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An Open Label Study of the Use of Dronabinol (Marinol) in the Management of Treatment-Resistant Self-Injurious Behavior in 10 Retarded Adolescent Patients
... It has been reported that CBD effects are dose-dependent (for example, > 160 mg/day elicits a sedating effect and lower doses have been associated with increased wakefulness) [16]. A few case reports and observational studies have suggested the safety and efficacy of lower dose CBD, for treating behavioral symptoms in ASD [11,17,18]. In a prospective study, 188 patients with ASD were treated with lower to medium doses of phytocannabinoids (from 15 mg of CBD three times a day to 300 mg of CBD three times a day), the majority taking 1:20 CBE: 30% CBD to 1.5% THC [19]. ...
... Only a few low-powered studies address the clinical efficacy of cannabinoids for such symptoms, and there are no established recommendations for its use in ASD treatment [5,6]. The majority of published studies for ASD either involve synthetic cannabinoids [11,17,18] or synthetic enzyme-inhibitors [25,29]. Only a few studies offer evidence for the use of phytocannabinoids in ASD. ...
Background:
The pharmacological treatment for autism spectrum disorders is often poorly tolerated and has traditionally targeted associated conditions, with limited benefit for the core social deficits. We describe the novel use of a cannabidiol-based extract that incidentally improved core social deficits and overall functioning in a patient with autism spectrum disorder, at a lower dose than has been previously reported in autism spectrum disorder.
Case presentation:
The parents of a 15-year-old boy, of South African descent, with autism spectrum disorder, selective mutism, anxiety, and controlled epilepsy, consulted a medical cannabis physician to trial cannabis extract to replace seizure medications. Incidentally, at a very low cannabidiol-based extract dose, he experienced unanticipated positive effects on behavioral symptoms and core social deficits.
Conclusion:
This case report provides evidence that a lower than previously reported dose of a phytocannabinoid in the form of a cannabidiol-based extract may be capable of aiding in autism spectrum disorder-related behavioral symptoms, core social communication abilities, and comorbid anxiety, sleep difficulties, and weight control. Further research is needed to elucidate the clinical role and underlying biological mechanisms of action of cannabidiol-based extract in patients with autism spectrum disorder.
... In a single-case-study, dronabinol (THC) has reduced hyperactivity, irritability, stereotyped behaviors, and improved speech in a boy with autism [125]. Another study has reported that dronabinol alleviated selfinjurious behavior of mentally retarded adolescents [126]. ...
Identification and development of pharmaceuticals for neurological disorders is associated with several unique challenges. The primary weakness of candidate neurological compounds is the poor penetration efficacy across the blood-brain barrier (BBB). The BBB is the bottleneck in nervous system drug development and is the paramount factor that limits success in neurotherapeutics. Findings suggest cannabinoids might overcome the limiting effects of the BBB and play a key role in improving neurological dysfunctions. This supports the therapeutic potential of cannabidiol for the treatment of ischemic and inflammatory diseases of the central nervous system (CNS). The potential application of cannabinoids for Parkinson’s disease, Autism, and childhood Epilepsy is explored in this chapter.
... Clinical studies suggest that nabilone may be useful in alleviating agitation in patients with dementia [37,38], nightmares in patients with post-traumatic stress disorder (PTSD) [39], non-motor symptoms (i.e., mood dysregulation, sleep, pain) in patients with Parkinson's disease [40], and core symptoms in those with anxiety and pain disorders [39]. Preliminary studies suggest that another synthetic THC, dronabinol (a full agonist at CB 1 and CB2), may be effective in alleviating SBPs in youth with IDD [41,42]. However, dronabinol has been withdrawn from the Canadian market for unknown reasons. ...
Severe behavioral problems (SBPs) are common contributors to morbidity and reduced quality of life for adults with intellectual and developmental disabilities (IDD) and their families. Current medications for SBPs show equivocal effectiveness and are associated with a high risk of side effects. New and safe treatments are urgently needed. While preliminary studies suggest that medical cannabinoids, particularly the synthetic cannabinoid nabilone, are plausible treatment options for SBPs in adults with IDD, data on the tolerability, safety and efficacy of nabilone in this population has never been investigated. Thus, we propose this first-ever Phase I pre-pilot open-label clinical trial to obtain preliminary data on the adherence, tolerability and safety profiles of nabilone in adults with IDD, and explore changes in SBPs pre- to post-treatment. We hypothesize that nabilone has favorable tolerability and safety profile for adults with IDD. The preliminary results will inform the next-stage pilot randomized controlled trials, followed by fully powered clinical trials eventually. This research helps fill the evidence gap in the use of cannabinoids in individuals with IDD to meet the needs of patients, families, and service providers.
... In a prospective single-case-study dronabinol (THC) produced improvement in hyperactivity, irritability, stereotyped behaviors, and speech in an ASD boy [159]. In another open label study dronabinol also produced significant improvements in self-injurious behavior of seven out of 10 mentally retarded adolescents [160]. ...
