This week’s Psychedelic News focuses on several new scientific studies examining the potential and possible pitfalls of psychedelic use. Of note, a new study explores issues with informed consent and the difficulties providers and researchers face when talking to patients about psychedelic-assisted therapy. Other news includes Colorado’s continuing efforts to regulate psychedelic medicine and a fresh attempt at cannabis reform in Congress.

Navigating Informed Consent in Psychedelic Medicine: A Critical Analysis

Informed Consent

The burgeoning interest in psychedelic medicine as a treatment for mental health conditions is driving rapid changes in both legislation and clinical practice. However, as highlighted in a recent article published in JAMA Psychiatry, the integration of psychedelics into healthcare systems is outpacing the development of appropriate informed consent processes. Informed consent is the process by which individuals voluntarily agree to participate in a procedure or research after being fully informed of its risks, benefits, and alternatives. This gap poses significant challenges, given the unique properties of psychedelic substances and the contexts in which they are administered.

The researchers underscore that the challenge is exacerbated by the fact that no classic psychedelics have yet received approval for general medical use by any government. Currently, only clinical researchers have navigated the informed consent process with participants in controlled trials. This situation points to a critical need for developing informed consent processes that are specifically tailored to the non-research settings where these substances might soon be used more broadly, especially in states like Oregon and Colorado, where psychedelics are available for supervised use outside traditional healthcare settings.

The authors of the study identify seven essential components that should be considered when designing and implementing informed consent for psychedelic therapy.

These include:

  • Addressing the possibility of both short- and long-term perceptual disturbances
  • Potential personality changes
  • Altered metaphysical beliefs
  • The limited role of physical reassurance through touch
  • Risks of patient abuse or coercion
  • The importance of data collection, and the necessity of practitioner disclosures
  • And the need for interactive patient education and thorough assessment of patient comprehension (1)

Evaluating the Safety of Psilocybin in Therapeutic Settings: A Comprehensive Meta-Analysis

Clinical Setting Psilocybin Safety

As the interest in psychedelic substances for mental health treatment grows, the safety of these compounds, particularly psilocybin, remains a critical area of investigation. Psilocybin, a naturally occurring psychedelic compound, is known for its potential to treat various psychiatric disorders, including depression and anxiety. Despite its promising therapeutic benefits, a systematic understanding of its safety profile is essential for its integration into clinical practice. This need led Akhila Yerubandi and colleagues to conduct a meta-analysis focusing on the acute adverse effects of psilocybin when used at therapeutic doses, which was published in JAMA Psychiatry.

The study analyzed data from six randomized, double-blind clinical trials involving 528 participants. These trials were specifically selected for their methodological rigor and the relevance of their data on the adverse effects of psilocybin. The primary adverse effects examined included headaches, nausea, anxiety, dizziness, and fluctuations in blood pressure, with the study aiming to provide a clear picture of the immediate risks associated with psilocybin administration. The meta-analysis utilized robust statistical methods to ensure the reliability of the findings, addressing potential biases and heterogeneity in the trial results.

The meta-analysis results revealed that while psilocybin is associated with several acute adverse effects, these are generally tolerable and transient. Specifically, the risks of experiencing headaches, nausea, anxiety, and dizziness were statistically significant but resolved quickly, typically within 48 hours. Importantly, the study found no significant risk associated with paranoia and transient thought disorder, which are often concerns with psychedelic use. These findings suggest that with proper medical supervision and patient selection, psilocybin can be safely administered in therapeutic contexts. However, the researchers emphasized the need for further studies to explore long-term safety and manage these adverse effects, ensuring that psilocybin’s therapeutic potential can be fully realized with minimal patient risks.


Colorado’s Legislative Efforts to Regulate Psychedelic Medicines Continue Amid Tight Deadlines

Regulate Psychedelic Medicines

Coming to us from the Green Market Report, in Colorado, the journey toward establishing a regulated medical psychedelics industry continues to evolve following the voter-approved legalization of psychedelic substances psilocybin, DMT, mescaline, and ibogaine in 2022. The state’s legislators are currently working against the clock to finalize the framework necessary to support the burgeoning industry, with the legislative session due to adjourn in just a month. This ongoing legislative effort aims to set up a structured environment for the medical use of psilocybin, among other substances.

