The dual orexin receptor antagonist suvorexant in alcohol use disorder and comorbid insomnia: A case report.

Key Clinical Message: This case suggests using dual orexin receptor antagonists to treat alcohol use disorder and comorbid sleep disorders may be effective, commencing treatment in withdrawal and continuing it to prevent relapse. Abstract: Effective medications for the treatment of alcohol use disorder are limited. This is partially due to the heterogenous nature of the symptomatology associated with alcohol use disorder and the abundance of presenting comorbidities. One common, and often overlooked, symptom that occurs during withdrawal of alcohol use is sleep disruption. Here, we report a case study of a participant with comorbid alcohol use disorder and insomnia. This participant was treated with a dual orexin receptor antagonist, suvorexant (Belsomra®), currently approved to treat insomnia. We demonstrate improvements in alcohol cravings, physical and psychological health, and sleep outcomes with treatment. These data support abundant preclinical and emerging clinical data in this space. The findings from this case report highlight the potential for suvorexant to treat comorbid alcohol use disorder and insomnia with fully powered, randomized controlled trials moving forward.

Priorities for research promoting mental health in the south and east of Asia.

Progress in promoting mental health, preventing mental illness, and improving care for people affected by mental illness is unlikely to occur if efforts remain separated from existing public health programs and the principles of public health action. Experts met recently to discuss integrating public health and mental health strategies in the south and east of Asia, especially in low- and middle-income countries. Areas of research identified as high priority were: 1) integrating mental health into perinatal care; 2) providing culturally-adjusted support for carers of people with mental and physical disorders; 3) using digital health technologies for mental health care in areas with limited resources and 4) building local research capacity. Selection of these areas was informed by their relative novelty in the region, ease of implementation, likely widespread benefit, and potential low costs. In this article, we summarise available evidence, highlight gaps and call for collaborations with research centres, leaders and persons with lived experience within and beyond the region.

Tobacco treatment incorporating contingency management, nicotine replacement therapy, and behavioral counseling for pregnant women who use substances: a feasibility trial.

Introduction: Most pregnant women with substance use problems smoke, and few will quit during their pregnancy. Tobacco treatment is often overlooked, with the focus usually placed on other substance use. Additionally, few targeted effective treatments for this group exist. To address this, the feasibility of an intensive tobacco treatment incorporating contingency management (CM) that featured non-face-to-face delivery was examined. Methods: A single-arm pre-post design feasibility trial was conducted in three antenatal services that support women who use substances in metropolitan Australia. Participants were over the age of 15, had <33-week gestation, and smoked tobacco daily. They received financial incentives for daily carbon monoxide-verified smoking abstinence or reduction through an internet-based CM programme, nicotine replacement therapy (NRT) posted to women and partners or household members who smoked and telephone-delivered behavioral counseling from study enrolment to birth. Results: Of the 101 referrals, 46 women (46%) consented. The mean (SD) age was 31(±6) years, and the gestation period was 22(±6) weeks. Nineteen (41%) of those enrolled were retained for 12-week postpartum. Of 46 women, 32 (70%) utilized CM; 32 (70%) used NRT for ≥2 weeks; 23 (50%) attended ≥1 counseling session; and 15 (22%) received NRT for partners/household members. Fifteen (33%) were verified abstinent from tobacco at delivery after a median (IQR) period of abstinence of 65(36-128) days. All non-smokers at birth utilized NRT and financial incentives, and 9/15 (60%) utilized counseling. Four (9%) were abstinent at 12-week postpartum. Median cigarettes smoked/day reduced from baseline to delivery (10(6-20) to 1(0-6) p =< 0.001). Women who quit smoking had more education (72% vs. 33% p =< 0.02), completed more CO samples (median (IQR) 101(59-157) vs. 2(0-20) p =< 0.001), and received more incentives (median (IQR) $909($225-$1980) vs. $34($3-$64) p =< 0.001). Intervention acceptability was rated favorably by participants (9 items rated 0-10 with scores >5 considered favorable). Discussion: This study demonstrated the feasibility and acceptability of a consumer-informed, non-face-to-face intensive tobacco treatment, highlighting the potential of remotely delivered technology-based CM to reduce the health impact of tobacco smoking in high-priority populations. The intervention demonstrates scale-up potential. Future studies should extend treatment into the postpartum period, utilizing new technologies to enhance CM delivery and improve counseling provision and partner support. Clinical trial registration: https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=374196, ACTRN1261800056224.

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.

Using Social Media Data to Investigate Public Perceptions of Cannabis as a Medicine: Narrative Review.

