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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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Psychedelic drugs for psychiatric disorders
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“Generally, psilocybin is considered safe, with minimal physiological side effects and low abuse potential (Hodge et al., 2023; Jaster et al., 2022; Johnson et al., 2018).”
Psilocybin Exposures Reported to U.S. Poison Centers: National Trends Over a Decade
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“Despite their long history of medicinal and ceremonial use, especially in indigenous contexts, psychedelics have only recently been rediscovered (R. L. Carhart-Harris & Goodwin, 2017) as putatively effective and safe (Johnson et al., 2018, 2019) treatments for a range of psychiatric disorders.”
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“12,13 The primary risks that have been associated with psychedelic use are psychological, including the capacity for a psychologically challenging experience (i.e., “ bad trip ” ), which can be highly distressing and potentially destabilizing for some individuals.”
The safety of psilocybin-assisted psychotherapy: A systematic review
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“In addition, the use of psilocybin has not been associated with later compulsive drug-seeking behaviour or physical dependence (Johnson et al., 2018).”
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“Classic psychedelics are thought to have a low abuse potential and they have not been proved to cause dependence in either animals or humans [37].”
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“Compared toother recreational substances, psilocybin is among the least harmful, with minor physiological side effects and minimal reinforcing effects (Krebs and Johansen, 2013; Hendricks et al. 2015; Johansen and Krebs, 2015; Johnson et al. 2018).”
BackgroundPsychedelics and Psychedelic-Assisted Psychotherapy
Reiff, C. M., Richman, E. E., Nemeroff, C. B., Carpenter, L. L., Widge, A. S., Rodríguez, C. I., Kalin, N. H., & McDonald, W. M. (2021) · FOCUS The Journal of Lifelong Learning in Psychiatry · doi:10.1176/appi.focus.19104 · Cited by 28
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The Health and Clinical Benefits of Medicinal Fungi
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Psychedelics and workplace harm
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Molecular and Medical Aspects of Psychedelics
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“Moreover, previous research suggests that classic psychedelics have immunomodulatory and anti-inflammatory properties [25–27], low physiological toxicity [22,28], and appears safe in clinical trials, at least when potential risk populations are screened out [17,29].”
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“Johnson et al. emphasize the need to understand the mechanisms of action of psilocybin and related compounds, which can lead to long-lasting positive changes in mood and well-being, especially in individuals who have not responded to conventional treatments [6].”
Social Work and Psychedelic-Assisted Therapies: Practice Considerations for Breakthrough Treatments
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“Although psychedelics have low physiological toxicity and abuse potential (Johnson et al., 2018), they can lead to psychological effects resulting in dangerous behaviors.”
Sociological investigations of human enhancement drugs: The case of microdosing psychedelics
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The need for publicly funded research on therapeutic use of psychedelic drugs
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Rediscovering Psilocybin as an Antidepressive Treatment Strategy
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Psilocybin for clinical indications: A scoping review
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Backgroundμ-opioid receptor agonists and psychedelics: pharmacological opportunities and challenges
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“…and have hypothesized which schedule of the CSA a classic psychedelic such as psilocybin may be placed in the hypothetical case that the drug, as the active pharmaceutical ingredient present in a pharmaceutical drug product, receives FDA approval (Johnson et al., 2018; Henningfield et al., 2022).”
BackgroundGlobal Drug SurveyPreprint
Petranker, R., Anderson, T., Maier, L. J., Barratt, M. J., Ferris, J., & WINSTOCK, A. R. (2020) · PsyArXiv (OSF Preprints) · doi:10.31234/osf.io/xb8ve · Cited by 14
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“low lethality risk with long term benefits (Van Amsterdam et al. 2011; Johnson et al. 2018).”
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Bogadi, M., & Kaštelan, S. (2021) · Croatian Medical Journal · doi:10.3325/cmj.2021.62.528 · Cited by 13
Human behavioral pharmacology of psychedelics
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Self-citationPsychedelic Microdosing, Mindfulness, and Anxiety: A Cross-Sectional Mediation Study
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“…non-commercial re-use, distribution, and reproduction in any medium, provided the original work is properly cited, and is not altered, transformed, or built upon in any way. potential of macrodoses (Carhart-Harris et al. 2018; Johnson et al. 2018; Moreno et al. 2006), they are not without risks.”
