Her concern is the lack of data surrounding the psychotherapeutic component of psychedelic-assisted therapy, leading to a lack of best practices, guidelines and regulations. We don’t know what they should look like until we have a better understanding of what doesn’t work,” says McGuire. “At this point, I don’t think we have enough to know what role psychotherapy plays in the overall treatment process,” she says.
McNamee’s concern is that the psychotherapeutic component is often hailed as an important safety measure for public and regulatory agencies wary of administering these drugs to vulnerable patients. In fact, therapy with drugs is a large-scale study that can be filled with controversial methods, spiritual beliefs, therapeutic misconceptions, and previous values, beliefs, and experiences that the therapist brings into those sessions. It’s Gap’s mixed bag.”
So what does better research look like? From a clinical trial perspective, Fried said, protocols need to be uniform enough for researchers to know what the mechanism of action is. They should use more evidence-based psychotherapy, such as cognitive-behavioral therapy (CBT). Researchers also need to share the protocols they use more openly, he says, McGuire. Bedi points out that many of the methods currently in use are based on his work in the 1970s, and therefore fail to account for the changes that have occurred in psychotherapy over the past 50 years.
That’s not to say there haven’t been studies that have explored different aspects of treatment.One study looked at the effects of different musical genres in a trial using psilocybin to treat smoking addiction. But in general, “we haven’t collected the data we need to advance the discussion,” says Devenot. “And that for me, [is] core problem. ”
meeting time This data is missing. MDMA could be approved by the US Food and Drug Administration (FDA) for the treatment of PTSD as early as 2024, and Australia recently approved the use of MDMA and psilocybin in the therapeutic context from July 2023. announced that it will allow
In Australia, the Therapeutic Goods Administration (TGA), the government agency responsible for regulating medicines and approving rescheduling of psychedelics, approves the therapist’s process on a case-by-case basis. But for now, the only organization offering training in this therapy is psychedelic medicine advocacy group Mind Medicine Australia. This training has not yet been recognized by the required authorities, so we need to know by June what the training should look like. “Australia is going to be a very important jurisdiction that we look to to see what some of the challenges are,” McGuire says.
Another testing ground is Oregon. Earlier this year, it became the first state to legalize the manufacture and administration of psilocybin, but only under the supervision of a facilitator. Hands-on experience must be completed. No experience in mental health treatment is required. High school diploma, background check, and Oregon residency only. Oregon regulations allow the facilitator to touch the patient’s hand or shoulder only with prior written consent. Importantly, the Oregon deployment does not require the facilitator to provide psychotherapy support. Rather, they prepare the patient, provide supervision during the session, and assist with subsequent integration. Whether this counts as treatment is debatable.
McNamee has no doubt that psychedelic therapy can help people. “But people will be harmed if these treatments are approved and scaled up, as they are currently being formulated based on insufficient safety and efficacy data,” she said. increase.
