The short-term impact of 3 smoked cannabis preparations versus placebo on PTSD symptoms: A randomized cross-over clinical trial

Bonn‐Miller, Marcel O.; Sisley, Sue; Riggs, Paula; Yazar‐Klosinski, Berra; Wang, Julie B.; Loflin, Mallory; Shechet, Benjamin; Hennigan, Colin; Matthews, Rebecca; Emerson, Amy; Doblin, Rick

doi:10.1371/journal.pone.0246990

Cited by 71 publications

(47 citation statements)

References 43 publications

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“…Currently, robust evidence exists only for Epidiolex, a plant-derived pure CBD isolate, to treat the following specific types of refractory epilepsy: Dravet syndrome [ 45 ], Lennox–Gastaut syndrome [ 46 ], and tuberous sclerosis complex [ 47 ]. Nevertheless, full-spectrum extracts of various cannabis strains and synthetic cannabinoids are being widely used to treat adults living with chronic pain [ 48 , 49 , 50 ], chemotherapy-induced nausea and vomiting [ 51 , 52 ], sleep disorders [ 26 ], depression, anxiety, psychosis [ 53 ], PTSD [ 54 ], and to treat children with various types of refractory epilepsy [ 55 ], and irritability associated with autism spectrum disorder (ASD) [ 22 , 24 , 25 , 56 ].…”

Section: Discussionmentioning

confidence: 99%

A Placebo-Controlled Trial of Cannabinoid Treatment for Disruptive Behavior in Children and Adolescents with Autism Spectrum Disorder: Effects on Sleep Parameters as Measured by the CSHQ

et al. 2022

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Autism spectrum disorder (ASD) is often associated with debilitating sleep disturbances. While anecdotal evidence suggests the positive effect of cannabinoids, randomized studies are lacking. Here, we report the effects of cannabinoid treatment on the sleep of 150 children and adolescents with ASD, as part of a double-blind, placebo-controlled study that assessed the impact of cannabinoid treatment on behavior (NCT02956226). Participants were randomly assigned to one of the following three treatments: (1) whole-plant cannabis extract, containing cannabidiol (CBD) and Δ9-Tetrahydrocannabinol (THC) in a 20:1 ratio, (2) purified CBD and THC extract in the same ratio, and (3) an oral placebo. After 12 weeks of treatment (Period 1) and a 4-week washout period, participants crossed over to a predetermined, second 12-week treatment (Period 2). Sleep disturbances were assessed using the Children’s Sleep-Habit Questionnaire (CSHQ). We found that the CBD-rich cannabinoid treatment was not superior to the placebo treatment in all aspects of sleep measured by the CSHQ, including bedtime resistance, sleep-onset delay, and sleep duration. Notably, regardless of the treatment (cannabinoids or placebo), improvements in the CSHQ total score were associated with improvements in the autistic core symptoms, as indicated by the Social Responsiveness Scale total scores (Period 1: r = 0.266, p = 0.008; Period 2: r = 0.309, p = 0.004). While this study failed to demonstrate that sleep improvements were higher with cannabinoids than they were with the placebo treatment, further studies are required.

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Section: Discussionmentioning

confidence: 99%

A Placebo-Controlled Trial of Cannabinoid Treatment for Disruptive Behavior in Children and Adolescents with Autism Spectrum Disorder: Effects on Sleep Parameters as Measured by the CSHQ

et al. 2022

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“…( Kayser, et al, 2020 ; Lawn, et al, 2020 ; Bebee, et al, 2021 ; Bonn-Miller, et al, 2021 ; Crippa, et al, 2021 )…”

