Étiquette : essai clinique

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

Cannabidiol in Anxiety and Sleep : A Large Case Series Scott Shannon, Nicole Lewis, Heather Lee,  Shannon Hughes, The Permanente Journal, 2019, 23, 18-041 doi.org/10.7812/TPP/18-041   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 [...]

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Pharmacokinetics and Tolerability of Multiple Doses of Pharmaceutical-Grade Synthetic Cannabidiol in Pediatric Patients with Treatment-Resistant Epilepsy, James W. Wheless et al., 2019

Pharmacokinetics and Tolerability of Multiple Doses of Pharmaceutical-Grade Synthetic Cannabidiol in Pediatric Patients with Treatment-Resistant Epilepsy James W. Wheless, · Dennis Dlugos, · Ian Miller, · D. Alexander Oh, · Neha Parikh, · Steven Phillips, · J. Ben Renfroe, · Colin M. Roberts, · Isra Saeed, · Steven P. Sparagana, · Jin Yu, · Maria Roberta Cilio, on behalf of the INS011-14-029 Study Investigators CNS Drugs, 2019 https://doi.org/10.1007/s40263-019-00624-4 Abstract Background : Prior studies have evaluated the use of various constituents of cannabis for their anti-seizure effects. Specifically, cannabidiol, a non-psychoactive component of cannabis, has been investigated for treatment-resistant epilepsy, but more information is needed particularly on [...]

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MDMA-assisted psychotherapy for treatment of PTSD : study design and rationale for phase 3 trials based on pooled analysis of sixphase 2 randomized controlled trials, Michael C. Mithoefer et al., 2019

MDMA-assisted psychotherapy for treatment of PTSD: study design and rationale for phase 3 trials based on pooled analysis of six phase 2 randomized controlled trials Michael C. Mithoefer, Allison A. Feduccia, Lisa Jerome, Anne Mithoefer, Mark Wagner, Zach Walsh, Scott Hamilton, Berra Yazar-Klosinski, Amy Emerson, Rick Doblin Psychopharmacology, 2019 https://doi.org/10.1007/s00213-019-05249-5 Abstract Background : Posttraumatic stress disorder is a prevalent mental health condition with substantial impact on daily functioning that lacks sufficient treatment options. Here we evaluate six phase 2 trials in a pooled analysis to determine the study design for phase 3 trials of MDMA-assisted psychotherapy for PTSD. Methods : Six randomized, double-blind, controlled clinical trials [...]

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Efficacy and Safety of Flexibly Dosed Esketamine Nasal Spray Combined With a Newly Initiated Oral Antidepressant in Treatment-Resistant Depression: A Randomized Double-Blind Active-Controlled Study, Vanina Popova et al., 2019

Efficacy and Safety of Flexibly Dosed Esketamine Nasal Spray Combined With a Newly Initiated Oral Antidepressant in Treatment-Resistant Depression: A Randomized Double-Blind Active-Controlled Study Vanina Popova, M.D., Ella J. Daly, M.D., Madhukar Trivedi, M.D., Kimberly Cooper, M.S., Rosanne Lane, M.A.S., Pilar Lim, Ph.D., Christine Mazzucco, M.Sc., David Hough, M.D., Michael E. Thase, M.D., Richard C. Shelton, M.D., Patricio Molero, M.D., Ph.D., Eduard Vieta, M.D., Ph.D., Malek Bajbouj, M.D., Husseini Manji, M.D., Wayne C. Drevets, M.D., Jaskaran B. Singh, M.D. American Journal of Psychiatry in Advance, 2019 ajp.psychiatryonline.org doi: 10.1176/appi.ajp.2019.19020172   Objective : About one-third of patients with depression fail to achieve remission despite treatment with multiple [...]

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A role for cannabidiol in psychiatry? Keep calm and follow the drug development rules, Gabriella Gobbi, 2019

A role for cannabidiol in psychiatry? Keep calm and follow the drug development rules Gabriella Gobbi THE WORLD JOURNAL OF BIOLOGICAL PSYCHIATRY, 2019, VOL. 20, NO. 2, 98–100 Commentary https://doi.org/10.1080/15622975.2019.1584680   Along with tetrahydrocannabinol (THC), cannabidiol (CBD) is one of the main pharmacological components of Cannabis sativa and indica. Unlike THC, which binds CB1 receptors, CBD does not cause any dependence, and acts mostly via 5-HT1A and TPRV1 receptors (De Gregorio et al. 2018). Khoury et al. (2019) recently published a systematic review on the role of cannabidiol in psychiatry in the World Journal of Biological Psychiatry. After analysing 609 articles, they found six case reports, [...]

