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Norway’s Health System Considers Funding Off-Label Ketamine for Treatment-Resistant Depression
The Norwegian Medical Products Agency (Direktoratet for medisinske produkter or DMP) has published its health technology assessment (HTA) of intravenous ketamine for treatment-resistant depression (TRD). It said that it was commissioned to conduct the review in the context of growing interest in ketamine’s potential in the disorder.
The agency reviewed 19 randomised controlled trials (RCTs) and 2 other trials (total N=1,761; none of the studies were conducted in Norway) to reach the following conclusions (lifted directly from the document):
- Ketamine vs. ECT: Multiple ketamine infusions probably improve response rates more than ECT (moderate certainty evidence).
- Ketamine vs. saline: Single ketamine infusions probably improve response rates more than saline (moderate certainty evidence).
- Ketamine vs. midazolam: Single ketamine infusions may/probably improve response rates more than midazolam (low/moderate certainty evidence).
- Ketamine vs. esketamine: There may be little or no difference in response rates between single infusions of ketamine and esketamine (low certainty evidence).
- Ketamine ≥0.5 mg/kg vs. <0.5 mg/kg: A single high dose ketamine infusion may improve response rates (slightly) more than low dose ketamine (low certainty evidence).
Results of its analysis for multiple infusions and long-term (>3 month) efficacy were “generally inconclusive due to very low certainty.”
The group chose ECT as the comparator for the purposes of its health economic evaluation in the Norwegian context. Its cost-comparison analysis1 suggested that the cost of a treatment series involving 6 infusion sessions over the course of 3 weeks was NOK 18,000, ($1,800) vs. NOK 28,000 – 42,000 ($2,800 – $4,200) for a twice- or thrice-weekly regimen of ECT. (For a single treatment with IV ketamine it was about NOK 3,000 ($300) versus one ECT treatment at NOK 4,700 ($470).)
Given the fact that ketamine is generic (the authors use a price of NOK 306 ($30) for the cost of all consumable materials used in each IV ketamine session, which includes things like a venous cannula and eye mask as well as the ketamine itself) and there is no patented drug product involved in ECT, the primary cost in both treatment series was personnel.2
Ketamine is already used off-label for TRD in the country, but such use has been relatively niche.
The Ketamine Unit at Østfold Hospital’s DPS Nordre prepared a 24-page protocol for the use of ketamine in TRD (PDF, machine-translated to English PDF). (Back in 2022, the hospital submitted an application for ketamine for TRD’s approval, which led to the present HTA report from the DMP.) Among a trio of public hospitals, around 350 patients have been treated via that protocol—we preview the outcomes in our wrap-up, below.
That protocol includes provisions of some kind of psychotherapy following the ketamine infusion, integration, as well as preparatory sessions, regular check-ins throughout the induction phase, and stipulations around what treatment rooms should feature (dimmable lights, duvets, noise-cancelling headphones, and so on).
“While not a universal solution”, the report writes, “ketamine’s potential inclusion in Norway’s specialist healthcare system could reduce financial barriers and substantially improve outcomes for both patients and their families.”
Despite EMA approval for TRD, Johnson & Johnson’s esketamine nasal spray (Spravato) has not received public financing approval in the Norwegian health system. That means it’s out of reach for the vast majority of Norwegians, who rely on the public health system.
But, the studies included in the HTA had relatively small sample sizes and heterogenous designs, as well as short follow-up periods. That, coupled with the lack of Norwegian studies, limits the strength of the evidence and its applicability to the national context, the agency states.
What’s more, despite potentially offering a more efficient alternative to ECT, the authors note that the successful integration of IV ketamine for TRD into the health system “would require clinician training, standardised protocols, and equitable access to avoid socioeconomic disparities.” There is also a need for policymakers to “address concerns around ketamine’s potential for misuse and abuse”, they add.
Still, their conclusion is broadly positive: “Intravenous ketamine is probably comparable or less costly than ECT provided sufficient capacity in terms of personnel.”
