Chronic Pain Treatment With Cannabidiol in Kidney Transplant Patients in Uruguay

Cuñetti, L.; Manzo, Lawaly Maman; Peyraube, R.; Arnáiz, Javier; Curi, L; Orihuela, Sergio

doi:10.1016/j.transproceed.2017.12.042

Cited by 67 publications

(57 citation statements)

References 28 publications

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“…20 Comparatively, our subject received a significantly higher dose of CBD (up to 25 mg/kg/day). 20 Comparatively, our subject received a significantly higher dose of CBD (up to 25 mg/kg/day).…”

Section: Discussionmentioning

confidence: 88%

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Evidence of a clinically significant drug-drug interaction between cannabidiol and tacrolimus

Leino

Emoto

Fukuda

et al. 2019

American Journal of Transplantation

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Cannabidiol (CBD), a major purified nonpsychoactive component of cannabis with anticonvulsant properties, was approved by the U.S. Food and Drug Administration (FDA) in June 2018 as an adjuvant treatment for refractory epilepsy (Epidiolex; GW Pharmaceuticals). CBD is metabolized by cytochrome P450 (CYP)3A4 and CYP2C19 with a growing body of evidence suggesting it is also a potent inhibitor of these pathways. We report for the first time a significant drug‐drug interaction between the purified CBD product and tacrolimus. A participant in a CBD clinical trial for epilepsy who was also receiving tacrolimus showed an approximately 3‐fold increase in dose‐normalized tacrolimus concentrations while receiving 2000‐2900 mg/day of CBD. Our report delineates an important concern for the transplant community with the increasing legalization of cannabis and advent of an FDA‐approved CBD product. Larger studies are needed to better understand the impact of this drug‐drug interaction in solid organ transplant recipients.

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Section: Discussionmentioning

confidence: 88%

“…Only one patient experienced an increase in Scr attributed to the elevated trough level. 20 Comparatively, our subject received a significantly higher dose of CBD (up to 25 mg/kg/day). As mentioned, a limitation of this report is the lack of CBD pharmacokinetic data.…”

Section: Discussionmentioning

confidence: 88%

Evidence of a clinically significant drug-drug interaction between cannabidiol and tacrolimus

Leino

Emoto

Fukuda

et al. 2019

American Journal of Transplantation

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“…However, the Joint FAO/WHO Expert Committee on Food Additives (JECFA) recommended the acceptable daily intake of Tween-20 without any side effects to be 25 mg/kg body weight. Since the effective CBD dose used to treat chronic pain in humans is 100 mg/day [34], the dose of Tween-20 contained in the prepared CBD-NE (70% ratio for Tween-20) can be calculated to be 20.2 mg/kg/day for a 70-kg human, which is less than the above-mentioned acceptable daily intake value (25 mg Tween-20/kg), assuming that the bioavailability of CBD was increased by the NE formulation by 65%.…”

Section: Discussionmentioning

confidence: 99%

Development of a Novel Nanoemulsion Formulation to Improve Intestinal Absorption of Cannabidiol

Nakano

Tajima

Sugiyama

et al. 2019

Med Cannabis Cannabinoids

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Background: Cannabidiol (CBD) is highly lipophilic, and its oral bioavailability is known to be very low in humans. In this study, we developed a novel nanoemulsion preparation of CBD (CBD-NE) to improve the poor solubility and absorption of CBD. The pharmacokinetic profiles of CBD in rats were evaluated after oral administrations of CBD oil and CBD-NE, and the effect of bile secretion on CBD absorption was also evaluated. Methods: The CBD-NE formulation developed in this study consisted of vitamin E acetate, ethanol, Tween-20, and distilled water (1.7/3.8/70/24.5, w/w%). A CBD oil formulation (CBD oil, control) 100 mg/kg or CBD-NE 50 mg/kg was orally administered to rats, and the blood samples were collected over time. Moreover, the CBD oil or CBD-NE was orally administered to bile-fistulated rats, and the pharmacokinetic profiles of CBD were also evaluated. CBD concentrations in plasma were measured using LC-MS/MS. Results: The particle size of CBD-NE was 35.3 ± 11.8 nm. Mean T_max of CBD-NE was shortened significantly by the factor of 3 (from 8.00 to 2.40 h, p < 0.001) and AUC_0–_∞/dose increased by 65% (from 0.272 ± 0.045 to 0.448 ± 0.087 h L/kg) compared with CBD oil. AUC_0–_∞/dose and C_max/dose after oral administration of CBD oil were significantly reduced by the factor of 27 and 23 (p < 0.05 and p < 0.01), respectively, in bile-fistulated rats compared with the untreated rats. In contrast, all pharmacokinetic parameters after oral administration of CBD-NE were not significantly different between the untreated and bile-fistulated rats. Therefore, these results demonstrated that conventional CBD oil formulation but not CBD-NE requires bile-mediated micelle formation. Conclusions: The novel NE formulation developed in this study successfully improved the absorption of CBD regardless of bile secretion. The newly developed oral CBD-NE preparation could be useful to achieve a more stable and quicker onset of action by CBD.

