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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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Libânio Osório Marta, R. F. (2019) · Drug Metabolism Reviews · doi:10.1080/03602532.2019.1638931 · Cited by 54
“Moreover, the dependence potential of psychoactive drugs such as LSD, psilocybin or mescaline is very low, and they are not considered to be reinforcing substances (O’Brien 2001; Nichols 2004; Johnson et al. 2018).”
BackgroundBelouin, S. J., Averill, L. A., Henningfield, J. E., Xenakis, S. N., Donato, I., Grob, C. S., Berger, A., Magar, V., Danforth, A. L., & Anderson, B. T. (2022) · Neuropharmacology · doi:10.1016/j.neuropharm.2022.109214 · Cited by 54
Self-citationClassic psychedelics and alcohol use disorders: A systematic review of human and animal studies
Calleja‐Conde, J., Morales-Garcia, J. A., Echeverry‐Alzate, V., Bühler, K., Giné, E., & López‐Moreno, J. A. (2022) · Addiction Biology · doi:10.1111/adb.13229 · Cited by 58
Yaden, D. B., Berghella, A. P., Regier, P. S., Garcia‐Romeu, A., Johnson, M. W., & Hendricks, P. S. (2021) · International Journal of Drug Policy · doi:10.1016/j.drugpo.2021.103380 · Cited by 55
Self-citationCarbonaro, T. M., Johnson, M. W., & Griffiths, R. R. (2020) · Psychopharmacology · doi:10.1007/s00213-020-05533-9 · Cited by 56
Self-citationPsychedelics and virtual reality: parallels and applications
Aday, J. S., Davoli, C. C., & Bloesch, E. K. (2020) · Therapeutic Advances in Psychopharmacology · doi:10.1177/2045125320948356 · Cited by 47
“23 In addition, while psychedelics are non-toxic (i.e., do not damage mammalian organ systems) 48 and have low potential for abuse, 49 the drugs are not risk-free as they can lead to psychologically challenging experiences for some individuals.”
BackgroundSexton, J. D., Nichols, C. D., & Hendricks, P. S. (2020) · Frontiers in Psychiatry · doi:10.3389/fpsyt.2019.00896 · Cited by 46
Self-citationPsychedelic Mushrooms in the USA: Knowledge, Patterns of Use, and Association With Health Outcomes
Matzopoulos, R., Morlock, R., Morlock, A., Lerer, B., & Lerer, L. B. (2022) · Frontiers in Psychiatry · doi:10.3389/fpsyt.2021.780696 · Cited by 57
“Animal studies have shown that they lack reinforcing properties that induce self-administration, which limits the potential for abuse as well as withdrawal symptoms (29, 30).”
Kratom Abuse Potential 2021: An Updated Eight Factor Analysis
Henningfield, J. E., Wang, D. W., & Huestis, M. A. (2022) · Frontiers in Pharmacology · doi:10.3389/fphar.2021.775073 · Cited by 45
“2 (Henning fi eld et al., 2018a; Johnson et al., 2018).”
Self-citationWitkin, J. M., Knutson, D. E., Rodriguez, G. J., & Shi, S. X.-Y. (2018) · Current Pharmaceutical Design · doi:10.2174/1381612824666180730104707 · Cited by 45
Jones, G. M., & Nock, M. K. (2022) · Scientific Reports · doi:10.1038/s41598-022-06580-2 · Cited by 47
Sakloth, F., Leggett, E., Moerke, M. J., Townsend, E. A., Banks, M. L., & Negus, S. S. (2019) · Experimental and Clinical Psychopharmacology · doi:10.1037/pha0000253 · Cited by 47
Psychotherapy with Psilocybin for Depression: Systematic Review
Dawood-Hristova, J. J., & Pérez‐Jover, V. (2023) · Behavioral Sciences · doi:10.3390/bs13040297 · Cited by 49
“In addition, the studies presented in this work did not report any cases of potential abuse or addiction to psilocybin, being a substance with a low addictive risk and no evidence that it causes any withdrawal symptoms [2,25].”
BackgroundLake, S., & Lucas, P. (2024) · International Journal of Drug Policy · doi:10.1016/j.drugpo.2024.104507 · Cited by 41
Martin, D. A., Gyawali, U., & Calu, D. J. (2020) · Addiction Biology · doi:10.1111/adb.12926 · Cited by 38
“This study examining the effects of 5-HT2A stimulation on fentanyl demand was motivated by renewed clinical interest in 5-HT2A agonists, such as psilocybin, for treating psychiatric illnesses including depression,(10,11) and addiction.(35,36) Previous studies in rats compared the effects of morphine alone with morphin…”
BackgroundNiles, H. F., Fogg, C., Kelmendi, B., & Lazenby, M. (2021) · BMC Palliative Care · doi:10.1186/s12904-021-00889-x · Cited by 39
“At the same time, stigma around psychedelics persists [25] despite their benign safety profile compared to similarly classified controlled substances [26, 27].”
