In an article published by Nature Medicine, Portuguese psychiatrists, psychologists and psychotherapists have drawn attention to the importance of protecting patients during “vulnerable states of altered consciousness,” highlighting that psychedelic drugs are being recognised more and more for their potential therapeutic properties.

Although psychedelics such as psilocybin, the main component in magic mushrooms and LSD, are safe and have “limited potential for abuse,” specialists have said that a “perfect transition from clinical trials to daily clinical practice” is not guaranteed.

The researcher Albino Oliveira-Maia, director of the Champalimaud Foundation’s Neuropsychiatric Unit and an author of the article, has reminded that psychedelic therapies have been confined to research and clinical studies, but says that reality seems to be changing.

He exemplified with the off-label use – different to the use in which the substance was studied – of ketamine (used here as just an anaesthetic) in the treatment of depression and other conditions, despite the lack of “clear directives, formal approval from regulating agencies and recommendations about psychologic support.”

“An investigation is being made which anticipates that these substances could gain a role within regulated reality, or rather, they could come to be approved as medication,” the researcher explained to Lusa.

These molecules, he adds, “since they perform an important qualitative change of the state of consciousness, will need a regulatory model adapted to them.”

Explaining that normally, when some substances are approved for clinical use, the instructions, dosages and environment for use (in hospital or a wider range) are defined, Albino Maia says that in these cases there are some elements that “aren’t in the regulation field of medication agencies,” namely “the additional use of psychological interventions, like psychotherapy or a less organised intervention in the field of psychotherapy.”

He says, as it’s necessary “for the efficacy and safety of the substance,” this use “doesn’t have any clear regulatory framework” – “Psychotherapy avoids the regulatory field of medication agencies.”

“Being important for the use of these molecules, or these news medications, in case they come to be approved, we enter a field in which we don’t have a very clear guide on what needs to be done beyond administering the medication,” he warns.

Miguel Ricou, the other co-author of the article, of the Order of Psychologists, explained to Lusa that “what’s being asked is that we start having a norm for using this type of substances.”

“This is all still experimental and it’s fundamental we are aware of that,” the specialist states, adding that “this isn’t using medications and being done with it. It doesn’t work the same way. The sessions in which you take these medications are experimental sessions, they last seven to eight hours in which the settings are totally different. There are always two therapists present.”

He says that specialists “believe in the potential of these medications,” especially for resilient conditions that can’t be helped in another way but warns: “If this begins to be used for everything, in an unregulated way, a repeat of the 80’s will happen, when everything started having a creative use and they ended up being banned.”

To Albino Maia, this would be “a particularly large problem for those who are sick and don’t have any other options.”

“In order to try defining ethical norms for the use of these substances, researchers and medical societies are already working together. The idea, Miguel Ricou reveals, is to have a group of people who can reflect and hold legitimacy to, alongside the professional societies, guarantee that everything is done as it should,” Maia continued.

“Especially in an area as sensitive as mental health, this is important if the treatments come to be accessible to everyone. We won’t create elitism on top of mental health. This is the present concern.”