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The abuse potential of medical psilocybin according to the 8 factors of the Controlled Substances Act
Open accessAbstract
This review assesses the abuse potential of medically-administered psilocybin, following the structure of the 8 factors of the US Controlled Substances Act (CSA). Research suggests the potential safety and efficacy of psilocybin in treating cancer-related psychiatric distress and substance use disorders, setting the occasion for this review. A more extensive assessment of abuse potential according to an 8-factor analysis would eventually be required to guide appropriate schedule placement. Psilocybin, like other 5-HT2A agonist classic psychedelics, has limited reinforcing effects, supporting marginal, transient non-human self-administration. Nonetheless, mushrooms with variable psilocybin content are used illicitly, with a few lifetime use occasions being normative among users. Potential harms include dangerous behavior in unprepared, unsupervised users, and exacerbation of mental illness in those with or predisposed to psychotic disorders. However, scope of use and associated harms are low compared to prototypical abused drugs, and the medical model addresses these concerns with dose control, patient screening, preparation and follow-up, and session supervision in a medical facility. CONCLUSIONS: (1) psilocybin has an abuse potential appropriate for CSA scheduling if approved as medicine; (2) psilocybin can provide therapeutic benefits that may support the development of an approvable New Drug Application (NDA) but further studies are required which this review describes; (3) adverse effects of medical psilocybin are manageable when administered according to risk management approaches; and (4) although further study is required, this review suggests that placement in Schedule IV may be appropriate if a psilocybin-containing medicine is approved. This article is part of the Special Issue entitled 'Psychedelics: New Doors, Altered Perceptions'.
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“are not associated with addiction [9, 11, 12]”
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“Hence, despite psilocybin being classified as a drug of abuse, the US Drug Enforcement Administration (DEA) does not include it among the drugs that can cause dependence and/or addiction. 45”
From The revival of psilocybin between scientific excitement, evidence of efficacy, and real-world challenges (2024) · cites this paper as [45]
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“Psilocybin is a serotonin 5-HT2A receptor agonist with very low abuse potential (11)”
From Psilocybin-assisted psychotherapy for methamphetamine dependence: a case report involving daily methamphetamine use (2024) · cites this paper as [11]
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“Psilocybin-assisted psychotherapy (PAT) also appears to be safe and potentially efficacious for substance use disorders, based on early trials for nicotine and alcohol use disorders [14,15], with little evidence of harmful use in the community [16].”
From Psilocybin‐assisted psychotherapy for methamphetamine use disorder: A pilot open‐label safety and feasibility study. (2025) · cites this paper as [16]
In the citing paper
“the use of a single dose of either LSD or psilocybin in a controlled clinical setting can considerably improve the quality of life of patients in parallel with relatively few side effects and a low prevalence of abuse”
From Novel pharmacological targets in drug development for the treatment of anxiety and anxiety-related disorders (2019) · cites this paper as Johnson, Griffiths, Hendricks, & Henningfield, 2018
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Can the gut-brain axis provide insight into psilocybin's therapeutic value in reducing stress?
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“In other words, the lethal dose has been estimated to be 1000 times the effective dosing (Johnson et al., 2018).”
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Earleywine, M., & Herrmann, Z. M. (2022) · Psychiatric Annals · doi:10.3928/00485713-20220810-01 · Cited by 6
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“However, the scope of use and associated harms appear to be lower compared to those of prototypical abused drugs (Johnson et al., 2018).”
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Exploring a Decade of Microdosing Research: A Qualitative Meta-synthesis of Microdosing Literature
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“…in recent years and has gained traction in both scientific and media discourse as a potential treatment for various psychological conditions, such as depression, anxiety, and stress (Johnson et al. 2018; Kuypers et al. 2019; Liechti 2017; Rosenbaum et al. 2020; Webb, Copes, and Hendricks 2019).”
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Jones, G. M., Lipson, J., & Wang, E. (2023) · Scientific Reports · doi:10.1038/s41598-023-29763-x · Cited by 3
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Self-citationCoelho, S. G., Kim, H. S. A., Keough, M. T., Dawson, S. J., Tabri, N., Hodgins, D. C., Shead, N. W., & Wardell, J. D. (2024) · International Journal of Mental Health and Addiction · doi:10.1007/s11469-024-01381-2 · Cited by 2
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Fluyau, D., Kailasam, V. K., & Revadigar, N. (2024) · Psychoactives · doi:10.3390/psychoactives3040029 · Cited by 2
“It is presumed that psilocybin use and harm are low compared to illicit substances [14].”