BACKGROUND: The use and acceptance of medicinal cannabis is on the rise across the globe. To support the interests of public health, evidence relating to its use, effects, and safety is required to match this community demand. Web-based user-generated data are often used by researchers and public health organizations for the investigation of consumer perceptions, market forces, population behaviors, and for pharmacoepidemiology. OBJECTIVE: In this review, we aimed to summarize the findings of studies that have used user-generated text as a data source to study medicinal cannabis or the use of cannabis as medicine. Our objectives were to categorize the insights provided by social media research on cannabis as medicine and describe the role of social media for consumers using medicinal cannabis. METHODS: The inclusion criteria for this review were primary research studies and reviews that reported on the analysis of web-based user-generated content on cannabis as medicine. The MEDLINE, Scopus, Web of Science, and Embase databases were searched from January 1974 to April 2022. RESULTS: We examined 42 studies published in English and found that consumers value their ability to exchange experiences on the web and tend to rely on web-based information sources. Cannabis discussions have portrayed the substance as a safe and natural medicine to help with many health conditions including cancer, sleep disorders, chronic pain, opioid use disorders, headaches, asthma, bowel disease, anxiety, depression, and posttraumatic stress disorder. These discussions provide a rich resource for researchers to investigate medicinal cannabis-related consumer sentiment and experiences, including the opportunity to monitor cannabis effects and adverse events, given the anecdotal and often biased nature of the information is properly accounted for. CONCLUSIONS: The extensive web-based presence of the cannabis industry coupled with the conversational nature of social media discourse results in rich but potentially biased information that is often not well-supported by scientific evidence. This review summarizes what social media is saying about the medicinal use of cannabis and discusses the challenges faced by health governance agencies and professionals to make use of web-based resources to both learn from medicinal cannabis users and provide factual, timely, and reliable evidence-based health information to consumers.

Corrigendum to: Use of electronic medical records to monitor the safe and effective prescribing of medicinal cannabis: is it feasible?

BACKGROUND: General practitioners are well positioned to contribute to the pharmacovigilance of medical cannabis via the general practice electronic medical record (EMR). The aim of this research is to interrogate de-identified patient data from the Patron primary care data repository for reports of medicinal cannabis to ascertain the feasibility of using EMRs to monitor medicinal cannabis prescribing in Australia. METHODS: EMR rule-based digital phenotyping of 1 164 846 active patients from 109 practices was undertaken to investigate reports of medicinal cannabis use from September 2017 to September 2020. RESULTS: Eighty patients with 170 prescriptions of medicinal cannabis were identified in the Patron repository. Reasons for prescription included anxiety, multiple sclerosis, cancer, nausea, and Crohn's disease. Nine patients showed symptoms of a possible adverse event, including depression, motor vehicle accident, gastrointestinal symptoms, and anxiety. CONCLUSIONS: The recording of medicinal cannabis effects in the patient EMR provides potential for medicinal cannabis monitoring in the community. This is especially feasible if monitoring were to be embedded into general practitioner workflow.

Social media discourse and internet search queries on cannabis as a medicine: A systematic scoping review.

The use of cannabis for medicinal purposes has increased globally over the past decade since patient access to medicinal cannabis has been legislated across jurisdictions in Europe, the United Kingdom, the United States, Canada, and Australia. Yet, evidence relating to the effect of medical cannabis on the management of symptoms for a suite of conditions is only just emerging. Although there is considerable engagement from many stakeholders to add to the evidence base through randomized controlled trials, many gaps in the literature remain. Data from real-world and patient reported sources can provide opportunities to address this evidence deficit. This real-world data can be captured from a variety of sources such as found in routinely collected health care and health services records that include but are not limited to patient generated data from medical, administrative and claims data, patient reported data from surveys, wearable trackers, patient registries, and social media. In this systematic scoping review, we seek to understand the utility of online user generated text into the use of cannabis as a medicine. In this scoping review, we aimed to systematically search published literature to examine the extent, range, and nature of research that utilises user-generated content to examine to cannabis as a medicine. The objective of this methodological review is to synthesise primary research that uses social media discourse and internet search engine queries to answer the following questions: (i) In what way, is online user-generated text used as a data source in the investigation of cannabis as a medicine? (ii) What are the aims, data sources, methods, and research themes of studies using online user-generated text to discuss the medicinal use of cannabis. We conducted a manual search of primary research studies which used online user-generated text as a data source using the MEDLINE, Embase, Web of Science, and Scopus databases in October 2022. Editorials, letters, commentaries, surveys, protocols, and book chapters were excluded from the review. Forty-two studies were included in this review, twenty-two studies used manually labelled data, four studies used existing meta-data (Google trends/geo-location data), two studies used data that was manually coded using crowdsourcing services, and two used automated coding supplied by a social media analytics company, fifteen used computational methods for annotating data. Our review reflects a growing interest in the use of user-generated content for public health surveillance. It also demonstrates the need for the development of a systematic approach for evaluating the quality of social media studies and highlights the utility of automatic processing and computational methods (machine learning technologies) for large social media datasets. This systematic scoping review has shown that user-generated content as a data source for studying cannabis as a medicine provides another means to understand how cannabis is perceived and used in the community. As such, it provides another potential 'tool' with which to engage in pharmacovigilance of, not only cannabis as a medicine, but also other novel therapeutics as they enter the market.

