Étiquette : essai clinique

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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Cannabinoid-Based Therapies and Brain Development : Potential Harmful Effect of Early Modulation of the Endocannabinoid System, P. Schonhofen et al., 2018.

Cannabinoid-Based Therapies and Brain Development : Potential Harmful Effect of Early Modulation of the Endocannabinoid System. Patricia Schonhofen, Ivi Juliana Bristot, José Alexandre Crippa, Jaime Eduardo Cecilio Hallak, Antonio Waldo Zuardi, Richard B. Parsons, Fabio Klamt CNS Drugs, 2018, 32 (Suppl 1), 1-16 https///doi.org/10.1007/s40263-018-0550-4 Abstract : The endocannabinoid retrograde signaling pathway is widely expressed in the central nervous system, where it plays major roles in regulating synaptic plasticity (excitatory and inhibitory) through long-term potentiation and long-term depression. The endocannabinoid system (ECS) components-cannabinoid receptors, endocannabinoids and synthesis/degradation enzymes-are expressed and are functional from early developmental stages and throughout adolescent cortical development, regulating progenitor cell fate, neural [...]

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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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Cannabis as a Substitute for Opioid-Based Pain Medication : Patient Self-Report, Amanda Reiman et al., 2017

Cannabis as a Substitute for Opioid-Based Pain Medication: Patient Self-Report Amanda REIMAN, Mark WELTY, Perry SOLOMON Cannabis and Cannabinoid Research, 2017, Vol 2, n°1 Abstract Introduction: Prescription drug overdoses are the leading cause of accidental death in the United States. Alternatives to opioids for the treatment of pain are necessary to address this issue. Cannabis can be an effective treatment for pain, greatly reduces the chance of dependence, and eliminates the risk of fatal overdose compared to opioid-based medications. Medical cannabis patients report that cannabis is just as effective, if not more, than opioid-based medications for pain. Materials and Methods: The current study examined the [...]

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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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Français, encore un effort pour le cannabis thérapeutique ! Dr Bertrand Lebeau, texte pour Michka, mai 2008)

Français, encore un effort pour le cannabis thérapeutique ! Dr Bertrand Lebeau, texte pour Michka, mai 2008.   La redécouverte des propriétés thérapeutiques du cannabis est récente dans les pays occidentaux mais, désormais, les recherches se multiplient et les cadres légaux se transforment. Pour comprendre la situation actuelle il faut faire un bref retour en arrière. Tout d’abord l’utilisation de « drogues » comme médicaments est habituelle et l’on peut affirmer que toute drogue a été, est ou sera un médicament. La morphine, et dans certains pays l’héroïne, sont utilisées pour leurs propriétés contre la douleur, la cocaïne a bouleversé la chirurgie de l’œil [...]

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