New research published in JAMA Psychiatry We report the results of the first-ever double-blind, placebo-controlled trial testing psilocybin-assisted psychotherapy to treat alcohol use disorders. Headline results were encouraging, with almost half of the psilocybin group abstaining from drinking altogether after treatment. So this study raises big questions about the credibility of these kinds of clinical trials for psychedelic drugs.
Led by a team at the NYU Grossman School of Medicine, the new trial enrolled 93 subjects with clinically diagnosable alcohol use dependence. Cohorts were evenly randomized into either the psilocybin group or a placebo control.
All subjects, including the placebo group, underwent a multi-month psychotherapy protocol four times before starting psychedelic treatment, four times between the first and second drug treatments, and four times at the end.
The placebo group received what was called an active placebo. In this case, it’s an antihistamine called diphenhydramine, which in high doses can cause flushing and even euphoria.
At 8-month follow-up, 48% of the psilocybin group had abstained completely compared to 24% of the placebo group. In terms of reduction, the psilocybin group had a 51% reduction in the number of significant drinking days, compared to an 83% reduction in the psilocybin group. placebo.
The results of this study are definitely encouraging. Using LSD to treat alcoholism was one of the first therapeutic goals investigated by researchers in the 1950s, and there is a relatively rich stream of older studies investigating this modality. However, these new findings highlight some important open questions in the field of contemporary psychedelic clinical research.
Randomized, blinded, controlled trials are the gold standard of modern research. Bringing two groups of people together to test an intervention, but blindly giving one group a placebo allows scientists to gather empirical evidence on whether a new treatment works fundamentally. is an important method for
But psychedelic science makes it virtually impossible to give someone an inactive placebo without immediately realizing that they weren’t given the real drug. It has been noted in trials that it can lead to excessive bloating effects.
In this new study, NYU researchers noted that virtually all subjects correctly guessed whether they were given psilocybin or a placebo. By the second drug session, nearly 95% of participants correctly guessed their assigned group.
Not only did the study participants effectively “break the blindness”, but the study therapist, who was also blind, finally guessed the treatment group. and correctly guessed which psilocybin was administered with 97.4% accuracy.
So even blinding the study seems a bit disingenuous, given that attempts to double-blind this study failed utterly. The eyes clearly state that “neither the researcher nor the study participants knew the drugs they received.” A fact that may have been true at the beginning of the study, but was not true in the end.
Michael Bogenshutz, lead author of the new study, said using the antihistamine diphenhydramine as an active placebo was the team’s attempt to overcome this problem.
“We weren’t very successful at keeping the blinds in this case,” admitted Bogenschutz. “Most people were able to guess what drugs they received, not necessarily with a better placebo condition in mind. If it has a positive effect, it is easily distinguishable.”
In presenting the new study results at a press conference, the researchers introduced two participants from the trial. I basically quit drinking.
However, in a strange moment later in the press conference, it was revealed via journalists’ questions that one of the two participants was actually from the placebo group. Paul Mavis, who vehemently described the treatment as “important” and “game-changing,” later emphasized the importance of psychotherapy in his positive experience from the trial.
Mavis also stressed that she didn’t know she had been given a placebo until she was asked to attend this press conference literally a week ago. All subjects in the trial were offered her third drug session with psilocybin, so subjects in the placebo group eventually experienced a psychedelic session.
Mavis had no idea that the first two sessions were a placebo, even after actually receiving psilocybin. He simply attributed the acute psychedelic experience he felt during his third session to how open he had become to drugs after his two previous sessions. Bogenschutz also pointed out that Mavis’ experience is a good example of how effective this common treatment protocol can be, even without his psychedelic drugs.
However, it was unclear why subjects in the placebo group were presented to the media as a successful trial. Does this suggest that the “psychedelics” in psychedelic psychotherapy are partially placebo? Or is psychotherapy producing significant clinical benefit from this new class of treatment? And why was there so little transparency about the details that this participant actually came from the placebo group? is it?
Biographies of seven patients who participated in the trial were provided to the media, but Mavis’ details did not indicate that he was in the placebo group. Instead, his biographical details speak to how meaningful the insights he gained during his sessions at the trial were.
“At our first session in January 2019, I recall negotiating with himself about when and why he would drink again,” Mavis’ NYU bio read. He realized that ‘drinking equals death.’ Boom, I knew I had completely finished my drink, as if someone had flipped a switch.
The researchers have clarified that they have no direct financial stake in this particular study. Bogenschutz said the NYU Grossman School of Medicine has applied for a provisional patent on the study, but the reasoning behind this is that commercial and for-profit entities have monopolized the treatment, making many people financially vulnerable in the future. He emphasized that this is to ensure that the information is not publicly accessible.
But all this suggests that there is an existing belief that this kind of psychedelic therapy works. expressed frankly.
“Over time, we believe we can get FDA approval,” Marmar said. “We, the New York University School of Medicine, and the field of psychedelic psychiatry in general, are reaching milestones in the next five to ten years to gain FDA approval for psilocybin and other drugs for addiction and mental illness. will achieve.”
The results of a new study are undoubtedly encouraging, showing that psilocybin may help treat alcohol use disorders. The researchers uncovered some of the biases that are relatively prevalent in the modern world of psychedelic science. is produced to serve and validate that pre-existing belief.
A new study was published in JAMA Psychiatry.
Source: NYU Langone Health