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CBD Dosing Deliberate

killhead
20.06.2018

Content:

  • CBD Dosing Deliberate
  • Sativex Oromucosal Spray
  • Language selection
  • Whether you're a first-time user or an experienced user, understanding how CBD works and how to use it can be somewhat confusing. CBD oil dosage depends largely on the disease. Everyones dosage needs are different, it is best to start with a small CBD dose and increase slowly. By all accounts the product was carefully made and delivered a consistent dosage of CBD. I know parents who moved to my home state of.

    CBD Dosing Deliberate

    A second 14 week Phase 3 study failed to show a significant treatment effect. The difference from placebo on the NRS score was 0. It was postulated that a clinically useful treatment effect in some patients might be partly masked by data from non-responders in the analyses of mean changes.

    A third Phase 3 trial incorporated a formalised 4-week therapeutic trial period prior to randomisation. The aim of the trial was to assess the benefit of continued treatment for patients who achieve an initial response to treatment. These patients were then randomised to either continue to receive active or switch to placebo for the 12 week double-blind phase, for a total of 16 weeks treatment overall. During the double-blind phase the mean NRS scores for patients receiving Sativex generally remained stable mean change from randomisation in NRS score The results over the week randomised phase are shown below for the secondary endpoints.

    The majority of secondary endpoints showed a similar pattern to the NRS score, with patients who continued to receive Sativex maintaining the improvement seen from the initial 4-week treatment period, while patients switching to placebo declined:. The benefit of continued treatment in the long-term was studied in a placebo controlled, parallel group, randomised withdrawal trial in subjects taking long-term Sativex.

    Thirty six patients with a mean duration of Sativex use prior to the trial of 3. In a study designed to identify its abuse potential, Sativex at a dose of 4 sprays taken at one time did not differ significantly from placebo.

    Higher doses of Sativex of 8 to 16 sprays taken at one time did show abuse potential comparable to equivalent doses of dronabinol, a synthetic THC. In a QTc study a dose of Sativex 4 sprays over 20 minutes twice daily was well-tolerated, but a substantially supratherapeutic dose of 18 sprays over 20 minutes twice daily resulted in significant psychoactivity and cognitive impairment.

    Following administration of Sativex four sprays , both THC and CBD are absorbed fairly rapidly and appear in the plasma within 15 minutes after single oromucosal administration.

    Corresponding parameters for CBD increased 3. There is a high degree of variability in pharmacokinetic parameters between patients. Following a single dose administration of Sativex four sprays under fasted conditions, the mean plasma level of THC showed a There is a high degree of variability in pharmacokinetic parameters within patients following single and repeat dosing. Of 12 subjects who received four sprays of Sativex as a single dose, eight had reductions in C max after nine days of multiple dosing, whilst three had increases 1 drop-out.

    For CBD, seven had reductions in C max after multiple dosing, whilst four had increases. When Sativex is administered oromucosally, plasma levels of THC and other cannabinoids are lower compared with the levels achieved following inhalation of cannabinoids at a similar dose.

    As cannabinoids are highly lipophilic, they are quickly absorbed and distributed into body fat. The resultant concentrations in the blood following oromucosal administration of Sativex are lower than those obtained by inhaling the same dose of THC because absorption is slower and redistribution into fatty tissues is rapid.

    THC and CBD may be stored for as long as four weeks in the fatty tissues from which they are slowly released at sub-therapeutic levels back into the blood stream, then metabolised and excreted via the urine and faeces. The P -3A subfamily catalyses the formation of other hydroxylated minor metabolites.

    CBD is extensively metabolised and more than 33 metabolites have been identified in urine. The major metabolic route is hydroxylation and oxidation at C-7 followed by further hydroxylation in the pentyl and propenyl groups. The major oxidized metabolite identified is CBDoic acid containing a hydroxyethyl side chain. In vitro, Sativex did not inhibit the following transporters at clinically relevant concentrations: From clinical studies with Sativex, a non-compartmental PK analysis shows that the first order terminal elimination half life from plasma is 1.

    From the literature, elimination of oral cannabinoids from plasma is bi-phasic with an initial half-life of approximately four hours, and the terminal elimination half-lives are of the order of 24 to 36 hours or longer. Cannabinoids are distributed throughout the body; they are highly lipid soluble and accumulate in fatty tissue. The release of cannabinoids from fatty tissue is responsible for the prolonged terminal elimination half-life.

    In a specific hepatic impairment PK study a single oromucosal dose of 4 sprays of Sativex However there was substantially reduced clearance and prolonged elimination half-life in the cohorts of subjects with moderate and severe hepatic impairment.

    Effects in non-clinical studies were observed only at exposures considered sufficiently in excess of the maximum human exposure indicating little relevance to clinical use.

    Reprotoxicity studies carried out with the THC and CBD extracts present in Sativex showed no adverse effects on either male or female fertility in terms of numbers of animals mating; number of fertile males and females, or on copulation or fertility indices.

