Medical Cannabis and Cannabinoids最新文献

{"title":"Abstracts for the 2023 Cannabis Clinical Outcomes Research Conference (CCORC)","authors":"","doi":"10.1159/000534044","DOIUrl":"https://doi.org/10.1159/000534044","url":null,"abstract":"Background: Ketamine is an anesthetic that has been proven to treat chronic pain via clinical trials; yet there is a gap in knowledge regarding the impact of the concomitant use of ketamine and cannabis on pain severity. This study examined cannabis consumers who participated in a pilot Ketamine-Assisted Psychotherapy (KAP) intervention study to examine pain severity. Methods: A subanalysis of regular cannabis consumers from a pilot intervention study comparing psychedelic (n=5) and psycholytic (n=5) KAP approaches were analyzed. Participants were placed into one of the two one a week for 6-weeks-long treatment groups based on the recommendations of their integrative pain management physician. The Brief Pain Inventory Short Form was administered via redcap to measure severity of pain and impact of pain on daily functioning via scores collected prior to and after participant’s first, third, and sixth treatment sessions. Data was analyzed via SAS to compare pain severity at each timepoint. Results: There were no statistically significant differences observed between the psy-chedelic and psycholytic KAP treatment’s impact on participants’ pain severity at any time points of the study (T-1, p =.85), (T-2, p =.34), (T-3, p = .67). The psychedelic group’s mean pain severity decreased by 21.88% from baseline to treatment termination, while the psycholytic group’s mean pain severity decreased by 3.39%. Furthermore, the psychedelic group saw a steady mean decrease in pain severity over time with a halt at the third session. We noticed a 4.69% decrease between baseline and session one, no change between session one and session three, and a 18.03%","PeriodicalId":18415,"journal":{"name":"Medical Cannabis and Cannabinoids","volume":"52 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-10-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135788874","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Proceedings of the 2023 Cannabis Clinical Outcomes Research Conference.","authors":"Amie J Goodin,&nbsp;Phuong T Tran,&nbsp;Sam McKee,&nbsp;Ruba Sajdeya,&nbsp;Jeevan Jyot,&nbsp;Robert L Cook,&nbsp;Yan Wang,&nbsp;Almut G Winterstein","doi":"10.1159/000533943","DOIUrl":"https://doi.org/10.1159/000533943","url":null,"abstract":"<p><p>The Consortium for Medical Marijuana Clinical Outcomes Research, a multi-university collaboration established by the state of Florida in the USA, hosted its third annual Cannabis Clinical Outcomes Research Conference (CCORC) in May 2023. CCORC was held as a hybrid conference, with a scientific program consisting of in-person sessions, with some sessions livestreamed to virtual attendees. CCORC facilitated and promoted up-to-date research on the clinical effects of medical cannabis, fostering collaboration and active involvement among scientists, policymakers, industry professionals, clinicians, and other stakeholders. Three themes emerged from conference sessions and speaker presentations: (1) disentangling conflicting evidence for the effects of medical cannabis on public health, (2) seeking solutions to address barriers faced when conducting clinical cannabis research - especially with medical cannabis use in special populations such as those who are pregnant, and (3) unpacking the data behind cannabis use and mental health outcomes. The fourth annual CCORC is planned for the summer of 2024 in Florida, USA.</p>","PeriodicalId":18415,"journal":{"name":"Medical Cannabis and Cannabinoids","volume":"6 1","pages":"97-101"},"PeriodicalIF":0.0,"publicationDate":"2023-09-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10601943/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"71412906","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Medical Cannabis Alleviates Chronic Neuropathic Pain Effectively and Sustainably without Severe Adverse Effect: A Retrospective Study on 99 Cases.","authors":"Lan Kluwe, Christian Scholze, Lisa Marie Schmidberg, Julian Lukas Wichmann, Mihail Gemkov, Martin Julian Keller, Said C Farschtschi","doi":"10.1159/000531667","DOIUrl":"10.1159/000531667","url":null,"abstract":"<p><strong>Introduction: </strong>Medical cannabis may provide a treatment option for chronic neuropathic pain. However, empirical disease-specific data are scarce.