BackgroundYu, C., Liang, C., Yang, F., Tu, Y., Hsu, C., Carvalho, A. F., Stubbs, B., Thompson, T., Tsai, C., Yeh, T., et al. (2022) · Journal of Clinical Medicine · doi:10.3390/jcm11040938 · Cited by 40
“In the 1950s and the 1960s, psilocybin was used to treat psychological distress in clinical trials; in the 1970s, with the enactment of the Controlled Substances Act, its use was discontinued, and it was classified as a Schedule I drug [2].”
MethodPepe, M., Hesami, M., de la Cerda, K. A., Perreault, M. L., Hsiang, T., & Jones, A. M. P. (2023) · Biotechnology Advances · doi:10.1016/j.biotechadv.2023.108247 · Cited by 36
Psilocybin’s effects on cognition and creativity: A scoping review
Bonnieux, J. N., VanderZwaag, B., Premji, Z., Garcia‐Romeu, A., & García-Barrera, M. A. (2023) · Journal of Psychopharmacology · doi:10.1177/02698811231179801 · Cited by 38
“These stringent regulations prompted an approximately 25-year period of limited advancement in psychedelic research (Belouin and Henningfield, 2018; Johnson et al., 2018).”
BackgroundHenningfield, J. E., Coe, M. A., Griffiths, R. R., Belouin, S. J., Berger, A. M., Coker, A. R., Comer, S. D., Heal, D. J., Hendricks, P. S., Nichols, C. D., et al. (2022) · Neuropharmacology · doi:10.1016/j.neuropharm.2022.109220 · Cited by 35
Self-citationPsilocybin-Assisted Compassion Focused Therapy for Depression
Pots, W. T. M., & Chakhssi, F. (2022) · Frontiers in Psychology · doi:10.3389/fpsyg.2022.812930 · Cited by 35
Psychedelics in neuroinflammation: Mechanisms and therapeutic potential
de Deus, J. L., Maia, J. M., Soriano, R. N., Amorim, M. R., & Branco, L. G. S. (2025) · Progress in Neuro-Psychopharmacology and Biological Psychiatry · doi:10.1016/j.pnpbp.2025.111278 · Cited by 35
Analysis of Psilocybin-Assisted Therapy in Medicine: A Narrative Review
Ziff, S., Stern, B., Lewis, G., Majeed, M., & Gorantla, V. R. (2022) · Cureus · doi:10.7759/cureus.21944 · Cited by 48
“Tolerance to the reinforcing effects builds rapidly in users who take psilocybin repeatedly [13].”
BackgroundInfluentialStrauss, D., Ghosh, S. B., Murray, Z., & Gryzenhout, M. (2022) · Frontiers in Forests and Global Change · doi:10.3389/ffgc.2022.813998 · Cited by 33
Validation of a new instrument for assessing attitudes on psychedelics in the general population
Žuljević, M. F., Buljan, I., Leskur, M., Kaliterna, M., Hren, D., & Duplančić, D. (2022) · Scientific Reports · doi:10.1038/s41598-022-23056-5 · Cited by 33
Roberts, C. A., Osborne-Miller, I., Cole, J. C., Gage, S. H., & Christiansen, P. (2020) · Journal of Psychopharmacology · doi:10.1177/0269881120936508 · Cited by 32
“Psilocybin abuse potential has never been assessed to standards set out by the Food and Drug Administration’s 2017 Guidance: Assessment of the Abuse Potential of Drugs (Johnson et al., 2018).”
BackgroundUse of Psychedelics for Pain: A Scoping Review
Goel, A., Rai, Y., Sivadas, S., Diep, C., Clarke, H. A., Shanthanna, H., & Ladha, K. S. (2023) · Anesthesiology · doi:10.1097/aln.0000000000004673 · Cited by 35
Psychedelics as Novel Therapeutics in Alzheimer’s Disease: Rationale and Potential Mechanisms
Garcia‐Romeu, A., Darcy, S., Jackson, H., White, T., & Rosenberg, P. B. (2021) · Current topics in behavioral neurosciences · doi:10.1007/7854_2021_267 · Cited by 33
“These compounds represent a novel frontier in the field of psychiatry as possibly transdiagnostic pharmacotherapies with low toxicity and addiction risk, and the potential for long-lasting benefits (Johnson et al. 2018).”