Autism spectrum disorder (ASD) is a group of disabilities with impairments in physical, verbal, and behavior areas. Regardless the growing frequency of autism, no medicine has been formed for the management of the ASD primary symptoms. The most frequently prescribed drugs are off-label. Therefore, there is necessity for an advance tactic for the treatment of autism. The endocannabinoid system has a central role in ruling emotion and social behaviors. Dysfunctions of the system donate to the behavioral deficits in autism. Therefore, the endocannabinoid system represents a potential target for the development of a novel autism therapy. Cannabis and associated compounds have produced substantial research attention as a capable therapy in neurobehavioral and neurological syndromes. In this review we examine the potential benefits of medical cannabis and related compounds in the treatment of ASD and concurrent disorders.
... Cannabidiol (CBD) products are thought to have neuroprotective and anti-inflammatory effects as well as the ability to modulate the endocannabinoid system [128]. While there is evidence for benefit for chemotherapyinduced nausea and vomiting and growing evidence to support use in epilepsy [128], at this time, evidence for use of CBD products in pediatric ASD is limited to small case reports [129,130]. In addition, there is concern that compounds containing delta-9-tetrahydrocannabidiol (THC)-like compounds may exacerbate neurologic symptoms without significant therapeutic benefit [131]. ...
Autism spectrum disorder (ASD) is a heterogeneous neuropsychiatric condition affecting an estimated one in 36 children. Youth with ASD may have severe behavioral disturbances including irritability, aggression, and hyperactivity. Currently, there are only two medications (risperidone and aripiprazole) approved by the US Food and Drug Administration (FDA) for the treatment of irritability associated with ASD. Pharmacologic treatments are commonly used to target ASD-associated symptoms including irritability, mood lability, anxiety, and hyperactivity. However, evidence for the efficacy of many commonly used treatments is limited by the lack of large placebo-controlled trials of these medications in this population. Research into the pathophysiology of ASD has led to new targets for pharmacologic therapy including the neuroimmune system, the endocannabinoid system, and the glutamatergic neurotransmitter system. The goal of this review is to provide an overview of the current evidence base for commonly used treatments, as well as emerging treatment options for common behavioral disturbances seen in youth with ASD.
... A prospective single-case-study of Dronabinol (a THC-based drug) showed significant improvements in hyperactivity, lethargy, irritability, stereotypy and inappropriate speech at 6 month follow-up 9 . Furthermore, Dronabinol treatment of 10 adolescent patients with intellectual disability resulted in 8 patients showing improvement in the management of treatment-resistant self-injurious behaviour 10 . ...
There has been a dramatic increase in the number of children diagnosed with autism spectrum disorders (ASD) worldwide. Recently anecdotal evidence of possible therapeutic effects of cannabis products has emerged. The aim of this study is to characterize the epidemiology of ASD patients receiving medical cannabis treatment and to describe its safety and efficacy. We analysed the data prospectively collected as part of the treatment program of 188 ASD patients treated with medical cannabis between 2015 and 2017. The treatment in majority of the patients was based on cannabis oil containing 30% CBD and 1.5% THC. Symptoms inventory, patient global assessment and side effects at 6 months were primary outcomes of interest and were assessed by structured questionnaires. After six months of treatment 82.4% of patients (155) were in active treatment and 60.0% (93) have been assessed; 28 patients (30.1%) reported a significant improvement, 50 (53.7%) moderate, 6 (6.4%) slight and 8 (8.6%) had no change in their condition. Twenty-three patients (25.2%) experienced at least one side effect; the most common was restlessness (6.6%). Cannabis in ASD patients appears to be well tolerated, safe and effective option to relieve symptoms associated with ASD.
... For example, one 6-yearold boy with autism was treated with daily dronabinol for 6 months and was noted to have improvement in 85 ). Another small case series 86 showed an improvement in self-injurious behaviors among adolescents after dronabinol therapy, but to date, the study has not been published, leaving protocol details scarce. In sum, none of these studies provide sufficient, high-quality data to suggest that cannabis should be recommended for treatment of ASD or ADHD at this time. ...
: Marijuana policy is rapidly evolving in the United States and elsewhere, with cannabis sales fully legalized and regulated in some jurisdictions and use of the drug for medicinal purposes permitted in many others. Amidst this political change, patients and families are increasingly asking whether cannabis and its derivatives may have therapeutic utility for a number of conditions, including developmental and behavioral disorders in children and adolescents. This review examines the epidemiology of cannabis use among children and adolescents, including those with developmental and behavioral diagnoses. It then outlines the increasingly well-recognized neurocognitive changes shown to occur in adolescents who use cannabis regularly, highlighting the unique susceptibility of the developing adolescent brain and describing the role of the endocannabinoid system in normal neurodevelopment. The review then discusses some of the proposed uses of cannabis in developmental and behavioral conditions, including attention-deficit hyperactivity disorder and autism spectrum disorder. Throughout, the review outlines gaps in current knowledge and highlights directions for future research, especially in light of a dearth of studies specifically examining neurocognitive and psychiatric outcomes among children and adolescents with developmental and behavioral concerns exposed to cannabis.
