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However, ibogaine has been linked to several deaths, mainly due to cardiac events called\n                      <jats:italic>torsades des pointes<\/jats:italic>\n                      preceded by QTc prolongation as well as other safety concerns. This study aimed to evaluate the cardiac, cerebellar and psychomimetic safety of ibogaine in patients with opioid use disorder.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Design<\/jats:title>\n                    <jats:p>A descriptive open\u2010label observational study.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Setting<\/jats:title>\n                    <jats:p>Department of psychiatry in a university medical center, the Netherlands.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Participants<\/jats:title>\n                    <jats:p>\n                      Patients with opioid use disorder (\n                      <jats:italic>n<\/jats:italic>\n                      \u00a0=\u00a014) on opioid maintenance treatment with a lasting wish for abstinence, who failed to reach abstinence with standard care.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Intervention and measurements<\/jats:title>\n                    <jats:p>After conversion to morphine\u2010sulphate, a single dose of ibogaine\u2010HCl 10\u00a0mg\/kg was administered and patients were monitored at regular intervals for at least 24\u00a0hours assessing QTc, blood pressure and heart rate, scale for the assessment and rating of ataxia (SARA) to assess cerebellar side effects and the delirium observation scale (DOS) to assess psychomimetic effects.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Findings<\/jats:title>\n                    <jats:p>The maximum QTc (Fridericia) prolongation was on average 95ms (range 29\u2010146ms). Fifty percent of subjects reached a QTc of over 500ms during the observation period. In six out 14 subjects prolongation above 450ms lasted beyond 24 hours after ingestion of ibogaine. No torsades des pointes were observed. Severe transient ataxia with inability to walk without support was seen in all patients. Withdrawal and psychomimetic effects were mostly well\u2010tolerated and manageable (11\/14 did not return to morphine within 24 hours, DOS scores remained below threshold).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>This open\u2010label observational study found that ibogaine treatment of patients with opioid use disorder can induce a clinically relevant but reversible QTc prolongation, bradycardia, and severe ataxia.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/add.15448","type":"journal-article","created":{"date-parts":[[2021,2,23]],"date-time":"2021-02-23T09:12:03Z","timestamp":1614071523000},"page":"118-128","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":45,"title":["Safety of ibogaine administration in detoxification of opioid\u2010dependent individuals: a descriptive open\u2010label observational study"],"prefix":"10.1111","volume":"117","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-9729-1283","authenticated-orcid":false,"given":"Thomas","family":"Knuijver","sequence":"first","affiliation":[{"name":"IrisZorg verslavingszorg  Arnhem the Netherlands"},{"name":"Nijmegen Institute for Science Practitioners in Addiction (NISPA)  Nijmegen the Netherlands"},{"name":"Department of Pharmacology\u2013Toxicology Radboud UMC Nijmegen  Nijmegen the Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7715-5209","authenticated-orcid":false,"given":"Arnt","family":"Schellekens","sequence":"additional","affiliation":[{"name":"Nijmegen Institute for Science Practitioners in Addiction (NISPA)  Nijmegen the Netherlands"},{"name":"Department of Psychiatry Radboud UMC  Nijmegen the Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1391-8673","authenticated-orcid":false,"given":"Maarten","family":"Belgers","sequence":"additional","affiliation":[{"name":"IrisZorg verslavingszorg  Arnhem the Netherlands"},{"name":"Nijmegen Institute for Science Practitioners in Addiction (NISPA)  Nijmegen the Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0484-1419","authenticated-orcid":false,"given":"Rogier","family":"Donders","sequence":"additional","affiliation":[{"name":"Department for Health Evidence Radboud UMC Nijmegen  Nijmegen the Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9971-0234","authenticated-orcid":false,"given":"Toon","family":"van Oosteren","sequence":"additional","affiliation":[{"name":"IrisZorg verslavingszorg  Arnhem the Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5398-6414","authenticated-orcid":false,"given":"Kees","family":"Kramers","sequence":"additional","affiliation":[{"name":"Department of Pharmacology\u2013Toxicology Radboud UMC Nijmegen  Nijmegen the Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3278-305X","authenticated-orcid":false,"given":"Robbert","family":"Verkes","sequence":"additional","affiliation":[{"name":"Department of Psychiatry Radboud UMC  Nijmegen the Netherlands"},{"name":"Centre of Forensic Psychiatry Pompe Kliniek  Nijmegen the Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2021,8,9]]},"reference":[{"key":"e_1_2_9_2_1","unstructured":"National Center for Biotechnology Information.PubChem Compound Database; CID=197060. 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