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Then there’s the training and experience of the therapists guiding both the dosing sessions and the drug-free integration sessions. COMPASS, which became a public company in September and earned a stock-market valuation exceeding US$1 billion, developed a five-tier training programme for therapists in its trial. Company co-founder and chief innovation officer Ekaterina Malievskaia says site investigators must adhere to the training if the company expects to win regulators’ approval.

Madras goes further to say that the conditions of the trial will have to be replicated for any wider roll-out of the drugs. They “have to be approved under the stringent conditions in which they were investigated”, she says. But the path forward for mandating such conditions is unclear. For the US FDA, there is a mechanism to ensure that drugs are administered in a specific way: Risk Evaluation and Mitigation Strategies, or REMS. Through REMS, the agency can require prescribing physicians and pharmacists to be certified for a treatment strategy. This would be designed to mitigate the risks associated with a drug — such as addiction and dependency for opiate prescription.

REMS could be used with psychedelics, Dunn says. The effect would be to bundle the delivery of the drug with the therapy component, and potentially certify practitioners. A source working on one of the trials says that discussions are under way with the FDA. They are talking about whether therapists who administer the drugs ought to be trained, what that training might involve and whether therapist certification should be required.

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Certification could mean legitimizing therapists who have been http://mushroom.com ‘treating’ individuals with the drugs illegally for as long as 30 years. But some of these therapists might resist the advice, or the involvement, of a government that has driven them underground.First look at LSD in action reveals acid-trip biochemistry

Approvals still have a long way to go. Towards the end of 2020, http://hausofutopiachocolate.com MAPS reported in a news release that there are statistically significant differences in the response between the control and placebo groups in its MDMA trial (see go.nature.com/362xsvp). But the company won’t say more about the results until it releases the full data some time this year. It is also recruiting for a second phase III study using MDMA therapy for people with moderate-to-severe PTSD, which it aims to complete before the end of the year. COMPASS expects to have results from its phase IIb study on psilocybin by that time, and the company says it is planning a phase III study.

Robert Malenka is a psychiatrist and neuroscientist at Stanford University in California who has studied MDMA’s effects on rodents. He says he thinks that some psychedelic drugs will eventually earn approval as treatments for certain conditions. “They have potential to be — I want to use the right analogy — a part of our toolset for treating patients,” he says. But he warns against overzealousness, particularly a brand of evangelism he’s seen among some of the underground purveyors of psychedelic-assisted psychotherapy. “I don’t think they’re going to be miracle cures,” he says.

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He argues that the hypotheses for how the drugs might be working in the brain still need further research, and that investigating compounds that provide the same benefits without the hallucinatory effects could prove worthwhile in the long run. Others point out that SSRIs work for many individuals without clinicians fully understanding their mechanism.

Regarding the clinical work, however, Madras says she’s concerned by the studies’ size and design. She noted that many of them recruit people who have had previous experience taking psychedelics. Those who are attracted to this type of experience, she argues, might be more likely to say positive things about it. Nutt has said that working with experienced users of the drugs minimizes the chance of adverse events. But there are other potential confounders, according to Madras. “The consent forms tell you what the expectations are,” she says. “So there’s bias on the part of the subjects.”

Rutter says that despite all that, he is convinced that the treatment he received in 2015 changed his life for the better. In the weeks after his sessions, he found himself wondering whether the automatic circuit would return. “I was terrified,” he says, “and I realized I’ve got a little bit of control over this, right?” The thought had never occurred to him before.

A week or so later, he was out with friends at a shopping centre and sensed the return of optimism and openness. “It felt like somebody had opened a window in a stuffy room.” Five years later, his depression has not returned.