Match!

Cannabidiol Drugs Clinical Trial Outcomes and Adverse Effects.

Published on Feb 25, 2020in Frontiers in Pharmacology3.845
· DOI :10.3389/FPHAR.2020.00063
Christopher S. Pauli3
Estimated H-index: 3
(Colorado State University–Pueblo),
Matthieu Conroy1
Estimated H-index: 1
(Colorado State University–Pueblo)
+ 1 AuthorsSang-Hyuck Park2
Estimated H-index: 2
(Colorado State University–Pueblo)
Abstract
This review aims to present completed clinical trial data surrounding the medicinal benefits and potential side effects of the increasingly popular cannabidiol (CBD)-based drug products, specifically Epidiolex. The article is divided into two sections based on if the ailment being treated by this cannabinoid is classified as either physiological or neurological conditions. In addition to describing the current status, we also examined the different primary and secondary outcomes recorded for each study, which varies greatly depending on the funding source of the clinical trial. With the recent FDA-approval of Epidiolex, this review mainly focused on trials involving this specific formulation since it is the only CBD-based drug currently available to clinicians, although all other clinically trialed CBD(A) drugs were also examined. We hope this review will help guide future research and clinical trials by providing the various outcomes measured in a single review.
  • References (35)
  • Citations (3)
📖 Papers frequently viewed together
1 Citations
1 Author (Yasmin L. Hurd)
2 Citations
78% of Scinapse members use related papers. After signing in, all features are FREE.
References35
Newest
#1Linda C. Laux (Children's Memorial Hospital)H-Index: 17
#2E. Martina Bebin (UAB: University of Alabama at Birmingham)H-Index: 17
Last. Arie Weinstock (Women & Children's Hospital of Buffalo)H-Index: 10
view all 14 authors...
Abstract Background Since 2014, patients with severe treatment-resistant epilepsies (TREs) have been receiving add-on cannabidiol (CBD) in an ongoing, expanded access program (EAP), which closely reflects clinical practice. We conducted an interim analysis of long-term efficacy and tolerability in patients with Lennox-Gastaut syndrome (LGS) or Dravet syndrome (DS) who received CBD treatment through December 2016. Methods Children and adults with LGS/DS taking stable doses of antiepileptic drugs ...
2 CitationsSource
#1Sang-Hyuck Park (Colorado State University–Pueblo)H-Index: 2
#2S. Kyle Staples (Colorado State University–Pueblo)H-Index: 1
Last. Brian Vanden Heuvel (Colorado State University–Pueblo)H-Index: 8
view all 9 authors...
Cannabis sativa, also known as marijuana or hemp, produces a non-psychoactive compound cannabidiol (CBD). To investigate the defensive role of CBD, a feeding preference assay was performed with tobacco hornworm Manduca sexta. The larvae clearly show feeding preference towards the Cannabis tissue containing low CBD over high CBD. While the larva avoided the high CBD diet, we investigated detrimental effects of CBD in the insects’ diet. Contrasted to the performance on low CBD-infused artificial d...
2 CitationsSource
#1Arsalan AnwarH-Index: 2
#2Sidra SaleemH-Index: 2
Last. Preeti MalikH-Index: 3
view all 5 authors...
: Dravet syndrome (DS), also known as severe myoclonic epilepsy of infancy (SMEI), is one of the rare early childhood intractable epileptic encephalopathies associated with pleomorphic seizure activity, cognitive decline, motor, and behavioral abnormalities. The convulsive seizure is the most common type seen in DS. After the first episode of seizure-like activity, behavioral disorders and cognitive decline are progressive and long-lasting. The most common etiology identified in patients with DS...
Source
#1Serena SilvestroH-Index: 4
#2Santa MammanaH-Index: 13
Last. Emanuela MazzonH-Index: 55
view all 5 authors...
Cannabidiol (CBD) is one of the cannabinoids with non-psychotropic action, extracted from Cannabis sativa. CBD is a terpenophenol and it has received a great scientific interest thanks to its medical applications. This compound showed efficacy as anti-seizure, antipsychotic, neuroprotective, antidepressant and anxiolytic. The neuroprotective activity appears linked to its excellent anti-inflammatory and antioxidant properties. The purpose of this paper is to evaluate the use of CBD, in addition ...
2 CitationsSource
#1Tibor Štark (Masaryk University)H-Index: 6
#2Jana Ruda-Kucerova (Masaryk University)H-Index: 10
Last. Vincenzo Micale (University of Catania)H-Index: 20
view all 21 authors...
