Randomized Laboratory Study of Single-Dose Cannabis, Dronabinol, and Placebo in Patients With Schizophrenia and Cannabis Use Disorder.

BACKGROUND AND HYPOTHESIS: Up to 43% of people with schizophrenia have a lifetime cannabis use disorder (CUD). Tetrahydrocannabinol (THC) has been shown to exacerbate psychosis in a dose-dependent manner, but little research has assessed its effects on schizophrenia and co-occurring CUD (SCZ-CUD). In this double-dummy, placebo-controlled trial (total n = 130), we hypothesized that a modest dose of THC would worsen cognitive function but not psychosis. STUDY DESIGN: Effects of single-dose oral THC (15 mg dronabinol) or smoked 3.5% THC cigarettes vs placebo in SCZ-CUD or CUD-only on positive and negative symptoms of schizophrenia (only for SCZ-CUD), cognition, and drug experiences assessed several hours after drug administration. SCZ-only and healthy control participants were also assessed. STUDY RESULTS: Drug liking was higher in THC groups vs placebo. Neither smoked THC nor oral dronabinol predicted positive or negative symptom subscale scores 2 and 5 h, respectively, after drug exposure in SCZ-CUD participants. The oral dronabinol SCZ-CUD group, but not smoked THC SCZ-CUD group, performed worse than placebo on verbal learning (B = -9.89; 95% CI: -16.06, -3.18; P = .004) and attention (B = -0.61; 95% CI: -1.00, -0.23; P = .002). Every 10-point increment in serum THC + THCC ng/ml was associated with increased negative symptoms (0.40 points; 95% CI: 0.15, 0.65; P = .001; subscale ranges 7-49) and trends were observed for worse positive symptoms and performance in verbal learning, delayed recall, and working memory. CONCLUSIONS: In people with SCZ-CUD, a modest single dose of oral THC was associated with worse cognitive functioning without symptom exacerbation several hours after administration, and a THC dose-response effect was seen for negative symptoms.

Use of cannabis and its derivates in chronic pain management: systematic review / Uso de cannabis e seus derivados no manejo da dor crônica: revisão sistemática

ABSTRACT BACKGROUND AND OBJECTIVES: Chronic pain is a clinical condition that affects an important part of the Brazilian and world population, significantly affecting their lives. The medicinal properties of Cannabis have been explored for millennia, but recently its use for the relief of chronic pain symptoms has increased. CONTENTS: A systematic review was carried out with the objective of evaluating the use of cannabis and its derivatives in the management of chronic pain, analyzing its potential side effects and safety. For this, the following databases were used: Pubmed, Embase, Cochrane Library and BVS, searching for studies published in the last 5 years, in Portuguese, Spanish or English, using MeSH descriptors and relevant free terms. Randomized, double-blind clinical trials with at least 10 participants in each comparison arm and with at least 2 weeks of intervention were included. After screening the authors, a quantitative analysis of 4 clinical trials (586 patients) was performed, which were analyzed for the outcomes of: patients with 50% or 30% reduction in pain intensity compared to baseline, improvement in pain intensity average pain, discontinuation due to adverse effects, serious adverse effects, and any adverse effects. CONCLUSION: The analysis did not yield high-quality evidence pertaining to the evaluation of efficacy, safety, or adverse effects associated with the use of cannabis-derived treatments in the management of chronic pain. Consequently, the formulation of recommendations or restrictions in these regards is not feasible, leaving the utilization of these therapeutic modalities subject to individual assessment.

