Regulators are under increasing pressure to expand access to psychedelics for the treatment of mental illness. Experts say the science is promising, but the hype is useless.
In December 2021, Therapeutic Goods Administration (TGA) denied a request to downschedule psilocybin and MDMA (3,4-methylenedioxymethamphetamine) from Schedule 9 (Prohibited Substances) to Schedule 8 (Controlled Substances). The move will allow patients to access the drug through channels such as the Special Access Scheme.
In its decision, the TGA cited expert advice, stating that while psychedelics show promise in highly selected populations as a psychotherapy, this should be done with intensive professional assistance and rigorous clinical supervision. The TGA says more high-quality studies using large studies are needed to determine the safety and efficacy of drugs.
In January 2022, then-Federal Health Minister Greg Hunt announced that more trials would take place. His $14.8 million government funding funded seven of his studies of innovative treatments for mental illness. These include MDMA-assisted psychotherapy for treatment-resistant social anxiety in young adults with autism spectrum disorders, psilocybin-assisted psychotherapy for anorexia nervosa and treatment-resistant depression, comorbid alcohol use disorder and trauma. Includes studies using MDMA-assisted exposure therapy for sequelae. Stress Disorders (PTSD).
A leading psychiatrist applauds the government for investing in science while resisting pressure to make drugs more widely available.
Professor Ian Hickey, co-director of health and policy at the Brain and Mind Center at the University of Sydney, is an investigator of MDMA research in young people with autism. “This is important research and there is an opportunity here. These drugs are unlike anything available and there are many people who do not respond to conventional treatments,” Professor Hickey said. Insight+.
“We need science to answer the question of which patients can benefit at what dose, for how long, under what circumstances, and what the long-term effects might be. increase.”
Associate Professor Vinay Lakula, Chancellor of the Royal Australian and New Zealand Psychiatric Society (RANZCP) said: Insight+ Science provided grounds for optimism.
However, he added:
Psychotherapy with MDMA and psilocybin
Melbourne psychiatrist Dr Nigel Strauss is at the forefront of efforts to bring psychedelic medical research to Australia. He personally helps fund trials at Monash University using his MDMA-assisted psychotherapy for treatment-resistant PTSD.
He is also involved in a trial at St. Vincent’s Hospital Melbourne using psilocybin-assisted psychotherapy for terminal anxiety and another trial at Swinburne University of Technology of psilocybin-assisted psychotherapy for treatment-resistant depression. .
Dr. Strauss is optimistic that recent federal funding will help legitimize research in this area, which has been stigmatized due to its history of recreational psychedelic drug use.
“From the early days of psychedelics in the 1970s, there would be enough soft evidence to suggest that these drugs are effective,” he said. Insight+.
“They are not a panacea. We hear certain organizations exaggerate their potential to solve mental health crises, but it is important to choose patients carefully.”
Dr. Strauss says psychedelic assisted therapy typically involves administering substances to patients in treatment sessions lasting up to eight hours. Patients wear eye masks and listen to gentle music under the supervision of two therapists. Depending on the condition, psychotherapy can be given during or after the medication session in a process called integration work.
“It works by enabling neuroplasticity,” Dr. Strauss said. “People see things differently. It helps with psychiatric conditions characterized by rigid thinking.” .”
Regarding the treatment of PTSD with MDMA-assisted therapy, Dr. Strauss said past psychiatric and psychological treatments were not always effective.
“MDMA allows patients to go back to frightening experiences and reprocess those events,” he said.
Dr. Strauss said MDMA-assisted psychotherapy for PTSD is a prime candidate to become the world’s first approved psychedelic medical application.
The U.S. Food and Drug Administration could approve the indication as early as 2024-2025 based on the fact that the Phase 3 trial was successful, and a second Phase 3 trial will be completed soon, he said. Stated.
A successful 2021 Phase 3 study included 90 patients with severe PTSD and found that manual therapy with MDMA was associated with a “significant improvement” in PTSD symptoms compared with manual therapy plus placebo. It has been found to be associated with a “strong and reliable” attenuation. His MDMA arm of study reported no serious safety issues.