Section: Resultsunclassified

Cannabis for Medical Use: Analysis of Recent Clinical Trials in View of Current Legislation

et al. 2022

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Cannabis has long been regarded as a recreational substance in the Western world. The recent marketing authorization of some medicinal products of industrial origin and the introduction onto the market of inflorescences for medical use mean that medical doctors can now prescribe Cannabis-based medicines in those countries which allow it. Nevertheless, there is still considerable controversy on this topic in the scientific community. In particular, this controversy concerns: the plant species to be used; the pathologies that can be treated and consequently the efficacy and safety of use; the routes of administration; the methods of preparation; the type and dosage of cannabinoids to be used; and, the active molecules of interest. As such, although medical Cannabis has been historically used, the results of currently completed and internationally published studies are inconclusive and often discordant. In light of these considerations, the aim of this work is to analyse the current legislation in countries that allow the use of medical Cannabis, in relation to the impact that this legislation has had on clinical trials. First of all, a literature search has been performed (PubMed and SciFinder) on clinical trials which involved the administration of Cannabis for medical use over the last 3 years. Of the numerous studies extrapolated from the literature, only about 43 reported data on clinical trials on medical Cannabis, with these mainly being performed in Australia, Brazil, Canada, Denmark, Germany, Israel, Netherlands, Switzerland, the United Kingdom and the United States of America. Once the reference countries were identified, an evaluation of the legislation in relation to Cannabis for medical use in each was carried out via the consultation of the pertinent scientific literature, but also of official government documentation and that of local regulatory authorities. This analysis provided us with an overview of the different legislation in these countries and, consequently, allowed us to analyse, with greater awareness, the results of the clinical trials published in the last 3 years in order to obtain general interest indications in the prosecution of scientific research in this area.

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“…Of these studies, a treatment naïve patient group with SAD was given CBD and had also exhibited indications of reduced anxiety, both subjective and physiological ( Bergamaschi et al, 2011 ). Clinical studies assessing the anxiolytic properties of cannabinoids in PTSD and chronic pain pathologies have also observed general improvements in patients having consumed whole cannabis products ( Greer et al, 2014 ; Bonn-Miller et al, 2021 ) or CBD alone ( Elms et al, 2019 ) as indicated by lowered scores in clinician administered posttraumatic stress scales and PTSD checklists which assess emotional response and cognitive function. Instances of self-reported anxiety associated with OCD were found to have been no different than placebo after administration of cannabis high in either CBD (0.4% THC/10.4% CBD) or THC (7.0% THC/0.18% CBD) ( Kayser et al, 2020a ).…”

Section: Cannabinoid Involvement In Central Nervous System Diseases A...mentioning

confidence: 99%

Medicinal Cannabis and Central Nervous System Disorders

2022

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Cannabinoids, including those found in cannabis, have shown promise as potential therapeutics for numerous health issues, including pathological pain and diseases that produce an impact on neurological processing and function. Thus, cannabis use for medicinal purposes has become accepted by a growing majority. However, clinical trials yielding satisfactory endpoints and unequivocal proof that medicinal cannabis should be considered a frontline therapeutic for most examined central nervous system indications remains largely elusive. Although cannabis contains over 100 + compounds, most preclinical and clinical research with well-controlled dosing and delivery methods utilize the various formulations of Δ9-tetrahydrocannabinol (THC) and cannabidiol (CBD), the two most abundant compounds in cannabis. These controlled dosing and delivery methods are in stark contrast to most clinical studies using whole plant cannabis products, as few clinical studies using whole plant cannabis profile the exact composition, including percentages of all compounds present within the studied product. This review will examine both preclinical and clinical evidence that supports or refutes the therapeutic utility of medicinal cannabis for the treatment of pathological pain, neurodegeneration, substance use disorders, as well as anxiety-related disorders. We will predominately focus on purified THC and CBD, as well as other compounds isolated from cannabis for the aforementioned reasons but will also include discussion over those studies where whole plant cannabis has been used. In this review we also consider the current challenges associated with the advancement of medicinal cannabis and its derived potential therapeutics into clinical applications.

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The short-term impact of 3 smoked cannabis preparations versus placebo on PTSD symptoms: A randomized cross-over clinical trial

Cited by 71 publications

References 43 publications

A Placebo-Controlled Trial of Cannabinoid Treatment for Disruptive Behavior in Children and Adolescents with Autism Spectrum Disorder: Effects on Sleep Parameters as Measured by the CSHQ

A Placebo-Controlled Trial of Cannabinoid Treatment for Disruptive Behavior in Children and Adolescents with Autism Spectrum Disorder: Effects on Sleep Parameters as Measured by the CSHQ

Cannabis for Medical Use: Analysis of Recent Clinical Trials in View of Current Legislation

Medicinal Cannabis and Central Nervous System Disorders

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