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In Canada, 21 subjects with chronic pain sequentially smoked single inhalations of 25 mg of cannabis 0, 2. Even after political and legal considerations, it remains extremely unlikely that crude cannabis could ever be approved by the FDA as a prescription medicine as outlined in the FDA Botanical Guidance document Food and Drug Administration ; Russo b , due to a lack of rigorous standardization of the drug, an absence of Phase III clinical trials, and pulmonary sequelae bronchial irritation and cough associated with smoking Tashkin Although cannabis vaporizers reduce potentially carcinogenic polyaromatic hydrocarbons, they have not been totally eliminated by this technology Gieringer et al ; Hazekamp et al Two open label studies in France of oral dronabinol for chronic neuropathic pain in 7 subjects Clermont-Gnamien et al and 8 subjects Attal et al , respectively, failed to show significant benefit on pain or other parameters, and showed adverse event frequently requiring discontinuation with doses averaging 15— Dronabinol did demonstrate positive results in a clinical trial of multiple sclerosis pain in two measures Svendsen et al , but negative results in post-operative pain Buggy et al Table 1.
Another uncontrolled case report in three subjects noted relief of intractable pruritus associated with cholestatic jaundice employing oral dronabinol Neff et al Some authors have noted patient preference for whole cannabis preparations over oral THC Joy et al , and the contribution of other components beyond THC to therapeutic benefits McPartland and Russo THC absorption orally is slow and erratic with peak serum levels in 45— minutes or longer. Systemic bioavailability is also quite low due to rapid hepatic metabolism on first pass to hydroxy-THC.
A rectal suppository of THC-hemisuccinate is under investigation Broom et al , as are transdermal delivery techniques Challapalli and Stinchcomb The terminal half-life of THC is quite prolonged due to storage in body lipids Grotenhermen Nabilone Cesamet Figure 1 , is a synthetic dimethylheptyl analogue of THC British Medical Association that displays greater potency and prolonged half-life. Serum levels peak in 1—4 hours Lemberger et al It was also primarily developed as an anti-emetic in chemotherapy, and was recently re-approved for this indication in the USA.
Prior case reports have noted analgesic effects in case reports in neuropathic pain Notcutt et al and other pain disorders Berlach et al Sedation and dysphoria were prominent sequelae. An RCT of nabilone in 41 post-operative subjects actually documented exacerbation of pain scores after thrice daily dosing Beaulieu Table 1. An abstract of a study of 82 cancer patients on nabilone claimed improvement in pain levels after varying periods of follow-up compared to patients treated without this agent Maida However, 17 subjects dropped out, and the study was neither randomized nor controlled, and therefore is not included in Table 1.
Part of its analgesic activity may relate to binding to intracellular peroxisome proliferator-activator receptor gamma Liu et al Peak plasma concentrations have generally been attained in 1—2 hours, but with delays up to 4—5 hours is some subjects Karst et al Debate surrounds the degree of psychoactivity associated with the drug Dyson et al Current research is confined to the indication of interstitial cystitis.
CBD ratios reviewed in Russo and Guy , generally approximately 2: Two pharmacokinetic studies on possibly related material have been reported Nadulski et al a ; Nadulski et al b. Both Marinol and Cannador produced reductions in pain scores in long-term follow-up Zajicek et al Cannador was assayed in postherpetic neuralgia in 65 subjects with no observed benefit Ernst et al Table 1 , and in 30 post-operative pain subjects CANPOP without opiates, with slight benefits, but prominent psychoactive sequelae Holdcroft et al Table 1.
It was approved by Health Canada in June for prescription for central neuropathic pain in multiple sclerosis, and in August , it was additionally approved for treatment of cancer pain unresponsive to optimized opioid therapy. Sativex effects commence in 15—40 minutes, an interval that permits symptomatic dose titration. A very favorable adverse event profile has been observed in over patient years of exposure in over experimental subjects. Patients most often ascertain an individual stable dosage within 7—10 days that provides therapeutic relief without unwanted psychotropic effects often in the range of 8—10 sprays per day.
