In the week’s Psychedelic news roundup, we cover ongoing efforts by veterans and advocacy groups to influence the FDA’s upcoming decision on Lykos Therapeutics‘ MDMA-assisted therapy application. Other news includes an overwhelming public response to the DEA regarding rescheduling cannabis, and two new psychedelic studies.

Navigating Regulatory Challenges: The Battle for MDMA’s Approval in PTSD Treatment

Navigating MDMA Regulatory Challenges

MedpageToday details continuing support from veterans and advocacy groups for MDMA-assisted therapy for post-traumatic stress disorder (PTSD), supported by the Multidisciplinary Association for Psychedelic Studies (MAPS). This movement seemed poised for success when VA Under-Secretary for Health Shereef Elnahal expressed readiness to implement MDMA therapy, pending FDA approval. However, the FDA advisory committee’s subsequent rejection due to concerns over data integrity and potential risks cast doubt on the drug’s regulatory future. However, it should be noted that the independent review board’s decision is not binding.

Key Developments:

  • The FDA’s advisory panel criticized the primary data and research methods, raising safety and addiction concerns, leading to an expectation of either a delay or denial in MDMA’s approval.
  • Veterans and researchers have combined efforts with MAPS to promote MDMA’s therapeutic potential, despite skepticism from regulatory bodies about the robustness of the supporting evidence.

Veterans who have participated in trials attest to MDMA’s transformative effects on traumatic memories, advocating for its therapeutic benefits. Meanwhile, the scientific community remains divided, with some urging larger, more impartial studies to validate MDMA’s efficacy and safety comprehensively.

The discussion extends beyond the U.S., with veterans traveling abroad to places like Mexico and Peru for psychedelic therapies unavailable at home. Organizations like the Heroic Hearts Project advocate for access and recognition of psychedelic treatments, emphasizing their potential to significantly improve veterans’ mental health. The community remains hopeful that continued advocacy and evolving research will eventually lead to broader acceptance and integration of these therapies into mainstream mental health treatment.(1)

Public Opinion Overwhelms DEA with Calls for Full Cannabis Legalization

Public Opinion on Cannabis Legalization

As reported by the Guardian, the U.S. Drug Enforcement Administration (DEA) concluded a two-month public comment period regarding the proposed rescheduling of cannabis, revealing a significant public push not just for rescheduling, but for full legalization. The agency received nearly 43,000 responses, the highest number ever recorded over a proposed rule change, indicating a strong public interest in the reform of cannabis laws.

Key Points:

  • Most comments favored more than just rescheduling; 69% supported full legalization or decriminalization of cannabis.
  • The DEA’s proposal would shift cannabis from Schedule I to Schedule III, recognizing it as a medicine but still maintaining federal restrictions.
  • Concerns were raised that rescheduling alone doesn’t address conflicts with state laws or correct historical racial injustices associated with marijuana criminalization.

The vast majority of feedback received highlighted dissatisfaction with the proposed changes being too conservative. Advocates and ordinary citizens alike expressed a desire to see cannabis removed from the Controlled Substances Act entirely, aligning its legal status more closely with alcohol and tobacco. This perspective was echoed by various organizations and echoed in personal testimonials regarding the benefits of cannabis, ranging from medical relief to personal well-being.

Despite President Biden’s campaign promises to decriminalize marijuana, the current proposal for rescheduling under the DEA would not prevent arrests or resolve the overarching issues of federal criminalization. Critics argue that rescheduling might prolong the adverse effects on communities, particularly those of color, which have been disproportionately affected by stringent drug laws.

The sentiment shared by many during the comment period suggests a growing frustration with the slow pace of federal reform in contrast to state-level advancements where cannabis has been legalized or decriminalized. The public’s feedback could potentially influence the DEA’s final decision, though the agency could also extend the deliberation process through hearings or face legal challenges.