</p><p><strong>Methods: </strong>This is a retrospective observational study including 99 patients with chronic neuropathic pain. These patients received medical cannabis by means of inhaling dried flowers with tetrahydrocannabinol content of <12-22% at a maximal daily dose of 0.15-1 g. Up to six follow-ups were carried out at intervals of 4-6 weeks. Pain severity, sleep disturbance, general improvement, side effects, and therapy tolerance at the follow-up consultations were assessed in interviews and compared with the baseline data using non-parametric Wilcoxon signed-rank test.</p><p><strong>Results: </strong>Within 6 weeks on the therapy, median of the pain scores decreased significantly from 7.5 to 4.0 (<i>p</i> < 0.001). The proportion of patients with severe pain (score >6) decreased from 96% to 16% (<i>p</i> < 0.001). Sleep disturbance was significantly improved with the median of the scores decreased from 8.0 to 2.0 (<i>p</i> < 0.001). These improvements were sustained over a period of up to 6 months. There were no severe adverse events reported. Mild side effects reported were dryness in mucous tissue (5.4%), fatigue (4.8%), and increased appetite (2.7%). Therapy tolerance was reported in 91% of the interviews.</p><p><strong>Conclusion: </strong>Medical cannabis is safe and highly effective for treating neuropathic pain and concomitant sleep disturbance.</p>","PeriodicalId":18415,"journal":{"name":"Medical Cannabis and Cannabinoids","volume":"6 1","pages":"89-96"},"PeriodicalIF":0.0,"publicationDate":"2023-08-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10601926/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"71412905","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Long-Term, Self-Dosing CBD Users: Indications, Dosage, and Self-Perceptions on General Health/Symptoms and Drug Use.","authors":"Robert Kaufmann, Amber Harris Bozer, Amanda Kube Jotte, Keith Aqua","doi":"10.1159/000531666","DOIUrl":"10.1159/000531666","url":null,"abstract":"<p><strong>Introduction: </strong>Self-dosing of off-the-shelf cannabidiol (CBD) for a myriad of health conditions is common in the USA. These CBD products are often mislabeled, suggesting that much less or much more CBD is being consumed than indicated on the label. This study examined the relationship between long-term self-dosing of CBD and (a) indications and, when a verified concentration of CBD is being consumed, (b) the daily CBD dosage, (c) the impact on general health and symptoms, and (d) over-the-counter (OTC) and prescription (Rx) drug usage.</p><p><strong>Methods: </strong>US adults 18-75 years of age who had used unverified CBD products for >1 month were recruited to participate in this decentralized, observational, IRB-approved study and provided a concentration-verified CBD product of their choice from 15 different vendors for 4 weeks. Prior to receiving product, they were queried on their primary reason for use (PRfU), primary symptom for use (PSfU), general health score (GHS), symptom score (SS), OTC and Rx drug use, and daily CBD dose. Individuals were queried daily on OTC and Rx drug use and CBD dose and weekly on SS and GHS prior to (pre-CBD) and after (post-CBD) ingestion of CBD on that day.</p><p><strong>Results: </strong>The PRfU included chronic pain, mental health, general health and wellness, sleep disorders, the central nervous system, digestive health, and others, while the PSfU included anxiety, back and/or joint pain, sleep, inflammation, and others. The mean daily dose was normally distributed, with a mean, median, and range of 53.1, 40.8, 8-390 mg/day, respectively. For both GHS and SS, the post-CBD was significantly higher than the pre-CBD score for each category of PRfU. The GHS scores did not change over the study, but pre- and post-CBD SS improved over time, with pre-improving more than post-CBD SS. The percentage of individuals decreasing or completely stopping OTC drugs or Rx drugs over the 4 weeks was 31.2% and 19.2%, respectively, with those taking CBD for chronic pain, decreasing drug use the most. OTC and Rx drug usage decreased when the CBD dose was changed and when GHS and SS improved.</p><p><strong>Conclusion: </strong>Pain, mental health (primarily anxiety/stress), and sleep are the most common reasons for CBD use. Self-administration of CBD reduced OTC and Rx drug usage at daily doses less than those reported in controlled studies. CBD self-administration significantly improves self-perception of general health and decreases symptom severity, and as these improve, fewer OTC and Rx drugs are used.