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Human Pharmacokinetics and Adverse Effects of Pulmonary and Intravenous THC-CBD Formulations, Pascale Meyer, Manuela Langos, Rudolf Brenneisen, 2018

Human Pharmacokinetics and Adverse Effects of Pulmonary and Intravenous THC-CBD Formulations Pascale Meyer, Manuela Langos, Rudolf Brenneisen Medical Cannabis and Cannabinoids, 2018, 1, 36–43 Preclinical Science and Clinical Studies – Research Article DOI: 10.1159/000489034   Abstract Background : Due to variable absorption and extensive firstpass metabolism, the bioavailability of oral delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD) is low, and, therefore, alternative application forms are necessary. Methods : In an open-label, 2-period phase-1 study on 11 healthy volunteers, a combination of THC and CBD was compared by pulmonary (inh) and intravenous (iv) application. The liquid aerosol was produced by an in vitro validated pressurized metered-dose inhaler (pMDI) device, releasing 41–44% [...]

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Rapid antidepressant effects of the psychedelic ayahuasca in treatment-resistant depression : a randomized placebo-controlled trial, Fernanda Palhano-Fontes et al., 2018

Rapid antidepressant effects of the psychedelic ayahuasca in treatment-resistant depression : a randomized placebo-controlled trial Fernanda Palhano-Fontes, Dayanna Barreto, Heloisa Onias, Katia C. Andrade, Morgana M. Novaes, Jessica A. Pessoa, Sergio A. Mota-Rolim, Flávia L. Osório, Rafael Sanches, Rafael G. dos Santos, Luís Fernando Tófoli, Gabriela de Oliveira Silveira, Mauricio Yonamine7, Jordi Riba, Francisco R. Santos, Antonio A. Silva-Junior, João C. Alchieri10, Nicole L. Galvão-Coelho5,11, Bruno Lobão-Soares5,12, Jaime E. C. Hallak, Emerson Arcoverde, João P. Maia-de-Oliveira and Dráulio B. Araújo Psychological Medicine, June 2018, 1-9 https://www.cambridge.org/core        doi.org/10.1017/S0033291718001356 Abstract Background. Recent open-label trials show that psychedelics, such as ayahuasca, hold promise as fast-onset antidepressants in treatment-resistant depression. Methods. [...]

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Individual and combined effects of acute delta-9-tetrahydrocannabinol and cannabidiol on psychotomimetic symptoms and memory function, Celia J. A. Morgan et al., 2018

Individual and combined effects of acute delta-9-tetrahydrocannabinol and cannabidiol on psychotomimetic symptoms and memory function Celia J. A. Morgan, Tom P. Freeman, Chandni Hindocha, Grainne Schafer, Chelsea Gardner and H. Valerie Curran Translational Psychiatry, 2018, 8, 181 DOI 10.1038/s41398-018-0191-x https://www.researchgate.net/publication/264860201   Abstract The main active ingredient in cannabis, delta-9-tetrahydrocannabinol (THC), can acutely induce psychotic symptoms and impair episodic and working memory. Another major constituent, cannabidiol (CBD), may attenuate these effects. This study aimed to determine the effects of THC and CBD, both alone and in combination on psychotic symptoms and memory function. A randomised, double-blind crossover design compared the effects of (i) placebo, (ii) THC 8mg, (iii) CBD [...]

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Cannabis and Pain : A Clinical Review, Kevin P. Hill et al., 2017

Cannabis and Pain : A Clinical Review Kevin P. Hill, Matthew D. Palastro, Brian Johnson, and Joseph W. Ditre Cannabis and Cannabinoid Research, Volume 2.1, 2017 DOI: 10.1089/can.2017.0017   Abstract Introduction : Cannabis has been used for medical purposes across the world for centuries. As states and countries implement medical and recreational cannabis policies, increasing numbers of people are using cannabis pharmacotherapy for pain. There is a theoretical rationale for cannabis' efficacy for pain management, although the subjective pain relief from cannabis may not match objective measurements of analgesia. As more patients turn to cannabis for pain relief, there is a need for additional scientific evidence [...]

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The Use of Cannabis for Headache Disorders, Bryson C. Lochte et al., 2017

The Use of Cannabis for Headache Disorders Bryson C. Lochte, Alexandre Beletsky, Nebiyou K. Samuel, Igor Grant Cannabis and Cannabinoid Research, 2017, Vol. 2, No 1., 61-71   https://doi.org/10.1089/can.2016.0033 Abstract Headache disorders are common, debilitating, and, in many cases, inadequately managed by existing treatments. Although clinical trials of cannabis for neuropathic pain have shown promising results, there has been limited research on its use, specifically for headache disorders. This review considers historical prescription practices, summarizes the existing reports on the use of cannabis for headache, and examines the preclinical literature exploring the role of exogenous and endogenous cannabinoids to alter headache pathophysiology. Currently, there is not [...]

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