It is unclear what impact the analysis will have on real-world practice.
Cecilie Byholt Endresen, President of the Norwegian Association for Psychedelic Science, told Psychedelic Alpha that, “while this is not yet a formal reimbursement decision, the HTA is an important step toward potential inclusion in the public healthcare system.”
“It will now serve as the basis for deliberations by the Ordering Forum (Bestillerforum) and the Decision Forum (Beslutningsforum),” she continued, “which are expected to rule on a possible introduction into the public specialist health service in August.”
Even still, a positive decision at the national level would be followed by individual, local hospitals to implement.
Pα: This is the latest in a series of generic-ketamine-for-TRD developments in the Nordic country.
In March, the Journal of the Norwegian Medical Association published an article on ketamine for TRD (Berthold-Losleben et al., 2025). There, they shared that more than 300 patients have been treated at Østfold Hospital, with more than half of those showing ‘a significant reduction in depression symptoms.’
At the two other hospitals offering the treatment—Innlandet and Stavanger University Hospital—around 40 geriatric psychiatric inpatients have received IV ketamine. ‘Older patients appear to have a somewhat lower response after initiation’, the authors said, ‘and a less stable effect during maintenance treatment.’
Based on this 350-odd patient sample, the authors say that their clinical experience is largely in line with foreign studies, with IV ketamine ‘a safe and effective treatment for a patient population with few options.’
In 2023, the Norwegian Rapid Acting Antidepressant Network was established to collaborate on such efforts, including a large Norwegian study of ketamine for TRD. That research is benefiting from a NOK 24.9M ($2.5M) grant from the National Program for Clinical Treatment Research in Specialist Health Services (KLINBEFORSK), awarded in December 2024. The study involves ten hospitals.
Advocates hope that establishing ketamine-assisted psychotherapy in the country’s healthcare system could provide fertile ground for the introduction of psychedelics, if approved. That progress could even be emulated at the bloc level, they think, with Norway as a leading light. Indeed, the country’s healthcare system is highly respected, regularly ranking in the top ten worldwide.
Given the emphasis on ketamine’s use ‘as part of a comprehensive treatment program in combination with psychotherapy’, some advocates also hope that this could set the tone for psychedelics’ potential roll-out.
Indeed, speaking to Psychedelic Alpha, Byholt Endresen emphasised that the HTA “did not involve studies examining the integration of psychotherapy with ketamine”. She believes that integrating the two together “is associated with stronger and more sustained outcomes”, and “is the approach we encourage when working with these medicines in this context.”
More to come. ∎
Spravato’s Monotherapy Success Puts Pressure on Psychedelics Developers
Earlier this month, results were published from Johnson & Johnson’s first randomised, placebo-controlled trial investigating its esketamine nasal spray (Spravato) as a monotherapy (Janik et al., 2025). Conducted between November 2020 and January 2024 across 51 outpatient centres in the United States, the study included 378 adults diagnosed with treatment-resistant depression (TRD).
Patients who fail to respond to first-line oral antidepressants (OADs) are typically treated using combination or adjunctive strategies. Crucially, this meant that, when Spravato first received FDA approval for TRD in the US, it was indicated only as an add-on to oral medications. Unfortunately, many individuals struggle with the adverse effects of OADs (such as weight gain, fatigue, and sexual dysfunction) which often lead to poor adherence or stopping the drug entirely.
In light of these challenges, the authors aimed to assess whether esketamine could be effective as a stand-alone treatment. An approved monotherapy would represent a valuable shift in treatment accessibility, offering a less complex option for patients unable or unwilling to tolerate oral antidepressants. It also marks a strategic and commercial milestone for Johnson & Johnson, which announced that it had received FDA approval for its use as “the first and only monotherapy for adults with treatment-resistant depression” in January.
All participants completed an antidepressant washout period of at least two weeks prior to randomisation, after which they received fixed-dose intranasal esketamine (56 mg or 84 mg) or a matched intranasal placebo, administered twice weekly for four weeks. Following the double-blind phase, participants were given the option to enter an open-label extension, beginning at 56 mg with potential dose adjustments based on tolerability.