Abstract In agreement with the neurodevelopmental hypothesis of schizophrenia, prenatal exposure of rats to the antimitotic agent methylazoxymethanol acetate (MAM) at gestational day 17 produced long-lasting behavioral alterations such as social withdrawal and cognitive impairment in the social interaction test and in the novel object recognition test, respectively. At the molecular level, an increased cannabinoid receptor type-1 (CB1) mRNA and protein expression, which might be due to reduction...
3 CitationsSource
#1Kerri A. SchoedelH-Index: 15
#2Isabella SzetoH-Index: 2
Last. Kenneth W. SommervilleH-Index: 21
view all 8 authors...
Abstract Rationale Treatment with a highly purified oral solution of cannabidiol (CBD), derived from the plant Cannabis sativa L., demonstrated some evidence of central nervous system (CNS)-related adverse events in patients enrolled in phase 3 trials for treatment of childhood-onset epilepsy. Cannabidiol was categorized as a Schedule 1 substance by the United States Drug Enforcement Administration; therefore, it was important to test CBD for human abuse potential. Methods This was a single-dose...
6 CitationsSource
#1Lesley TaylorH-Index: 2
#2Barry E. Gidal (UW: University of Wisconsin-Madison)H-Index: 40
Last. Gilmour MorrisonH-Index: 1
view all 5 authors...
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.
18 CitationsSource
#1Jerzy P. Szaflarski (UAB: University of Alabama at Birmingham)H-Index: 51
#2E Bebin (UAB: University of Alabama at Birmingham)H-Index: 4
Last. Lawrence W. Ver Hoef (UAB: University of Alabama at Birmingham)H-Index: 17
view all 12 authors...
Abstract The objective of this study was to characterize the changes in adverse events, seizure severity, and frequency in response to a pharmaceutical formulation of highly purified cannabidiol (CBD; Epidiolex®) in a large, prospective, single-center, open-label study. We initiated CBD in 72 children and 60 adults with treatment-resistant epilepsy (TRE) at 5 mg/kg/day and titrated it up to a maximum dosage of 50 mg/kg/day. At each visit, we monitored treatment adverse events with the adverse ev...
17 CitationsSource
#1Orrin Devinsky (NYU: New York University)H-Index: 84
#2Chloe Verducci (NYU: New York University)H-Index: 2
Last. Daniel Freidman (NYU: New York University)H-Index: 35
view all 15 authors...
Abstract Objective We studied our collective open-label, compassionate use experience in using cannabidiol (CBD) to treat epilepsy in patients with CDKL5 deficiency disorder and Aicardi, Doose, and Dup15q syndromes. Methods We included patients aged 1–30 years with severe childhood-onset epilepsy who received CBD for ≥10 weeks as part of multiple investigator-initiated expanded access or state access programs for a compassionate prospective interventional study: CDKL5 deficiency disorder (n = 20...
18 CitationsSource
#1Douglas L. Boggs (Yale University)H-Index: 15
#2Toral Surti (Yale University)H-Index: 9
Last. Mohini Ranganathan (Yale University)H-Index: 26
view all 11 authors...
Rationale Preliminary evidence suggests that cannabidiol (CBD) may be effective in the treatment of neurodegenerative disorders; however, CBD has never been evaluated for the treatment of cognitive impairments associated with schizophrenia (CIAS).
25 CitationsSource
Cited By3
Newest
#1Bill J. Gurley (University of Mississippi)H-Index: 2
#2Timothy P. MurphyH-Index: 14
Last. Mahmoud A. ElSohly (University of Mississippi)H-Index: 47
view all 5 authors...
: Products containing cannabidiol (CBD) are now available throughout the United States, but their quality is oftentimes questionable. The CBD and Δ9-tetrahydrocannabinol (THC) content of 25 commercially available hemp oil products, obtained throughout the state of Mississippi, was determined via gas chromatography/flame ionization detection (GC/FID). These products were also analyzed for the presence of synthetic cannabinoids using full scan gas chromatography/mass spectrometry (GC/MS). Analytic...
Source
#1Nicholas Lintzeris (USYD: University of Sydney)H-Index: 32
#2Llewellyn Mills (USYD: University of Sydney)H-Index: 2
Last. Iain S. McGregor (USYD: University of Sydney)H-Index: 68
view all 8 authors...
In 2016, the Australian federal government passed legislation enabling a range of cannabis-based products to be prescribed to patients by registered healthcare professionals. An online survey conducted immediately prior to these legislative changes found that the vast majority of respondents at the time were illicitly sourcing cannabis plant matter, smoking was the preferred route of administration and mental health, chronic pain, and sleep conditions were the most frequently cited reasons for m...
1 CitationsSource