Preparing insurers and patients for MDMA-assisted therapy; NIH announces $20 million grant to study psychedelics and chronic pain; Are psychedelics an “inner healer”?
Plus: MAPS’s MDMA clinical trial team responds to critical report, and a new Compass and Journey partnership
Happy Friday and welcome back to The Microdose, an independent journalism newsletter brought to you by the U.C. Berkeley Center for the Science of Psychedelics.
Preparing insurers and patients for MDMA-assisted therapy
The U.S. Food and Drug Administration is expected to make a decision by August about whether to approve MDMA-assisted therapy as a treatment for PTSD. If approved, the Mental Health Parity and Addiction Equity Act (MHPAEA) requires that health plans not subject people seeking treatment for mental health issues to greater barriers to access than those seeking other types of medical assistance for physical ailments such as a broken bone or tonsillitis.
This week, mental health advocacy group BrainFutures published a report called A Path Toward Parity analyzing how the MHPAEA law can protect patients’ rights in seeking MDMA-assisted therapy and presents hypothetical cases outlining potential violations of the MHPAEA. “We encourage patients, providers, and payers to thoughtfully consider MHPAEA’s requirements now so that [psychedelic-assisted therapy] can be readily available and accessible upon FDA approval to patients who may benefit from this emerging treatment modality,” the report states.
NIH announces $20 million grant to study psychedelics and chronic pain
Last week, the National Institutes of Health announced it would provide grant funding for researchers to conduct clinical trials investigating the use of psychedelic-assisted therapy in treating older adults with chronic pain conditions. Chronic pain, the announcement reads, is associated with other decreases in quality of life, including depression and anxiety, sleep issues, social isolation, and suicidal ideation. Existing treatment options have “limited efficacy,” according to the NIH. Next year, the agency will award one project a five-year budget of up to $22 million.
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Are psychedelics an “inner healer”?
Many practitioners and users see psychedelics as a tool for “inner healing,” and some even believe that positive outcomes come not from some pharmacological effect but rather from the drugs tapping into a person’s ability to heal themselves. In a new paper published in the Journal of Psychopharmacology, researchers ask what mechanisms might underlie psychedelics’ apparent healing powers, and whether the narrative of inner healing might enhance expectancy and placebo effects. To probe this question, researchers from Imperial College London and the Lisbon Psychiatric Hospital Center asked 59 participants to rate their agreement with a single statement on a scale of 1 (strongly agree) to 5 (strongly disagree): “I felt like my body/mind/brain was healing itself, automatically/naturally/by itself.” All participants were from a previous clinical trial in which they received either a daily placebo pill and two 25 mg psilocybin doses over 6 weeks or a daily dose of the antidepressant escitalopram and two 1 mg psilocybin doses over that same 6 week time period.
Participants who received the larger doses of psilocybin were more likely to report that they agreed with the inner healing statement, and in that group, participants who more strongly agreed with the inner healing statement also reported fewer depression symptoms after their psilocybin sessions. That correlation did not appear in the group that received escitalopram and 1 mg psilocybin doses, suggesting that people’s perceptions of the “inner healer” appear to have real effects on their depressive symptoms. Future work, the researchers suggest, could probe “patients’ perception of the locus of therapeutic action; that is, do they attribute a healing action (1) directly to the drug, plant or fungi itself, (2) how it acts on the body and brain to alter its dynamics in a meaningful way, (3) how it alters the patient’s relationship to their therapists or ‘guides’ or (4) something else?”
MAPS’s MDMA clinical trial team responds to critical report
A month ago, the Institute for Clinical and Economic Review (ICER), a non-profit research institute, released a draft report evaluating MAPS’s clinical trials using MDMA-assisted therapy in treating PTSD. Those clinical trials are the evidentiary basis for Lykos Therapeutics’ pending application to the U.S. Food and Drug Administration. This week, more than 70 MAPS clinical trial investigators, therapists, and others who contributed to the effort co-signed an op-ed in Psychedelic Alpha in which they responded to ICER’s criticisms.
The letter writers say that none of the 109 therapists or investigators that worked on the trials were consulted for ICER’s report and that “a number of assertions in the ICER report represent hearsay.” They push back on concerns that participants in the trial were not effectively blinded in the clinical trials, meaning they were often able to tell whether they had received the active drug or the placebo. The letter reads that “pharmaceutical interventions are frequently unblinded,” and that “the fact of functional unblinding therefore cannot undermine efforts to approve new treatments for PTSD.” The op-ed also responds to other concerns referenced in the ICER draft report about the trials, such as the effect of participants’ expectations on outcomes, and ethical concerns about abuse. “We hope that the final report will take into consideration our input, which draws on the collective effort and scientific data amassed by hundreds of contributors across over a dozen sites, all under the oversight of institutional, state, and federal regulatory bodies,” they write.
New Compass and Journey Clinical partnership
On Monday, psychedelics company Compass Pathways and ketamine-assisted therapy platform Journey Clinical announced “a research collaboration agreement to inform the development of a scalable and practical delivery and healthcare provider training model for COMP360 psilocybin treatment, if approved for treatment-resistant depression (TRD).” Compass is currently the company furthest along in the potential U.S. Food and Drug Administration’s approval pipeline for psilocybin; it’s currently conducting Phase III clinical trials for COMP 360, its formulation of the drug. If those results are promising, many expect the company to apply for FDA approval.
In January, the company also entered into an agreement with a New Jersey-based healthcare network to investigate how Compass can roll out COMP360 if it receives FDA approval. “Compass is forming a comprehensive and diverse network of research collaborations to inform how COMP360 psilocybin treatment can be best integrated into the US health system,” the company’s CEO Kabir Nath said in a press release.
On Tuesday, the Associated Press reported that the U.S. Drug Enforcement Agency will move to reclassify marijuana from Schedule I to Schedule III, pending a review by the White House Office of Management and Budget.
The Los Angeles Times interviews people who have hallucinogen persisting perception disorder, a condition in which they experience visual distortions years after using psychedelics like LSD and psilocybin.
Ukrainian soldiers are struggling with PTSD and mental health issues after combat, and a shortage of qualified professionals to help, reports The Kyiv Independent. Some are turning to psychedelic-assisted therapy.
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