RESUMO JUSTIFICATIVA E OBJETIVOS: A dor crônica é uma condição clínica que atinge parte importante da população brasileira e mundial, afetando significativamente a vida dessas pessoas. As propriedades medicinais da Cannabis vêm sendo exploradas por milênios, mas recentemente seu uso para alívio dos sintomas da dor crônica tem aumentado. CONTEÚDO: Foi conduzida uma revisão sistemática com o objetivo de avaliar o uso de cannabis e seus derivados no manejo da dor crônica, analisando seus potenciais efeitos adversos e sua segurança. Para isso, foram utilizadas as seguintes bases de dados: PubMed, Embase, Cochrane Library e BVS, buscando estudos publicados nos últimos 5 anos, nos idiomas português, espanhol ou inglês, utilizando os descritores MeSH e termos livres relevantes. Foram incluídos ensaios clínicos randomizados, duplos-cegos, com pelo menos 10 participantes em cada braço de comparação e com no mínimo 2 semanas de intervenção. Após a triagem dos autores, foi procedida a análise quantitativa de 4 ensaios clínicos (586 pacientes), que foram analisados para os desfechos de: pacientes com redução da intensidade da dor 50% ou 30% em relação à linha de base, melhora na intensidade média da dor, descontinuidade devido a efeitos adversos, efeitos adversos graves e qualquer efeito adverso. CONCLUSÃO: Não foram encontradas evidências de alta qualidade quanto à avaliação dos desfechos de eficácia, segurança ou de efeitos adversos relacionados ao uso de tratamentos derivados da cannabis no manejo de dor crônica, não podendo ser produzidas recomendações ou restrições nesses aspectos, ficando o uso dessas modalidades terapêuticas sujeito a análise individual.

DMSO potentiates the suppressive effect of dronabinol on sleep apnea and REM sleep in rats.

INTRODUCTION: Dimethyl sulfoxide (DMSO) is an amphipathic molecule with innate biological activity that also is used to dissolve both polar and nonpolar compounds in preclinical and clinical studies. Recent investigations of dronabinol, a cannabinoid, dissolved in DMSO demonstrated decreased sleep apnea frequency and time spent in REM sleep in rats. Here, we tested the effects of dronabinol dissolved in 25% DMSO diluted in phosphate-buffered saline (PBS) to rule out potentiating effects of DMSO. METHODS: Sprague-Dawley rats were anesthetized and implanted with bilateral stainless steel screws into the skull for electroencephalogram recording and bilateral wire electrodes into the nuchal muscles for electromyogram recording. Each animal was recorded by polysomnography. The study was a fully nested, repeated measures crossover design, such that each rat was recorded following each of 8 intraperitoneal injections separated by three days: vehicle (25% DMSO/PBS); vehicle and CB1 antagonist (AM 251); vehicle and CB2 antagonist (AM 630); vehicle and CB1/CB2 antagonist; dronabinol (CB1/CB2 agonist); dronabinol and CB1 antagonist; dronabinol and CB2 antagonist; and dronabinol and CB1/CB2 antagonists. Sleep was manually scored into NREM and REM stages, and sleep apneas were quantified. RESULTS: Dronabinol dissolved in 25% DMSO did not suppress sleep apneas or modify sleep efficiency compared to vehicle controls, in contrast to previously published results. However, dronabinol did suppress REM sleep, which is in line with previously published results. CONCLUSIONS: Dronabinol in 25% DMSO partially potentiated dronabinol's effects, suggesting a concomitant biological effect of DMSO on breathing during sleep.

Pronounced State-Level Disparities in Prescription of Cannabinoids to Medicaid Patients.