Both esketamine doses yielded statistically significant and clinically meaningful improvements in depressive symptoms compared with placebo, exceeding the threshold of a ≥2-point difference on the Montgomery–Åsberg Depression Rating Scale (MADRS).
Notably, symptom reduction was observed as early as 24 hours after the initial dose, with significant differences recorded for both doses (56 mg: −3.8, P = .004; 84 mg: −3.4, P = .006), demonstrating a substantial therapeutic advantage over OADs in the form of a rapid antidepressant effect. These effects persisted through the 28-day double-blind phase, with least-squares mean MADRS score differences versus placebo of −5.1 for the 56-mg dose (95% CI: −7.91 to −2.33; P < .001) and −6.8 for the 84-mg dose (95% CI: −9.48 to −4.07; P < .001).
Response and remission rates were consistently higher in both esketamine groups—on clinician and self-reported scales—relative to placebo throughout the double-blind phase. Symptom improvement continued into the open-label phase, and participants who transitioned from placebo to esketamine showed improvement at the first open-label assessment.
The safety profile observed was consistent with previous short-term esketamine trials conducted alongside oral antidepressants, including the TRANSFORM studies. Rates of suicidal ideation and commonly reported side effects—nausea (24.8%), dissociation (24.3%), and dizziness (21.7%)—aligned with existing ketamine research and were not considered clinically concerning. Of the three serious adverse events reported in the esketamine groups (a suicide attempt, ophthalmic migraine, and ankle fracture), none were attributed to the treatment. Importantly, only six participants across both esketamine groups discontinued due to adverse events; a noteworthy finding given the high early dropout rates typically seen with oral antidepressants.
As anticipated, adverse events were indeed more common in the esketamine arms compared to placebo—a perhaps predictable outcome, and one that may have contributed to functional unblinding. Despite employing separate raters for safety and efficacy, most participants receiving esketamine correctly guessed their treatment allocation (71.1% in the 56 mg group and 78.3% in the 84 mg group), a finding most likely attributable to its distinctive dissociative effects. Nevertheless, the authors referred to a post-hoc analysis that revealed similar antidepressant response rates between participants who did and didn’t experience an adverse event of dissociation as one argument against the potential of unblinding undermining the study’s findings.
These findings support esketamine’s use as a promising monotherapy for treatment-resistant depression, particularly for individuals who cannot tolerate oral antidepressants. The 84 mg dose, which demonstrated a greater effect size without additional safety concerns, may be a suitable candidate for initial monotherapy. While the study’s generalisability is somewhat limited by the exclusion of comorbid psychiatric and substance use disorders, the high clinical severity of the cohort—including elevated rates of prior suicidal ideation and behaviour—underscores the significance and potential applicability of these results in real-world settings.
Pα: This is the latest win for J&J when it comes to its esketamine nasal spray product, which —after a sluggish start—has achieved blockbuster drug status.
While its pivotal TRANSFORM trials were sufficient for FDA approval as an adjunct to oral antidepressants back in 2019, the package wasn’t exactly a slam dunk. TRANSFORM-1 (NCT02417064), for example, failed to achieve statistical significance.
But this latest cut of data delivers a much more convincing signal, this time as a standalone treatment.
It piles further pressure on psychedelic drug developers like Compass Pathways, also pursuing a TRD indication, which will need to deliver comparable efficacy and superior durability in order to go toe-to-toe with Spravato. ∎
Longevity Crowd Hypes Psilocybin Study But Researchers Urge Caution
There’s been a lot of buzz around a new Brief Communication published in npj Aging earlier this month, which found that psilocybin extended cellular lifespan and improved survival of aged mice (Kato et al., 2025). (Of all the sensational headlines based on this article, Fast Company’s takes the biscuit: ‘Forget Botox! Scientists say tripping on mushrooms might keep you young’.)