</p>","PeriodicalId":18415,"journal":{"name":"Medical Cannabis and Cannabinoids","volume":"6 1","pages":"77-88"},"PeriodicalIF":0.0,"publicationDate":"2023-08-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10601936/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"71412904","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Tolerability and Efficacy of a 10:25 Preparation of Δ9-Tetrahydrocannabinol and Cannabidiol for Treatment of Chronic Back or Neck Pain: A Multiple-Dose Escalation Study.","authors":"Paul Glare, Richard Chye, Mark Bloch, Mark Arya, Andrew Moore, John Montgomery","doi":"10.1159/000531232","DOIUrl":"10.1159/000531232","url":null,"abstract":"<p><strong>Introduction: </strong>The aim was to demonstrate the safety and tolerability of cannabidiol (CBD) with Δ9-THC in patients with moderate to severe chronic back or neck pain unresponsive to over-the-counter non-opioid analgesics.</p><p><strong>Methods: </strong>This was a non-randomized, single-arm, open-label study. Participants received escalating doses of an oromucosal-administered combination containing 10 mg/mL of Δ9-THC, 25 mg/mL of CBD. On day 1, patients received once-daily 0.5 mL Cybis^® 10:25 (5 mg Δ9-THC plus 12.5 mg CBD daily), escalated at days 8, 15, and 22 to 0.5 mL twice-daily (bd) (10 mg Δ9-THC plus 25 mg CBD daily), 1.0 mL bd (20 mg Δ9-THC plus 50 mg CBD daily), and 1.5 mL bd (30 mg Δ9-THC plus 75 mg CBD daily), respectively. The primary outcome was safety and tolerability, with secondary objectives including pharmacokinetic and efficacy outcomes.</p><p><strong>Results: </strong>28 patients were enrolled in the study. Their median age was 63.3 years, and half were female. The median history of neck/back pain was 10 years. The pharmacokinetics following single doses of 0.5 mL were variable; however, there were dose-dependent increases in trough levels of CBD and Δ9-THC. Cybis^® 10:25 was well tolerated, with the majority of adverse events of mild severity. The most common adverse events were nausea, vomiting, fatigue, dizziness, headache, paresthesia, and anxiety. There were dose-dependent improvements in numerical pain rating scores (<i>p</i> < 0.001), with clinically significant reductions in pain at 1.0 mL bd and 1.5 mL bd doses (28.8% and 34.1% reductions, respectively, <i>p</i> < 0.001). Depressive symptoms and stress had dose-dependent reductions (<i>p</i> = 0.0182, <i>p</i> < 0.01, respectively).</p><p><strong>Conclusion: </strong>In patients with chronic neck/back pain, CBD and Δ9-THC are well tolerated and doses of 1.0 mL bd and 1.5 mL bd showed clinically significant reductions in pain compared to baseline pain scores.</p>","PeriodicalId":18415,"journal":{"name":"Medical Cannabis and Cannabinoids","volume":"6 1","pages":"66-76"},"PeriodicalIF":0.0,"publicationDate":"2023-07-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/67/03/mca-2023-0006-0001-531232.PMC10350899.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9854606","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Protocol of a Combined Cohort and Cross-Sectional Study of Persons Receiving Medical Cannabis in Florida, USA: The Medical Marijuana and Me (M³) Study.","authors":"Ruba Sajdeya, Hannah J Fechtel, Gabriel Spandau, Amie J Goodin, Joshua D Brown, Sebastian Jugl, Nicole E Smolinski, Almut G Winterstein, Robert L Cook, Yan Wang","doi":"10.1159/000530052","DOIUrl":"10.1159/000530052","url":null,"abstract":"<p><p>Significant knowledge gaps regarding the effectiveness and safety of medical cannabis (MC) create clinical challenges for MC physicians, making treatment recommendations and patients choosing treatment among the growing number of options offered in dispensaries. Additionally, data describing the characteristics of people who use MC and the products and doses they receive are lacking. The Medical Marijuana and Me (M³) Study was designed to collect patient-centered data from MC users. We aim to describe preferred MC use patterns that patients report as \"most effective\" for specific health conditions and symptoms, identify user characteristics associated with such use patterns, characterize adverse effects, including cannabis use disorder, identify products and patient characteristics associated with adverse effects, describe concurrent prescription medication use, and identify concomitant medication use with potential drug-MC interaction risk. Among MC initiators, we also aim to quantify MC use persistence and identify reasons for discontinuation, assess MC utilization pattern trajectories over time, describe outcome trajectories of primary reasons for MC use and determine factors associated with different trajectories, track changes in concomitant substance and medication use after MC initiation, and identify factors associated with such changes. M³ is a combined study comprised of: (1) a prospective cohort of MC initiators completing surveys at enrollment, 3 months, and 9 months after MC initiation and (2) a cross-sectional study of current MC users. A