Introduction: Dronabinol is approved in the USA for chemotherapy-induced nausea as well as vomiting and HIV-induced anorexia, while cannabidiol is primarily approved for childhood epileptic disorders Lennox-Gastaut and Dravet syndrome. The use pattern for these prescription cannabinoids in the USA is unknown. This study examined Medicaid claims for two FDA-approved prescription cannabinoids, dronabinol and cannabidiol, approved in 1985 and 2018, respectively, from 2016-2020 to better understand the pharmacoepidemiologic trends and distribution of these drugs in US Medicaid amidst the increasing use of non-pharmaceutical formulations of cannabis. Methods: The longitudinal study analyzed Medicaid prescription claims that were calculated by extracting the prescriptions on a state level from 2016 to 2020 for two cannabinoids, dronabinol and cannabidiol, where outcomes over each year were calculated. Outcomes were (1) the number of prescriptions for each state corrected for the number of Medicaid enrollees and (2) dronabinol and cannabidiol spending. Spending refers to the amount reimbursed by the state Medicaid program. Results: Dronabinol prescriptions per state decreased by 25.3% from 2016 to 2020, while cannabidiol prescriptions increased by 16,272.99% from 2018 to 2020. The spending on these drugs parallels that of their prescription trend with a 66.3% decrease in reimbursement for dronabinol ($5.7 million in 2020), whereas cannabidiol increased by +26,582.0% ($233.3 million in 2020). Dronabinol prescriptions, when corrected for the number of enrollees, in Connecticut were 136.4 times larger than in New Mexico, and seventeen states had zero prescriptions. Idaho's prescriptions of cannabidiol (27.8/10,000 enrollees) were significantly elevated relative to the national average and were 15.4-fold higher than Washington, DC (1.8/10K enrollees). Conclusions: The prescriptions of pharmaceutical-grade tetrahydrocannabinol decreased while those of cannabidiol increased. This study also identified pronounced state-level variation in cannabinoid prescribing to Medicaid patients. State formularies and prescription drug list variation may contribute to the drug reimbursements in Medicaid, though further research is needed to identify the health policy or pharmacoeconomic origins of these disparities.

Evaluation of morphine, methadone, digoxin, and dronabinol poisoning during the years 2017 to 2019 in Ilam, Iran.

Background: Every year, drug poisoning is the most prevalent reason for referring patients to medical centers. This study aimed to evaluation of morphine, methadone, digoxin, and dronabinol poisoning in Shahid Mostafa Khomeini Hospital in Ilam. Methods: In this In this Cross-sectional study, patient samples suspected of morphine, methadone, digoxin, and dronabinol poisoning referred to the toxicology laboratory of Ilam University of Medical Sciences were analyzed using the HPLC method, and the results were analysed using SPSS software. Results: Results showed that the percentage of drug use is greater in men than in women. The highest percentage of morphine and methadone poisonings were detected in those under the age of 40, whereas the highest percentage of digoxin poisonings were recorded in those over the age of 80. As a result, the average age of digoxin users was substantially greater in men than in women. Methadone consumers showed significantly greater blood levels than others. In addition, there was a significant difference (P<0.01) in blood levels between men and women who used morphine. Conclusion: In general, it is important to understand the status of drug poisoning with drugs such as morphine, methadone, digoxin, and dronabinol, as well as the prognosis associated with the treatment process of such poisoning.

Treating nightmares in posttraumatic stress disorder with dronabinol: study protocol of a multicenter randomized controlled study (THC PTSD-trial).

BACKGROUND: Distressing nightmares are a core symptom of posttraumatic stress disorder (PTSD) and contribute to psychiatric comorbidity, impaired physical health and decreased social functioning. No specific pharmacological treatment for PTSD-related nightmares is yet approved. Preliminary clinical data indicate that cannabinoid agonists can improve nightmares and overall PTSD symptoms in patients with PTSD. The primary objective of the study is to examine the efficacy of oral dronabinol (BX-1) versus placebo in reducing nightmares in patients with PTSD. The secondary objectives of the study are to examine the efficacy of oral BX-1 in reducing other PTSD symptoms. METHODS: The study is designed as a multi-centric, double-blind, randomized (1:1), placebo-controlled, parallel group interventional trial. Eligible patients will be randomized to BX-1 or placebo, receiving a once-daily oral dose before bedtime for 10 weeks. Primary efficacy endpoint is the Clinician-Administered PTSD Scale (CAPS-IV) B2 score for the last week, measuring frequency and intensity of nightmares. Secondary efficacy endpoints are other disorder-specific symptoms in patients with PTSD. Further, tolerability and safety of dronabinol will be assessed. DISCUSSION: This randomized controlled trial will provide evidence whether treating patients with PTSD and nightmares with dronabinol is safe and efficacious. TRIAL REGISTRATION: NCT04448808, EudraCT 2019-002211-25.

Preliminary study of the interactive effects of THC and ethanol on self-reported ability and simulated driving, subjective effects, and cardiovascular responses.