The study, conducted out of Emory University and Baylor College of Medicine, reported that psilocin “extends cellular lifespan and psilocybin treatment promotes increased longevity in aged mice, suggesting that psilocybin may be a potent geroprotective agent.”
Microdosing evangelist Paul Austin took to X to share the study multiple times, speculating whether ‘psychedelic medicine’ will have an additive effect when combined with “stem cells and peptides to reverse aging”. He also seemed to imply that Albert Hofmann’s LSD microdosing regimen was at least partially responsible for his longevity, and suggested that Kato et al.’s finding “related to [psilocybin’s] anti-inflammatory mechanisms”.
But a closer look at the study suggests that the thirty mice dosed with psilocybin would have been on one hell of a trip. Despite describing the doses as “lower” (5 mg/kg) or “high” (15 mg/kg), both doses are enormous when converted to human doses.
That dosing, coupled with the standard disclaimers around animal research, has raised questions from many in the research community around the validity or utility of the group’s findings. Still, the headline results certainly warrant more investigation.
Psychedelic Alpha spoke to Stanford psychedelics researcher Boris Heifets about the publication.
“Much like the marriage of quantum mechanics and consciousness,” he started, “it was only a matter of time until someone drew a straight line between two things we know so little about: longevity and psychedelics!”
On the positive side, Heifets said that there is a “large, obvious effect that should be easily reproducible across labs”, adding that its basic hypothesis, “that psilocybin activates proliferative pathways in cells, has been around for quite some time”. (He pointed to Azmitia, 2001, for example.) “It’s nice to see it fleshed out in the context of longevity science”, he added.
He also praised the authors for carrying out a single-sex mice study in females, ‘for once!’
On the more questionable side, Heifets pointed to those large doses. He was particularly surprised by the 15 mg/kg dose, which he described as “galactic”. “The authors do justify it to an extent,” he accepted, but suggested that this element of the study, “certainly deserves some scrutiny”. “It would be wonderful if we could study this effect at a lower dose”, he added.
He also wondered whether the phenomenon reported in the study has anything to do with 5-HT2A, “as psilocybin’s off-target effects multiply with escalating doses.” It could, for example, simply be “an effect of giving bored aging mice something to get excited about in their otherwise unenriched lives.”
Finally, Heifets pointed to a particular passage in the study’s Discussion section:
However, it could be argued that delayed exhaustion of proliferative potential and/or senescence could impact oncogenesis or cancer progression. Future research should rigorously assess the potential impacts of long-term psilocybin treatment in vivo on cancer incidence and/or progression.
“If it’s powerful, it’s also risky”, he said in reference to the statement. “There’s a whole field of medicine called oncology that has something to say about immortal cells.”
Other Stories
Will State-Legal Psychedelics Eat Psychedelic Pharma's Lunch?
Earlier this month, we published our Q1 2025 Oregon Psilocybin Services Tracker, which provides an annotated look at the first cut of data from the U.S.’ inaugural state-legal psychedelics program.
Aside from giving us a glimpse of how the program is faring, it might also provide an idea of how competitive such access pathways might be with FDA-approved psychedelics, should they arrive.
We can see, for example, that lots of clients sought out psilocybin services in the state in the hopes of dealing with depression, anxiety, PTSD, and other mental issues. Affordability remains a key barrier for the program, however, with data showing that the average client is much wealthier than the average Oregonian, let alone the average Oregonian struggling with a treatment-resistant mental health disorder.
With that in mind, psychedelic drug developers might continue to emphasise that accessibility is the primary goal, achieved via insurance coverage. Still, it is likely that—at least in the first instance—psychedelic therapies will only be available on the more expensive healthcare plans, which will likely see access skew to wealthier Americans, just like in Oregon.
But other factors, such as stigma and the preference that many Americans presumably have for accessing psychiatric care within the metes and bounds of the established healthcare system, will likely shelter much of the total addressable market from state-program cannibalisation.
Still, it’s certainly something to watch, especially as advocates for such programs insist they will become more accessible as they scale. We’re looking forward to the Q2 cut of data, which should be released in the coming months, to see whether OPS is trending toward that goal.
