What is ibogaine, and what does it treat?伊博格碱是什么?它能治疗哪些疾病?
Psychedelic drugs, once pushed to the fringes of medicine, are gaining serious attention within the Trump administration as potential treatment options for people with certain mental health conditions. And they could be getting closer to receiving approval from the US Food and Drug Administration.
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Ibogaine, a psychoactive compound made from the roots of an African shrub, has been gaining popularity as a treatment for opioid and cocaine addiction. There is a new emphasis on research into ibogaine, although it is currently illegal to possess or prescribe it in the United States.
It’s drawn more attention on social media too, including from Presley Gerber, a model, mental health advocate and son of supermodel Cindy Crawford, who died Sunday at age 27 at a rehabilitation facility in California. Gerber’s death is being investigated by the Santa Monica Police Department as a “suspected overdose,” according to a news release from the law enforcement agency. No cause or manner of death has been confirmed.
Gerber, who had been open about his struggles with substance use, mentioned ibogaine in an Instagram post in March, saying in the caption on the video, “Pre-Ibogaine Flood Dose - quiet moment before everything changed….praying it’s the last time I have to come back.”
Ibogaine is one of several psychedelic drugs that have been given serious attention by the Trump administration as potential treatment options for people with certain mental health conditions. And they could be getting closer to receiving approval from the US Food and Drug Administration.
President Donald Trump signed an executive order in April designed to fast-track research on and access to these drugs, including a $50 million investment in state governments to study how psychedelics might help people struggling with mental illnesses. The executive order specifically names “ibogaine compounds” as showing potential to address serious mental illness.
Nathan Howard/Reuters
Trump accelerates research on psychedelic treatments and asks, ‘Can I have some?’
Dr. Marty Makary, who was then FDA commissioner, told CNN in April that ibogaine could receive FDA approval once the agency reviews data from late-stage clinical trials.
“These are potentially promising treatments,” he said. “We’ll see how the data reads out when we get the applications, but we don’t want to waste any time, because this is an urgent matter, given the mental health crisis.”
Ibogaine and some other psychedelics are classified as Schedule I substances by the US Drug Enforcement Administration, a designation the federal government uses for substances it considers to have no currently accepted medical use and a high potential for abuse.
In rare cases, it can also disturb the heart’s electrical rhythms, leading to cardiac arrest and sudden death.
But “the FDA has a system with the DEA by which, when a drug becomes FDA-approved and the FDA sets clear criteria, then it can be given with a transient de-scheduling that is exempt from those enforcement rules, because it’s given in a hospital setting or in a clinic setting under clinical supervision,” Makary said earlier this year. “If they do get approved, these are not the medications you’ll just pick up at a pharmacy. These are given in a controlled, supervised setting in a hospital.”
In April, the FDA accepted an investigational new drug application for a drug that uses an ibogaine derivative, which researchers hope will provide the benefits of ibogaine, but without the hallucinogenic trip or potential heart toxicity.
Dr. Kirsten Cherian, a researcher at Stanford University who led a landmark study on ibogaine, called the executive order a “great step,” adding that it may open the door to offering the treatment in US research facilities.
“The first step is to be able to do the research at home,” she said. “And it could open up a lot of research possibilities. It is kind of an exciting time.”
The compound, extracted from the iboga plant in Central Africa, has long been used to decrease opioid cravings and treat severe depression, anxiety and post-traumatic stress disorder symptoms in veterans.
Anthropologists trace its discovery to the Pygmy people in Central Africa, who viewed ibogaine as a sacred medium given by God that allowed them to reconnect with the divine and the dead. During the colonial period, as indigenous structures were disrupted, the compound provided communities in the region with a sense of unity and shared experience.
Years later, in 1962, ibogaine was introduced by researchers in the US as a potential treatment for substance-related disorders. Early results proved to be promising, but psychedelics were considered controversial, and broadly, researchers “abandoned” it, said Dr. Arnt Schellekens, who studies the compound at Radboud University in the Netherlands.
In 1967, the DEA classified ibogaine as a Schedule I controlled drug, making it illegal to use.
