Catégorie : Essais Cliniques

Randomized, dose-ranging safety trial of cannabidiol in Dravet syndrome, Orrin Devinsky et al., 2018

Randomized, dose-ranging safety trial of cannabidiol in Dravet syndrome Orrin Devinsky,  Anup D. Patel, Elizabeth A. Thiele, Matthew H. Wong,  Richard Appleton, Cynthia L. Harden, Sam Greenwood,  Gilmour Morrison, and Kenneth Sommerville,  On behalf of the GWPCARE1 Part A Study Group Neurology® 2018, 0:e1-e8.   doi:10.1212/WNL.0000000000005254 Abstract Objective : To evaluate the safety and preliminary pharmacokinetics of a pharmaceutical formulation of purified cannabidiol (CBD) in children with Dravet syndrome. Methods : Patients aged 4–10 years were randomized 4:1 to CBD (5, 10, or 20 mg/kg/d) or placebo taken twice daily. The double-blind trial comprised 4-week baseline, 3-week treatment (including titration), 10-day taper, and 4-week follow-up periods. Completers [...]

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A Phase 1, Open-Label, Pharmacokinetic Trial to Investigate Possible Drug-Drug Interactions Between Clobazam, Stiripentol, or Valproate and Cannabidiol in Healthy Subjects, G. Morrison et al., , 2019

A Phase 1, Open-Label, Pharmacokinetic Trial to Investigate Possible Drug-Drug Interactions Between Clobazam, Stiripentol, or Valproate and Cannabidiol in Healthy Subjects. G. Morrison, J. Crockett, G. Blakey, K. Sommerville Clinical Pharmacology in Drug Development, 2019, PMID : 30791225, DOI : 10.1002/cpdd.665 Abstract GW Pharmaceuticals' formulation of highly purified cannabidiol oral solution is approved in the United States for seizures associated with Lennox-Gastaut and Dravet syndromes in patients aged ≥2 years, for which clobazam, stiripentol, and valproate are commonly used antiepileptic drugs. This open-label, fixed-sequence, drug-drug interaction, healthy volunteer trial investigated the impact of cannabidiol on steady-state pharmacokinetics of clobazam (and N-desmethylclobazam), stiripentol, and valproate; [...]

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Psilocybin with psychological support for treatment-resistant depression : six-month follow-up, R. L. Carhart-Harris et al., 2018

Psilocybin with psychological support for treatment resistant depression : six-month follow-up R. L. Carhart-Harris, M. Bolstridge, C. M. J. Day, J. Rucker, R. Watts, D. E. Erritzoe,  M. Kaelen,  B. Giribaldi, M. Bloomfield, S. Pilling, J. A. Rickard, B. Forbes,  A. Feilding,  D. Taylor, H. V. Curran, D. J. Nutt Psychopharmacology, 2017 https://doi.org/10.1007/s00213-017-4771-x   Abstract : Rationale : Recent clinical trials are reporting marked improvements in mental health outcomes with psychedelic drug-assisted psychotherapy. Objectives : Here, we report on safety and efficacy outcomes for up to 6 months in an open-label trial of psilocybin for treatment-resistant depression. Methods : Twenty patients (six females) with (mostly) severe, unipolar, treatment-resistant [...]

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Striking lung cancer response to self-administration of cannabidiol: A case report and literature review, Josep Sulé-Suso et al., 2019

Striking lung cancer response to self-administration of cannabidiol : A case report and literature review Josep Sulé-Suso, Nick A Watson, Daniel G van Pittius, Apurna Jegannathen SAGE Open Medical Case Reports, 2019, 7, 1-4.   Abstract : In spite of new drugs, lung cancer is associated with a very poor prognosis. While targeted therapies are improving outcomes, it is not uncommon for many patients to have only a partial response, and relapse during follow-up. Thus, new drugs or reevaluation of existing therapies used to treat other non-malignant diseases (drug repurposing) are still needed. While this research both in vitro and in vivo is being carried [...]

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Cannabidiol in Anxiety and Sleep : A Large Case Series, S. Shannon et al. , 2019

Cannabidiol in Anxiety and Sleep : A Large Case Series SHANNON S., LEWIS N., LEE H., HUGHES S. The Permanente Journal, 2019, 23   Abstract CONTEXT: Cannabidiol (CBD) is one of many cannabinoid compounds found in cannabis. It does not appear to alter consciousness or trigger a "high." A recent surge in scientific publications has found preclinical and clinical evidence documenting value for CBD in some neuropsychiatric disorders, including epilepsy, anxiety, and schizophrenia. Evidence points toward a calming effect for CBD in the central nervous system. Interest in CBD as a treatment of a wide range of disorders has exploded, yet few clinical studies of [...]