Three Years of Psychedelics Access via Canada’s Special Access Programme
A new commentary from Nicolas Garel and colleagues (2025) presents the first published data on how psychedelic therapies, particularly psilocybin, have been accessed and utilised via Canada’s Special Access Programme (SAP) over the past three years.
Despite stable application numbers—primarily for major depressive disorder (MDD) and end-of-life distress—approval rates through the SAP have declined markedly, falling from 82% in 2022 to just 59.1% in 2024. To the authors’ knowledge, no changes in screening protocols or regulatory criteria account for this decline, nor does the number of overall requests to SAP, suggesting that the barriers may lie within the implementation process itself.
Crucially, SAP was not developed for psychedelic therapies, and is fraught with obstacles to adoption. Chief among them is the administrative burden: referring physicians must provide extensive documentation and detailed justification for each case, and may be asked to complete a resubmission, adding further complexity and delays. Given the pressures facing Canada’s already overburdened healthcare workforce, such demanding processes likely discourage applications altogether—a pattern reflected in the rising number of incomplete submissions.
The authors also point to a lack of clinical infrastructure, including protocols for psychotherapy, preparatory support, and validated outcome measures. In the absence of formal guidance, it is unsurprising that clinicians are proceeding with caution given the considerable medicolegal risk posed.
Additional constraints mentioned include the lack of specialised training and standardised accreditation pathways for clinicians engaging with SAP. Training opportunities specific to psychedelic substances remain limited in Canada, and general education around their therapeutic use is lacking. Access is further complicated by the resource-intensive demands of psychedelic therapy—often involving lengthy therapeutic sessions—and by the limited availability of GMP-compliant psilocybin.
The Canadian SAP offers a critical case study for other jurisdictions grappling with how to incorporate psychedelic therapies into conventional healthcare systems pre-approval. The findings highlight the need for systemic investment across multiple levels, including clear guidance to support clinical decision-making, nationally recognised standards for training and certification, and ongoing professional education and training. The authors note that dedicated centres of excellence—integrating research, treatment, education, and regulatory engagement—could be instrumental in accelerating best practice development and knowledge translation.
The New Neuroplastogen Developer on the Block
French-Belgian neuroplastogen drug developer Elkedonia has emerged from stealth with the announcement of an €11.25M Seed financing led by Kurma Partners, WE Life Sciences, and a tech fund associated with the French government.
The project was founded by Argobio, a startup studio that is looking to build on Dr Jocelyne Caboche’s research on intracellular Elk1, which is implicated in reward brain circuits and neuroplasticity. She and the Elkedonia team believe that this target could translate into novel treatments for psychiatric disorders like depression and PTSD.
The company says it will use the funds to identify small molecule inhibitors of Elk1, as well as “biomarker research and validation efforts, supporting a precision-based therapeutic strategy.”
Other Headlines
UK Government Outlines 10-Year Plan for NHS, Focus Includes Mental Health Shakeup. The recently announced 10-year plan set out by the British Labour Government includes a strong focus on prevention and local services. Healthcare will become more digital through the use of AI and other technologies, while access to weight loss jabs will be expanded and new job opportunities created. The move prioritises structural changes, with hospitals focused on caring for the most unwell and new community health hubs introduced to support outpatient care. Crucially, the plan will enable self-referrals for mental health therapies, alongside a £120m investment into 85 mental health emergency departments and support teams in schools.
Montana’s Experimental Treatment Centers Could Offer Drugs Based on Phase I Data Alone. Montana has enacted Senate Bill 535, allowing “experimental treatment centers” to dispense investigational medicines following successful completion of a Phase I trial. In theory, this opens the door for psychedelics to be offered to patients years ahead of FDA approval, with digital tools used to capture longitudinal outcomes and safety data. It also goes beyond Right to Try laws. Success will hinge on transparency and responsible implementation, positioning this as an opportunity to showcase innovation rather than exploit a regulatory loophole. Other matters, such as rescheduling, are also unclear; yet very relevant in the case of psychedelics, for example.
