Dataset Information

Self-Reported Effectiveness and Safety of Trokie^® Lozenges: A Standardized Formulation for the Buccal Delivery of Cannabis Extracts.

ABSTRACT: Therapeutic use of cannabinoids, the main active ingredients of Cannabissativa L., is often hindered by their limited bioavailability and undesirable psychoactivity. We conducted an observational study in December 2016 and another one in February 2018 to investigate respectively: (i) the effectiveness of Trokie^® lozenges, a standardized formulation containing cannabis extracts, to deliver cannabinoids via buccal absorption and (ii) its long-term safety. Participants were members of the Palliative Care Corporation health clinic, registered California cannabis patients, and had a diagnosis of chronic non-cancer pain. For the effectiveness study, 49 participants were asked to self-report pain perception before and after 1-12 weeks of taking Trokie^® lozenges, using an 11-point pain intensity numeric rating scale (PI-NRS). A mean reduction in PI-NRS score of 4.9 ± 2.0 points was observed. Onset of analgesia typically varied between 5 and 40 min, which seems consistent with, at least partial, buccal absorption. In the safety study, 35 participants were asked to complete a questionnaire about adverse events (AEs) associated with Trokie^® lozenges. AEs were reported by 16 subjects (46%), the most common being dizziness/unsteadiness (N = 7), bad taste (N = 5), and throat irritation/dry mouth (N = 4). None of the self-reported AEs resulted in a serious medical situation and most of them had limited impact on daily functions. Despite the AEs, 90% of participants reported being "satisfied" or "very satisfied" with the product. These observations suggest that buccal administration of standardized extracts via Trokie^® lozenges may represent an efficacious and safe approach to cannabis administration.

SUBMITTER: Crowley K

PROVIDER: S-EPMC6102350 | biostudies-literature | 2018

REPOSITORIES: biostudies-literature

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Self-Reported Effectiveness and Safety of Trokie® Lozenges: A Standardized Formulation for the Buccal Delivery of Cannabis Extracts.

Crowley Kenton K de Vries Sieta T ST Moreno-Sanz Guillermo G

Frontiers in neuroscience 20180814

Therapeutic use of cannabinoids, the main active ingredients of Cannabissativa L., is often hindered by their limited bioavailability and undesirable psychoactivity. We conducted an observational study in December 2016 and another one in February 2018 to investigate respectively: (i) the effectiveness of Trokie® lozenges, a standardized formulation containing cannabis extracts, to deliver cannabinoids via buccal absorption and (ii) its long-term safety. Participants were ...[more]

PMID: 30154694

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Project description:Phenolics enriched pomegranate fruit (Pomella®) and red maple leaf (Maplifa®) extracts and their major phenolic constituents have demonstrated beneficial skin effects through the protection of human skin keratinocytes from oxidative-stress-induced damage. However, their mechanisms of protection of cutaneous collagen are still unclear. Herein, the collagen protective effects of Pomella® and Maplifa®, and their major bioactive phytochemicals, namely, punicalagin (PA) and ginnalin A (GA), respectively, were evaluated using enzymatic assays including collagenase, anti-glycation and cell-based models as well as computational methods. The importance of the modulatory effects was validated at the protein level for type I collagen and matrix metalloproteinases (MMPs) using human-skin-derived keratinocytes. The synergistic collagenase inhibitory effects upon combinations of Pomella® + Maplifa® and PA + GA at a combination ratio of 1:2 and 1:1, respectively, were evaluated using their combination index (CI; a well-established assessment of synergism). Pomella® (50-400 µg/mL), Maplifa® (100-800 µg/mL), PA (50-400 µM), and GA (50-400 µM) dose-dependently inhibited collagenase activity by 26.3-86.3%, 25.7-94.0%, 26.2-94.0%, and 12.0-98.0%, respectively. The CI of the anti-collagenase activity of Pomella® and Maplifa® ranged from 0.53-0.90, while that of PA and GA (12.5/12.5 and 25/25 µM) ranged from 0.66 and 0.69, respectively, suggesting a synergistic inhibitory effect. Interestingly, in the cell-based assays by Western blotting, Pomella® and Maplifa® reduced the protein expression levels of collagen degradation enzymes (MMPs), while simultaneously increasing that of type I collagen in epidermoid carcinoma A431 cells. This is the first report to show that these extracts exert synergistic collagen protective effects. Taken together, these findings provide molecular insights into the usefulness of Pomella® and Maplifa® or their phenolics as bioactive ingredients for skin care products to slow down aging and enhance skin tone.

Project description:Short form measures from the Patient Reported Outcomes Measurement Information System® (PROMIS®) are used widely. The present study was among the first to examine differential item functioning (DIF) in the PROMIS Depression short form scales in a sample of over 5000 racially/ethnically diverse patients with cancer. DIF analyses were conducted across different racial/ethnic, educational, age, gender and language groups.MethodsDIF hypotheses, generated by content experts, informed the evaluation of the DIF analyses. The graded item response theory (IRT) model was used to evaluate the five-level ordinal items. The primary tests of DIF were Wald tests; sensitivity analyses were conducted using the IRT ordinal logistic regression procedure. Magnitude was evaluated using expected item score functions, and the non-compensatory differential item functioning (NCDIF) and T1 indexes, both based on group differences in the item curves. Aggregate impact was evaluated with expected scale score (test) response functions; individual impact was assessed through examination of differences in DIF adjusted and unadjusted depression estimates.ResultsMany items evidenced DIF; however, only a few had slightly elevated magnitude. No items evidenced salient DIF with respect to NCDIF and the scale-level impact was minimal for all group comparisons. The following short form items might be targeted for further study because they were also hypothesized to evidence DIF. One item showed slightly higher magnitude of DIF for age: nothing to look forward to; conditional on depression, this item was more likely to be endorsed in the depressed direction by individuals in older groups as contrasted with the cohort aged 21 to 49. This item was also hypothesized to show age DIF. Only one item (failure) showed DIF of slightly higher magnitude (just above threshold) for Whites vs. Asians/Pacific Islanders in the direction of higher likelihood of endorsement for Asians/Pacific Islanders. This item was also hypothesized to show DIF for minority groups. The impact of DIF was negligible. Conditional on depression, the items, worthless and hopeless were more likely to be endorsed in the depressed direction by respondents with less than high school education vs. those with a graduate degree; the magnitude of DIF was slightly above the T1 threshold, but not that of NCDIF. These items were also hypothesized to show DIF in the direction of more feelings of worthlessness by groups with lower education. While the magnitude and aggregate impact of DIF was small, in a few instances, individual impact was observed. Information provided was relatively high, particularly in the middle upper (depressed) tail of the distribution. Reliability estimates were high (> 0.90) across all studied groups, regardless of estimation method.ConclusionsThis was the first study to evaluate measurement equivalence of the PROMIS Depression short forms across large samples of ethnically diverse groups. There were few items with DIF, and none of high magnitude, thus supporting the use of PROMIS Depression short form measures across such groups. These results could be informative for those using the short forms in minority populations or clinicians evaluating individuals with the depression short forms.

Dataset Information

Self-Reported Effectiveness and Safety of Trokie^® Lozenges: A Standardized Formulation for the Buccal Delivery of Cannabis Extracts.

Publications

Self-Reported Effectiveness and Safety of Trokie<sup>®</sup> Lozenges: A Standardized Formulation for the Buccal Delivery of Cannabis Extracts.

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