Nogueira, M., García-Hernández, S., Roberto, G. S., & Marques, L. Z. (2024) · International journal of medicinal mushrooms · doi:10.1615/intjmedmushrooms.2024057053 · Cited by 2
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“Despite psychedelics having been classified as a controlled substance internationally, animal models of psychedelic use indicate that they are not self-administered the way abused substances are (Johnson et al. 2018; Kuhn, Kalivas, and Bobadilla 2019).”
Is there a place for psychedelics in sports practice?
Portes, M. A. M., Werle, I., & Bertoglio, L. J. (2025) · Acta Neuropsychiatrica · doi:10.1017/neu.2025.13 · Cited by 3
“Clinical studies conducted in supervised settings have also demonstrated low addictive potential (Johnson et al ., 2008; Johansen & Krebs, 2015; Johnson et al ., 2018; Schlag et al ., 2022; Hinkle et al ., 2024).”
The psychedelic renaissance: psilocybin, a breakthrough for treatment resistant depression?
Norman, T. R. (2025) · Exploration of neuroscience · doi:10.37349/en.2025.1006105 · Cited by 2
Youssef, F. F., Widelski, J., & Kukula-Koch, W. A. (2023) · Elsevier eBooks · doi:10.1016/b978-0-443-18657-8.00022-0 · Cited by 2
Uso da psilocibina no tratamento de transtornos psiquiátricos: Revisão da literatura
Teixeira, G. B., Passos, A. C. D. B., Farias, B. V., Girão, A. B. C. F., Marçal, L. D. S., Albuquerque, K. O. D. S., & Ferreira, M. A. D. (2024) · Research Society and Development · doi:10.33448/rsd-v13i2.44971 · Cited by 2
Akzeptanz psilocybin-assistierter Therapie in den deutschsprachigen Ländern
Hartter, N., Däumichen, M., Schmidt, C., Wolff, M., Gründer, G., & Jungaberle, H. (2025) · Der Nervenarzt · doi:10.1007/s00115-024-01792-5 · Cited by 2
Afrooghe, A., Ahmadi, E., Lesani, A., Mehranjani, M. S., Elahi, M. M., Babaei, M., Shayan, M., Shafaroodi, H., Jafari, R. M., Foroumadi, A., et al. (2025) · Naunyn-Schmiedeberg s Archives of Pharmacology · doi:10.1007/s00210-025-04152-5 · Cited by 1
“Furthermore, psilocybin exhibits a reduced propensity for addiction and toxicity in comparison to ketamine (Gable 1993; Johnson et al. 2018).”
University Students’ Motives for Psilocybin Use: A Mixed-Methods Analysis
Frinton, S., & Robinson, J. O. (2025) · Journal of Drug Issues · doi:10.1177/00220426251338187 · Cited by 1
“Despite the potential bene fi ts and relative safety of psilocybin in comparison to other substances (Bonomo et al., 2019; Johnson et al., 2018; Van Amsterdam et al., 2015), there are risks associated with psilocybin use.”
Kratina, S., Strıke, C., Schwartz, R. D., Nayfeh, A., Jopling, S. A., Lo, C., & Rush, B. R. (2025) · PLoS ONE · doi:10.1371/journal.pone.0318343 · Cited by 1
“The systematic reviews examined the long-term effects (such as lasting changes in anxiety, depression and spirituality) [36], safety [37,38] and selected mechanisms that may fall along disciplinary lines [39–43].”
