Originally posted 27 Jan 21
Here is an excerpt:
Psychedelic-assisted psychotherapy could provide needed options for debilitating mental-health disorders including PTSD, major depressive disorder, alcohol-use disorder, anorexia nervosa and more that kill thousands every year in the United States, and cost billions worldwide in lost productivity.
But the strategies represent a new frontier for regulators. “This is unexplored ground as far as a formally evaluated intervention for a psychiatric disorder,” says Walter Dunn, a psychiatrist at the University of California, Los Angeles, who sometimes advises the US Food and Drug Administration (FDA) on psychiatric drugs. Most drugs that treat depression and anxiety can be picked up at a neighbourhood pharmacy. These new approaches, by contrast, use a powerful substance in a therapeutic setting under the close watch of a trained psychotherapist, and regulators and treatment providers will need to grapple with how to implement that safely.
“The clinical trials that have been reported on depression have been done under highly circumscribed and controlled conditions,” says Bertha Madras, a psychobiologist at Harvard Medical School who is based at McLean Hospital in Belmont, Massachusetts. That will make interpreting results difficult. A treatment might show benefits in a trial because the experience is carefully coordinated, and everyone is well trained. Placebo controls pose another challenge because the drugs have such powerful effects.
And there are risks. In extremely rare instances, psychedelics such as psilocybin and LSD can evoke a lasting psychotic reaction, more often in people with a family history of psychosis. Those with schizophrenia, for example, are excluded from trials involving psychedelics as a result. MDMA, moreover, is an amphetamine derivative, so could come with risks for abuse.
But many researchers are excited. Several trials show dramatic results: in a study published in November 2020, for example, 71% of people who took psilocybin for major depressive disorder showed a greater than 50% reduction in symptoms after four weeks, and half of the participants entered remission1. Some follow-up studies after therapy, although small, have shown lasting benefits2,3.