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Psychoactives
Special Issues
Clinical Pharmacology and Toxicology of Cannabis-Based Medicinal Products
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Clinical Pharmacology and Toxicology of Cannabis-Based Medicinal Products

A special issue of Psychoactives (ISSN 2813-1851).

Deadline for manuscript submissions: closed (31 December 2023) | Viewed by 7308

Special Issue Editors

Dr. Márcia Carvalho

E-Mail Website
Guest Editor
Faculty of Health Sciences, University Fernando Pessoa, Rua Carlos da Maia, 4200-150 Porto, Portugal
Interests: toxicology; drugs of abuse; amphetamines; synthetic cathinones; psychoactive substances; toxicometabolomics; cancer metabolomics; biomarkers; hepatotoxicity; nephrotoxicity; cardiotoxicity; oxidative stress
Special Issues, Collections and Topics in MDPI journals
Prof. Dr. Maria Augusta Vieira-Coelho

E-Mail Website
Guest Editor
Department of Biomedicine‑Therapeutics and Pharmacology Unit, Faculty of Medicine, University of Porto, Porto, Portugal
Interests: pharmacology; substance use disorders; psychiatric disorders; cannabis; cannabinoid receptor; genetic polymorphisms; catechol-O-methyltransferase; depression

Special Issue Information

Dear Colleagues,

In light of recent policy changes, cannabis and its derivatives can now be prescribed for medicinal use in many countries. This has created new therapeutic opportunities for the treatment of a variety of diseases and clinical symptoms such as chronic pain, spasticity in multiple sclerosis, seizures in refractory epilepsy, intractable nausea and/or vomiting, depression and anxiety, to name a few. A wide range of cannabis-based products, including dried flowers, standardized plant extracts, THC- or CBD-only products, and pure synthetic cannabinoids are available for therapeutic purposes. However, medicinal cannabis may also pose health risks associated with its use, such as psychoactive, intoxicating, and impairing effects. Therefore, high-quality evidence of its safety and efficacy must be provided before cannabis and its derivatives can be used to their full potential as future medicines.

The aim of this Special Issue is to publish novel research contributing to the development of knowledge on the potential uses and side effects associated with medical cannabis and its derivatives. As such, we encourage submissions addressing, but not limited to, pharmacologic mechanisms, therapeutic uses, clinical trials, medical and psychiatric adverse effects, pharmacovigilance, and drug interactions. Original research and review papers are welcomed.

We look forward to receiving your work.

Dr. Márcia Carvalho
Prof. Dr. Maria Augusta Vieira-Coelho
Guest Editors

Manuscript Submission Information

Manuscripts should be submitted online at www.mdpi.com by registering and logging in to this website. Once you are registered, click here to go to the submission form. Manuscripts can be submitted until the deadline. All submissions that pass pre-check are peer-reviewed. Accepted papers will be published continuously in the journal (as soon as accepted) and will be listed together on the special issue website. Research articles, review articles as well as short communications are invited. For planned papers, a title and short abstract (about 100 words) can be sent to the Editorial Office for announcement on this website.

Submitted manuscripts should not have been published previously, nor be under consideration for publication elsewhere (except conference proceedings papers). All manuscripts are thoroughly refereed through a single-blind peer-review process. A guide for authors and other relevant information for submission of manuscripts is available on the Instructions for Authors page. Psychoactives is an international peer-reviewed open access quarterly journal published by MDPI.

Please visit the Instructions for Authors page before submitting a manuscript. The Article Processing Charge (APC) for publication in this open access journal is 1000 CHF (Swiss Francs). Submitted papers should be well formatted and use good English. Authors may use MDPI's English editing service prior to publication or during author revisions.

Keywords

  • medicinal cannabis
  • cannabinoids
  • endocannabinoid system
  • pharmacology
  • toxicology
  • efficacy
  • safety
  • adverse effect
  • drug interactions
  • pharmacovigilance

Published Papers (1 paper)

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10 pages, 417 KiB  
Opinion
Does Cannabidiol (CBD) in Food Supplements Pose a Serious Health Risk? Consequences of the European Food Safety Authority (EFSA) Clock Stop Regarding Novel Food Authorisation
by Dirk W. Lachenmeier, Constanze Sproll and Stephan G. Walch
Psychoactives 2023, 2(1), 66-75; https://doi.org/10.3390/psychoactives2010005 - 13 Mar 2023
Cited by 7 | Viewed by 6768
Abstract
In the European Union (EU), cannabidiol (CBD) products extracted from Cannabis sativa L. require pre-marketing authorisation under the novel food regulation. Currently, 19 CBD applications are being assessed by the European Food Safety Authority (EFSA). During the initial assessment of the dossiers, the [...] Read more.
In the European Union (EU), cannabidiol (CBD) products extracted from Cannabis sativa L. require pre-marketing authorisation under the novel food regulation. Currently, 19 CBD applications are being assessed by the European Food Safety Authority (EFSA). During the initial assessment of the dossiers, the EFSA Panel on Nutrition, Novel Foods, and Food Allergens (NDA) identified several knowledge gaps that need to be addressed before the evaluation of CBD can be finalised. The effects of CBD on the liver, gastrointestinal tract, endocrine system, nervous system, psychological function, and reproductive system need to be clarified. The contribution of this research is to provide an evidence-based assessment of the potential risks associated with CBD products, and to provide recommendations for risk management in the European Union while awaiting the finalisation of novel food applications. The available literature allows for a benchmark dose (BMD)–response modelling of several bioassays, resulting in a BMD lower confidence limit (BMDL) of 20 mg/kg bw/day for liver toxicity in rats. Human data in healthy volunteers showed increases in the liver enzymes alanine aminotransferase and aspartate aminotransferase in one study at 4.3 mg/kg bw/day, which was defined by the EFSA NDA panel as the lowest observed adverse effect level (LOAEL). The EFSA NDA panel recently concluded that the safety of CBD as a novel food cannot be assessed, resulting in a so-called clock stop for the applications until the applicants provide the required data. The authors suggest that certain CBD products still available on the EU market as food supplements despite the lack of authorisation should be considered “unsafe”. Products exceeding a health-based guidance value (HBGV) of 10 mg/day should be considered “unfit for consumption” (Article 14(1) and (2)(b) of Regulation No. 178/2002), while those exceeding the human LOAEL should be considered “injurious to health” (Article 14(1) and (2)(a) of Regulation No 178/2002). Full article
(This article belongs to the Special Issue Clinical Pharmacology and Toxicology of Cannabis-Based Medicinal Products)
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