In a Phase II double-blind crossover study of intractable chronic pain Notcutt et al in 24 subjects, visual analogue scales VAS were 5. During that time, there was no escalation of dose indicating an absence of tolerance to the preparation. Similarly, no withdrawal effects were noted in a subset of patients who voluntarily stopped the medicine abruptly. Upon resumption, benefits resumed at the prior established dosages. In a Phase II double-blind, randomized, placebo-controlled, 5-week study of 56 rheumatoid arthritis patients with Sativex Blake et al , employed nocturnal treatment only to a maximum of 6 sprays per evening In a study of spinal injury pain, NRS of pain were not statistically different from placebo, probably due to the short duration of the trial, but secondary endpoints were clearly positive Table 1.
Finally, in an RCT of intractable lower urinary tract symptoms in MS, accompanying pain in affected patients was prominently alleviated Table 1. Common adverse events AE of Sativex acutely in RCTs have included complaints of bad taste, oral stinging, dry mouth, dizziness, nausea or fatigue, but do not generally necessitate discontinuation, and prove less common over time.
While there have been no head-to-head comparative RCTs of Sativex with other cannabinoid agents, certain contrasts can be drawn. Sativex Rog et al and Marinol Svendsen et al have both been examined in treatment of central neuropathic pain in MS, with comparable results Table 1. However, adverse events were comparable or greater with Marinol than with Sativex employing THC dosages some 2.
Similarly, while Sativex and smoked cannabis have not been employed in the same clinical trial, comparisons of side effect profiles can be made on the basis of SAFEX studies of Sativex for over a year and up to several years in MS and other types of neuropathic pain Russo b ; Wade et al , and government-approved research programs employing standardized herbal cannabis from Canada for chronic pain Lynch et al and the Netherlands for general conditions Janse et al ; Gorter et al over a period of several months or more.
As is evident in Figure 2 Figure 2 , all adverse events are more frequently reported with herbal cannabis, except for nausea and dizziness, both early and usually transiently reported with Sativex see Russo b for additional discussion.
Comparison of adverse events AE encountered with long term therapeutic use of herbal cannabis in the Netherlands Janse et al ; Gorter et al and Canada Lynch et al , vs that observed in safety-extension SAFEX studies of Sativex oromucosal spray Russo ; Wade et al Phytocannabinoids are lipid soluble with slow and erratic oral absorption.
While cannabis users claim that the smoking of cannabis allows easy dose titration as a function of rapid onset, high serum levels in a short interval inevitably result. This quick onset is desirable for recreational purposes, wherein intoxication is the ultimate goal, but aside from paroxysmal disorders eg, episodic trigeminal neuralgia or cluster headache attack , such rapid onset of activity is not usually necessary for therapeutic purposes in chronic pain states.
The vast majority of subjects in Sativex clinical trials do not experience psychotropic effects outside of initial dose titration intervals Figure 2 and most often report subjective intoxication levels on visual analogue scales that are indistinguishable from placebo, in the single digits out of Wade et al Thus, it is now longer tenable to claim that psychoactive effects are a necessary prerequisite to symptom relief in the therapeutic setting with a standardized intermediate onset cannabis-based preparation.
Intoxication has remained a persistent issue in Marinol usage Calhoun et al , in contrast. Recent controversies have arisen in relation to non-steroidal anti-inflammatory drugs NSAID , with concerns that COX-1 agents may provoke gastrointestinal ulceration and bleeding, and COX-2 drugs may increase incidents of myocardial infarction and cerebrovascular accidents Fitzgerald ; Topol Frequent questions have been raised as to whether psychoactive drugs may be adequately blinded masked in randomized clinical trials.
Internal review and outside analysis have confirmed that blinding in Sativex spasticity studies has been effective Clark and Altman ; Wright Sativex and its placebo are prepared to appear identical in taste and color.
Great public concern attends recreational cannabis usage and risks of dependency. The addictive potential of a drug is assessed on the basis of five elements: Drug abuse liability DAL is also assessed by examining a drug's rates of abuse and diversion. US Congress placed cannabis in Schedule I of the Controlled Substances Act in , with drugs categorized as addictive, dangerous, possessing severe abuse potential and no recognized medical value.
