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Pharmacy must pay $9.5 million for prescription fraud

S. Ana Crippa C.



  • S. Ana Crippa C.
  • Publicações ano 2014
  • Introduction
  • Ana Crippa's 12 research works with 14 citations and reads, including: Ana Crippa has expertise in Psychology and Engineering. Ana C S Crippa; [ ]. Full Remission after Switching to Purified Cannabidiol. José A. S. Crippa,1,* Ana C. S. Crippa,2 Jaime E. C. Hallak,1 Rocio Martín-Santos,1,3. Cannabidiol's anti-anxiety (Zuardi et al., , ; Crippa et al., . Crippa J. A., Zuardi A. W., Garrido G. E., Wichert-Ana L., Guarnieri R., Ferrari L., et al. . [ CrossRef]; Spielberger C. D., Gorsuch R. L., Lushene R. E. ().

    S. Ana Crippa C.

    Niemann-Pick disease type C: Arquivos de Neuro-Psiquiatria Impresso , v. The natural history of MPS I: Genetics in Medicine, v. A new approach for the screening of females in high-risk groups. Lysosomal enzymes may cross the blood-brain-barrier by pinocytosis: Implications for Enzyme Replacement Therapy. Gene delivery strategies for the treatment of mucopolysaccharidoses.

    Expert Opinion on Drug Delivery Print , v. The aim of the present study was to evaluate the effect of a clinically anxiolytic dose of CBD on the sleep-wake cycle of healthy subjects in a crossover, double-blind design. Twenty-seven healthy volunteers that fulfilled the eligibility criteria were selected and allocated to receive either CBD mg or placebo in the first night in a double-blind randomized design one volunteer withdrew from the study.

    In the second night, the same procedure was performed using the substance that had not been administered in the previous occasion. CBD or placebo were administered 30 min before the start of polysomnography recordings that lasted 8 h. Cognitive and subjective measures were performed immediately after polysomnography to assess possible residual effects of CBD. Different from anxiolytic and antidepressant drugs such as benzodiazepines and selective serotonin reuptake inhibitors, acute administration of an anxiolytic dose of CBD does not seem to interfere with the sleep cycle of healthy volunteers.

    The present findings support the proposal that CBD do not alter normal sleep architecture. Future studies should address the effects of CBD on the sleep-wake cycle of patient populations as well as in clinical trials with larger samples and chronic use of different doses of CBD.

    Such studies are desirable and opportune. Cannabidiol CBD , one of the major compounds of Cannabis sativa , has been shown to have several therapeutic effects including antipsychotic Zuardi et al. Cannabidiol may play a therapeutic role in sleep regulation Monti, ; Chagas et al. In healthy volunteers with regular sleep cycle, mg of CBD induced sedative effects Zuardi et al. More recently, Chagas et al. After discontinuation of the drug, the frequency of symptoms returned to baseline levels, prior to treatment with CBD.

    Finally, CBD-enriched extract was described as a safe treatment for reducing anxiety and improving sleep in a young girl with post-traumatic stress disorder Shannon and Opila-Lehman, Although some studies have demonstrated the potential effect of CBD on sleep behavior, research about the effects of CBD on the slow wave sleep SWS of humans with regular sleep is still lacking.

    The impact of CBD on sleep, possible side-effects or the advantages of lack of them, including objective measures through polysomnography, has not yet been investigated.

    Thus, the objective of the present study was to assess the effect of the acute administration of an anxiolytic dose mg, Zuardi et al.

    Initially, individuals who were interested in participating were evaluated, of whom were excluded in the recruitment interview which contained questions about clinical data, demographics, psychiatric symptoms, sleep patterns, among others. CBD — placebo matched in terms of sex, age, and years of education. To ensure the adequacy of the matching procedure, one participant of each pair had his treatment blindly chosen between the two treatment options available and the other participant matched to the first one was assigned to the remaining option.

    Schematic representation of the participants selection and of the protocol — this was a four period crossover study. The exclusion criteria for the trial were: Thus, the volunteers were all non-smokers and had not taken any medications for at least 3 months before the study. Moreover, none of them had used marijuana more than five times in their lives no use in the last year and none had ever used any other illegal drug.

    The following instruments were used: The apparatus used for the polysomnography exams consisted of different devices including electroencephalogram with the international 10—20 system to rule out the occurrence of epileptic seizures , electrooculogram, electromyogram of chin muscles and upper and lower limbs, nasal pressure cannula, oral thermistor, thoracic and abdominal respiratory inductive plethysmography straps, pulse oximetry, electrocardiogram, and snoring and body position sensors.

    Video and sound were also recorded during the exam. Sleep stages were recorded in periods of 30 s, according to the criteria established by Rechtschaffen and Kales The following polysomnographic parameters were evaluated: Cannabidiol mg , The same amount of corn oil was used as placebo.

    The drug and placebo were packed in identical gelatin capsules. The mg dose was chosen based on previous studies that detected the acute anxiolytic effect of this dose Zuardi et al.

    The time of drug delivery was based on previous studies that showed that the peak plasma concentration of an oral dose of CBD normally occurs 1—2 h after ingestion Agurell et al. Subjects were instructed to abstain from alcohol for 24 h and caffeine for at least 24 h before each visit to the laboratory. Subjects who reported having less than 6 h of sleep the previous night were excluded from the trial.

    After at least 8 h of fasting, subjects were instructed to have a light, standardized meal 2 h before the experiment. For the present study, a randomized, double blind, and crossover model was used. Once one volunteer gave up participating the study, the 26 participants were assessed on two different occasions, in a 2-week interval, with identical procedures except for the substance that was administered.