Pramipexole Shows Promise as Adjunctive Treatment for TRD. A recent RCT funded by the UK’s National Institute for Health and Care Research (NIHR) found that pramipexole is a clinically useful augmentation medication for cases of treatment-resistant depression (TRD; Browning et al., 2025). When combined with participants’ ongoing antidepressant regimens, a target dose of approximately 2.5 mg pramipexole significantly reduced depressive symptoms compared to placebo, although common side effects of the drug, dosed daily, included nausea, headache, and sleep disturbances.
ChatGPT as Trip Sitter? A new piece in MIT Technology Review details the recent rise in people using AI tools like ChatGPT as ‘trip sitters’, from curating custom playlists to providing emotional reassurance and “companionship” through challenging experiences. Experts, however, are concerned. One psychotherapist from MAPS explains that the art of knowing when to stay silent is key to psychedelic therapy, a skill that chatbots have evidently not mastered just yet. Others go further, raising fears that the bots—which technically only mimic human-generated data—may in fact reinforce dangerous tendencies like delusions and suicidal ideation, leading users into negative feedback loops and validating troublesome personal beliefs and worldviews.
SEAL Who Claims to Have Killed Bin Laden Talks Psychedelics on Tucker Carlson. The man who controversially claims to have killed Osama Bin Laden has appeared on right-wing media personality Tucker Carlson’s podcast, wearing a cap that reads ‘DMT’, to discuss a whole host of topics, including psychedelics. The 20-minute discussion on the topic starts at around the 1hr 36min mark.
Sensorium Scores IND Clearance, Appoints Jacob Hooker as CEO. Sensorium Therapeutics, a clinical-stage biotech focused on brain and mental health therapies, has received FDA clearance for its Investigational New Drug (IND) application for SNTX-2643, the company’s lead program targeting anxiety. Described as a re-engineered derivative of a natural compound with a long history of human use, the specific source compound remains undisclosed. While Sensorium is also advancing candidates for epilepsy and Alzheimer’s-related cognitive decline, SNTX-2643 is the first to enter Phase I human trials. If successful, it could offer “A fast acting, well-tolerated anxiolytic …. for the hundreds of millions worldwide living with anxiety disorders”, the company says.
Naturalistic Psychedelic Use May Result in Worsening Depressive Symptoms, Study Finds. An observational study by Simonsson et al. (2025) that surveyed thousands of psychedelics users in the U.S. found that naturalistic psychedelic use “may not be generally therapeutic and may result in worsening depressive symptoms under certain circumstances.” One of the study’s authors, Peter Hendricks, said that these findings might point to the importance of set and setting.
Norwegian Proof of Principle Study Finds MDMA-Assisted Therapy Safe and Feasible in Major Depressive Disorder. A small (N=12) proof of principle study of MDMA-assisted therapy in moderate to severe major depressive disorder (MDD) found the intervention to be feasible and safe. The study (Kvam et al., 2025) was conducted by authors at Østfold Hospital, which we mentioned earlier in our feature on IV ketamine for TRD in the country. Lykos Therapeutics provided the MDMA used in the study as well as a grant.
FDA Publishes CRLs. Last week, FDA announced the publication of more than 200 complete response letters (CRL). Many in the field went searching for Lykos’ MDMA for PTSD CRL. But, it is not contained within the cache, which only includes those that concern interventions that have since been approved.
Healing Advocacy Fund’s 2024 Filings Show Revenue of $1.7M. Healing Advocacy Fund, the nonprofit working to support the implementation of state-regulated psychedelics access programs in places like Oregon and Colorado, raised $1.7M last year, according to its latest filing.
Psychedelic Science Institute Launches Two Clinics in LA. The Psychedelic Science Institute (PSI) has officially launched two clinics in California. Backed by $1.2 million in early philanthropic funding, PSI unites a multidisciplinary team of leading voices from the Pacific Neuroscience Institute’s TRIP Center and the California Center for Psychedelic Therapy. These newly established ‘TRIP Clinics’ (Treatment and Research in Psychedelics) will act as clinical hubs, aimed at serving clinical trial populations and ultimately helping to accelerate the development of FDA-approved psychedelic therapies.