multidisciplinary committee including researchers, physicians, pharmacists, patients, and dispensary personnel designed and planned study protocols, established study measures, and created survey questionnaires. M³ will recruit 1,000-1,200 participants aged ≥18 years, with ∼50% new and ∼50% current MC patients from MC clinics across Florida, USA. Study enrollment started in May 2022 and will continue until the target number of patients is achieved. Survey domains include sociodemographic characteristics, physical and mental health, cannabis use history, reasons for MC use and discontinuation, MC products and use patterns, concurrent use of prescription medications and other substances, and side effects. Data collected in the M³ Study will be available for interested researchers affiliated with the Consortium for Medical Marijuana Clinical Outcomes Research. The M³ Study and Databank will be the largest cohort of current and new MC users in Florida, USA, which will provide data to support MC-related health research necessary to inform policy and clinical practice and ultimately improve patient outcomes.</p>","PeriodicalId":18415,"journal":{"name":"Medical Cannabis and Cannabinoids","volume":"6 1","pages":"46-57"},"PeriodicalIF":0.0,"publicationDate":"2023-05-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/00/2e/mca-0006-0046.PMC10228286.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9568263","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Phytochemical Comparison of Medicinal Cannabis Extracts and Study of Their CYP-Mediated Interactions with Coumarinic Oral Anticoagulants.","authors":"Andrea Treyer, Jakob K Reinhardt, Daniela Elisabeth Eigenmann, Mouhssin Oufir, Matthias Hamburger","doi":"10.1159/000528465","DOIUrl":"10.1159/000528465","url":null,"abstract":"<p><strong>Introduction: </strong>Treatment with cannabis extracts for a variety of diseases has gained popularity. However, differences in herb-drug interaction potential of extracts from different plant sources are poorly understood. In this study, we provide a characterization of cannabis extracts prepared from four cannabis chemotypes and an in vitro assessment of their Cytochrome P450 (CYP)-mediated herb-drug interaction profiles.</p><p><strong>Methods: </strong>Plant extracts were either commercially obtained or prepared using ethanol as solvent, followed by overnight decarboxylation in a reflux condenser system. The extracts were characterized for their cannabinoid content using NMR and HPLC-PDA-ELSD-ESIMS. CYP inhibition studies with the cannabis extracts and pure cannabinoids (tetrahydrocannabinol [THC] and cannabidiol [CBD]) were performed using pooled, mixed gender human liver microsomes. Tolbutamide and testosterone were used as specific substrates to assess the inhibitory potential of the extracts on CYP2C9 and CYP3A4, and the coumarinic oral anticoagulants warfarin, phenprocoumon, and acenocoumarol were studied as model compounds since in vivo herb-drug interactions have previously been reported for this compound class.</p><p><strong>Results: </strong>In accordance with the plant chemotypes, two extracts were rich in THC and CBD (at different proportions); one extract contained mostly CBD and the other mostly cannabigerol (CBG). Residual amounts of the corresponding acids were found in all extracts. The extracts with a single major cannabinoid (CBD or CBG) inhibited CYP2C9- and CYP3A4-mediated metabolism stronger than the extracts containing both major cannabinoids (THC and CBD). The inhibition of CYP3A4 and CYP2C9 by the extract containing mostly CBD was comparable to their inhibition by pure CBD. In contrast, the inhibitory potency of extracts containing both THC and CBD did not correspond to the combined inhibitory potency of pure THC and CBD. Although being structural analogs, the three coumarin derivatives displayed major differences in their herb-drug interaction profiles with the cannabis extracts and the pure cannabinoids.</p><p><strong>Conclusion: </strong>Despite the fact that cannabinoids are the major components in ethanolic, decarboxylated cannabis extracts, it is difficult to foresee their herb-drug interaction profiles. Our in vitro data and the literature-based evidence on in vivo interactions indicate that cannabis extracts should be used cautiously when co-administered with drugs exhibiting a narrow therapeutic window, such as coumarinic anticoagulants, regardless of the cannabis chemotype used for extract preparation.