Psilocybine dans le traitement d’une dépression résistante unipolaire : à propos d’un cas clinique
Dumenil, M., Cordova, G., & El‐Hage, W. (2025) · L Encéphale · doi:10.1016/j.encep.2025.02.007 · Cited by 1
Psychological Effects Related to Psychedelic Substance Use in the Previous 12 Months
Williams, J. D., & Murphy, P. N. (2025) · European Journal of Psychology Open · doi:10.1024/2673-8627/a000081 · Cited by 1
Psychedelic studies in nonhuman primates: Past and future
Masthay, J. C., Kwan, A. C., & Chang, S. W. C. (2025) · Molecular Psychiatry · doi:10.1038/s41380-025-03240-5 · Cited by 2
“Daily usage is extremely uncommon; as a review of LSD use notes, psychedelics can have such intense subjective effects that individuals who use them naturally tend to space out their frequency of use, reducing the occurrence of tolerance [47, 58, 59, 63].”
Psilocybin use in bipolar disorder: A comprehensive review
Do, A., Cloutier, L., Hébert‐Tremblay, L., & Thauvin, C. (2025) · Journal of Affective Disorders · doi:10.1016/j.jad.2025.120485 · Cited by 3
Psykologisk behandling av vedvarende vansker etter bruk av psykedelika
Holmøy, B., & Andersen, K. A. A. (2025) · Tidsskrift for Norsk psykologforening · doi:10.52734/qaow7353 · Cited by 1
Castellano-Ramírez, D., Hernández‐Álvarez, E., Borkel, L. F., Rojas‐Hernández, J., Hernández, D. J. Q., & Henríquez‐Hernández, L. A. (2026) · PLoS ONE · doi:10.1371/journal.pone.0344698 · Cited by 1
“…professionals, addressing past shortcomings such as overly punitive drug policies, and providing concrete education on the pharmacology, therapeutic potential, and risks of psyche-delics, alongside practical guidance for safe and ethical implementation within clinical and research settings [22,23].”
Abrahms, Z. N., Majdi, M., Madsen, S. M., Morton, C. J., Sen, A. K., Fried, N. B., Sawyer, L. E., Cegielski, E. R., Spezzano, S. J., & Jones, J. A. (2026) · Metabolic Engineering · doi:10.1016/j.ymben.2026.102490 · Cited by 1
Berg, C. J., McCready, D. M., LoParco, C. R., Schubel, L., Romm, K. F., Thakkar, S., Williams, J., Cavazos‐Rehg, P. A., & Yang, Y. T. (2026) · Journal of Psychoactive Drugs · doi:10.1080/02791072.2026.2685527 · Cited by 1
Blocking 5-HT2B receptors abolishes psilocybin’s efficacy in the rat forced swim test
Seillier, L., Seillier, A., Zvolska, M. A., & Šlamberová, R. (2026) · Journal of Psychopharmacology · doi:10.1177/02698811261458349 · Cited by 1
Postránecká, Z., Lucký, M., Mravčík, V., & Páleníček, T. (2026) · Journal of Psychedelic Studies · doi:10.1556/2054.2026.00514 · Cited by 1
Neuropharmacological analysis of the anti-addictive and therapeutic effects of psilocybin
Principe, A. (2022) · SURG Journal · doi:10.21083/surg.v14i1.6870 · Cited by 1
A Rare Case of MDMA-Induced Hyponatremia
Dorsen, C. G., Penn, A., Carew, N., & Lloyd, M. M. (2022) · The Journal for Nurse Practitioners · doi:10.1016/j.nurpra.2022.10.013 · Cited by 1
The role of psilocybin in depressive disorders
Najib, J. S. (2024) · Current Medical Research and Opinion · doi:10.1080/03007995.2024.2396536 · Cited by 1
“Suggestions have been made for psilocybin to be classified as Controlled Substance Schedule IV, since adverse effects of psilocybin are manageable when administered according to risk management 76 .”