    There was no evidence to suggest any teratogenic activity in either rats or rabbits at dosage levels considerably in excess of likely human maximum dosage levels. In studies in animals, as expected, due to the lipophilic nature of cannabinoids, considerable levels of cannabinoids were found in the maternal breast milk. Following repeat dosing, cannabinoids are concentrated in breast milk 40 to 60 times the plasma level.

    Doses in excess of normal clinical doses may affect growth rates of breast-fed infants. In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products. A Type I amber glass spray container 10 ml container has amber plastic-coated glass fitted with a metering pump possessing a polypropylene dip tube and elastomer neck covered with a polyethylene cap. The metering pump delivers microlitres per spray. Any unused product or waste material should be disposed of in accordance with local requirements.

    This site uses cookies. By continuing to browse the site you are agreeing to our policy on the use of cookies. Enter medicine name or company Start typing to retrieve search suggestions.

    Continue typing to refine. Back to top GW Pharma Ltd contact details. Active ingredient deltatetrahydrocannabinol cannabidiol.

    Last updated on eMC: Show table of contents Hide table of contents 1. Name of the medicinal product 2. Qualitative and quantitative composition 3. Marketing authorisation holder 8. Marketing authorisation number s 9. Date of revision of the text. This information is intended for use by health professionals. Each single microlitre spray contains: For the full list of excipients, see section 6.

    Sativex is for oromucosal use only. Sativex is intended to be used in addition to the patient's current anti-spasticity medication. Sativex is contraindicated in patients: Women of childbearing potential Sativex may reduce the effectiveness of hormonal contraceptives See section 4. General Care should be taken with hypnotics, sedatives and drugs with potential sedating effects as there may be an additive effect on sedation and muscle relaxing effects.

    Hormonal contraceptives Sativex has been observed to induce drug metabolizing enzymes and transporters in vitro. Fertility In fertility studies in rodents, there was no effect of treatment with Sativex in males or females.

    When prescribing this medicine, patients should be told: In the case of overdose, treatment should be symptomatic and supportive. N02BG10 The European Medicines Agency has deferred the obligation to submit the results of studies with Sativex in one or more subsets of the paediatric population in spasticity.

    Mechanism of action As part of the human endocannabinoid system ECS , cannabinoid receptors, CB 1 and CB 2 receptors are found predominantly at nerve terminals where they have a role in retrograde regulation of synaptic function. Younger age of initiation and other substance use were strong predictors of the transition from use to CUD.

    Social phobia and panic disorder were also associated with transition from cannabis use to CUD. Male cannabis users had greater risk of CUD than female users, but among women, those with depression were more likely to develop a CUD. Early-onset of alcohol and daily cigarette smoking were each associated with marked increased risk of early initiation of cannabis use. A handful of clinical studies have examined the differences between men and women with respect to development of dependence, withdrawal symptoms and relapse Reference Physical dependence is most often manifested in the appearance of withdrawal symptoms when use is abruptly halted or discontinued.

    Withdrawal symptoms associated with cessation of cannabis use oral or smoked appear within the first one to two days following discontinuation; peak effects typically occur between days 2 and 6 and most symptoms resolve within one to two weeks Reference - Reference Other symptoms appear to include depressed mood, chills, stomach pain, shakiness and sweating Reference Reference Reference Reference Cannabis withdrawal symptoms appear to be moderately inheritable with both genetic and environmental factors at play Reference There are also emerging reports of increased physical dependence with highly potent cannabis extracts e.

    There are no approved pharmacotherapies for managing cannabis withdrawal symptoms Reference A range of medications have been explored including antidepressants e. Zolpidem has also been explored as a potential pharmacotherapy to specifically target abstinence-induced disruptions in sleep Reference Reference However, agonist substitution therapy e.

    Self-titrated doses were lower and showed limited efficacy compared to high fixed doses and subjects typically reported significantly lower ratings of "high" and shorter duration of "high" with nabiximols and placebo compared to smoking cannabis. A randomized, double-blind, placebo-controlled, six-day, inpatient clinical study of nabiximols as an agonist replacement therapy for cannabis withdrawal symptoms reported that nabiximols treatment attenuated cannabis withdrawal symptoms and improved patient retention in treatment Reference However, placebo was as effective as nabiximols in promoting long-term reductions in cannabis use at follow-up.

    Nabiximols treatment significantly reduced the overall severity of cannabis withdrawal symptoms relative to placebo including effects on irritability, depression and craving as well as a more limited effect on sleep disturbance, anxiety, appetite loss, physical symptoms and restlessness. A placebo-controlled, within-subject, clinical study demonstrated that nabilone 6 - 8 mg daily decreased cannabis withdrawal symptoms including abstinence-related irritability and disruptions in sleep and food intake in daily, non-treatment seeking cannabis smokers Reference It also decreased cannabis self-administration during abstinence in a laboratory model of relapse.