Parents of children with developmental, behavioural and mental health disorders are increasingly asking whether medicinal cannabis might be a therapeutic option for their child. This paper presents the current evidence for medicinal cannabis in this population. Preliminary evidence from open-label studies suggests the potential for medicinal cannabis to ameliorate some symptoms in children with autism spectrum disorder. However, only one double-blind placebo-controlled trial has been completed, with inconclusive findings. Synthetic, transdermal cannabidiol gel has demonstrated efficacy for reducing social avoidance in a sub-group of children with Fragile X syndrome. Studies of medicinal cannabis are planned or underway for children and/or adolescents with autism, intellectual disability, Tourette’s syndrome, anxiety, psychosis, anorexia nervosa and a number of specific neurodevelopmental syndromes. High -evidence from double-blind placebo-controlled trials is needed to guide clinical practice.
Background
Autism spectrum disorder (ASD) is a neurodevelopmental condition estimated to affect 1 in 66 children in Canada, and 1 in 270 individuals worldwide. As effective therapies for the management of ASD core and associated symptoms are limited, parents are increasingly turning to clinicians for advice regarding the use of medicinal cannabis to manage behavioural disturbances.
Objective
The objective of this scoping review was to identify and map symptoms, outcomes and adverse events related to medicinal cannabis treatment for ASD-related behaviours.
Methods
Ovid MEDLINE, Embase, CINAHL, PsycInfo, Web of Science Core Collection, Google Scholar, and grey literature sources were searched up to January 5, 2020 for studies. Included studies met the following criteria: 1) investigate the use of medicinal cannabis, 2) at least 50% participants had ASD, 3) at least 50% of the study population was 0-18 years old, and 4) any study design (published or unpublished).
Results
We identified eight completed and five ongoing studies meeting the inclusion criteria. All studies reported substantial behaviour and symptom improvement on medicinal cannabis, with 61-93% of subjects showing benefit. In the three studies reporting on concomitant psychotropic medication usage and with cannabis use, up to 80% of participants observed a reduction in concurrent medication use. Adverse events related to cannabis use were reported in up to 27% of participants related, and two participants had psychotic events.
Conclusions
Early reports regarding medicinal cannabis in pediatric ASD symptom management are presented as positive; the evidence, however, is limited to very few retrospective cohort and observational studies. Evidence of safety and efficacy from prospective clinical trials is needed.
Introduction
Severe behavioural problems (SBPs) are a common contributor to morbidity and reduced quality of life in children with intellectual disability (ID). Current medication treatment for SBP is associated with a high risk of side effects. Innovative and safe interventions are urgently needed. Anecdotal reports and preliminary research suggest that medicinal cannabis may be effective in managing SBP in children with developmental disabilities. In particular, cannabidiol (CBD) may be a plausible and safe alternative to current medications. Families who are in urgent need of solutions are seeking cannabis for their ID children with SBP. However there is no evidence from randomised controlled trials to support the use of CBD for SBP. This pilot study aims to investigate the feasibility of conducting a randomised placebo-controlled trial of CBD to improve SBP in children with ID.
Methods and analysis
This is a single-site, double-blind, parallel-group, randomised, placebo-controlled pilot study of 10 participants comparing 98% CBD oil with placebo in reducing SBP in children aged 8–16 years with ID. Eligible participants will be randomised 1:1 to receive either CBD 20 mg/kg/day or placebo for 8 weeks. Data will be collected regarding the feasibility and acceptability of all study components, including recruitment, drop-out rate, study visit attendance, protocol adherence and the time burden of parent questionnaires. Safety outcomes and adverse events will be recorded. All data will be reported using descriptive statistics. These data will inform the design of a full scale randomised controlled trial to evaluate the efficacy of CBD in this patient group.
Ethics and dissemination
This protocol has received ethics approval from the Royal Children’s Hospital ethics committee (Human Research Ethics Committee no. 38236). Results will be disseminated through peer-reviewed journals, professional networks, conferences and social media.
Trial registration number
ACTRN12618001852246
Despite its controversial nature, the use of medical marijuana and cannabis-derived medicinal products grows more popular with each passing year. As of November 2016, over 40 states have passed legislation regarding the use of either medical marijuana or cannabidiol products. Many providers have started encountering patients experimenting with cannabis products for a wide range of conditions. While the debate continues regarding these agents for both medicinal and recreational use in the general population, special consideration needs to be made for pediatric use. This review will deliver the history of marijuana use and legislation in the United States in addition to the currently available medical literature to equip pediatric health care providers with resources to provide patients and their parents the best recommendation for safe and appropriate use of cannabis-containing compounds.
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