Methamphetamine-associated cardiomyopathy: an addiction medicine perspective.

Methamphetamine-associated cardiomyopathy (MaCM) is an increasingly recognised serious complication from methamphetamine (MA) use. It is characterised as the development of otherwise unexplained heart failure in the context of MA use. MaCM predominantly affects a young and vulnerable population with high morbidity and mortality. It is the second leading cause of mortality in patients with MA use disorder (MUD). Our understanding of MaCM pathogenesis is based on observational cohorts and autopsy studies. Currently, the treatment of MaCM is predicated on abstinence. Medical therapies offer some benefit to a minority of patients; however, without abstinence, medical therapies are often ineffective. Abstinence is difficult for most patients to achieve; all clinicians require an understanding of MaCM and how to educate patients on the risks of ongoing use. Where available, referral to addiction medicine specialists to assist with treatment of MUD is recommended. This review aims to: (i) explain the proposed pathologic mechanisms of MaCM; (ii) summarise recent recommendations of the screening and treatment of MaCM; and (iii) highlight the role of addiction medicine in the management of patient with MaCM.

A Placebo-Controlled Randomized Trial of Vigabatrin in the Management of Acute Alcohol Withdrawal.

OBJECTIVE: To undertake a double blinded randomised placebo-controlled trial to assess the efficacy of vigabatrin, a GABA-transaminase inhibitor, as a benzodiazepine sparing agent in the management of acute alcohol withdrawal syndrome in a residential setting. METHODS: We enrolled 120 patients with alcohol use disorder who were randomly assigned to either treatment with vigabatrin (2g/day for 4 days) or placebo. The primary outcome was defined as the number of participants in each treatment arm needing diazepam for withdrawal management. A secondary outcome prespecified was the total dose of diazepam received by participants in each treatment arm. Participants were recruited on admission to a residential withdrawal unit at St Vincent's Hospital Melbourne from December 2014 to April 2019. RESULTS: No significant difference was observed in the number of participants requiring benzodiazepines during their residential withdrawal stay with 44 participants (78.6%) in placebo arm requiring at least one dose of diazepam compared to 38 (66.7%) in vigabatrin arm (p = .156). An 18.1% difference was observed between the proportion of participants who received a total dose of >100mg of diazepam during their residential withdrawal stay in placebo arm (32.1%), compared to vigabatrin arm (14.0%, p = .022). There were higher rates of reported adverse events in placebo arm with nine (15.0%) participants reporting adverse events compared with two (3.3%) participants in vigabatrin arm (p = .027). CONCLUSION: Vigabatrin significantly reduced the number of participants requiring >100mg diazepam over the course of their alcohol withdrawal and was associated with a reduction in adverse effects when compared to placebo.

Consumer-Generated Discourse on Cannabis as a Medicine: Scoping Review of Techniques.

BACKGROUND: Medicinal cannabis is increasingly being used for a variety of physical and mental health conditions. Social media and web-based health platforms provide valuable, real-time, and cost-effective surveillance resources for gleaning insights regarding individuals who use cannabis for medicinal purposes. This is particularly important considering that the evidence for the optimal use of medicinal cannabis is still emerging. Despite the web-based marketing of medicinal cannabis to consumers, currently, there is no robust regulatory framework to measure clinical health benefits or individual experiences of adverse events. In a previous study, we conducted a systematic scoping review of studies that contained themes of the medicinal use of cannabis and used data from social media and search engine results. This study analyzed the methodological approaches and limitations of these studies. OBJECTIVE: We aimed to examine research approaches and study methodologies that use web-based user-generated text to study the use of cannabis as a medicine. METHODS: We searched MEDLINE, Scopus, Web of Science, and Embase databases for primary studies in the English language from January 1974 to April 2022. Studies were included if they aimed to understand web-based user-generated text related to health conditions where cannabis is used as a medicine or where health was mentioned in general cannabis-related conversations. RESULTS: We included 42 articles in this review. In these articles, Twitter was used 3 times more than other computer-generated sources, including Reddit, web-based forums, GoFundMe, YouTube, and Google Trends. Analytical methods included sentiment assessment, thematic analysis (manual and automatic), social network analysis, and geographic analysis. CONCLUSIONS: This study is the first to review techniques used by research on consumer-generated text for understanding cannabis as a medicine. It is increasingly evident that consumer-generated data offer opportunities for a greater understanding of individual behavior and population health outcomes. However, research using these data has some limitations that include difficulties in establishing sample representativeness and a lack of methodological best practices. To address these limitations, deidentified annotated data sources should be made publicly available, researchers should determine the origins of posts (organizations, bots, power users, or ordinary individuals), and powerful analytical techniques should be used.

