December 11, 2023

A new phase 1 clinical trial has found that a single dose of psilocybin combined with psychotherapy may be a promising approach for treating anorexia nervosa, a notoriously difficult-to-treat psychiatric disorder for which there are currently no approved drug treatments.

Psilocybin, the main psychoactive ingredient in psychedelic mushrooms, is still being explored for its mental health benefits in clinical trials. There have been trials testing psilocybin-assisted psychotherapy as a treatment for depression and anxiety, and now a new clinical trial examines whether the drug can be effective in treating anorexia nervosa.

Anorexia nervosa (AN) usually occurs during adolescence and is characterized by excessive preoccupation, fear, and distress about food, weight, size, and eating. It can lead to hunger, malnutrition, severe mental distress, and suicidal thoughts. AN can be difficult to treat and has one of the highest mortality rates of all mental illnesses. There are currently no drugs approved to treat this disease.

Therefore, researchers at UC San Diego and the University of Michigan School of Medicine initiated a phase 1 clinical trial to evaluate the safety, tolerability and efficacy of a single dose of synthetic psilocybin plus psychological support in 10 women aged 18 to 40 with anorexia.

Psilocybin is thought to act on serotonin receptors, the body’s natural mood stabilizer, controlling feelings of well-being and well-being. Studies have shown that brain serotonin function is altered in patients with AN, suggesting that psilocybin treatment may respond positively to the disease. Additionally, the openness and self-acceptance that often accompany psilocybin therapy may alter existing thoughts about body image and food and lead to new attitudes.

Trial participants were evaluated for three months after being given a single 25 mg dose of psilocybin along with psychotherapy. To assess the safety of the treatment, researchers monitored participants’ vital signs, electrocardiogram (ECG), laboratory tests and suicidal thoughts. They also assessed participants’ self-reported changes in weight, body shape, and eating problems using the Eating Disorders Examination (EDE) questionnaire.

The researchers found that all women tolerated psilocybin. Except for mild and transient headache, nausea and fatigue, no serious adverse events were observed. There was no increase in suicidal thoughts among participants.

Most participants reported positive changes after receiving psilocybin for three months, including a significant reduction in weight problems after three months. Concern about shape was significantly reduced at the one-month follow-up, but was no longer significant after three months. Although the effects of psilocybin varied widely, four participants (40% of the sample) showed substantial reductions in EDE scores after three months, qualifying for remission of eating disorders.

Overall, participants found the psilocybin experience meaningful, with 90% reporting they felt more positive about their life endeavors and 70% reporting an overall shift in personal identity and quality of life. Notably, 90% of the participants felt that a single dose of psilocybin was not enough.

The response from the wider research community to the study has been generally positive.

“New treatment strategies are urgently needed for anorexia nervosa, one of the psychiatric disorders with the highest mortality rates, but until now there have been concerns that these individuals are at specific risk of adverse effects from medical abnormalities such as low body weight and cardiovascular complications,” said Claire Foldi, a senior research fellow at Monash University’s Biomedicine Discovery Institute. unmet needs.”

Marion Roberts, a clinical psychologist and lecturer at the University of Auckland’s School of Medicine and Health Sciences, who also supported the research, said: “As current treatments are only effective in a small number of adult patients, it is very appropriate for the field to think creatively – in this case, the use of hallucinogens. These early but promising findings certainly deserve further study.”

But others warn against getting caught up in the psychedelic hype.

“Psilocybin therapy offers a glimmer of hope for other mental health conditions, particularly with evidence that it improves anxiety, cognitive flexibility and self-acceptance in some people,” said Trevor Steward, a senior research fellow at the University of Melbourne’s School of Psychological Sciences. “However, this study did not prove that psilocybin therapy could be used to treat anorexia nervosa… While these results suggest that psilocybin therapy is safe under controlled conditions, it is important not to let the hype surrounding the psychedelic drug outweigh the scientific evidence. Ongoing research and caution are critical to ensuring we make informed decisions about the potential of psilocybin therapeutics to treat this deadly disease.”

The researchers note that their study has limitations. It had a small, self-referenced sample size and did not include a placebo group. They say that although psilocybin therapy was well tolerated, further randomized controlled trials are needed to validate their findings.

The study was published in the journal natural medicine.

source: University of California, San Diego pass Simex