    While nabilone did not engender subjective ratings associated with abuse liability i. A follow-up study found that nabilone 3 mg, b. A double-blind, placebo-controlled, week clinical trial testing lofexidine and dronabinol for the treatment of CUD reported no significant beneficial effect compared to placebo for promoting abstinence, reducing withdrawal symptoms, or retaining individuals in treatment Reference in contrast to a previous study that showed efficacy of 40 mg dronabinol daily vs.

    A recent systematic review of the evidence of CBD as an intervention for addictive behaviours reported that to date, only 14 studies have been conducted, the majority in animals with only a handful in humans Reference The limited number of pre-clinical studies carried out to date suggest that CBD may have therapeutic potential for the treatment of opioid, cocaine and psychostimulant addiction, and some preliminary data suggest CBD may also be beneficial in cannabis and tobacco addiction in humans Reference The limited number of pre-clinical studies published thus far suggest CBD may have an impact on the intoxication and relapse phase of opioid addiction, while CBD does not appear to have an impact on the rewarding effects of stimulants e.

    With respect to cannabis dependence, pre-clinical studies show that CBD is not reinforcing on its own, but its impact on cannabis-related dependence behaviour remains unclear Reference In one clinical study, a 19 year-old female with cannabis dependence exhibiting cannabis withdrawal symptoms upon cannabis cessation was administered up to mg of CBD range: In another human study, cannabis with a higher CBD to THC ratio was associated with lower ratings of pleasantness for drug stimuli explicit "liking" , but no group difference in "craving" or "stoned" ratings was noted Reference Reference However, a multi-site, double-blind, placebo-controlled study demonstrated that CBD - mg had no effect on subjective ratings associated with cannabis abuse liability Reference A randomized, double-blind, crossover clinical study in 10 healthy volunteers examining the effects of CBD on the intoxication phase of alcohol addiction reported no differences in feelings of "drunk", "drugged", or "bad" between the alcohol only and the alcohol and CBD groups Reference Reference No pre-clinical studies exist on the use of CBD for hallucinogen-, sedative-, tobacco-, or alcohol-addictive behaviours and no human studies exist on the use of CBD for opioid-, psychostimulant-, hallucinogen-, or sedative-addictive behaviours Reference The ECS is present in early development, is critical for neurodevelopment and maintains expression in the brain throughout life Reference Furthermore, the ECS undergoes dynamic changes during adolescence with significant fluctuations in both the levels and locations of the CB 1 receptor in the brain as well as changes in the levels of the endocannabinoids 2-AG and anandamide Reference The dynamic changes occurring in the ECS during adolescence also overlap with a significant period of neuronal plasticity that includes neuronal proliferation, rewiring and synaptogenesis, and dendritic pruning and myelination that occurs at the same time Reference This period of significant neuroplasticity does not appear to be complete until at least the age of 25 Reference Thus, this neurodevelopmental time window is critical for ensuring proper neurobehavioural and cognitive development and is also influenced by external stimuli, both positive and negative e.

    Based on the available scientific evidence, youths are more susceptible to the adverse effects associated with cannabis use, especially chronic use Reference Reference Studies examining non-medical use of cannabis strongly suggest early onset i. Based on the current available evidence, it is unclear for how long some or all of the neurocognitive effects persist following cessation of use.

    Some investigators have found certain cognitive deficits to persist for up to one year or longer after cannabis cessation, while others have demonstrated a far shorter period of recovery i. Though the data from human studies do not establish causality solely from cannabis use, the pre-clinical studies in animals do indicate that adolescent exposure to cannabinoids can catalyze molecular processes leading to functional deficits in adulthood - deficits that are not found following adult exposure to cannabis.

    The authors note that definitive conclusions cannot be made yet as to whether cannabis use - on its own - negatively impacts the adolescent brain, and future research can help elucidate this relationship by integrating assessments of molecular, structural, and behavioral outcomes Reference Factors that may influence persistence of cognitive deficits can include age at onset of use, frequency and duration of use, co-morbidities, and use of other drugs tobacco, alcohol, and other psychoactive drugs.

    While adverse effects associated with THC-predominant cannabis use in youth have been well documented, far less is known about the adverse effects associated with CBD-predominant cannabis use. Nevertheless, as mentioned above, the ECS plays important roles in nervous system development in utero as well as during youth see Section 7.

