; Sempio, Cristina ; Klawitter, Jost ; Leehey, Maureen A.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c3887-11521858047997519a42d3ab301140a35b895952da79530504a0ada2c8eda60b3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2023</creationdate><topic>Cannabidiol</topic><topic>Cannabidiol - adverse effects</topic><topic>Cannabinoids</topic><topic>Cannabis</topic><topic>cognition</topic><topic>Cognition & reasoning</topic><topic>Cognition - drug effects</topic><topic>Cognitive ability</topic><topic>Double-Blind Method</topic><topic>Double-blind studies</topic><topic>Dronabinol - adverse effects</topic><topic>Drug dosages</topic><topic>Humans</topic><topic>Movement disorders</topic><topic>Neurodegenerative diseases</topic><topic>Parkinson Disease - drug therapy</topic><topic>Parkinson's disease</topic><topic>Placebos</topic><topic>Regression analysis</topic><topic>Tetrahydrocannabinol</topic><topic>THC</topic><topic>Δ9‐tetrahydrocannabinol</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Domen, Christopher H.</creatorcontrib><creatorcontrib>Sillau, Stefan</creatorcontrib><creatorcontrib>Liu, Ying</creatorcontrib><creatorcontrib>Adkins, Michelle</creatorcontrib><creatorcontrib>Rajkovic, Sarah</creatorcontrib><creatorcontrib>Bainbridge, Jacquelyn</creatorcontrib><creatorcontrib>Sempio, Cristina</creatorcontrib><creatorcontrib>Klawitter, Jost</creatorcontrib><creatorcontrib>Leehey, Maureen A.</creatorcontrib><collection>Wiley-Blackwell Open Access Titles</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Neurosciences Abstracts</collection><collection>Technology Research Database</collection><collection>Engineering Research Database</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Premium</collection><collection>Biotechnology and BioEngineering Abstracts</collection><collection>Genetics Abstracts</collection><collection>MEDLINE - Academic</collection><jtitle>Movement disorders</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Domen, Christopher H.</au><au>Sillau, Stefan</au><au>Liu, Ying</au><au>Adkins, Michelle</au><au>Rajkovic, Sarah</au><au>Bainbridge, Jacquelyn</au><au>Sempio, Cristina</au><au>Klawitter, Jost</au><au>Leehey, Maureen A.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Cognitive Safety Data from a Randomized, Double‐Blind, Parallel‐Group, Placebo‐Controlled Phase IIb Study of the Effects of a Cannabidiol and Δ9‐Tetrahydrocannabinol Drug on Parkinson's Disease‐Related Motor Symptoms</atitle><jtitle>Movement disorders</jtitle><addtitle>Mov Disord</addtitle><date>2023-07</date><risdate>2023</risdate><volume>38</volume><issue>7</issue><spage>1341</spage><epage>1346</epage><pages>1341-1346</pages><issn>0885-3185</issn><eissn>1531-8257</eissn><abstract>Background
Cannabis is increasingly available worldwide but its impact on cognition in Parkinson's disease (PD) is unknown.
Objective
Present cognitive safety data from study of an oral high‐dose cannabidiol (CBD; 100 mg) and low‐dose Δ9‐tetrahydocannabinol (THC; 3.3 mg) drug in PD.
Methods
Randomized, double‐blind, parallel‐group, placebo‐controlled study of a CBD/THC drug administered for 16.3 (SD: 4.2) days, with dosage escalating to twice per day. Neuropsychological tests were administered at baseline and 1–1½ hours after final dose; scores were analyzed with longitudinal regression models (alpha = 0.05). Cognitive adverse events were collected.
Results
When adjusted for age and education, the CBD/THC group (n = 29) performed worse than the placebo group (n = 29) on Animal Verbal Fluency. Adverse cognitive events were reported at least twice as often by the CBD/THC than the placebo group.
Conclusion
Data suggest this CBD/THC drug has a small detrimental effect on cognition following acute/short‐term use in PD. © 2023 The Authors. Movement Disorders published by Wiley Periodicals LLC on behalf of International Parkinson and Movement Disorder Society.</abstract><cop>Hoboken, USA</cop><pub>John Wiley & Sons, Inc</pub><pmid>37212386</pmid><doi>10.1002/mds.29447</doi><tpages>26</tpages><orcidid>https://orcid.org/0000-0003-1075-5389</orcidid><orcidid>https://orcid.org/0000-0002-9878-766X</orcidid><oa>free_for_read</oa></addata></record> |
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| ispartof | Movement disorders, 2023-07, Vol.38 (7), p.1341-1346 |
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| source | MEDLINE; Wiley Online Library Journals Frontfile Complete |
| subjects | Cannabidiol Cannabidiol - adverse effects Cannabinoids Cannabis cognition Cognition & reasoning Cognition - drug effects Cognitive ability Double-Blind Method Double-blind studies Dronabinol - adverse effects Drug dosages Humans Movement disorders Neurodegenerative diseases Parkinson Disease - drug therapy Parkinson's disease Placebos Regression analysis Tetrahydrocannabinol THC Δ9‐tetrahydrocannabinol |
| title | Cognitive Safety Data from a Randomized, Double‐Blind, Parallel‐Group, Placebo‐Controlled Phase IIb Study of the Effects of a Cannabidiol and Δ9‐Tetrahydrocannabinol Drug on Parkinson's Disease‐Related Motor Symptoms |
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