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“…anxiety and/or depression (Muttoni et al., 2019), and may provide therapeutic relief longer (Carhart-Harris et al., 2018) than ketamine (Hibicke et al., 2019; Romeo et al., 2015), while circumventing toxic and addictive risks (Heal et al., 2018; Johnson et al., 2018; Nichols and Grob, 2018).”
Religion, Psychedelics, Risky Behavior, and Violence
Viña, S. M. (2024) · Journal of Psychoactive Drugs · doi:10.1080/02791072.2024.2346132 · Cited by 12
“The first independent variable is classic psychedelic use, a subclass of psychedelics that has little toxicity (dos Santos et al. 2018; Johnson et al. 2018; Rodríguez Arce and Winkelman 2021).”
Mystical experiences without mysticism: An argument for mystical fictionalism in psychedelics
Armour‐Garb, B., & Earleywine, M. (2022) · Journal of Psychedelic Studies · doi:10.1556/2054.2022.00207 · Cited by 12
Psychedelic Psychiatry: Preparing for Novel Treatments Involving Altered States of Consciousness
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Henningfield, J. E., Ashworth, J., Heal, D. J., & Smith, S. L. (2023) · Journal of Psychopharmacology · doi:10.1177/02698811221140004 · Cited by 13
“…overly restrictive and not commensurate with the relatively low reinforcing efficacy, physical withdrawal potential, or human use patterns of the classic hallucinogens that are not generally considered addictive (see discussion at National Institute on Drug Abuse, 2021, and Johnson et al., 2018).”
BackgroundInfluentialSelf-citationPsychiatry might need some psychedelic therapy
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“…would almost be surprising if psychedelics did not have therapeutic potential, at least in limited circumstances, especially given their substantially lower physical toxicity and addiction potential in comparison to the other psychoactive drugs with approved therapeutic use (Johnson et al., 2018).”
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The Relationship Between Naturalistic Psychedelic Use and Clinical Care in Canada
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“…a policy perspective, some of these risks could be mitigated by rescheduling or decriminalizing psychedelic substances to align with modern research findings of therapeutic potential and known risk factors, and to remove criminal charges associated with drug possession or use (Johnson et al. 2018).”
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Bremler, R., Katati, N., Shergill, P., Erritzøe, D., & Carhart-Harris, R. L. (2023) · doi:10.31234/osf.io/yzmcj · Cited by 11
Psilocybin Conspectus: Status, Production Methods, and Considerations
Plotnik, L., Gibbs, G., & Graham, T. (2021) · International journal of medicinal mushrooms · doi:10.1615/intjmedmushrooms.2021041921 · Cited by 11
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“[4] High concentrations of synaptic 5-HT can bind to various receptors pre-and post-synaptically.”
Review of Psilocybin Use for Depression among Cancer Patients after Approval in Oregon
Bellman, V. (2024) · Cancers · doi:10.3390/cancers16091702 · Cited by 11
“Psilocybin exerts its effects primarily through agonist activity at the 5-HT2A receptor [48,65–68].”
BackgroundGibbons, W. J., McKinney, M. G., O’Dell, P. J., Bollinger, B. A., & Jones, J. A. (2021) · Bioengineered · doi:10.1080/21655979.2021.1987090 · Cited by 10
“However, if the United States Food and Drug Administration (FDA) approves psilocybin for medical use in the future, experts speculate that it would be reclassified as a Schedule IV compound, supported by recent data indicating high safety and low addictive properties [32].”