RATIONALE: Drug- and alcohol-related motor vehicle accidents are a leading cause of morbidity and mortality worldwide. Compared to alcohol, less is known about the effects of cannabis on driving and even less about their combined effects. OBJECTIVE: To characterize the combined and separate effects of ethanol and tetrahydrocannabinol (THC) on perceived ability to drive, subjective effects, and simulated driving. METHODS: In a within-subject (crossover), randomized, placebo-controlled, double-blind, 2 × 2 design, the effects of oral THC (10 mg [dronabinol] or placebo) and low-dose intravenous ethanol (clamped at BAC 0.04% or placebo) on perceived ability to drive, simulated driving (standard deviation of lateral position [SDLP]), subjective effects (e.g., "high"), and physiological effects (e.g., heart rate) were studied in healthy humans (n = 18). RESULTS: Subjects reported reductions in perceived ability to drive (THC < ethanol < combination) which persisted for ~ 6 h (placebo = ethanol, THC < combination). Ethanol and THC produced synergistic effects on heart rate, significant differences compared to either drug alone on perceived ability to drive and feeling states of intoxication (e.g., high), as well increases in SDLP compared to placebo. CONCLUSIONS: Perceived ability to drive is reduced under the influence of THC against the backdrop of blood alcohol levels that are below the legal limit. People should be aware that the effects of oral THC on driving may persist for up to six hours from administration. Findings are relevant to the increasingly common practice of combining alcohol and cannabinoids and the effects on driving.

Evidence from Human Studies for Utilising Cannabinoids for the Treatment of Substance-Use Disorders: A Scoping Review with a Systematic Approach.

Substance-use disorders are pervasive, comorbid with a plethora of disease and possess limited treatment options. Medicinal cannabinoids have been proposed as a novel potential treatment based on preclinical/animal trials. The objective of this study was to examine the efficacy and safety of potential therapeutics targeting the endocannabinoid system in the treatment of substance-use disorders. We performed a scoping review using a systematic approach of systematic reviews, narrative reviews, and randomised control trials that utilised cannabinoids as treatment for substance-use disorders. For this scoping review we used the PRISMA guidelines, a framework for systematic reviews and meta-analyses, to inform our methodology. We conducted a manual search of Medline, Embase, and Scopus databases in July 2022. Of the 253 results returned by the databases, 25 studies including reviews were identified as relevant, from which 29 randomised controlled trials were derived and analysed via a primary study decomposition. This review captured a small volume of highly heterogenous primary literature investing the therapeutic effect of cannabinoids for substance-use disorders. The most promising findings appeared to be for cannabis-use disorder. Cannabidiol appeared to be the cannabinoid showing the most promise for the treatment of multiple-substance-use disorders.

A review of the efficacy of appetite stimulating medications in hospitalized adults.

BACKGROUND: The majority of evidence on efficacy of appetite-stimulating medications is limited to specific populations and the outpatient treatment setting. However, hospitalized adults remain at risk for poor appetite and inadequate intake. METHOD: The purpose of this review was to assess recent evidence on the efficacy of dronabinol, megestrol acetate, and mirtazapine (used to stimulate appetite) on promoting change in intake; somatic symptoms, such as appetite and nausea; and weight change during hospital stay. The population was limited to hospitalized adults or adults who demonstrated a need for appetite stimulation during hospitalization. RESULTS: Of the 382 articles screened, four met inclusion criteria (one randomized control trial, two retrospective cohort studies, and one retrospective case series). Based on the studies included, these appetite stimulants have limited efficacy on improving appetite and meal intake. There was no significant change in weight. CONCLUSION: Current data lack standardization, generalizability, and comparability, and higher quality evidence is needed before conclusions can be identified on the efficacy of dronabinol, megestrol acetate, and mirtazapine in the inpatient setting.

Dronabinol as an answer to flavivirus infections: an in-silico investigation.