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Oral Cannabidiol Use in Children With Autism Spectrum Disorder to Treat Related Symptoms and Co-morbidities, D. Barchel et al., Frontiers in Pharmacology, Tel Aviv, 2019

Oral Cannabidiol Use in Children With Autism Spectrum Disorder to Treat Related Symptoms and Co-morbidities BARCHEL D., STOLAR O., De-HAAN T., ZIV-BARAN T., SABAN N., FUCHS D.O., KOREN G., BERKOVITCH M. Frontiers in Pharmacology, 2019, 9, 1521. doi : 10.3389/fphar.2018.01521,   PMID : 30687090   Objective: Children with autism spectrum disorder (ASD) commonly exhibit comorbid symptoms such as aggression, hyperactivity and anxiety. Several studies are being conducted worldwide on cannabidiol use in ASD; however, these studies are still ongoing, and data on the effects of its use is very limited. In this study we aimed to report the experience of parents who administer, under supervision, oral [...]

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What Is the CBD Dosing Required for Effective Pain Relief ? Medscape, 14/12/2018

What Is the CBD Dosing Required for Effective Pain Relief ? Damian McNamara, CME, Laurie Barclay, MD Posted: 12/14/2018 Clinical Context The effects of cannabis in humans include euphoria, increased sensitivity to external experience, relaxation, and potential for addiction. Cannabidiol is a compound in the cannabis plant that lacks euphoric and addictive qualities and that may be useful to treat conditions including chronic pain, nausea, epilepsy, psychosis, and anxiety. The optimal therapeutic dose of CBD has not yet been determined, and it has been used in a wide dose range from 2.85 to 50 mg/kg/day. The therapeutic effects of CBD appear to emanate from its interaction [...]

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An Update on Safety and Side Effects of Cannabidiol: A Review of Clinical Data and Relevant Animal Studies, Kerstin IFFLAND, Franjo GROTENHERMEN, 2017

An Update on Safety and Side Effects of Cannabidiol: A Review of Clinical Data and Relevant Animal Studies Kerstin IFFLAND, Franjo GROTENHERMEN Cannabis and Cannabinoid Research, 2017, 2, (1), 139–154. DOI: 10.1089/can.2016.0034 https://www.liebertpub.com/doi/10.1089/can.2016.0034?utm_source=sfmc&utm_medium=email&utm_campaign=CAN%20OA%20Feb%201%202019&d=2/1/2019&mcid=1909944349   Abstract Introduction: This literature survey aims to extend the comprehensive survey performed by Bergamaschi et al. in 2011 on cannabidiol (CBD) safety and side effects. Apart from updating the literature, this article focuses on clinical studies and CBD potential interactions with other drugs. Results: In general, the often described favorable safety profile of CBD in humans was confirmed and extended by the reviewed research. The majority of studies were performed for treatment of epilepsy [...]

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Review on clinical studies with cannabis and cannabinoids 2010-2014

http://cannabis-med.org/data/pdf/en_2016_01_1.pdf   Cannabinoids 2016; 11 (special issue), 1-18 © International Association for Cannabinoid Medicines   Review Review on clinical studies with cannabis and cannabinoids 2010-2014   Mikael A. Kowal1, Arno Hazekamp1, Franjo Grotenhermen2 Bedrocan, Veendam, The Netherlands nova-Institut, Chemiepark Knapsack, Industriestraße, D-50354 Hürth, Germany   Abstract In 2010 a review by Hazekamp and Grotenhermen covered controlled clinical trials of the years 2006-2009 on cannabis-based medicines, which followed the example of the review by Ben Amar (2006). The current review reports on the more recent clinical data available from 2010- 2014. A systematic search was performed in the scientific database of PubMed, focused on clinical studies that were randomized, (double) blinded, and placebo-controlled. The key words [...]

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Tous les essais cliniques réalisés de part le monde avec du cannabis, et des cannabinoides

Sur l'excellent site de l'IACM (International Association for Cannabinoid Medicines), sur le lien suivant, vous trouverez tous les essais cliniques (Cannabis et cannabinoides) répertoriés par nos voisins allemands (merci au Dr Franjo Grotenhermen, fondateur de l'Association) http://www.cannabis-med.org/studies/study.php   le lien suivant,répertorie ces essais cliniques, en français, par pathologies étudiées : http://www.cannabis-med.org/french/studies.htm      

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