    There is evidence to suggest that like the changes seen with the ECS during development and adolescence, there are changes in the ECS associated with ageing. In addition, the coupling of CB 1 receptors to G proteins is also reduced in specific brain areas in older animals Reference Age-related changes in the expression of components of the ECS appear similar in rodents and humans Reference Disruption of CB receptors appears to enhance age-related decline of a number of tissues suggesting an important role for the ECS in the control of the ageing process Reference In general, the elderly may be more sensitive to the effects of drugs acting on the CNS Reference A number of physiological factors may lie at the root of this increased sensitivity such as: There is very little information available on the effects of cannabis and cannabinoids in geriatric populations and based on current levels of evidence, no firm conclusions can be made with regard to the safety or efficacy of cannabinoid-based drugs in elderly patients but see below for one of the few clinical studies of safety carried out specifically in geriatric populations Reference Reference Reference Furthermore, as cannabinoids are lipophilic, they may tend to accumulate to a greater extent in elderly individuals since such individuals are more likely to have an increase in adipose tissue, a decrease in lean body mass and total body water, and an increase in the volume of distribution of lipophilic drugs Reference Lastly, age-related changes in hepatic function such as a decrease in hepatic blood flow and slower hepatic metabolism can slow the elimination of lipophilic drugs and increase the likelihood of adverse effects Reference A randomized, double-blind, placebo-controlled, cross-over clinical trial that evaluated the pharmacokinetics of THC in 10 older patients with dementia mean age 77 years over a week period reported that the median time to reach maximal concentration in the blood T max was between 1 and 2 h with THC pharmacokinetics increasing linearly with increasing dose but with wide inter-individual variation Reference Only one clinical study has thus far been carried out looking specifically at the safety of THC in an elderly population.

    In this study, 12 adults aged 65 and older who were deemed to be healthy were included, and exclusion criteria included high falls risk, regular cannabis use, history of sensitivity to cannabis, drug and alcohol abuse, compromised cardiopulmonary function, and psychiatric comorbidities.

    The most commonly reported health problems were hypertension and hypercholesterolemia and subjects reported using an average of 2 medications e.

    Adverse events first occurred within 20 min of dosing, with all adverse events occurring between 55 and min after dosing and resolving completely within 3. No moderate or serious adverse events were reported in this trial. While this clinical study adds important information regarding the safety and tolerability of THC in a healthy elderly population, additional studies are needed to evaluate the safety and tolerability of cannabis and cannabinoids in elderly populations having various co-morbidities.

    In humans, sex-dependent differences have been often observed in the biological and behavioural effects of substances of abuse, including cannabis Reference In male animals, higher densities of CB 1 receptors have been observed in almost all cerebral regions analyzed whereas in females a more efficient coupling of the CB 1 receptor to downstream G-protein signaling has been observed Reference In humans, sex differences in CB 1 receptor density have also been reported, with men having higher receptor density compared to women Reference Sex-dependent differences have also been noted with respect to cannabinoid metabolism.

    Pre-clinical studies in females report increased metabolism of THC to hydroxy-THC compared to males where THC was also biotransformed to at least three different, less active metabolites Reference There is also evidence to suggest that effects of cannabinoids vary as a function of fluctuations in reproductive hormones Reference Reference Together, these findings suggest that the neurobiological mechanism underlying the sex-dependent effects of cannabinoids may arise from sexual dimorphism in the ECS and THC metabolism, but also from the effects of fluctuations in hormone levels on the ECS Reference Reference There is also evidence to suggest sex-dependent differences in subjective effects and development of dependence, withdrawal symptoms, relapse and incidence of mood disorders.

    Data combined from four double-blind, within-subject studies measuring the effects of smoked "active" cannabis 3. These findings suggest that, at least among near-daily cannabis users, women may be more sensitive to the subjective effects of cannabis, especially effects related to cannabis abuse liability compared to men.

    Another study demonstrated dose-dependent sex differences in subjective responses to orally administered THC Reference In this study, women showed greater subjective effects at the lowest dose 5 mg , whereas men showed greater subjective responses at the highest 15 mg dose. Together, these studies suggest that while women may be more sensitive to the subjective effects of THC at lower doses, they may develop tolerance to these effects at higher doses, which could, for example, have implications for the development of dependence.

    For example, while cannabis use among men is more prevalent and men appear to be more likely than women to become dependent on cannabis, women tend to have shorter intervals between the onset of use and regular use or development of dependence commonly referred to as the "telescoping effect" Reference In addition, women abstaining from cannabis use reported more withdrawal symptoms, with some being more severe, than those seen in men and which have been linked to relapse Reference Reference Women with CUD also present with higher rates of certain comorbid health problems such as mood and anxiety disorders Reference Reference Reference The College of Family Physicians of Canada, along with other provincial medical regulatory colleges, has issued a guidance document in for authorizing the use of cannabis for medical purposes.

    Please consult these and any other official guidance documents, as applicable, for additional information regarding dosing and other matters associated with authorizing cannabis for medical purposes. Cannabis has many variables that do not fit well with the typical medical model for drug prescribing Reference While precise dosages have not been established, some "rough" dosing guidelines for smoked or vapourized cannabis have been published see below.

    Besides smoking and vapourization, cannabis is known to be consumed in baked goods such as cookies or brownies, or drunk as teas or infusions. However, absorption of these products by the oral route is slow and erratic, varies with the ingested matrix e. Other forms of preparation reported in the lay literature include cannabis-based butters, candies, edibles, oils, compresses, creams, ointments, and tinctures Reference 80 Reference - Reference but again, limited dosing information exists here with much of the information being anecdotal in nature.