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“…Patients (n = 7; age range, 58-75 years) with renal transplant asking for pain relief received increasing doses of oral CBD 50 to 150 mg twice a day for 3 weeks. 55 Two patients had total pain improvement, 4 had a partial response in the first 15 days, and 1 had no change. No statistical tests were applied.…”

Section: Pain and Spasticitymentioning

confidence: 94%

“…The studies assessing CBD alone for pain relief are scant, and 2 of 3 use methodologies with weak strength of evidence. 54,55 An open-label, single-arm study investigated the short-term effect of CBD-enriched hemp oil for relieving symptoms and improving the quality of life in young girls (n = 12; age range, 12-24 years) with significant somatoform psychological and chronic pain as a result of the human papillomavirus vaccine. 54 Pain issues included chronic headache, fibromyalgia, arthralgia, myalgia, and gastrointestinal pain among the girls.…”

Section: Pain and Spasticitymentioning

confidence: 99%

A Review of Human Studies Assessing Cannabidiol's (CBD) Therapeutic Actions and Potential

White

2019

The Journal of Clinical Pharma

191

142

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Cannabidiol (CBD) is a highly touted product for many different disorders among the lay press. Numerous CBD products are available, ranging from a US Food and Drug Administration (FDA)-approved product called Epidiolex to products created for medical marijuana dispensaries and products sold in smoke shops, convenience stores, and over the Internet. The legal status of the non-FDA-approved products differs depending on the source of the CBD and the state, while the consistency and quality of the non-FDA-approved products vary markedly. Without independent laboratory verification, it is impossible to know whether the labeled CBD dosage in non-FDA-approved CBD products is correct, that the delta-9-tetrahydrocannabinol content is <0.3%, and that it is free of adulteration and contamination. On the Internet, CBD has been touted for many ailments for which it has not been studied, and in those diseases with evaluable human data, it generally has weak or very weak evidence. The control of refractory seizures is a clear exception, with strong evidence of CBD's benefit. Acute CBD dosing before anxiety-provoking events like public speaking and the chronic use of CBD in schizophrenia are promising but not proven. CBD is not risk free, with adverse events (primarily somnolence and gastrointestinal in nature) and drug interactions. CBD has been shown to increase liver function tests and needs further study to assess its impact on suicidal ideation.

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Chronic Pain Treatment With Cannabidiol in Kidney Transplant Patients in Uruguay

Cited by 67 publications

References 28 publications

Evidence of a clinically significant drug-drug interaction between cannabidiol and tacrolimus

Evidence of a clinically significant drug-drug interaction between cannabidiol and tacrolimus

Development of a Novel Nanoemulsion Formulation to Improve Intestinal Absorption of Cannabidiol

A Review of Human Studies Assessing Cannabidiol's (CBD) Therapeutic Actions and Potential

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Chronic Pain Treatment With Cannabidiol in Kidney Transplant Patients in Uruguay

Cited by 67 publications

References 28 publications

Evidence of a clinically significant drug-drug interaction between cannabidiol and tacrolimus

Evidence of a clinically significant drug-drug interaction between cannabidiol and tacrolimus

Development of a Novel Nano­emulsion Formulation to Improve Intestinal Absorption of Cannabidiol

A Review of Human Studies Assessing Cannabidiol's (CBD) Therapeutic Actions and Potential

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Product

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Development of a Novel Nanoemulsion Formulation to Improve Intestinal Absorption of Cannabidiol