IrisZorg verslavingszorg, Arnhem, the Netherlands.
Nijmegen Institute for Science Practitioners in Addiction (NISPA), Nijmegen, the Netherlands.
Addiction. 2022 Jan;117(1):118-128. doi: 10.1111/add.15448. Epub 2021 Aug 9.
Ibogaine is an indole alkaloid used in rituals of the African Bwiti tribe. It is also used in non-medical settings to treat addiction. However, ibogaine has been linked to several deaths, mainly due to cardiac events called torsades des pointes 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.
A descriptive open-label observational study.
Department of psychiatry in a university medical center, the Netherlands.
Patients with opioid use disorder (n = 14) on opioid maintenance treatment with a lasting wish for abstinence, who failed to reach abstinence with standard care.
After conversion to morphine-sulphate, a single dose of ibogaine-HCl 10 mg/kg was administered and patients were monitored at regular intervals for at least 24 hours 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.
The maximum QTc (Fridericia) prolongation was on average 95ms (range 29-146ms). 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-tolerated and manageable (11/14 did not return to morphine within 24 hours, DOS scores remained below threshold).
This open-label 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.
伊博加因是一种吲哚生物碱，用于非洲比提部落的仪式中。它也被用于非医疗环境中治疗成瘾。然而，伊博加因已经与几例死亡有关，主要是由于称为尖端扭转型室性心动过速的心脏事件，其之前伴有 QTc 延长以及其他安全问题。本研究旨在评估伊博加因在阿片类药物使用障碍患者中的心脏、小脑和拟精神病安全性。
描述性开放标签观察性研究。
荷兰一所大学医学中心的精神病学系。
正在接受阿片类药物维持治疗且渴望戒断的阿片类药物使用障碍患者（n=14），他们在标准护理下未能达到戒断。
在转换为硫酸吗啡后，给予伊博加因盐酸盐 10mg/kg 单剂量，并在至少 24 小时内定期监测患者，评估 QTc、血压和心率、评估小脑副作用的共济失调评估和评分量表 (SARA) 和评估拟精神病作用的谵妄观察量表 (DOS)。
最大 QTc（Fridericia）延长平均为 95ms（范围 29-146ms）。50%的受试者在观察期间达到 QTc 超过 500ms。在 14 名受试者中的 6 名中，伊博加因摄入后 450ms 以上的延长持续超过 24 小时。未观察到尖端扭转型室性心动过速。所有患者均出现严重的短暂性共济失调，无法在无支撑下行走。戒断和拟精神病作用大多耐受良好且可管理（14 名中有 11 名在 24 小时内未返回吗啡，DOS 评分仍低于阈值）。
这项开放标签观察性研究发现，阿片类药物使用障碍患者的伊博加因治疗可引起临床相关但可逆转的 QTc 延长、心动过缓和严重的共济失调。