Flavivirus infections are common in several parts of the world. Two major types of flaviviruses are dengue and zika viruses. Both these two viral infections have caused many fatalities around the world. There is an absence of a vaccine and an effective medication against these viruses. In this study, we analyzed the ability of dronabinol to act as a potential cure against these viral infections. We performed the docking of dronabinol with several viral proteins followed by molecular dynamics simulation, MM/PBSA and PCA analysis. We checked the ability of the polyphenol dronabinol to interfere with the binding of viral helicases to their cellular targets. We performed 2 D-QSAR studies, drug likeliness, ADMET and target prediction studies. From our study, we observed that dronabinol had the best docking ability against the helicase proteins of dengue and zika. Molecular dynamics simulation and MM/PBSA investigation confirmed the stability of the binding while PCA investigation showed a lowering of molecular motions in response to dronabinol docking to the helicases. Dronabinol interfered in the binding of the helicases to RNA. 2 D QSAR studies revealed a low IC50 value for dronabinol. Dronabinol showed favorable drug-likeness, ADMET properties and target prediction results. Thus we propose dronabinol be further investigated in-vitro as a cure against dengue and zika virus infections.Communicated by Ramaswamy H. Sarma.

[Use of dronabinol in the treatment of resistant neuropathic pain: Feedback from patients followed in a multidisciplinary pain center]. / Utilisation du dronabinol dans le traitement des douleurs neuropathiques réfractaires : retour d'expérience des patients suivis dans un Centre d'évaluation et de traitement de la douleur.

INTRODUCTION: Dronabinol is a drug composed of synthetic delta-9-tetrahydrocannabinol. In France, dronabinol requires a named Temporary Utilisation Authorisation (TUA), for the treatment of refractory neuropathic pain. Few data currently exist concerning its efficacy and tolerance. We present our feedback on its use for chronic pain patients, the multidisciplinary supervision and the monitoring set up by the clinical pharmacist. METHOD: This retrospective monocentric study presents Patients Global Impression of Change and tolerance data from patients treated with dronabinol in a pain center between October 2020 and July 2021. We present their satisfaction towards the care process. RESULTS: Nineteen patients were treated with dronabinol during the study period. - The clinical pharmacist issued 180 advices for patients and doctors. Patients reported a positive impact of the telephone follow-up carried out by the clinical pharmacist. - 75% (n=9/12) of patients who continued treatment for more than 3 months reported improvement in their health. - 74% (n=14/19) of patients had at least one adverse event, six patients needed to discontinue the treatment. DISCUSSION-CONCLUSION: Dronabinol represents an alternative that can improve the quality of life of some patients suffering from refractory neuropathic pain. Nevertheless, as with any medicine, its initiation requires a rigorous evaluation of the benefit-risk balance. The close collaboration between the physician and the clinical pharmacist allows a secure management patients and makes this complex drug circuit easer.

Cannabinoids in hyperhidrosis.

Hyperhidrosis can significantly curtail patient quality of life, from debilitating physical symptoms to social stigmatization and reduced life opportunities. Current treatments often prove unsatisfactory, especially in sufferers of generalized hyperhidrosis. In this open trial, we present the case of a refractory generalized hyperhidrosis treated with cannabinoids. We found a remarkable reduction in the volume of sweat and an improvement to the patient's quality of life using this novel low-cost and low-impact approach.

Cannabinoid-Associated Hyperemesis Syndrome Treated With Dronabinol: Killing a Poison With the Poison.

Cannabinoid hyperemesis syndrome (CHS) is a medical condition characterized by recurrent nausea, vomiting, and abdominal pain in individuals who frequently use cannabis. This case report highlights the successful treatment of CHS using dronabinol, a synthetic cannabinoid compound. A 21-year-old female presented with severe abdominal symptoms, including vomiting and pain, alongside a history of chronic cannabis use. Despite initial symptomatic treatment, her symptoms persisted. After being diagnosed with CHS, the patient was administered one dose of haloperidol, which led to agitation and worsening of her symptoms. Eventually, she was given one dose of dronabinol resulting in significant symptom improvement. Subsequent doses of dronabinol led to the complete resolution of her CHS symptoms. This case underscores the importance of thorough history-taking, especially for complex patients. Also, with cannabis legalization, cases of CHS are on the rise, and widespread awareness is vital for healthcare practitioners to recognize and appropriately manage nausea and vomiting induced by long-term cannabis intake. Although this case provides valuable insights, its limitations emphasize the need for further research to establish evidence-based guidelines for CHS management.