Marinol was placed in Schedule II, the category for drugs with high abuse potential and liability to produce dependency, but certain recognized medical uses, after its FDA approval in Marinol was reassigned to Schedule III in , a category denoting a lesser potential for abuse or lower dependency risk after documentation that little abuse or diversion Calhoun et al had occurred.
Nabilone was placed and has remained in Schedule II since The degree to which a drug is reinforcing is determined partly by the by the rate of its delivery to the brain Samaha and Robinson Sativex has effect onset in 15—40 minutes, peaking in a few hours, quite a bit slower than drugs of high abuse potential.
It has been claimed that inclusion of CBD diminishes psychoactive effects of THC, and may lower potential drug abuse liability of the preparation see Russo b for discussion. Prior studies from Sativex clinical trials do not support the presence reinforcement or euphoria as problems in administration Wade et al Certain facets of acute cannabinoid exposure, including tachycardia, hypothermia, orthostatic hypotension, dry mouth, ocular injection, intraocular pressure decreases, etc.
No dose tolerance to the therapeutic effects of Sativex has been observed in clinical trials in over patient-years of administration. Additionally, therapeutic efficacy has been sustained for several years in a wide variety of symptoms; SAFEX studies in MS and peripheral neuropathic pain, confirm that Sativex doses remain stable or even decreased after prolonged usage Wade et al , with maintenance of therapeutic benefit and even continued improvement. Debate continues as to the existence of a clinically significant cannabis withdrawal syndrome with proponents Budney et al , and questioners Smith While symptoms recurred after 7—10 days of abstinence from Sativex, prior levels of symptom control were readily re-established upon re-titration of the agent Wade et al Overall, Sativex appears to pose less risk of dependency than smoked cannabis based on its slower onset, lower dosage utilized in therapy, almost total absence of intoxication in regular usage, and minimal withdrawal symptomatology even after chronic administration.
No known abuse or diversion incidents have been reported with Sativex to date as of November Cognitive effects of cannabis have been reviewed Russo et al ; Fride and Russo , but less study has occurred in therapeutic contexts.
Effects of chronic heavy recreational cannabis usage on memory abate without sequelae after a few weeks of abstinence Pope et al Studies of components of the Halstead-Reitan battery with Sativex in neuropathic pain with allodynia have revealed no changes vs placebo Nurmikko et al , and in central neuropathic pain in MS Rog et al , 4 of 5 tests showed no significant differences.
While the Selective Reminding Test did not change significantly on Sativex, placebo patients displayed unexpected improvement. Slight improvements were observed in Hospital Anxiety and Depression Scales depression and anxiety scores were noted with Sativex in MS patients with central neuropathic pain Rog et al , although not quite statistically significant.
No long-term mood disorders have been associated with Sativex administration. Debate continues with regard to the relationship between cannabis usage and schizophrenia reviewed Fride and Russo An etiological relationship is not supported by epidemiological data Degenhardt et al , but if present, should bear relation to dose and length of high exposure.
It is likely that lower serum levels of Sativex in therapeutic usage, in conjunction with anti-psychotic properties of CBD Zuardi and Guimaraes , would minimize risks.
Children and adolescents have been excluded from Sativex RCTs to date. SAFEX studies of Sativex have yielded few incidents of thought disorder, paranoia or related complaints. Adverse effects of cannabinoids on immune function have been observed in experimental animals at doses 50— times the psychoactive level Cabral In four patients using herbal cannabis therapeutically for over 20 years, no abnormalities were observed in leukocyte, CD4 or CD8 cell counts Russo et al Investigation of MS patients on Cannador revealed no major immune changes Katona et al , and similarly, none occurred with smoked cannabis in a short-term study of HIV patients Abrams et al Hematological measures have been normal in all Sativex RCTs without clinical signs of immune dysfunction.
Concerns are frequently noted with new drug-drug interactions, but few have resulted in Sativex RCTs despite its adjunctive use with opiates, many other psychoactive analgesic, antidepressant and anticonvulsant drugs Russo a , possibly due to CBD ability to counteract sedative effects of THC Nicholson et al Thus, Sativex should be safe to use in conjunction with other drugs metabolized via this pathway. The Sativex product monograph in Canada http: Given that THC is the most active component affecting such abilities, and the low serum levels produced in Sativex therapy vide supra , it would be logical that that patients may be able to safely engage in such activities after early dose titration and according to individual circumstances, much as suggested for oral dronabinol.