BackgroundCard, K. G., Grewal, A., Closson, K., Martin, G., Baracaldo, L., Allison, S., Kruger, D. J., & Walsh, Z. (2023) · Journal of Psychoactive Drugs · doi:10.1080/02791072.2023.2268640 · Cited by 10
“…use as a therapeutic agent, feasibility studies suggest that psilocybin has good safety profile and low addiction potential (Hodge et al. 2023; Johnson et al. 2018), particularly at low doses (Garcia-Romeu et al. 2021; Henríquez-Hernández et al. 2023) and even among those with complex…”
Psilocybin as a Novel Pharmacotherapy for Treatment-Refractory Anorexia Nervosa
Rodan, S.-C., Aouad, P., McGregor, I. S., & Maguire, S. (2021) · OBM Neurobiology · doi:10.21926/obm.neurobiol.2102102 · Cited by 12
“To ensure patient safety, blood pressure and heart rate are continuously measured during a psilocybin dosing session and individuals who are not medically stable, especially those with compromised cardiovascular function, are strictly excluded from trials [188].”
BackgroundResultInfluentialScala, M., Fabbri, C., Fusar-Poli, P., Di Lorenzo, G., Ferrara, M., Amerio, A., Fusar-Poli, L., Pichiecchio, A., Asteggiano, C., Menchetti, M., et al. (2024) · CNS Spectrums · doi:10.1017/s1092852924002268 · Cited by 13
Psilocybin and chronic neuropathic pain: a systematic review
Jevotovsky, D. S., Chopra, H., Pak, D., Durbhakula, S., Shustorovich, A., Juneja, T., Broachwala, M. Y., AlFarra, T., Silver, C., Kreitzer, G., et al. (2024) · Regional Anesthesia & Pain Medicine · doi:10.1136/rapm-2024-105532 · Cited by 9
VanderZwaag, B., Garcia‐Romeu, A., & García-Barrera, M. A. (2024) · Therapeutic Advances in Psychopharmacology · doi:10.1177/20451253241264812 · Cited by 10
Clinical and preclinical evidence of psilocybin as antidepressant. A narrative review
Erkizia-Santamaría, I., Horrillo, I., Meana, J. J., & Ortega, J. E. (2025) · Progress in Neuro-Psychopharmacology and Biological Psychiatry · doi:10.1016/j.pnpbp.2025.111249 · Cited by 12
“Abuse potential of psilocybin is relatively low, as compared to other substances that carry high risk of compulsive use and abuse (Schlag et al., 2022), and there is no clear evidence of physical dependence and withdrawal in preclinical or clinical studies (Johnson et al., 2018).”
Modzelewski, S., Stankiewicz, A., Waszkiewicz, N., & Łukasiewicz, K. (2025) · Neuropharmacology · doi:10.1016/j.neuropharm.2025.110402 · Cited by 9
“…for psilocybin it is typically in the range of 0.1 – 0.5 g from mushrooms and around 1 – 5 mg for synthetic psilocybin (the therapeutic dose is about 10 – 30 mg for synthetic psilocybin p. o., and 3 – 5 g from mushrooms) (Johnson et al., 2018; Passie et al., 2008; V. Polito & P. Liknaitzky, 2022).”
InfluentialFive-year outcomes of psilocybin-assisted therapy for Major Depressive Disorder
Davis, A. K., DellaCrosse, M. A., Sepeda, N. D., Levin, A. W., Cosimano, M. P., Shaub, H., Washington, T., Gooch, P. M., Gilead, S., Gaughan, S. J., et al. (2025) · Journal of Psychedelic Studies · doi:10.1556/2054.2025.00461 · Cited by 9
An Assessment of Psychedelic Knowledge Among People Using Psychedelics Naturalistically
Kruger, D. J., Glynos, N. G., Fields, C. W., Herberholz, M., & Boehnke, K. F. (2022) · Journal of Psychoactive Drugs · doi:10.1080/02791072.2022.2142709 · Cited by 9
“2021), side effects, and abuse potential (Johnson et al. 2018).”