In recent years, ibogaine has garnered several high-profile supporters, including former Texas Gov. Rick Perry, former Sen. Kyrsten Sinema of Arizona and podcast host Joe Rogan.
When Trump signed the executive order this year, he invited Rogan to speak about the initiative.
“I want to tell everybody how this happened,” Rogan said from the Oval Office. “I sent President Trump some information.”
“The text message that came back,” Rogan said, “ ‘sounds great, do you want FDA approval? Let’s do it.’ ” He added that it was “literally that quick.”
Early research suggests that ibogaine may alter certain neural pathways , potentially leading to improvements in some mental health conditions, including PTSD, anxiety or depression.
People who have ibogaine treatment typically describe an initial “visual” phase that lasts one to four hours, followed by an “introspective” phase that can last several hours to days.
During that time, the brain becomes more malleable and can form new connections, Cherian says.
“It acts across multiple neurotransmitter systems,” Cherian said, adding that its effects are more intense than those of other psychedelics like psilocybin and LSD. “That’s contributing to sort of reorganizing brain networks.”
These mechanisms are thought to underlie some of the benefits that come with treatment. But Schellekens warns that much is still unknown about ibogaine and that evidence for its use remains “modest.”
“We are just not there yet,” he added, emphasizing that mainstream mental health treatments such as therapy and prescription medications are preferred.
The hallucinogen is known to raise the risk of abnormal heart rhythms and rates and could cause vomiting. Several deaths have been associated with the ingestion of ibogaine, though it’s not always clear whether the drug itself, underlying health conditions or other factors were the direct cause.
“It is sort of romanticized,” Schellekens said. “But going for ibogaine treatment can be very dangerous. As a scientist and as a doctor, I always am very cautious about this type of substance.”
That’s why he says more research is needed to shed light on the safety profile.
For patients, families and clinicians navigating the realities of mental health, questions remain around whether ibogaine’s potential benefits outweigh its risks — and for whom.
A growing number of military veterans have turned to ibogaine, many seeking treatment for traumatic brain injuries. The treatment is often done in Mexico — where it is unregulated — and is the last resort for many who have found traditional treatments ineffective.
“Anecdotally, we hear about veterans traveling abroad to ibogaine clinics when they feel like conventional treatments have been ineffective for their conditions,” Dr. Fayzan Rab, a physician resident at the Emory School of Medicine, wrote in an email earlier this year.
Kevin Mohatt/Reuters
RFK Jr. and other Trump officials embrace psychedelics after FDA setback
Charles Graham Jr., a veteran who was diagnosed with an unspecified depressive disorder, had treatment with ibogaine in Mexico.
“I’ve never felt peace like this in my life,” Graham told CNN two days later. “I won’t say it healed everything overnight, but it gave me the ability to break free of the cycles that were holding me prisoner.”
The popularity of the treatment among veterans has spawned advocacy groups like Veterans Exploring Treatment Solutions, co-founded by Amber Capone seven years ago. She says her organization has funded and supported ibogaine treatment — which can cost upward of $5,000 — for over 1,300 veterans.
“Veterans are given outdated treatments for their invisible wounds,” Capone said. Her husband, a veteran who experienced PTSD and suicidal ideation, received the treatment in 2017. “It truly felt like a Hail Mary, and overnight, our life was completely transformed.”
Overall, experts are hoping to learn more through additional research to better understand the risks and benefits of ibogaine.
“We are enthusiastic [about] any federal attention toward developing new treatments for people struggling with PTSD and opioid addiction. These are populations that are often underserved by what we currently have,” Rab said. “Novel treatments deserve rigorous examination and time to prove their efficacy.”
The general response to Trump’s executive order was a “mixed bag,” because while experts have expressed excitement, others have concerns about the need to conduct more research on psychedelics’ risks and benefits, and concerns that the $50 million that the order allocates to state governments to advance research may not be sufficient, said Melissa Lavasani, founder and chief executive of the advocacy group Psychedelic Medicine Coalition, which works to pave the way for safe, effective psychedelic medicines to enter mainstream health care.