As the debate continues, it is clear that public opinion on cannabis is shifting towards a more liberal stance, reflecting broader societal changes and an increasing acknowledgment of the drug’s safety and efficacy compared to other legal substances. Whether this will translate into significant federal policy change remains to be seen, but the overwhelming response to the DEA’s call for comments is a strong indicator of where many Americans stand on the issue.(2)

Innovative LSD Microdosing Study in New Zealand Focuses on Cancer Patients and Cultural Inclusivity

LSD Study in New Zealand

A new study at the University of Auckland is exploring the effects of LSD microdosing on patients with late-stage cancer, with a particular focus on including a significant number of Māori participants. This research aims to assess the potential benefits of psychedelic-assisted therapies in a culturally respectful manner, enhancing the standard care for these patients.

The study, led by Dr. Lisa Reynolds and her team, is distinctive in its approach, combining LSD microdosing with meaning-centered psychotherapy. They hypothesize that while all participants may benefit from the psychotherapy, those receiving LSD might experience additional improvements in their quality of life. This trial is particularly novel as it integrates a tikanga-based approach, ensuring that the research is culturally appropriate for Māori participants.

Key Points:

  • The trial aims to enroll an equal number of Māori and non-Māori participants, reflecting its commitment to cultural inclusivity.
  • Participants will receive either a microdose of LSD or one of several placebos, alongside psychotherapy, to evaluate the combined effects on their mental health.
  • The research also addresses significant health disparities, as Māori are historically diagnosed later and have poorer cancer outcomes compared to non-Māori.

The inclusion of Māori perspectives and practices in the study design is expected to enhance the relevance and effectiveness of the treatments for Māori patients and potentially provide a model for other health interventions in New Zealand. The study also aims to set the groundwork for future changes in the regulation of psychedelic substances in New Zealand, taking a proactive approach to potential health policy changes.

As the trial progresses, it will provide valuable insights into the safety and optimal dosing of LSD microdosing, with the ultimate goal of expanding to larger randomized controlled trials. This could significantly impact the way late-stage cancer is treated, offering new, effective options for those who currently have limited treatment success.(3)

DemeRx Launches Noribogaine Study

DemeRx Logo

A new clinical trial announced and spearheaded by DemeRx NB, Inc. is investigating the efficacy of DMX-1001, a new treatment for Alcohol Use Disorder (AUD), marking a significant advancement in addiction medicine. This Phase I trial, enrolling healthy volunteers, aims to evaluate the safety, tolerability, and how the body processes DMX-1001—a derivative of ibogaine known as noribogaine but without the psychedelic effects associated with its parent compound.

  • Innovative Approach: Unlike ibogaine, DMX-1001 does not induce psychedelic effects, which significantly reduces the risks of misuse and other safety concerns, making it a potentially safer option for widespread clinical use.
  • Trial Structure: The study involves up to 60 participants divided into four groups, receiving varying doses of DMX-1001 or a placebo, to carefully assess the drug’s pharmacokinetics and optimize dosage for future testing phases.
  • Significance for Public Health: AUD is a major public health challenge in the U.S., linked to approximately 95,000 deaths annually. If proven effective, DMX-1001 could drastically reduce this mortality rate and help alleviate the broad societal and economic burdens of alcohol dependency.
  • Economic Impact: The financial strain of AUD on the healthcare system is enormous, with costs running into billions annually due to treatments, lost productivity, and other related expenses. Effective management of AUD with DMX-1001 could result in healthcare savings and improved workforce productivity.

By targeting the complex brain circuits involved in addiction, DMX-1001 represents a novel therapeutic approach in psychiatry, potentially offering a more targeted and effective treatment for those battling severe alcohol addiction.

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. Press, A. (2024, July 27). Veterans Lobby for Psychedelic Therapy, but Will It Influence MDMA’s Approval? Medpagetoday.com; Medpage Today. https://www.medpagetoday.com/psychiatry/generalpsychiatry/111259 
  2. Green, H. H. (2024, July 27). Nearly 43,000 people commented on the DEA reclassifying cannabis. What did they say? The Guardian. https://www.theguardian.com/society/article/2024/jul/27/dea-cannabis-classification 
  3. LSD microdosing trial seeks 50 percent Maori – The University of Auckland. (n.d.). Www.auckland.ac.nz. Retrieved July 31, 2024, from https://www.auckland.ac.nz/en/news/2024/07/30/lsd-microdosing-trial-seeks-50-percent-maori.html 
  4. Articles & Podcast – DemeRx. (n.d.). Retrieved July 31, 2024, from https://www.demerx.com/articles/