Controversial Link between Cannabis and Anticancer Treatments-Where Are We and Where Are We Going? A Systematic Review of the Literature.

BACKGROUND AND OBJECTIVES: Cannabinoids are currently used in cancer patients primarily for their pain-relieving and antiemetic properties. The aim of our review was to synthesize all available data of studies evaluating the therapeutic efficacy of cannabis in combination with oncological treatments in cancer patients and to explore ongoing studies with different goals and medical areas registered in the field of oncology worldwide. MATERIALS AND METHODS: This study was performed in accordance with the PRISMA guidelines. A search using MEDLINE/PubMed database was performed between 1 January 2006 and 1 March 2022. Search terms included the following: cannabidiol, cannabis, CBD, dronabinol, endocannabinoids, medical marijuana, nabiximols, nabilone, THC, and cancer. All studies that examined the efficacy of cannabis administered during oncological treatments, regardless of cancer localization, subtype, and sample size, were considered eligible. RESULTS: In three studies, cannabis was administered to patients with glioblastoma, and in two other studies, cannabis was used in combination with immunotherapy in various cancer subgroups. The results of the clinical trials in cancer patients are not sufficient to draw conclusions at this time. Interestingly, several other studies addressing the systemic effects of cannabinoids in cancer patients are currently listed in the U.S. National Library of Medicine's registry on the ClinicalTrials.gov website. However, only one of the registered studies examined the efficacy of cannabinoids as a potential option for systemic cancer treatment. CONCLUSIONS: Although cannabis is touted to the public as a cancer cure, clinical trials need to clarify which combinations of chemotherapeutic agents with cannabinoids are useful for cancer patients.

[Characterization of the problem of the therapeutic use of Cannabis Oil in Córdoba, Argentina]. / Caracterización de la problemática del uso terapéutico del Aceite de Cannabis en Córdoba, Argentina.

Introduction: The therapeutic use of the "cannabis" oil is a social problem that puts legal, health, scientific and cultural aspects under stress. Difficulty in access generates an emptiness exploited by the illegal market, to which patients and relatives resort to improve their health and quality of life. These oils, with unknown chemical composition, are used without therapeutic follow-up. An interdisciplinary team from the Universidad Nacional de Córdoba (UNC) started the study of this problem with the aim of characterizing the socio-therapeutic use of "cannabis" oil in Córdoba and establishing a relationship with the real content of cannabinoids. Methodology: Observational-descriptive and cross-sectional study approved by the Comité Institucional de Ética de las Investigaciones en Salud, Hospital Nacional de Clínicas from UNC (CIEIS-HNC-UNC): interviews with patients/caregivers of legal age who used the "cannabis" oil (year 2019). Experimental study: analysis of oil samples obtained from interviewees to determine their cannabinoid content, specifically delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD), by High Performance Liquid Chromatography analysis (HPLC). Results: thirty-seven interviews were conducted, and 48 samples were analysed. The 73% were adults and older adults. The 92% started using the oil without prescription or medical suggestion, mainly due to the lack of effectiveness of other therapies (54%) and in the search for therapeutic alternatives (33%). The 84% perceived it to be effective (moderate to highly effective), and 78% reported no adverse events. Main uses: refractory epilepsy 27% and arthritis/arthrosis 24%. Fifteen percent of the samples showed no quantifiable content of CBD and THC, and 67% had only THC. The quantifiable content of cannabinoids was very low. Conclusions: This work allowed carrying out a preliminary information-gathering on several aspects (social and therapeutic) about the use of "cannabis" oil in Córdoba, and to analyze the chemical quality of the oils consumed. An important finding was the discrepancy between the effectiveness perceived by users and the low cannabinoid content detected.