</p>","PeriodicalId":18415,"journal":{"name":"Medical Cannabis and Cannabinoids","volume":"6 1","pages":"21-31"},"PeriodicalIF":0.0,"publicationDate":"2023-02-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9940649/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10770615","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Pronounced State-Level Disparities in Prescription of Cannabinoids to Medicaid Patients.","authors":"Edward Y Liu,&nbsp;Kenneth L McCall,&nbsp;Brian J Piper","doi":"10.1159/000531058","DOIUrl":"https://doi.org/10.1159/000531058","url":null,"abstract":"<p><strong>Introduction: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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).</p><p><strong>Conclusions: </strong>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.</p>","PeriodicalId":18415,"journal":{"name":"Medical Cannabis and Cannabinoids","volume":"6 1","pages":"58-65"},"PeriodicalIF":0.0,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10315157/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9792718","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Cannabis Effects on Driving Performance: Clinical Considerations.","authors":"Brianna Costales,&nbsp;Shanna L Babalonis,&nbsp;Joshua D Brown,&nbsp;Amie J Goodin","doi":"10.1159/000528714","DOIUrl":"https://doi.org/10.1159/000528714","url":null,"abstract":"aConsortium for Medical Marijuana Clinical Outcomes Research, University of Florida, Gainesville, FL, USA; bCenter for Drug Evaluation and Safety (CoDES), Department of Pharmaceutical Outcomes and Policy, University of Florida, Gainesville, FL, USA; cDepartment of Behavioral Science, College of Medicine, University of Kentucky, Lexington, KY, USA Received: June 29, 2022 Accepted: December 7, 2022 Published online: January 30, 2023","PeriodicalId":18415,"journal":{"name":"Medical Cannabis and Cannabinoids","volume":"6 1","pages":"8-14"},"PeriodicalIF":0.0,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/ea/93/mca-0006-0008.PMC9940647.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10770619","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The Effects of Long-Term Self-Dosing of Cannabidiol on Drowsiness, Testosterone Levels, and Liver Function.","authors":"Robert Kaufmann,&nbsp;Amber Harris Bozer,&nbsp;Amanda Rose Kube Jotte,&nbsp;Keith Aqua","doi":"10.1159/000529677","DOIUrl":"https://doi.org/10.1159/000529677","url":null,"abstract":"<p><strong>Introduction: </strong>Previous research indicated that cannabidiol (CBD) may result in low levels of male total testosterone (TT), elevations in liver tests (LTs), and daytime drowsiness (DD). We investigated the prevalences of TT and LT in a large adult sample self-administering CBD and determined the effect self-dosing of CBD has on the severity of DD.</p><p><strong>Methods: </strong>Adult participants (18-75 years of age) who self-dose CBD orally for a minimum of 30 days were recruited for this decentralized observational study from companies that offer CBD products. Participants were sent their usual CBD regimen. A clinical study platform was used on a phone app to obtain consent and collect study data. Data included demographic information, reasons for self-dosing, dosage, current medications and dosage, medical history, adverse effects, effects on DD, and efficacy. After 30 days, LT and TT were obtained and follow-up LT was offered to participants who demonstrated elevated values of alanine transaminase (ALT).</p><p><strong>Results: </strong>A total of 28,121 individuals were contacted, 1,475 met the criteria and were enrolled, and 1,061 (female: 65.2%, male: 34.8%) completed the study. Most of the participants used full-spectrum CBD oil or CBD isolate with the mean ± SD daily dose of CBD for all users of 55.4 ± 37.8 mg. CBD use was associated with a significant decrease in DD and a decrease in the prevalence of low TT in males >40 years of age. The prevalences of elevations in ALT and aspartate aminotransferase were not significantly different from those of the general adult population, and the prevalences of elevated levels of alkaline phosphatase and bilirubin were less than those of a healthy adult population. There was no relationship between LT and CBD dose.</p><p><strong>Conclusions: </strong>In this large-sample study, self-dosing CBD was not associated with an increased prevalence of elevation of LT or low levels of TT in men. Furthermore, CBD administration decreased DD and was associated with a lower prevalence of low testosterone levels in older men as compared to age-adjusted population norms.</p>","PeriodicalId":18415,"journal":{"name":"Medical Cannabis and Cannabinoids","volume":"6 1","pages":"32-40"},"PeriodicalIF":0.0,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10036916/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9188290","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}