    In each visit, participants were first submitted to a cognitive and subjective evaluation, then an oral dose of CBD mg or placebo was administered 30 min before the polysomnographic recordings began. Polysomnography recordings were performed over 8 h. The Kolmogorov-Smirnov test was used to check for normality. Non-parametric Wilcoxon or Friedman tests analyzed results that failed this test.

    A preliminary analysis indicated no gender effect; thus, the factors analyzed were drug, order of drug administration placebo-CBD versus CBD-placebo , and the interaction between drug and phase. A three-way repeated-measures ANOVA was employed to analyze data throughout the three phases of each exam. In cases where sphericity conditions were not reached, the degrees of freedom of the repeated factor were corrected with the Huynh-Feldt epsilon.

    The results are presented according to the seven components assessed in the PSQI. The data obtained in the seven components and the total PSQI score are indicative of good sleep quality. Total PSQI scores greater than five suggest difficulties in at least two components or moderate difficulties in more than three components Buysse et al. The comparative analyses between CBD and placebo indicate that none of the parameters evaluated presented statistically significant changes.

    To check if this interaction could have potentially interfered with the results, we split the subjects, comparing the placebo and CBD groups separately in the two orders first placebo or CBD. Again, there was no difference between groups in the two situations.

    We found no significant differences in polysomnography results following the administration of CBD and placebo to healthy volunteers. Likewise, there were no statistically significant changes in the subjective and cognitive measures collected during the two nights of polysomnographic exams. Several parameters were recorded during polysomnography, considering that the essential tests for sleep staging are electroencephalogram, electrooculogram, and electromyogram.

    Given the lack of studies on the effect of CBD on human polysomnography-monitored sleep, other parameters were selected based on studies that tested the effect of other drugs in healthy volunteers Orr et al. No side-effects were reported for any dose of CBD used and plasmatic levels of the adjuvant antiepileptics did not change during the trial in the two cases.

    The use of edible products makes it difficult to titrate doses and to establish the actual amount of cannabinoids across different products or different batches of a same product.

    Our patients, for instance, who received mg and mg of CBD-enriched extract with 4. Surveys with caregivers and patients have also examined the effects of CBD-enriched extracts in epilepsy. More recently, a retrospective study described the successful effects of CBD-enriched medical cannabis in 74 children 1—18 years old with refractory epilepsy from five Israeli pediatric epilepsy clinics Tzadok et al.

    Despite this, minor and infrequent side effects were reported. There are anecdotal reports describing the antiepileptic effects of crude cannabis Friedman and Devinsky, , but evidence of seizure exacerbation and lack of effects is also available Tofighi and Lee, ; Hamerle et al. Some therapeutic trials have tested the effects of isolated cannabinoids in the treatment of epilepsy.

    More recently, in an open-label trial Devinsky et al. The authors reported that CBD reduced seizure frequency and presented an adequate safety profile. The pharmacological mechanisms underlying the antiepileptic action of CBD are not yet well understood, as CBD interferes with different neurotransmitter systems in a number of ways. For instance, there is evidence that CBD inhibits the reuptake and metabolism of anandamide, increases hippocampal neurogenesis, interacts with 5HT1A and TRPV1 receptors, and presents antioxidant and neuroprotective effects which may, at least in part, help to explain its anticonvulsant profile Reif et al.

    Moreover, the analysis of endocannabinoid signaling elements and related proteins in lymphocytes of patients with Dravet syndrome showed changes in the alpha-1H unit of the voltage-dependent calcium channel and an up-regulation of CB2 receptors, associated with an activation of lymphocytes and changes in inflammation-related genes Rubio et al. These changes have been described in inflammatory diseases and epilepsy and may support a potential dysregulation of the endocannabinoid system in the SNC.

    We cannot exclude the possibility that the case presentations may have been impacted by the side effects and pharmacokinetic interactions of the other medications the children were taking, or even by other chemical substances that could be present in the cannabis extracts initially used. However, neither the cannabinoids nor the other medications are known to induce mydriasis or eye redness and the patients presented improvements with CBD.

    Therefore, randomized clinical trials using high-quality and reliable cannabis-derived substances without other impurities e. All authors had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis.

    Case study concept and design: Acquisition, analysis, or interpretation of data: Drafting of the manuscript: Critical revision of the manuscript for important intellectual content: Administrative, technical, or material support: All the other authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

    A signed statement of informed consent to publish patient descriptions and photographs was obtained from parents.

    National Center for Biotechnology Information , U. Journal List Front Pharmacol v. Published online Sep Crippa , 2 Jaime E.

    Author information Article notes Copyright and License information Disclaimer. This article was submitted to Neuropharmacology, a section of the journal Frontiers in Pharmacology. Received Jul 13; Accepted Sep The use, distribution or reproduction in other forums is permitted, provided the original author s or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice.

    No use, distribution or reproduction is permitted which does not comply with these terms.

    Publicações ano 2014

    Abstract: Animal studies and preliminary clinical trials have shown that cannabidiol (CBD)-enriched extracts may have beneficial effects for children with. . Ana C.S. Crippa - Serviço de Neurologia / Hospital de Clínicas da UFPR - Rua General Fabio Agertt, Ana C.S. Crippa, Paulo J. Lorenzoni, Rosana H. Scola. Menkes' disease: case report. Doença de Menkes: relato de caso. Fabio Agertt; Ana C.S. Crippa; Paulo J. Lorenzoni; Rosana H. Scola; Isac Bruck; Luciano de.



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