    Dosing remains highly individualized and relies largely on titration Reference Patients with no prior experience with cannabis and initiating cannabis therapy for the first time are cautioned to begin at the very lowest dose and to stop therapy if unacceptable or undesirable side effects occur.

    Subsequent dose escalation should be done slowly, once experience with the subjective effects is fully appreciated, to effect or tolerability.

    If intolerable adverse effects appear without significant benefit, dosing should be tapered and stopped. Tapering guidelines have not been published, but the existence of a withdrawal syndrome see Section 2. Clinical studies of cannabis and cannabis-based products for therapeutic purposes are limited to studies carried out with dried cannabis that was smoked or vapourized and with synthetic or natural cannabis-based products that have received market authorization i.

    As such, providing precise dosing guidelines for such products is not possible although existing sources of information can be used as a reference point see below. Naturally, dosing will vary according to the underlying disorder and the many other variables mentioned above.

    Average daily dose of dronabinol is 20 mg and maximal recommended daily dose is 40 mg Reference Doses less than 1 mg of THC per dosing session may further avoid incidence and risks of adverse effects. Various surveys published in the peer-reviewed literature have suggested that the majority of people using smoked or orally ingested cannabis for medical purposes reported using between 10 and 20 g of cannabis per week or approximately 1 to 3 g of cannabis per day Reference Reference Reference An international, web-based, cross-sectional survey examining patients' experiences with different methods of cannabis intake reported that from among a group of self-selected participants, from 31 countries, the vast majority preferred inhalation over other means of administration e.

    Mean daily doses with smoked or vapourized cannabis were 3. Information regarding cannabinoid potencies of cannabis products i. Daily frequency of use for smoking was six times per day, whereas with vapourizing it was five times per day. First onset of effects for smoking were noted on average around 7 min after start of smoking, 6. Other data suggests that those patients who use cannabis for medical purposes use up to one gram or less per day. For example, data from the Netherlands suggests the average daily dose of dried cannabis for medical purposes stood at 0.

    Canadian market data collected from licensed producers under the Access to Cannabis for Medical Purposes Regulations ACMPRs showed that, from April to March , clients had been authorized by their healthcare practitioners to use, monthly, an average of 2. However, since this data is collected per licensed producer, it does not include cases where clients split their authorization into two or more authorizations in order to register with more than one licensed producer at a time or personal production registrations with Health Canada Reference To fulfill orders for oils, licensed producers equate oil to dried cannabis based on the formulation of their oil products.

    On average, licensed producers equate 1 g of dried cannabis to 6. Using this average conversion factor, healthcare practitioners have authorized an equivalent average of Satisfaction ratings for criteria such as onset of effects and ease of dose finding were reported to be higher for smoking and vapourizing i. However, prescription cannabinoid medications e. Satisfaction ratings in terms of side-effects were higher for non-prescription unregulated cannabis products, with the inhaled route rated best, although the survey did not ask specific questions about the types of side effects.

    Satisfaction ratings were only slightly higher for orally ingested cannabis products for criteria such as duration of effects. The majority of survey participants had indicated having used cannabis products prior to onset of their medical condition.

    A prospective, open-label, longitudinal study of patients with treatment resistant chronic pain reported that patients titrate their cannabis dose starting with one puff or one drop of cannabis oil per day, increasing in increments of one puff or one drop of oil per dose, three times per day until satisfactory pain relief was achieved or side effects appeared Reference Mean monthly prescribed amount of cannabis was 43 g or 1.

    Data from randomized, double-blind, placebo-controlled clinical studies of smoked or vapourized cannabis used a daily dose of up to 3.

    In contrast to the gram amounts of cannabis used with smoked, vapourized, and oral routes of administration, the mean daily amounts for prescription cannabinoids such as dronabinol were 30 mg, for nabilone 4. With respect to the relationship between dosing and psychotropic effects , it has been estimated that an inhaled dose of 0.

    Furthermore, it has been estimated that between one and three puffs of higher potency cannabis would be sufficient to produce significant psychoactive effects Reference One study has shown that while cannabis smokers titrate their dose of THC by inhaling lower volumes of smoke when smoking "strong" joints i. For oral administration, a dose of 0. Other provincial bodies may also provide guidelines on monitoring Reference The College of Family Physicians of Canada has recently published a simplified guideline for prescribing medical cannabinoids in primary care Reference The recommendations are as follows:.

    The majority of clinical trials with smoked cannabis for medical purposes have used joints of dried cannabis weighing between and mg. Estimates that are more recent suggest the mean weight of cannabis in a joint is mg Reference In addition, expectation of drug reward can also influence smoking dynamics Reference Little reliable information exists regarding conversion of a "smoked dose" of THC to an equivalent oral dose.

    It is also important to emphasize that this "conversion factor" appears to relate mostly to psychoactive effects e. Further rigorous comparative pharmacology studies are required. In addition, no comparative studies have been done with vaping.

