{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,9]],"date-time":"2026-06-09T12:03:14Z","timestamp":1781006594464,"version":"3.54.1"},"reference-count":39,"publisher":"SAGE Publications","issue":"3","license":[{"start":{"date-parts":[[2025,7,4]],"date-time":"2025-07-04T00:00:00Z","timestamp":1751587200000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["J Psychopharmacol"],"published-print":{"date-parts":[[2026,3]]},"abstract":"<jats:sec>\n                    <jats:title>Background:<\/jats:title>\n                    <jats:p>Although only two drugs are FDA approved for autism spectrum disorder (ASD), clinical practice treatment includes off-label use of medications to address the troubling symptoms of ASD. Several trials showed the beneficial effects of medical cannabis for alleviating symptoms of ASD. However, data are lacking regarding its safety and effectiveness as a single agent compared to add-on therapy.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Aims:<\/jats:title>\n                    <jats:p>To compare the safety and effectiveness of medical cannabis as a monotherapy and add-on therapy in autistic children.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods:<\/jats:title>\n                    <jats:p>An open-label trial recruiting autistic children was performed and treated with medical cannabis oil with a THC:CBD ratio of 1:20, respectively. Tests were conducted at baseline and after 6\u2009months of therapy. A secondary analysis was done to compare physical and behavior parameters, using tests such as Autism Diagnostic Observation Schedule and Wechsler tests in the two groups.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results:<\/jats:title>\n                    <jats:p>\n                      Out of 109 participants, 81 completed the treatment. Thirty received cannabis as add-on therapy to a pre-existing treatment, whereas 51 received cannabis as monotherapy, with no observed differences in baseline characteristics between the groups. The mean maximal CBD dose was 3.1\u2009mg\/kg\/day in the monotherapy group, compared to 2.8\u2009mg\/kg\/day in the add-on group (\n                      <jats:italic toggle=\"yes\">p<\/jats:italic>\n                      \u2009=\u20090.40). In patients treated with drugs for psychosis, the mean maximal dose was 2.48\u2009mg\/kg\/day (\n                      <jats:italic toggle=\"yes\">p<\/jats:italic>\n                      \u2009=\u20090.12). No differences were observed in most physical and behavioral parameters. In addition, no differences in CBD blood levels were observed.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions:<\/jats:title>\n                    <jats:p>Add-on cannabis therapy is as safe as monotherapy treatment, without significant differences in efficacy.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1177\/02698811251332841","type":"journal-article","created":{"date-parts":[[2025,7,4]],"date-time":"2025-07-04T07:00:33Z","timestamp":1751612433000},"page":"401-409","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":0,"title":["Evaluating the impact of cannabis oil for autistic children with and without concomitant medications: Insights from an open-label study"],"prefix":"10.1177","volume":"40","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-8525-5840","authenticated-orcid":false,"given":"Nir","family":"Treves","sequence":"first","affiliation":[{"name":"School of Pharmacy, Hebrew University of Jerusalem, Jerusalem, Israel"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Adi","family":"Dagan","sequence":"additional","affiliation":[{"name":"Pediatric Division, Shamir Medical Center, Tzrifin, Israel"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Elkana","family":"Kohn","sequence":"additional","affiliation":[{"name":"Clinical Pharmacology and Toxicology Unit, Shamir Medical Center, Tzrifin, Israel"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ariela","family":"Hazan","sequence":"additional","affiliation":[{"name":"Clinical Pharmacology and Toxicology Unit, Shamir Medical Center, Tzrifin, Israel"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Matityahu","family":"Berkovitch","sequence":"additional","affiliation":[{"name":"Pediatric Division, Shamir Medical Center, Tzrifin, Israel"},{"name":"Clinical Pharmacology and Toxicology Unit, Shamir Medical Center, Tzrifin, Israel"},{"name":"Shamir Medical Center, The Andy Lebach Chair of Clinical Pharmacology and Toxicology, School of Medicine, Be\u2019er Ya\u2019akov, Israel"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ibrahim","family":"Abu-Kishk","sequence":"additional","affiliation":[{"name":"Pediatric Division, Shamir Medical Center, Tzrifin, Israel"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Netanel","family":"Agajani","sequence":"additional","affiliation":[{"name":"Pediatric Division, Shamir Medical Center, Tzrifin, Israel"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dana","family":"Barchel","sequence":"additional","affiliation":[{"name":"Clinical Pharmacology and Toxicology Unit, Shamir Medical Center, Tzrifin, Israel"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Eli","family":"Heyman","sequence":"additional","affiliation":[{"name":"Pediatric Division, Shamir Medical Center, Tzrifin, Israel"},{"name":"Children Neurology Dept., Shamir Medical Center, Be\u2019er Ya\u2019akov, Israel"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mirit","family":"Lazinger","sequence":"additional","affiliation":[{"name":"Pediatric Division, Shamir Medical Center, Tzrifin, Israel"},{"name":"Children Neurology Dept., Shamir Medical Center, Be\u2019er Ya\u2019akov, Israel"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Inbar","family":"Hartmann","sequence":"additional","affiliation":[{"name":"Pediatric Division, Shamir Medical Center, Tzrifin, Israel"},{"name":"Children Neurology Dept., Shamir Medical Center, Be\u2019er Ya\u2019akov, Israel"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Orit","family":"Stolar","sequence":"additional","affiliation":[{"name":"Autism Center (ALUT), Tzrifin, Israel"},{"name":"Child Development Center, Maccabi Health Services, Hasharon Region, Tel Aviv, Israel"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"179","published-online":{"date-parts":[[2025,7,4]]},"reference":[{"key":"e_1_3_3_2_1","doi-asserted-by":"publisher","DOI":"10.3389\/FPHAR.2022.908198"},{"key":"e_1_3_3_3_1","doi-asserted-by":"publisher","DOI":"10.1007\/s10803-018-3808-2"},{"key":"e_1_3_3_4_1","doi-asserted-by":"publisher","DOI":"10.1186\/S13229-021-00420-2"},{"key":"e_1_3_3_5_1","doi-asserted-by":"publisher","DOI":"10.3389\/FPHAR.2018.01521"},{"key":"e_1_3_3_6_1","doi-asserted-by":"publisher","DOI":"10.1038\/S41598-018-37570-Y"},{"key":"e_1_3_3_7_1","doi-asserted-by":"publisher","DOI":"10.1523\/JNEUROSCI.0678-08.2008"},{"key":"e_1_3_3_8_1","doi-asserted-by":"publisher","DOI":"10.1097\/WCO.0000000000000660"},{"key":"e_1_3_3_9_1","unstructured":"Center for Drug Evaluation and Research (2018) The voice of the patient: a series of reports from the U.S. Food and Drug Administration\u2019s patient-focused drug development initiative autism. 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