“The $50 million is a great starting point. But we know that psychedelic studies in general are really expensive to execute on, because the psychedelic experience is time-intensive. You have to be in a clinical setting,” she said, adding that most states typically don’t have the bandwidth or the resources to conduct large-scale studies in the same way the federal government does.
“So many states don’t necessarily have the capacity to run large-scale studies that need to be done for psychedelics, and really, those have to be coming out of the federal government, just because they cost so much,” Lavasani said. “Hopefully, the $50 million will jump start other agencies that are grant-making agencies to go out and start funding larger-scale studies.”
The executive order also directed the FDA to provide national priority vouchers to certain psychedelic drugs. The FDA Commissioner’s National Priority Voucher pilot program, which was announced last year, was developed as a pathway to speed the review process for certain drugs and biological products seeking approval.
“This is to grease the wheels internally within government to make things move a little quicker and get some of these reviews out the door much faster, so that we can work towards FDA approval,” Lavasani said, adding that prior to the executive order, psychedelic companies tried to get fast-track reviews and were denied.
Days after the executive order, the FDA issued national priority vouchers to companies studying psilocybin for treatment-resistant depression and major depressive disorder and metylone for post-traumatic stress disorder.
“This is significant in that it speeds up access. It speeds up these drugs being available on the market, and it can advance dialogues about what insurance coverage is going to look like and what health care infrastructure needs to be,” Lavasani said. “There’s not a question of if the Trump administration will allow FDA approvals for psychedelics, it’s ‘when this happens, what do we need to do to be prepared for this?’ So that this can get rolled out properly, so that folks can have access, so that insurance can eventually cover this and we can come up with some training and credentialing and protocols.”
She added that “it’s going to be a trial and error process, and it’s not going to happen overnight. Even with an executive order, this stuff takes a lot of time.”
Nao Mukadi/AFP/Getty Images
伊博格碱是一种从非洲灌木根部提取的精神活性化合物,近年来作为治疗阿片类药物和可卡因成瘾的药物越来越受欢迎。尽管目前在美国持有或开具伊博格碱处方仍属违法行为,但对伊博格碱的研究正受到越来越多的关注。
此事在社交媒体上也引起了更多关注,其中包括模特兼心理健康倡导者、超模辛迪·克劳馥之子普雷斯利·格伯。格伯于周日在加州一家康复中心去世,年仅27岁。据圣莫尼卡警察局发布的新闻稿称,格伯的死因正在被调查,初步判断为“疑似过量用药”。目前尚未确认死因或死亡方式。
格伯曾公开谈论过自己与药物滥用作斗争的经历。今年 3 月,他在 Instagram 上发布了一段视频,并配文说:“服用伊博格碱大剂量之前——一切改变之前的安静时刻……祈祷这是我最后一次回来。”
伊博格碱是特朗普政府高度关注的几种迷幻药物之一,被视为治疗某些精神健康问题的潜在方案。它们可能很快就会获得美国食品药品监督管理局的批准。
今年4月,唐纳德·特朗普总统签署了一项行政命令,旨在加快对这些药物的研究和获取,其中包括向各州政府投资5000万美元,用于研究迷幻药如何帮助精神疾病患者。该行政命令特别指出,“伊博格碱化合物”具有治疗严重精神疾病的潜力。
内森·霍华德/路透社
特朗普加快了对迷幻药疗法的研究,并问道:“我能尝尝吗?”