Transcend Scores Breakthrough Therapy Designation for Methylone. Transcend Therapeutics, a New York-based clinical-stage biotech, has been granted Breakthrough Therapy Designation (BTD) by the FDA for its methylone candidate (TSND-201) for post-traumatic stress disorder (PTSD). The designation is based on positive results from IMPACT-1, a Phase 2 randomised, placebo-controlled trial conducted at numerous trial sites across the United States and Europe. In the study, TSND-201 produced statistically significant improvements in PTSD symptoms by Day 10, which were sustained through Day 64, with the company reporting that over 60% of participants lost their PTSD diagnosis. Blake Mandell, co-founder and CEO, said: “No new PTSD treatments have been approved in over two decades. This Breakthrough Therapy designation enables us to work more closely with the FDA as we prepare to launch our Phase 3 program.”
Veronika Gold’s Correction Request Passed Over by American Journal of Bioethics. Last week, the American Journal of Bioethics published two significant articles that spotlight a deepening ethical tussle in psychedelic-assisted therapy. One was a formal correction request from therapist Veronika Gold, responding to Neşe Devenot’s January 2025 commentary, in which Devenot raised concerns about Gold’s use of therapeutic touch in MDMA-assisted therapy (MDMA-AT) and ketamine-assisted psychotherapy (KAP). Gold’s response argued that Devenot had not “fully appreciated” the nuances of trauma-informed practice and had overlooked important clinical context, asserting that her own methods were licensed, safe, and intended to support clients as they navigated trauma responses. In her letter, Gold defended continuing physical resistance with a KAP client who had shouted, “Get your f[**]king hands away from me!”, explaining that she interpreted this as part of the client’s inner process rather than a literal refusal.
After reviewing Gold’s request, the journal declined to issue corrections, instead publishing both her letter and Devenot’s rebuttal. In Devenot’s open-access response, she argued that Gold’s methods cross ethical lines, especially considering the profound power imbalance inherent in a scenario where the patient’s capacity to consent has been diminished by a mind-altering substance. Devenot linked these practices to what some deem to be outdated and harmful bodywork traditions rooted in Stanislav Grof’s work, criticising protocols that empower therapists to disregard client requests unless a specific “safe word” is used, and challenged the distinction between “applying force” and “offering resistance” as effectively redundant in the current context. Devenot concluded that a lack of transparency in clinical trials—especially regarding touch-related risks—represents a profound ethical failure in the space. “Real science,” she wrote, “is built on the principles of transparency, replicability, and external review,” and she warned that practices shielded from outside scrutiny have no place in medicine, particularly in treatments targeting vulnerable populations.
Sunstone Study Shows Lasting Relief in Depressed Cancer Patients. A Phase 2 study from Sunstone Therapies published last month showed that a single 25 mg dose of psilocybin, paired with psychological support, can lead to long-lasting relief for cancer patients facing depression. Two years later, half of participants (14 of 28) had sustained improvements in mood, nearly half saw reduced anxiety, and a quarter no longer needed psychiatric medication. Sunstone CEO Manish Agrawal told us: “These results reinforce the potential of psychedelic-assisted therapy as a transformative approach for people facing depression and anxiety in the context of cancer.”
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- The group chose to do a simplified cost analysis “due to uncertainty of clinical effect beyond the acute phase of treatment.”
- One might wonder what the cost-comparison study might look like if generic IV ketamine were compared to esketamine. The review found that there is perhaps “little or no difference in response rates between single infusions of ketamine and esketamine”, though there was low certainty evidence in that realm. That could be boosted by a Patient-Centered Outcomes Research Institute (PCORI) comparative effectiveness study of the two products that’s underway at Yale, which aims to enroll 400-odd TRD patients (NCT06713616).