This is particularly the case in view of a report by an expert panel Grotenhermen et al that comprehensively analyzed cannabinoids and driving. Prior studies document that 4 rapid oromucosal sprays of Sativex greater than the average single dose employed in therapy produced serum levels well below this threshold Russo b. Sativex is now well established as a cannabinoid agent with minimal psychotropic effect.
These include anti-emetic effects, well established with THC, but additionally demonstrated for CBD Pertwee , the ability of THC and CBD to produce apoptosis in malignant cells and inhibit cancer-induced angiogenesis Kogan ; Ligresti et al , as well as the neuroprotective antioxidant properties of the two substances Hampson et al , and improvements in symptomatic insomnia Russo et al The degree to which cannabinoid analgesics will be adopted into adjunctive pain management practices currently remains to be determined.
Given their multi-modality effects upon various nociceptive pathways, their adjunctive side benefits, the efficacy and safety profiles to date of specific preparations in advanced clinical trials, and the complementary mechanisms and advantages of their combination with opioid therapy, the future for cannabinoid therapeutics appears very bright, indeed. National Center for Biotechnology Information , U. Ther Clin Risk Manag.
Author information Copyright and License information Disclaimer. This article has been cited by other articles in PMC. Abstract This article reviews recent research on cannabinoid analgesia via the endocannabinoid system and non-receptor mechanisms, as well as randomized clinical trials employing cannabinoids in pain treatment.
Introduction Chronic pain represents an emerging public health issue of massive proportions, particularly in view of aging populations in industrialized nations.
Cannabinoids and analgesic mechanisms Cannabinoids are divided into three groups. Open in a separate window. Molecular structures of four cannabinoids employed in pain treatment. Available cannabinoid analgesic agents and those in development Very few randomized controlled trials RCTs have been conducted using smoked cannabis Campbell et al despite many anecdotal claims Grinspoon and Bakalar Table 1 Results RCTs of cannabinoids in treatment of pain syndromes.
Practical issues with cannabinoid medicines Phytocannabinoids are lipid soluble with slow and erratic oral absorption. Broad experience with pain sparks search for relief [online] Short-term effects of cannabinoids in patients with HIV-1 infection. A randomized, placbo-controlled clinical trial. Cannabis in painful HIV-associated sensory neuropathy: Cannabinoids mediate analgesia largely via peripheral type 1 cannabinoid receptors in nociceptors.
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Anandamide acts as a vasodilator of dural blood vessels in vivo by activating TRPV1 receptors. Are oral cannabinoids safe and effective in refractory neuropathic pain?
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Enhancement of mu opioid antinociception by oral delta9-tetrahydrocannabinol: Dose-response analysis and receptor identification. Antinociceptive synergy between delta 9 -tetrahydrocannabinol and opioids after oral administration. Modulation of oral morphine antinociceptive tolerance and naloxone-precipitated withdrawal signs by oral Delta 9-tetrahydrocannabinol.
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Antihyperalgesic properties of the cannabinoid CT-3 in chronic neuropathic and inflammatory pain states in the rat. Potency trends of delta9-THC and other cannabinoids in confiscated marijuana from — Standardized cannabis extract in the treatment of postherpetic neuralgia: The separation of central from peripheral effects on a structural basis. Opiate, cannabinoid, and eicosanoid signaling converges on common intracellular pathways nitric oxide coupling.
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Schizophrenia, depression, and anxiety. Taylor and Francis; Affective, behavior and cognitive disorders in the elderly with chronic musculoskelatal pain: Isolation, structure and partial synthesis of an active constituent of hashish. J Am Chem Soc. International Cannabinoid Research Society; Cannabigerol behaves as a partial agonist at both CB1 and CB2 receptors; p. Flavonoids inhibit cytokine-induced endothelial cell adhesion protein gene expression.
Screening of plant extracts for new CB2-selective agonists revewals new players in Cannabis sativa ; p. IASP global year against pain in older persons: Cannabis vaporizer combines efficient delivery of THC with effective suppression of pyrolytic compounds. Comparative study of different essential oils of Bupleurum gibraltaricum Lamarck.
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