Addressing blinding limitations, the authors said it was encouraging that, anecdotally, at least 10% of participants incorrectly guessed their treatment group.
This study was sponsored by the Multidisciplinary Association for Psychedelic Research (MAPS), and its protocol and statistical analysis plan were developed in collaboration with the FDA. It has been designated a “Breakthrough Therapy” by the FDA, a process designed to expedite its review and review.
Still, Professor Hickey said most research on MDMA and psilocybin-supported therapy is in the “very early stages.”
“The most respectable centers are looking at who benefits in what ways, trying to compare existing treatments, looking not only at short-term effects, but also long-term effects.” he said.
“Establishing the efficacy of these compounds is very difficult because of the theater surrounding the situation – setting, expectations, psychotherapy, companionship during travel,” he said. [magnetic resonance imaging (MRI)] Studies looking for independent brain markers are very important so that treatments can be evaluated more objectively and compared with other treatments. ”
Professor Hickey said another important issue to consider with psychedelic therapy is that the affected patient is in a “very vulnerable state.”
“They can be exploited,” he said.
Recent ABC four corners The episode included interviews with patients who accessed MDMA-assisted psychotherapy in Canada as part of the MAPS trial. The patient claimed that the therapist sexually assaulted her after her therapy session ended. The exam is currently being reviewed by Health Canada.
“These drugs make people very suggestive, so we have to be very careful about who is providing the treatment and under what conditions,” Dr. Strauss said.
Dr. Strauss urged RANZCP to establish educational programs for psychedelic medicine interest groups and psychiatrists to ensure they are ready for the arrival of psychedelic-assisted psychotherapy in the near future. .
Ketamine: Another Drug
The anesthetic ketamine, and its components esketamine and alketamine, tend to induce dissociative states rather than hallucinations, but are sometimes called psychedelic.
There are some ongoing studies of ketamine infusions for major depression in Australia. Last year, the TGA also registered its first ketamine product for psychiatric disorders, esketamine hydrochloride nasal spray (Spravato, Janssen-Cilag). This product is approved as an adjunctive therapy for treatment-resistant depression. This is the first new class of drug approved as an antidepressant in Australia in 30 years.
Professor Hickie, who is involved in Australia’s Spravato trial, estimates that about 300 Australians are currently accessing products for treatment-resistant depression. Sprays are given to him twice a week in combination with newly started oral antidepressants.
“One of the most promising features of esketamine is its rapid onset,” said Professor Hickey. “It acts rapidly, unlike existing antidepressants that have been reported to reduce suicidal behavior.”
However, the effects typically last for less than a week after a single dose, and each dose costs hundreds of dollars, making it prohibitively expensive for patients not enrolled in clinical trials.
Professor Hickey emphasized that unlike MDMA and psilocybin, ketamine is not used as a psychotherapeutic guide.
“Patients just sit quietly and have a dream-like experience and report how they’re feeling after 90 minutes,” he said. have not reported a change in their overall outlook on life, quite unlike the hype surrounding hallucinogens such as MDMA and psilocybin.”
The exact mechanism of action of this drug is not fully understood, but it affects not only the glutamatergic system, but also the monoamine, cholinergic, opiate and cytokine systems.
An observational study published in 2022 found that of 537 depressed patients who received a series of ketamine infusions in U.S. clinics between 2016 and 2020, about half had symptoms of depression of at least 50%. found to have decreased.
These symptoms were relieved in 73% of patients with suicidal ideation. However, the study found that a subset of patients (8.4%) experienced an increase in depressive symptoms after induction, and 6% of his patients reported an increase in suicidal ideation.
Professor Hickey said more research is needed on the long-term effects of ketamine, including investigating whether ketamine causes addiction.
RANZCP has produced detailed clinical memorandums on the therapeutic use of psychedelic substances and the use of ketamine in clinical settings (here and here).
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