    In addition, this theoretical conversion factor may or may not apply for therapeutic effects. Indeed, it is important to highlight that two studies reported that individuals using cannabis for therapeutic purposes indicated they used approximately similar gram amounts of cannabis regardless of route of administration Reference Reference A single-dose, open-label, clinical trial of patients with neuropathic pain and using very low doses of inhaled THC reported a statistically significant improvement in neuropathic pain with minimal adverse effects Reference THC administration was associated with a statistically significant reduction in baseline VAS for pain intensity of 3.

    These above-mentioned studies suggest that, at least in the case of chronic neuropathic pain, psychoactive effects can be separated from therapeutic effects and that very low doses of THC may actually be sufficient to produce analgesia while keeping psychoactive effects to a minimum.

    A review of U. Product has been discontinued by the manufacturer post-market; as of February ; not for safety reasons.

    Newfoundland and Labrador; NS: Prince Edward Island; QC: The pharmacokinetic information described in Section 2. Tea prepared from Cannabis flowering tops and leaves has been documented, but no data are available regarding efficacy Reference On the other hand, to reduce or prevent CINV, a dosage of 5 mg t.

    In either case, the dose should be carefully titrated to avoid the manifestation of adverse effects. The second dose is usually administered 1 to 3 h before chemotherapy.

    If required, the administration of nabilone can be continued up to 24 h after the chemotherapeutic agent is given. The maximum recommended daily dose is 6 mg in divided doses. Dose adjustment titration may be required in order to attain the desired response, or to improve tolerability. More recent clinical trials report starting doses of nabilone of 0. Data from an open-label longitudinal study of cannabis oil for patients with treatment-resistant chronic non-cancer pain reported that patients titrated their cannabis oil dose starting with one drop of cannabis oil per day, increasing in increments of one drop of oil per dose, three times per day, until satisfactory analgesia was achieved or until side effects appeared Reference Maximum daily dose was 5 mg b.

    On subsequent days, the number of sprays can be increased by one spray per day, as needed and tolerated. A fifteen-minute time gap should be allowed between sprays.

    During the initial titration, sprays should be evenly spread out over the day. If at any time unacceptable adverse reactions such as dizziness or other CNS-type reactions develop, dosing should be suspended or reduced or the dosing schedule changed to increase the time intervals between doses. According to the drug product monograph, the average dose of nabiximols is five sprays per day i. The majority of patients appear to require 12 sprays or less; dosage should be adjusted as needed and tolerated.

    Administration of four sprays to healthy volunteers total The Dutch Office of Medicinal Cannabis has published "rough" guidelines on the use of vapourizers Reference Although the amount of cannabis used per day needs to be determined on an individual basis, the initial dosage should be low and may be increased slowly as symptoms indicate. The amount of cannabis to be placed in the vapourizer may vary depending on the type of vapourizer used. The levels of cannabinoids released into the vapour phase increased with the temperature of vapourization Reference Participants inhaled as much of the mg dose of dried cannabis 3.

    In another study, patients followed a similar "cued-puff" procedure and inhaled 4 puffs, followed by an additional round of between 4 and 8 puffs 2 h later for a total of between 8 and 12 puffs over a 2 h period Reference Subjects inhaled 4 puffs at the beginning of the testing session, followed by an additional round of between 4 and 8 puffs 3 h later for a total of between 8 and 12 puffs over a 3 h period. While there are countless anecdotal reports concerning the therapeutic uses of cannabis, clinical studies supporting the safety and efficacy of cannabis for therapeutic purposes in a variety of disorders are limited, but slowly increasing in number.

    Furthermore, the current level of evidence for the safety and efficacy of cannabis for medical purposes does not meet the requirements of the Food and Drugs Act and its Regulations except for those products that have received a notice of compliance and market authorization from Health Canada. It has been repeatedly noted that the psychotropic side effects associated with the use of psychoactive cannabinoids have been found to limit their therapeutic utility Reference 23 Reference 55 Reference 57 Reference Reference A comprehensive review of 72 controlled clinical studies evaluating the therapeutic effects of cannabinoids mainly orally administered THC, nabilone, nabiximols, or an oral extract of cannabis up to the year reported that cannabinoids present an interesting therapeutic potential as anti-emetics, appetite stimulants in debilitating diseases cancer and AIDS , analgesics, and in the treatment of MS, SCIs, Tourette's syndrome TS , epilepsy, and glaucoma Reference However, a more recent systematic review and meta-analysis of randomized clinical trials of cannabinoids i.

    Compared with placebo, cannabinoids were associated with a greater average number of patients showing a complete improvement in nausea and vomiting, reduction in pain, a greater average reduction in numerical rating scale pain assessment, and average reduction in the Ashworth spasticity scale Reference There was also an increased risk of short-term adverse events with cannabinoids.