IsHak, W. W., García, P., Pearl, R., Dang, J., William, C., Totlani, J., & Danovitch, I. (2023) · PubMed Central · Cited by 8
Bouso, J. C., Révész, D., Oña, G., Rossi, G. N., Rocha, J. M., SANTOS, R. G. D., Hallak, J. E. C., & Alcázar‐Córcoles, M. Á. (2023) · Scientific Reports · doi:10.1038/s41598-023-41199-x · Cited by 9
“Notably, scientists are asking for the reclassification of these substances 82,83 given the emerging body of evidence, which the present study strengthens by showing the positive consequences of their use in both informal and experimental settings.”
BackgroundBrett, J., Knock, E., Watson, K., Albert, S., Siefried, K. J., & Guss, J. (2024) · Frontiers in Psychiatry · doi:10.3389/fpsyt.2024.1490907 · Cited by 7
“Psilocybin is a serotonin 5-HT 2A receptor agonist with very low abuse potential (11).”
Attitudes of European psychiatrists on psychedelics: a qualitative study
Žuljević, M. F., Breški, N., Kaliterna, M., & Hren, D. (2024) · Frontiers in Psychiatry · doi:10.3389/fpsyt.2024.1411234 · Cited by 8
Zhang, Y., Yang, L., Zhang, Q., Li, C., Mao, F., & Zhuo, C. (2025) · Translational Psychiatry · doi:10.1038/s41398-025-03410-7 · Cited by 9
“Future studies, including clinical trials, are essential to con fi rm the mechanisms and therapeutic potential of psilocybin in suicide prevention.”
Jones, G. M., Herrmann, F. M., & Wang, E. (2023) · Addictive Behaviors Reports · doi:10.1016/j.abrep.2023.100513 · Cited by 8
Self-administration of Psilocybin in the Setting of Treatment-resistant Depression.
Lyons, A. (2022) · PubMed Central · Cited by 8
Knock, E., Siefried, K. J., Bedi, G., Albert, S., Day, R. O., Ezard, N., Ross, M., Liknaitzky, P., & Brett, J. (2025) · Addiction · doi:10.1111/add.70187 · Cited by 9
Amid magic and menace: psychiatrists’ attitudes to psilocybin therapy
Gribben, A. D., Burke, T., Harrington, C., Husein, A., Murnane, K. S., Hendricks, P. S., Tobin, K., Ivers, J., Thuery, G., Harkin, A., et al. (2024) · Irish Journal of Psychological Medicine · doi:10.1017/ipm.2024.49 · Cited by 7
“%) of the total sample had concerns about the addictive potential of psilocybin, which appears somewhat disproportionate to the existing evidence base (Calderon et al., 2023; Henningfield et al., 2022; Johnson et al., 2018).”
Self-citationDominiak, M., Gędek, A., Modrzejewski, S., Permoda-Pachuta, A., & Antosik-Wójcińska, A. Z. (2025) · Journal of Clinical Medicine · doi:10.3390/jcm15010253 · Cited by 7
Escamilla-Orozco, R. I., González-Trujano, M. E., Mariscal, J. M. G., Torres-Valencia, J. M., Guzmán-González, H., Vega, J. L., & Loizaga-Velder, A. K. (2023) · Journal of Psychoactive Drugs · doi:10.1080/02791072.2023.2246459 · Cited by 7
“Given the new evidence of their therapeutic potential, their reclassification is necessary (Johnson et al. 2018), in our country, to facilitate research in this promising mental health field.”
BackgroundPsychedelics – Re-opening the doors of perception
Heal, D. J., Henningfield, J. E., Frenguelli, B. G., Nutt, D., & Smith, S. L. (2018) · Neuropharmacology · doi:10.1016/j.neuropharm.2018.08.024 · Cited by 7
Self-citationPsychedelics and Hallucinogens in Psychiatry: Finding New Pharmacological Targets
de Sousa, T. R., Rema, J., Machado, S. E. D. C., & Novais, F. (2021) · Current Topics in Medicinal Chemistry · doi:10.2174/1568026621666211201145800 · Cited by 7
Belitzky, E., Carvalho, L. V. R., Taylor, M. V., Naranjo-Ortiz, C., Baum, L. V. M., Fiellin, D. A., & Lustberg, M. B. (2025) · Cancer Medicine · doi:10.1002/cam4.70586 · Cited by 6
“These risks are generally low with psychedelics that have a low potential for misuse, especially compared to opioids [39].”