Rural‐urban divide in risk perception of LSD: Implications for psychedelic‐assisted therapy
Bradley, M., Grossman, D., Simonsson, O., Copes, H., & Hendricks, P. S. (2024) · The Journal of Rural Health · doi:10.1111/jrh.12906 · Cited by 1
Self-citationPsilocybin and Magic Mushrooms: Patterns of Abuse and Consequences of Recreational Misuse
Brito-da-Costa, A. M., da Silva, D. D., Madureira-Carvalho, Á., & Dinis‐Oliveira, R. J. (2022) · Springer eBooks · doi:10.1007/978-3-030-92392-1_130 · Cited by 1
Journey To The Centre Of The Mind: Psychedelic Treatment of Mental Health in Aotearoa
Lutyens, D. (2023) · Open Access Victoria University of Wellington | Te Herenga Waka (Figshare) · doi:10.26686/wgtn.21904854 · Cited by 2
Nogueira, M., García-Hernández, S., Roberto, G. S., & Marques, L. Z. (2024) · medRxiv · doi:10.1101/2024.07.11.24310147 · Cited by 1
Boehnke, K. F. (2024) · doi:10.64628/aai.pjrhwgred · Cited by 1
The Nature of Healing in the Psychedelic Experience
Criddle, A. (2020) · PhilPapers (PhilPapers Foundation)
Response to Mukhdomi and Mukhdomi’s letter to the editor
Castellanos, J. P., Woolley, C., Bruno, K. A., Zeidan, F. Z., Halberstadt, A. L., & Furnish, T. J. (2020) · Regional Anesthesia & Pain Medicine · doi:10.1136/rapm-2020-102064
Analysis, design, and setup of controlled drugs monitoring system (San-Tech)
Safa, O., Khorami, F., Javedan, G., Zarei, H., & Fathalipour, M. (2020) · Journal of Modern Medical Information Sciences · doi:10.29252/jmis.6.4.73
Meil, W. M., Farrell, W., & Satti, R. (2021) · IntechOpen eBooks · doi:10.5772/intechopen.98514
SUBJECTIVE EXPERIENCES OF CLASSIC PSYCHEDELIC SUBSTANCES USERS
Bienemann, B. (2022) · doi:10.17771/pucrio.acad.59337 · Cited by 1
Psilocybin decelerates cellular senescencePreprint
Hecker, L., Kato, K., Kleinhenz, J., Shin, Y.-J., Papageorgiou, J., & Zarrabi, A. (2023) · Research Square · doi:10.21203/rs.3.rs-2921423/v1 · Cited by 1
Tetem, J., Fischmann, T., & Möller, T. J. (2023) · PsyArXiv (OSF Preprints) · doi:10.31234/osf.io/ztyxh
Klassieke psychedelica: veiligheid, neveneffecten en medicatie-interacties
Geleyn, E., Kuypers, K. P. C., Seynaeve, M., & Lemmens, G. M. D. (2023) · Tijdschrift voor Geneeskunde · doi:10.47671/tvg.79.23.049
Psilocybin Use in Palliative Care #464
Sims, M. D., & Hendrick, J. (2023) · Journal of Palliative Medicine · doi:10.1089/jpm.2023.0180
Metadata
- Authors
- Johnson, M. W., Griffiths, R. R., Hendricks, P. S., & Henningfield, J. E.
- Affiliations
- Johns Hopkins University (US)
- University of Alabama (US)
- Corresponding author
- Johnson, Matthew W.
- Venue
- Neuropharmacology
- Publisher
- Elsevier BV
- Published
- 2018-11
- Volume
- 142
- Pages
- 143-166
- ISSN
- 0028-3908 (ISSN-L)
- PMC
- PMC6791528
- OpenAlex
- W2806419184
- Cited by
- 354
- References
- 180
- Citations by year
- 2026: 36 · 2025: 61 · 2024: 57 · 2023: 55 · 2022: 60 · 2021: 31 · 2020: 33 · 2019: 15 · 2018: 4
- FWCI
- 3.50
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Licence
- Locations
- Neuropharmacology (publishedVersion, cc-by)
- PubMed (publishedVersion)
- Europe PMC (PubMed Central) (acceptedVersion)
- PubMed Central (acceptedVersion)
- Funders
- Heffter Research Institute
- NIH (RO1DA03889)
- Topics
- Social Sciences › Psychology › Clinical Psychology › Psychedelics and Drug Studies
- Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Toxicology › Forensic Toxicology and Drug Analysis
- Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Pharmacology › Alkaloids: synthesis and pharmacology
- Keywords
- psilocybin, abuse liability, Controlled Substances Act, drug scheduling, classic psychedelics, substance use disorders, adverse effects, psychosis, risk management, dose control
- MeSH terms
- Animals, Drug and Narcotic Control, Hallucinogens, Humans, Psilocybin, Substance-Related Disorders
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