时任美国食品药品监督管理局局长马蒂·马卡里博士在 4 月份告诉 CNN,一旦该机构审查了后期临床试验的数据,伊博格碱就可能获得 FDA 的批准。
他说:“这些疗法很有潜力。等收到申请后,我们会看看数据结果如何,但我们不想浪费任何时间,因为鉴于当前的心理健康危机,这件事非常紧急。”
伊博格碱和其他一些迷幻剂被美国缉毒局列为一级管制物质,联邦政府将此类物质归类为目前没有公认的医疗用途且具有很高的滥用潜力。
在极少数情况下,它还会扰乱心脏的电节律,导致心脏骤停和猝死。
但马卡里今年早些时候表示,“FDA与DEA之间有一套机制,当一种药物获得FDA批准,并且FDA制定了明确的标准后,该药物就可以暂时解除管制,不受相关执法规定的约束,因为它是在医院或诊所的临床监督下使用的。”他补充道,“如果这些药物最终获得批准,它们并不是你可以在药房随便买到的。这些药物是在医院的受控监督环境下使用的。”
今年 4 月,FDA 受理了一项使用伊博格碱衍生物的药物的试验性新药申请。研究人员希望该药物能够提供伊博格碱的益处,但不会产生致幻作用或潜在的心脏毒性。
斯坦福大学研究员 Kirsten Cherian 博士领导了一项关于伊博格碱的里程碑式研究,她称这项行政命令是“一大步”,并补充说,这可能会为在美国研究机构提供这种疗法打开大门。
“第一步是能够在家进行研究,”她说。“这可能会开启很多研究可能性。这真是一个令人兴奋的时刻。”
这种化合物提取自中非的伊博加植物,长期以来一直被用于减少对阿片类药物的渴望,并治疗退伍军人的严重抑郁症、焦虑症和创伤后应激障碍症状。
人类学家认为伊博格碱起源于中非的俾格米人,他们将伊博格碱视为上帝赐予的神圣媒介,使他们能够与神灵和亡灵重新建立联系。在殖民时期,随着本土文化遭到破坏,伊博格碱的发现为该地区的社群提供了一种团结感和共同的经历。
多年后的1962年,美国的研究人员将伊博格碱作为一种潜在的物质相关疾病治疗方法引入临床。早期结果令人鼓舞,但迷幻剂被认为具有争议性,因此研究人员普遍“放弃”了它。荷兰拉德布德大学研究该化合物的阿恩特·谢勒肯斯博士说道。
1967 年,美国缉毒局将伊博格碱列为一级管制药物,禁止使用。
近年来,伊博格碱获得了几位知名人士的支持,其中包括前德克萨斯州州长里克·佩里、前亚利桑那州参议员克里斯滕·西内玛和播客主持人乔·罗根。
今年特朗普签署行政命令时,他邀请罗根就此发表讲话。
“我想告诉大家事情的经过,”罗根在椭圆形办公室说。“我给特朗普总统发了一些信息。”
罗根说:“我收到的回复短信是:‘听起来不错,你想获得FDA批准吗?那就开始吧。’” 他补充说,事情“真的就是这么快”。
早期研究表明,伊博格碱可能会改变某些神经通路,从而可能改善某些精神健康状况,包括创伤后应激障碍、焦虑或抑郁。
接受伊博格碱治疗的人通常会描述一个持续一到四个小时的初始“视觉”阶段,随后是一个持续数小时到数天的“内省”阶段。
切里安说,在此期间,大脑变得更具可塑性,可以形成新的连接。
“它作用于多种神经递质系统,”切里安说,并补充道,它的效果比其他迷幻剂(如裸盖菇素和LSD)更强烈。“这有助于重组大脑网络。”
这些机制被认为是治疗带来部分益处的基础。但谢勒肯斯警告说,关于伊博格碱仍有很多未知之处,其疗效证据仍然“有限”。
“我们还没有达到那个阶段,”他补充道,并强调主流心理健康治疗方法,如心理治疗和处方药,才是首选。
这种致幻剂已知会增加心律失常和心率异常的风险,并可能导致呕吐。虽然尚不清楚伊博格碱本身、潜在的健康状况或其他因素是否是直接死因,但已有数起死亡案例与服用伊博格碱有关。
“这多少有点被浪漫化了,”谢勒肯斯说。“但接受伊博格碱治疗可能非常危险。作为一名科学家和医生,我对这类物质始终非常谨慎。”
因此他表示,需要进行更多研究来阐明其安全性。