Informed Consent Documents from Psychedelic Clinical Trials: A Descriptive Ethical Analysis
Cheung, K., Propes, C., Graziosi, M., Patch, K., & Yaden, D. B. (2025) · AJOB Empirical Bioethics · doi:10.1080/23294515.2025.2526339 · Cited by 6
“…directed at comprehensive-ness and legal compliance, their mention may place an emphasis on highly unlikely risks that are not well quantified—in particular, psilocybin’s potential for abuse and physical dependence has been found to be low in preclinical and clinical studies (Johnson et al. 2018).”
Religious Social Integration, Psychedelics, and Psychological Distress
Viña, S. M. (2024) · Journal of Psychoactive Drugs · doi:10.1080/02791072.2024.2425021 · Cited by 6
“The first independent variable is classic psychedelic use, a low-toxicity subclass of psychedelics (dos Santos et al. 2018; Johnson et al. 2018; Rodríguez Arce and Winkelman 2021).”
Systematic review and rationale of using psychedelics in the treatment of cannabis use disorder
Phan, A. N., & Terry, G. E. (2023) · Frontiers in Psychiatry · doi:10.3389/fpsyt.2023.1144276 · Cited by 6
Ross, B. M., & Neill, J. T. (2023) · Journal of Psychedelic Studies · doi:10.1556/2054.2023.00264 · Cited by 6
Earleywine, M., & Gomez, S. G. (2024) · Psychedelic Medicine · doi:10.1089/psymed.2023.0054 · Cited by 6
“61,62 Those who have psychotic biological relatives might decide to focus on alternative approaches for generating nonordinary states, 63 but these disorders are rare.”
Luoma, J. B., Davis, A. K., Watts, R., & McCracken, L. M. (2020) · Journal of Contextual Behavioral Science · doi:10.1016/j.jcbs.2020.01.004 · Cited by 6
Hallucinogenic mushroom misuse reported to Texas poison centers
Forrester, M. B. (2020) · Journal of Addictive Diseases · doi:10.1080/10550887.2020.1785817 · Cited by 6
Advancing elite athlete mental health treatment with psychedelic-assisted psychotherapy
Walton, C. C., & Liknaitzky, P. (2020) · Journal of Applied Sport Psychology · doi:10.1080/10413200.2020.1848941 · Cited by 6
“Indeed, a strong case has been made for the down-scheduling of psychedelics in the United States from Schedule 1 (no currently accepted medical use and a high potential for abuse) to Schedule 4 (low potential for abuse and low risk of dependence) (Johnson et al., 2018).”
BackgroundClifton, J. M., Belcher, A. M., Greenblatt, A. D., Welsh, C., Cole, T. O., & Davis, A. K. (2022) · Journal of Psychedelic Studies · doi:10.1556/2054.2022.00214 · Cited by 6
“…substance use disorders (Bogenschutz and Johnson, 2016; Dos Santos, Bouso, Alcázar-Córcoles, & Hallak, 2018; Garcia-Romeu, Kersgaard, & Addy, 2016; Johnson et al., 2018), there are no existing data on the attitudes and beliefs towards psilocybin among Black individuals diagnosed with Opioid Use…”
BackgroundMyers, M. G., & Toal, C. B. (1995) · PubMed · Cited by 6
The Psychedelic Social Club: a regulatory concept for people who use psychedelics?
Harder, H., Steinmetz, F. P., & Kohek, M. (2023) · Drugs Education Prevention and Policy · doi:10.1080/09687637.2023.2276067 · Cited by 6
“…relatively infrequently (Winstock et al., 2021). the psychoactive component psilocybin presents a very low potential for dependence (gable, 1993; Johnson et al., 2018; morgenstern et al., 1994), relatively low toxicity (gable, 2004), and comparatively low harm to individuals and society (Bonomo…”
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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