The latest legislative proposal, Senate Bill 24-198, is designed to address several key aspects of the psychedelic medicines framework that were not fully defined in the initial implementation of Proposition 122 (which decriminalized naturally occurring psychedelics and created a path forward for supervised adult use). This includes the establishment of the Natural Medicine Division (NMD), which is tasked with overseeing the industry. The bill proposes several important provisions: it outlines expanded educational and training programs for psilocybin facilitators, exempts these programs from conventional private school regulations, updates laboratory testing and certification requirements for psychedelic products, and introduces restrictions on financial ownership in the psychedelic business to prevent monopolistic practices. Additionally, the bill clarifies the permissible types of product transfers among various stakeholders in the industry, such as healing centers and cultivation facilities.

With the legislative session ending on May 8, the pressure is on for the Colorado legislature to act swiftly. The bill’s passage is crucial for the timely opening of medical psilocybin treatment centers and clinics slated for next year. Public hearings and rulemaking sessions are underway, with industry rules expected to be established by fall. This legislative activity is not only pivotal for the structured growth of the psychedelic medicine sector in Colorado but also sets a precedent for how other states might approach the regulation of these substances. The outcomes of these efforts will likely influence the broader national discourse on the medical and therapeutic use of psychedelics.


Senate Majority Leader Chuck Schumer and Senate Democrats Revive Efforts for Federal Marijuana Legalization with a Focus on Social Justice

Federal Marijuana Legalization

Coming to us from Mybizdaily, Senate Majority Leader Chuck Schumer, alongside other top Senate Democrats, has initiated a renewed effort to pass comprehensive federal marijuana legalization. This latest push, encapsulated in the Cannabis Administration and Opportunity Act (CAOA), marks Schumer’s second attempt to navigate the complex legislative landscape to legalize cannabis at the federal level. The initiative, which stalled in 2022 due to internal disagreements within the Democratic Party over the extent of criminal justice reforms to be included, has been reinvigorated with modifications to address past concerns and strengthen the bill’s appeal. Some of the previous concerns revolved around state’s rights, individuals incarcerated on federal cannabis charges, and concerns surrounding banking regulations.

CAOA seeks to transform the legal landscape for cannabis in the United States by introducing federal regulations to enhance product safety, restrict access to minors, and equip state and local jurisdictions with the necessary resources to address impaired driving. Furthermore, the act emphasizes rectifying the historical injustices inflicted by the War on Drugs, particularly on communities of color, by integrating substantial social justice reforms into the legislation. Senators Cory Booker of New Jersey and Ron Wyden of Oregon, vocal advocates for equity in cannabis legislation and federal banking reforms for marijuana businesses, are key collaborators in this legislative effort.

Despite the optimistic restart, the path to passing the CAOA remains fraught with challenges. Achieving the necessary 60 votes in the Senate for such a sweeping reform is daunting, especially when previous, more modest reforms like the SAFER Banking Act, have failed to advance. However, this legislative effort coincides with President Joe Biden’s review of cannabis scheduling, which might lead to downgrading marijuana to a Schedule 3 substance, signaling a potential shift in federal policy. Schumer’s strategy also appears to be a tactical move to galvanize support among younger voters, aligning with broader Democratic Party goals to capture this crucial demographic by championing progressive issues such as marijuana legalization.


This material is not intended as a replacement or substitute for any legal or medical advice. Always consult a medical professional about your health needs. Psychedelics are widely illegal in the United States, and readers should always be informed about local, state, and federal regulations regarding psychedelics or other drugs.

  1. Marks, M., Brendel, R. W., Shachar, C., & Cohen, I. G. (2024). Essentials of Informed Consent to Psychedelic Medicine. JAMA Psychiatry. 
  2. Akhila Yerubandi, Thomas, J. E., Alam, M., Harrington, C., Lorenzo Villa Zapata, & Caballero, J. (2024). Acute Adverse Effects of Therapeutic Doses of Psilocybin: A Systematic Review and Meta-Analysis. JAMA Network Open, 7(4), e245960–e245960. 
  3. Schroyer, J. (2024, April 10). Colorado Legislature takes up psychedelic medicines regulation – again. Green Market Report. 
  4. Roberts, C. (2024, April 10). Schumer, Senate Democrats signal new attempt at federal marijuana legalization. MJBizDaily.