Exploring the regulatory framework of psychedelics in the US & Europe.
Hitesh Kumar Behera, Ramesh Joga, Sravani Yerram, Praveena Karnati, Tejaswini Mergu, Kajal Gandhi, M Sowndharya, Deepak Nathiya, Ravindra Pal Singh, Saurabh Srivastava, Sandeep Kumar
Asian Journal of Psychiatry December 1, 2024 DOI: 10.1016/j.ajp.2024.104242 (opens in new tab)
Study at a glance
AI-extracted from the abstract| Characteristics | Review Peer reviewed |
|---|---|
| Topics | DMT Ketamine LSD MDMA Mescaline Psilocybin |
| Keywords | Law Regulatory Drug policy Controlled substances Behavioral health Clinical psychedelics |
| Key findings | Psychedelic drug therapy has therapeutic potential for mental health conditions, but careful regulation and legislation are necessary to balance benefits and risks. |
Abstract
Psychedelic drug therapy has gained prominence for its potential in treating various mental health conditions, including depression, post-traumatic stress disorder (PTSD), and anxiety. Psychedelic treatment differs from conventional psychiatric approaches in mode of action, legal status, and treatment approach. This work delves into the therapeutic potential, mechanisms, and regulatory approvals of key psychedelic substances like psilocybin, 3,4-Methyl enedioxy methamphetamine (MDMA), mescaline, ketamine, and Lysergic acid diethylamide (LSD). It also provides an overview of legal aspects, and regulations surrounding psychedelics in the US & Europe, emphasizing their Schedule I classification due to potential misuse. The United States Food & Drug Administration (USFDA) closely monitors psychedelics, employing expedited pathways for evaluation. Further, recent guidance from the FDA on considerations for clinical Investigations supports the safe development of psychedelics for human welfare. European Medicines Agency (EMA) regulators focus on atypical psychedelics, addressing challenges in safety and efficacy. Marketed products, such as Spravato nasal spray, face limited distribution due to safety concerns. The call for careful regulation and legislation is essential for harnessing psychedelics' potential for therapeutic benefits and human welfare.
Comparable studies
Other narrative reviews on mescaline, most cited first.
| Study | Year | Design | Participants |
|---|---|---|---|
| Study of a New Schizophrenomimetic Drug—Sernyl | 1959 | Review | |
| Hallucinogens and Serotonin 5-HT2A Receptor-Mediated Signaling Pathways | 2017 | Review | |
| Hallucinogens in Mental Health: Preclinical and Clinical Studies on LSD, Psilocybin, MDMA, and Ketamine | 2020 | Review | |
| Legal highs: staying on top of the flood of novel psychoactive substances | 2015 | Review | |
| Psychedelic Drugs in Biomedicine | 2017 | Review |
Citations in the library
Cited by 19
- Exploring Psilocybe cubensis Strains: Cultivation Techniques, Psychoactive Compounds, Genetics and Research Gaps Journal of Fungi January 28, 2025
- Psychedelic-related deaths in England, Wales and Northern Ireland (1997-2022). Progress in Neuro-Psychopharmacology and Biological Psychiatry January 10, 2025
- Unraveling the policies, legislations, and regulations of psychedelics in Australia, Canada, Netherlands, New Zealand, and India. Health policy (Amsterdam, Netherlands) July 8, 2025
- Psychedelics and mental health: reimagining care through science, insight, and compassion. Frontiers in Pharmacology September 3, 2025
- Mushroom bioactives—polysaccharides to psilocybin: a viewpoint on the therapeutic use of mushrooms for consumers and patients for health and neuroplasticity Translational Food Sciences 2025
and 14 more in the library
Cites 15
- Psilocybin produces substantial and sustained decreases in depression and anxiety in patients with life-threatening cancer: A randomized double-blind trial Journal of Psychopharmacology November 30, 2016
- Effects of Psilocybin-Assisted Therapy on Major Depressive Disorder JAMA Psychiatry November 4, 2020
- Classic psychedelics: An integrative review of epidemiology, therapeutics, mystical experience, and brain network function. Pharmacology & Therapeutics May 1, 2019
- MDMA-assisted therapy for moderate to severe PTSD: a randomized, placebo-controlled phase 3 trial. Nature Medicine October 1, 2023
- MDMA-assisted psychotherapy for treatment of PTSD: study design and rationale for phase 3 trials based on pooled analysis of six phase 2 randomized controlled trials. Psychopharmacology September 1, 2019
and 10 more in the library