    Commonly reported adverse events included dizziness, dry mouth, fatigue, somnolence, euphoria, vomiting, disorientation, drowsiness, confusion, loss of balance and hallucinations Reference Overall, the review and meta-analysis conducted using the Grading of Recommendations, Assessment, Development and Evaluation GRADE approach suggested that there was moderate-quality evidence to support the use of cannabinoids for the treatment of chronic neuropathic or cancer pain as well as MS-associated spasticity, but low-quality evidence to support use for CINV, weight gain in HIV infection, sleep disorders, and TS Reference The review and meta-analysis only included only one study with smoked cannabis and all other included clinical studies were with oral or oro-mucosal administration of cannabinoid-based medicines e.

    This comprehensive report includes information on the therapeutic effects of cannabis and the cannabinoids but also other health effects such as cancer, cardiometabolic risks, respiratory disease, immunity, injury and death, prenatal, perinatal and neonatal effects, psychosocial and mental health effects. It also discusses challenges and barriers in conducting cannabis research as well as recommendations to support and improve cannabis research.

    Much of the evidence included in the report came from systematic reviews and meta-analyses and selected high quality primary research. Evidence gathered from in vitro or in vivo animal studies was not included. It was available for sale in Canada in capsules containing 2. The drug is no longer sold in Canada post-market discontinuation of the drug product as of February ; not for safety reasons. It is available as capsules 0. It is also marketed with conditions as an adjunctive treatment for the symptomatic relief of neuropathic pain in adults with MS and with conditions as an adjunctive analgesic in adult patients with advanced cancer who experience moderate to severe pain during the highest tolerated dose of strong opioid therapy for persistent background pain Reference The existing scientific and clinical evidence for cannabis and certain cannabinoids in treating various symptoms associated with various medical conditions is summarized in the following sections beginning on the next page.

    Among the goals of palliative care described by the WHO are relief from pain and other distressing symptoms, and the enhancement of quality of life QoL Reference While integration of cannabis into mainstream medical use can be characterized as extremely cautious, its use appears to be gaining some ground in palliative care settings where the focus is on individual choice, patient autonomy, empowerment, comfort and especially QoL Reference Nevertheless, establishing the effectiveness of cannabis as a viable treatment option in a palliative care context requires a careful assessment of its effects in a wide range of conditions; such evidence is not yet abundant and further research is needed Reference Certain patient populations e.

    A prospective, non-randomized, and unblinded observational case-series study assessing the effectiveness of adjuvant nabilone therapy in managing pain and symptoms experienced by advanced cancer patients in a palliative care setting reported that those patients using nabilone had a lower rate of starting NSAIDs, tricyclic anti-depressants, gabapentin, dexamethasone, metoclopramide, and ondansetron and a greater tendency to discontinue these drugs Reference Treated patients were started on 0.

    At follow-up, the majority of patients were on a 2 mg daily nabilone dose with a mean daily dose of 1. The two primary outcomes of the study, pain and opioid use in the form of total morphine sulfate equivalents were reduced significantly in treated patients compared to untreated patients. Side effects from nabilone consisted mainly of dizziness, confusion, drowsiness, and dry mouth.

    Patients also demonstrated less tendency to initiate additional new medications and could reduce or discontinue baseline medications. One observational study that examined over self-reported cannabis-using patients in a cancer palliative care setting reported significant improvement in a variety of cancer and anti-cancer treatment-related symptoms including nausea, vomiting, mood disorders, fatigue, weight loss, anorexia, constipation, sexual function, sleep disorders, itching, and pain Reference The reported decrease in memory among a proportion of the study sample could be a function of cannabis use along with the use of other medications such as opioids, anti-depressants, or even vary with age.

    Improvements in symptom and distress scores were also noted. Limitations of the study included its observational nature, the lack of an appropriate control group, and the reliance on self-report.

    Another observational study looking at the patterns of cannabis use among adult Israeli advanced cancer patients reported that of approximately 17, cancer patients monitored at a single Israeli healthcare institution, patients were authorized to use cannabis for medical purposes; among these, the median age of patients was 60 years range: In most patients, cannabis was requested for multiple indications.

    Eighty-three percent of patients rated the overall efficacy of cannabis as being high. A handful of clinical studies have used standardized QoL instruments to measure whether the use of cannabis or prescription cannabinoids e. The evidence from these studies is summarized below. A two-centre, phase II, randomized, double-blind, placebo-controlled day pilot study carried out in adult patients suffering from chemosensory alterations i. Statistically significant improvements were also noted for quality of sleep and relaxation with dronabinol treatment compared to placebo.

    Some companies take advantage of potential customers lack of understanding. Educate yourself so you do not become a target. The labelling should state total amount of CBD per product but unfortunately some companies deliberately confuse customers by stating the amount of hemp extract in the product, or the percentage of CBD in the extract, rather than the total CBD. If you are still insure, join a CBD support group and ask lots of questions or even better, choose a supplier with clear and transparent labelling.

    Reputable companies will provide lab reports for their CBD products. These are important as they confirm the safety and potency of the product, but they also allow you to match your needs to the individual CBD product. Some, or all of the following information should be on the report: You need to be able to verify the report is genuine, and for the company and product stated.