Introducción: El uso terapéutico del aceite de "cannabis" es una problemática social que pone en tensión aspectos legales, sanitarios, científicos y culturales. La dificultad en el acceso genera un vacío aprovechado por el mercado ilegal, al que recurren pacientes y familiares para mejorar su salud y calidad de vida. Estos aceites, de composición química desconocida, se emplean sin un seguimiento terapéutico. Un equipo interdisciplinario de la UNC se involucró en esta problemática con el objetivo de aportar elementos para su caracterización en nuestro medio. Metodología: Estudio observacional-descriptivo y transversal (aprobado por el CIEIS-HNC-UNC): entrevistas a pacientes/cuidadores mayores de edad que usaban el aceite (2019). Estudio experimental: análisis de muestras de aceites de los entrevistados para determinar su contenido de cannabinoides (THC y CBD), mediante HPLC. Resultados: Se realizaron 37 entrevistas y analizaron 48 muestras. El 73% fueron adultos y adultos-mayores. El 79% empiezan a usar el aceite por recomendación de parientes/amigos o por iniciativa propia, principalmente por falta de efectividad de otras terapias (54%) y por búsqueda de alternativas (33%). El 84% lo percibe efectivo (moderado-muy efectivo) y el 78% no manifestó eventos adversos. Usos principales: epilepsia refractaria 27% y artritis/artrosis 24%. El 15% de las muestras no presentaron contenidos cuantificables de CBD y THC, y el 67% presentó THC sin CBD. El contenido de cannabinoides cuantificables fue muy bajo. Conclusiones: Se obtuvo una aproximación sobre el uso terapéutico del aceite de "cannabis" en Córdoba y su calidad. Se observó discrepancia entre la efectividad percibida y el bajo contenido de cannabinoides detectados.

Comparison of the Effectiveness and Tolerability of Nabiximols (THC:CBD) Oromucosal Spray versus Oral Dronabinol (THC) as Add-on Treatment for Severe Neuropathic Pain in Real-World Clinical Practice: Retrospective Analysis of the German Pain e-Registry.

PURPOSE: To compare the effectiveness and tolerability of add-on treatment with nabiximols (NBX: delta-9-tetrahydrocannabinol: cannabidiol) oromucosal spray or oral dronabinol (DRO: synthetic tetrahydrocannabinol) in patients with severe neuropathic pain poorly responsive to established treatments. METHODS: An analysis was conducted of anonymized, propensity score-matched real-world data from the German Pain e-Registry, using a sequential non-inferiority superiority approach, for adult outpatients with neuropathic pain who had initiated treatment with NBX or DRO between 10 March 2017 and 31 December 2019. The primary effectiveness variable was percent change from baseline in a 9-factor aggregated symptom relief (ASR-9) score, a composite index of nine distinct pain- and health-related parameters assessed using validated patient-reported instruments. Safety was assessed by the incidence of physician-confirmed treatment-related adverse events (TRAEs), and TRAEs leading to discontinuation. RESULTS: Propensity score-matched data were analyzed for 337 patients treated with NBX and 337 patients treated with DRO. Mean (standard deviation) THC dose over the 24-week evaluation period was 16.6 (6.5) mg for NBX and 17.2 (7.6) mg for DRO (p<0.001). Median (standard error) improvement relative to baseline in the ASR-9 composite score was 55.4% (0.5) for NBX and 40.5% (0.5) for DRO (least squares mean difference, 14.0 (0.7), 95% confidence interval 12.6-15.4; p<0.001), and incidences of TRAEs (21.1 vs 35%) and TRAE-related discontinuations (5.9 vs 14.8%) were significantly lower with NBX than DRO (p<0.001 for both), collectively indicating pre-specified non-inferiority and superiority of NBX. More NBX- than DRO-treated patients discontinued non-cannabinoid background pain medications and rescue analgesics, especially opioid analgesics (p<0.001 for both). CONCLUSION: Add-on treatment with cannabinoids is effective for treatment of severe neuropathic pain with inadequate response to established treatments. In daily practice, NBX had superior effectiveness and tolerability compared to DRO. The results emphasize the importance of combining CBD with THC in this patient population.