Catégorie : Essais Cliniques

Pharmacokinetics and Tolerability of Δ9-THC-Hemisuccinate in a Suppository Formulation as an Alternative to Capsules for the Systemic Delivery of Δ9-THC, Mahmoud A. ElSohly et al., 2018,

Pharmacokinetics and Tolerability of Δ9-THC-Hemisuccinate in a Suppository Formulation as an Alternative to Capsules for the Systemic Delivery of Δ9-THC Mahmoud A. ElSohly, Waseem Gul, Larry A. Walker Medical Cannabis and Cannabinoids, 2018, 1, 44–53 Preclinical Science and Clinical Studies – Research Article DOI: 10.1159/000489037   Abstract The objectives of this study were: (1) to assess the safety, tolerability, and pharmacokinetics of ascending doses of Δ9- tetrahydrocannabinol-hemisuccinate (THC-HS) after rectal administration as suppositories in male volunteers; and (2) to compare the pharmacokinetics of oral administration of Δ9-tetrahydrocannabinol (Δ9-THC) with an equivalent amount of Δ9-THC delivered as THC-HS via the suppository formulation. In support of the pharmacokinetic evaluations, [...]

Lire la suite

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% [...]

Lire la suite

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 [...]

Lire la suite

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 [...]

Lire la suite

Intranasal Ketamine Succeeds for Resistant Depression in Phase 3 Trial, Deborah Brauser, May 11, 2018

Intranasal Ketamine Succeeds for Resistant Depression in Phase 3 Trial Deborah Brauser May 11, 2018 https://www.medscape.com/viewarticle/896510 NEW YORK — Administering intranasal esketamine (Janssen) plus an antidepressant is safe, effective, and well tolerated in adult patients with treatment-resistant depression (TRD), a new phase 3 trial suggests. Dr Vanina Popova In the global study, those who received a newly initiated oral antidepressant combined with esketamine nasal spray (56 or 84 mg) showed a 4-point greater improvement from baseline to 4 weeks on the Montgomery-Åsberg Depression Rating Scale (MADRS) total score than those who received an antidepressant plus placebo, meeting the study's primary endpoint. In addition, the response rate was nearly 70% [...]

Lire la suite

3,4-Methylenedioxymethamphetamine assisted psychotherapy for treatment of chronic posttraumatic stress disorder : A randomized phase 2 controlled trial, Marcela Ot’alora G et al., 2018

3,4-Methylenedioxymethamphetamine assisted psychotherapy for treatment of chronic posttraumatic stress disorder : A randomized phase 2 controlled trial Marcela Ot’alora G, Jim Grigsby, Bruce Poulter1, Joseph W Van Derveer III, Sara Gael Giron, Lisa Jerome, Allison A Feduccia, Scott Hamilton, Berra Yazar-Klosinski, Amy Emerson, Michael C Mithoefer and Rick Doblin Journal of Psychopharmacology, 2018, 1-13 Doi : 10.1177/0269881118806297   Abstract Background : Posttraumatic stress disorder often does not resolve after conventional psychotherapies or pharmacotherapies. Pilot studies have reported that 3,4-methylenedioxymethamphetamine (MDMA) combined with psychotherapy reduces posttraumatic stress disorder symptoms. Aims : This pilot dose response trial assessed efficacy and safety of MDMA-assisted psychotherapy across multiple therapy teams. Methods : [...]

Lire la suite

Chapter : The endocannabinoid system in Fragile X Syndrome, Henry G. S. Martin et al., 2017

Chapter : The endocannabinoid system in Fragile X Syndrome Henry G. S. Martin, Daniela Neuhofer and Olivier J.J. Manzoni Fragile X Syndrome : From Genetics to Targeted Treatment, 2017, Pages 241-259 DOI: 10.1016/B978-0-12-804461-2.00012-3 Addresses: INSERM U901, INMED and UMR S901, Aix-Marseille University Marseille 13009, France. Abstract : Endocannabinoid signaling is a finely tuned system of molecules and lipid messengers that modulate neurotransmission in a rapid and sustained manner at many central synapses. The endocannabinoid system is important for many brain activities, but is also implicated in several neuropsychiatric disorders. In this chapter we discuss emerging evidence of dysfunction in endocannabinoid signaling in Fragile X Syndrome from the Fmr1 knockout mouse model. [...]

Lire la suite

Overcoming the Bell‐Shaped Dose‐Response of Cannabidiol by Using Cannabis Extract Enriched in Cannabidiol, Ruth Gallily et al.,

Overcoming the Bell‐Shaped Dose‐Response of Cannabidiol by Using Cannabis Extract Enriched in Cannabidiol Ruth Gallily, Zhannah Yekhtin, Lumír Ondřej Hanuš Pharmacology & Pharmacy, 2015, 6, 75-85 http://dx.doi.org/10.4236/pp.2015.62010 Abstract : Cannabidiol (CBD), a major constituent of Cannabis, has been shown to be a powerful anti inflammatory and anti‐anxiety drug, without exerting a psychotropic effect. However, when given either intraperitoneally or orally as a purified product, a bell‐shaped dose‐response was observed, which limits its clinical use. In the present study, we have studied in mice the anti‐inflammatory and anti nociceptive activities of standardized plant extracts derived from the Cannabis sativa L., clone 202, which is highly enriched [...]

Lire la suite

A Phase I, Randomized, Double‑Blind, Placebo‑Controlled, Single Ascending Dose, Multiple Dose, and Food Effect Trial of the Safety, Tolerability and Pharmacokinetics of Highly Purified Cannabidiol in Healthy Subjects, Lesley Taylor et al., 2018

A Phase I, Randomized, Double‑Blind, Placebo‑Controlled, Single Ascending Dose, Multiple Dose, and Food Effect Trial of the Safety, Tolerability and Pharmacokinetics of Highly Purified Cannabidiol in Healthy Subjects Lesley Taylor,·Barry Gidal,·Graham Blakey, Bola Tayo, Gilmour Morrison CNS Drugs, 2018 https://doi.org/10.1007/s40263-018-0578-5 Abstract Background : A formal single ascending and multiple dose pharmacokinetic (PK) trial of cannabidiol (CBD) oral solution was required to determine the safety and tolerability of CBD, the maximum tolerated dose, and to examine the effect of food on CBD PK parameters. Objective : This trial assessed the safety, tolerability and PK of CBD oral solution in healthy adult volunteers, as well as the effect [...]

Lire la suite

Cannabidiol as a Novel Candidate Alcohol Use Disorder Pharmacotherapy : A Systematic Review, Jasmine Turna et al., 2019

Cannabidiol as a Novel Candidate Alcohol Use Disorder Pharmacotherapy : A Systematic Review Jasmine Turna, Sabrina K. Syan, Benicio N. Frey, Brian Rush, Mary Jean Costello, Mark Weiss, and James MacKillop ALCOHOLISM: CLINICAL AND EXPERIMENTAL RESEARCH, 2019, 1-14   Abstract : There is substantial interest in the therapeutic potential of cannabidiol (CBD), a nonpsychoactive cannabinoid found in plants of the genus Cannabis. The goal of the current systematic review was to characterize the existing literature on this topic and to evaluate the credibility of CBD as a candidate pharmacotherapy for alcohol use disorder (AUD). Using a comprehensive search strategy, 303 unique potential articles were identified [...]

Lire la suite