    To do this you need to check the report has the following information: A common misconception is that you need a high strength CBD product for it to be effective. In most cases, starting with a high strength can actually be detrimental, and a low and slow method of introducing CBD is preferable.

    Therefore, taking a CBD product that is too strong, too soon is not only a waste of money, but it can also have a negative effect on your health.

    It needs to be noted that certain conditions, like epilepsy may need higher doses of CBD from the outset, so what condition you are looking to treat is also an important consideration. But what does this mean? In terms of CBD oils, a strength of between 2. This equates to a starting dose of mg, times a day. As I mentioned previously, the low and slow approach may not be suitable for conditions involving seizures, like epilepsy.

    But what is the difference? As I have discussed, each cannabis compound has its own potential therapeutic benefits. Therefore a product containing a full array of cannabinoids and terpenes should have a more beneficial effect on the body than one made from CBD alone. The combined benefits of all the compounds found in Cannabis in known as the Entourage Effect — the combined effect is greater than the individual components.

    Also, price does not always reflect quality. Whether a CBD product produces a relaxing or stimulating effect is due to the array of cannabinoids and terpenes present, not the strain. For example a CBD product containing higher levels of CBG and Myrcene terpene will have a more relaxing effect, while one containing more Pinene terpene may cause you to be more alert. Also we all react differently to CBD. Some people naturally find CBD stimulating while for others it can have a sedating effect.

    I know there is a lot of information to take in, but by doing a bit of research before starting your CBD journey, you can save yourself a lot of time and money in the long run. All advice and information given is impartial and unbiased. I have lots more CBD related articles on my website. Please click here to read them. I am not a medical professional. I would always recommend you speak to your pharmacist or GP about any possible interactions.

    Hi thank you for this very interesting article on CBD. I only joined a CBD group a week ago…. I am being treated for anxiety and high blood pressure the latter a result of anxiety. I also have lower back pain. I only take drops in the day but it seems to make the anxiety much worse. I fear I will be unable to tolerate any CBD because of the heightened anxiety ….. CBD has been very beneficial for my anxiety. I suffer from quite severe anxiety and panic attacks.

    Anxiety seems to respond well to lower doses of CBD. My advice would be to start with just 1 drop a day. You could try continuing with the Holland and Barrett oil or you could try the oil I take. Thank you for this information, it has helped me understand CBD a bit more but I still have lots to learn!

    It is helping with the arthritis in my shoulder but maybe I should be taking CBDa instead. I would stick with the Jacob Hooy oil sold by Holland and Barrett for a while and see if it helps. Then maybe move onto an oil containing higher levels of cbda. Sending gentle hugs xx. It sounds like you are doing everything right. The capsules may just be too strong for you. If you are on Facebook I would recommend joining this group and asking the members what they would recommend.

    Very clear information, many thanks. Thanks for taking the time to comment. It is the chicken and egg situation, we need the professors to teach the lecturers to get to the teachers to teach the kids! They will do what they always do refer to Google or their own secret sites. There are millions today doing their own trials without GP knowledge so results cannot be ratified.

    It has taken over 50 years to reach this stage of knowing how our very complex body systems are kept in control by these amazing endogenous biochemicals and the research goes on. Medicinal cannabis is cannabis just different strains and different THC and CBD alongside hundreds of others to make a very safe compound. Hi Thanks for this article.

    I have severe pain in the shoulders due to arthritis. So there are days that it is so dificult to actually stand up with the pain and walk.

    Is there anything you could recomend please? Sorry to hear you are in pain. You may need to increase your dose, or you may need to switch to a CBD oil with higher levels of CBDa, which is a good anti inflammatory. You may also benefit from a CBD or hemp topical balm. I hope you find some relief. My friend has ME. I recommended he try CBD. Any advice as to which product is best for fatigue. Also in cases of arthritis which is best?

    Thanks for this very informative article. I can only really comment on what has worked for me. I have ME and Fibromyalgia.

    Sativex Oromucosal Spray

    mg deltatetrahydrocannabinol (THC) and mg cannabidiol (CBD) from . However, following dosing in healthy volunteers with Sativex up to 18 sprays twice . There is no experience of deliberate overdose with Sativex in patients. "Skunk", as this new strain of high-THC/low-CBD marijuana is called, of cannabis appears to be partly accidental and partly deliberate. Generic name, Trade name, Use, Dosage and component(s), Reference dopa- induced dyskinesias, Δ9-THC + CBD The potency, especially ∆9-THC content, is kept deliberately low to limit side effects (or patient.

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    Comments

    kraftmoney

    mg deltatetrahydrocannabinol (THC) and mg cannabidiol (CBD) from . However, following dosing in healthy volunteers with Sativex up to 18 sprays twice . There is no experience of deliberate overdose with Sativex in patients.

    ionutemanuel

    "Skunk", as this new strain of high-THC/low-CBD marijuana is called, of cannabis appears to be partly accidental and partly deliberate.

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