BackgroundPearson, C., Siegel, J. S., & Gold, J. A. (2021) · Journal of the Neurological Sciences · doi:10.1016/j.jns.2021.120096 · Cited by 34
Psychedelic-Assisted Therapy for People with Eating Disorders
Gukasyan, N., Schreyer, C. C., Griffiths, R. R., & Guarda, Á. S. (2022) · Current Psychiatry Reports · doi:10.1007/s11920-022-01394-5 · Cited by 33
Self-citationMolecular targets of psychedelic‐induced plasticity
Jaster, A. M., Revenga, M. D. L. F., & González‐Maeso, J. (2021) · Journal of Neurochemistry · doi:10.1111/jnc.15536 · Cited by 33
“Currently, however, psychedelics are not considered addictive— although some can produce tolerance in rodents (Smith et al., 2014), they lack reinforcement effects (Johnson et al., 2018).”
BackgroundThe Role of Psychedelics and Counseling in Mental Health Treatment
Curtis, R., Roberts, L. C., Graves, E. G., Rainey, H. T., Wynn, D. D., Krantz, D., & Wieloch, V. (2020) · Journal of Mental Health Counseling · doi:10.17744/mehc.42.4.03 · Cited by 35
DellaCrosse, M., Pleet, M., Morton, E., Ashtari, A., Sakai, K., Woolley, J., & Michalak, E. (2022) · PLOS ONE · doi:10.1371/journal.pone.0279073 · Cited by 28
“These mushrooms have been used in ritual and healing contexts for thousands of years [21, 22], and despite schedule I status designation [23], an estimated 9.68% of adults in the United States have used psilocybin at least once [24].”
InfluentialStrategies for resolving challenging psychedelic experiences: insights from a mixed-methods study
Wood, M. J., McAlpine, R. G., & Kamboj, S. K. (2024) · Scientific Reports · doi:10.1038/s41598-024-79931-w · Cited by 29
Boehnke, K. F., Cox, K., Weston, C. L., Herberholz, M., Glynos, N. G., Kolbman, N., Fields, C. W., Barron, J., & Kruger, D. J. (2023) · Frontiers in Psychiatry · doi:10.3389/fpsyt.2023.1224551 · Cited by 30
“Accordingly, the expeditious revision of regulations and recommendations that are incongruent with our best understanding of medical reality should be a paramount priority (32).”
BackgroundEffects of classic psychedelic drugs on turbulent signatures in brain dynamics
Cruzat, J., Perl, Y. S., Escrichs, A., Vohryzek, J., Timmermann, C., Roseman, L., Luppi, A. I., Ibáñez, A. M., Nutt, D. J., Carhart-Harris, R. L., et al. (2022) · Network Neuroscience · doi:10.1162/netn_a_00250 · Cited by 26
Wang, E. Y., Mathai, D. S., Gukasyan, N., Nayak, S. M., & Garcia‐Romeu, A. (2024) · Scientific Reports · doi:10.1038/s41598-024-78736-1 · Cited by 29
Psilocybin for major depressive disorder: a systematic review of randomized controlled studies
Li, L., Mo, Y., Shi, Z.-M., Huang, X., Ning, Y.-P., Wu, H., Yang, X.-H., & Zheng, W. (2024) · Frontiers in Psychiatry · doi:10.3389/fpsyt.2024.1416420 · Cited by 28
Thal, S. B., Wieberneit, M., Sharbanee, J. M., Skeffington, P., Baker, P., Bruno, R., Wenge, T., & Bright, S. J. (2022) · Journal of Psychopharmacology · doi:10.1177/02698811221127954 · Cited by 24
“Serotonergic psychedelics (in the doses that are recommended for administration) are physiologically safe (Nichols, 2016), non-addictive (Johnson et al., 2018), and long-term adverse effects related to research procedures or substances have not been reported in clinical trials (Bender and…”
BackgroundPsilocybin, an Effective Treatment for Major Depressive Disorder in Adults - A Systematic Review
Watford, T., & Masood, N. (2024) · Clinical Psychopharmacology and Neuroscience · doi:10.9758/cpn.23.1120 · Cited by 23
“…reinitiating interest back into psyche-delics, with US Food and Drug Administration (FDA)-ap- proved clinical studies indicating strong potential for psi-locybin-assisted psychotherapy in treating a range of mental health disorders but this research is scarce with strict regulatory constraints [5].”
Background
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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