对于正在应对精神健康现实的患者、家属和临床医生来说,关于伊博格碱的潜在益处是否大于其风险,以及对哪些人有益,仍然存在疑问。
越来越多的退伍军人开始使用伊博格碱,其中许多人寻求治疗创伤性脑损伤。这种疗法通常在墨西哥进行——那里的伊博格碱疗法不受监管——对于许多发现传统疗法无效的患者来说,伊博格碱是最后的选择。
“据传闻,一些退伍军人在感觉传统疗法对他们的病情没有效果时,会前往国外的伊博格碱诊所就诊,”埃默里大学医学院的住院医师费赞·拉布博士在今年早些时候的一封电子邮件中写道。
凯文·莫哈特/路透社
在FDA受挫后,小罗伯特·肯尼迪和其他特朗普政府官员开始使用迷幻药
查尔斯·格雷厄姆二世是一名退伍军人,被诊断患有不明抑郁症,他在墨西哥接受了伊博格碱治疗。
两天后,格雷厄姆告诉CNN:“我这辈子从未感受过如此平静。我不会说它一夜之间治愈了一切,但它让我能够挣脱束缚我的恶性循环。”
这种疗法在退伍军人中广受欢迎,催生了像“退伍军人探索治疗方案”这样的倡导组织,该组织由安珀·卡彭七年前联合创立。她说,她的组织已经资助和支持了超过1300名退伍军人接受伊博格碱治疗——这种治疗的费用可能高达5000美元。
“退伍军人接受的都是过时的治疗方法,无法治愈他们的隐形创伤,”卡波内说道。她的丈夫也是一名退伍军人,曾患有创伤后应激障碍(PTSD)和自杀倾向,于2017年接受了治疗。“这感觉就像是孤注一掷,一夜之间,我们的生活彻底改变了。”
总的来说,专家们希望通过进一步的研究来了解更多信息,以便更好地了解伊博格碱的风险和益处。
拉布表示:“我们热切希望联邦政府关注开发治疗创伤后应激障碍和阿片类药物成瘾的新疗法。这些人群往往无法得到我们现有疗法的充分服务。新疗法需要经过严格的检验和时间来证明其疗效。”
特朗普的行政命令总体反响“褒贬不一”,因为尽管一些专家表示兴奋,但也有人担心需要对迷幻药的风险和益处进行更多研究,并担心该命令拨给各州政府用于推进研究的 5000 万美元可能不够。倡导组织“迷幻药联盟”(Psychedelic Medicine Coalition)的创始人兼首席执行官梅丽莎·拉瓦萨尼(Melissa Lavasani)表示,该联盟致力于为安全有效的迷幻药进入主流医疗保健铺平道路。
“5000万美元是一个很好的起点。但我们知道,迷幻药研究总体来说成本很高,因为迷幻体验非常耗时。你必须在临床环境下进行,”她说道,并补充说,大多数州通常没有足够的人力或资源像联邦政府那样开展大规模研究。
拉瓦萨尼说:“很多州并不一定有能力开展迷幻剂所需的大规模研究,而这些研究实际上必须由联邦政府资助,因为它们成本太高了。希望这5000万美元能够带动其他拨款机构,促使它们也开始资助更大规模的研究。”
该行政命令还指示FDA向某些迷幻药发放国家优先券。FDA局长去年宣布的“国家优先券试点项目”旨在加快某些药物和生物制品的审批流程。
拉瓦萨尼表示:“这是为了在政府内部推动事情进展,加快速度,更快地完成一些审查,以便我们能够争取获得FDA的批准。”他还补充说,在行政命令发布之前,迷幻药公司曾试图获得快速审查,但遭到了拒绝。
行政命令发布几天后,FDA 向研究用于治疗难治性抑郁症和重度抑郁症的裸盖菇素以及用于治疗创伤后应激障碍的甲硝唑的公司发放了国家优先券。
拉瓦萨尼表示:“这意义重大,因为它加快了药物的获取速度。它加快了这些药物上市的速度,并能推动关于保险覆盖范围和医疗基础设施建设的对话。现在的问题不是特朗普政府是否会批准FDA批准迷幻药,而是‘一旦批准,我们需要做些什么准备?’这样才能确保药物顺利上市,让民众能够获得,最终纳入保险覆盖范围,并制定相应的培训、认证和操作规程。”
她补充说:“这将是一个反复试验的过程,不会一蹴而就。即使有行政命令,这些事情也需要很长时间。”