Use of electronic medical records to monitor the safe and effective prescribing of medicinal cannabis: is it feasible?

BACKGROUND: General practitioners are well positioned to contribute to the pharmacovigilance of medical cannabis via the general practice electronic medical record (EMR). The aim of this research is to interrogate de-identified patient data from the Patron primary care data repository for reports of medicinal cannabis to ascertain the feasibility of using EMRs to monitor medicinal cannabis prescribing in Australia. METHODS: EMR rule-based digital phenotyping of 1 164 846 active patients from 109 practices was undertaken to investigate reports of medicinal cannabis use from September 2017 to September 2020. RESULTS: Eighty patients with 170 prescriptions of medicinal cannabis were identified in the Patron repository. Reasons for prescription included anxiety, multiple sclerosis, cancer, nausea, and Crohn's disease. Nine patients showed symptoms of a possible adverse event, including depression, motor vehicle accident, gastrointestinal symptoms, and anxiety. CONCLUSIONS: The recording of medicinal cannabis effects in the patient EMR provides potential for medicinal cannabis monitoring in the community. This is especially feasible if monitoring were to be embedded into general practitioner workflow.

The Rise and Rise of Medicinal Cannabis, What Now? Medicinal Cannabis Prescribing in Australia 2017-2022.

Medicinal cannabis was legalised in Australia in November 2016. By August 2022, there were 5284 specialist physician and general practitioner (GP) prescribers who submitted Special Access Scheme (SAS) applications to the Therapeutic Goods Administration (TGA) for the provision of medicinal cannabis prescriptions their patients. In this article we examine the impact of the delivery of publicly available clinical guidance documents, provision of education to prescribers, establishment of the TGA online portal, and launching of cannabis clinics on the number of applications approved by the TGA over time. We considered these findings in the context of the need to align the interventions facilitating the prescribing of medicinal cannabis with the establishment of processes to enable the systematic monitoring of patient outcomes. The cumulative number of medicinal cannabis Special Access Scheme-B (SAS-B) prescription approvals from January 2017 to June 2022 was 258,926. SAS-B approvals increased at an average rate of 208.55% p < 0.000, (95% CI 187.25−229.85) per month. Conclusion: There has been a rapid growth in prescribing since the legalisation of medicinal cannabis in Australia and this expansion has not been accompanied by parallel processes for the monitoring of medicinal cannabis. The capture of more highly granulated data, as found in the electronic medical record (EMR), patient smartphone applications, and social media provide an opportunity to monitor medicinal cannabis effectiveness and safety across multiple prescribing indications.

Alcohol use in the year following approach bias modification during inpatient withdrawal: secondary outcomes from a double-blind, multi-site randomized controlled trial.

BACKGROUND AND AIMS: Approach bias modification (ApBM) targeting alcohol approach bias has been previously shown to reduce likelihood of relapse during the first 2 weeks following inpatient withdrawal treatment (IWT). We tested whether ApBM's effects endure for a longer period by analysing alcohol use outcomes 3, 6 and 12 months post-discharge. DESIGN: A double-blind, sham-controlled randomized controlled trial. SETTING: Four IWT units in Melbourne, Australia. PARTICIPANTS: Three hundred alcohol IWT patients (173 men, 126 women, 1 non-binary; mean age 43.5 years) were recruited between 4 June 2017 and 14 July 2019. Follow-up data collection was completed on 22 September 2020. INTERVENTION AND CONTROL TRAINING: Four ApBM sessions were delivered during IWT. ApBM trained participants (n = 147) to avoid alcohol and approach non-alcohol beverage cues. Controls (n = 153) responded to the same stimuli, but without approach/avoidance training. MEASUREMENTS: Date of first lapse was recorded for non-abstinent participants to determine time to first lapse. Time-line follow-back interviews assessed past-month alcohol consumption at each follow-up, with participants reporting no alcohol consumption classified as abstinent. In analyses of past-month abstinence, non-abstinence was assumed in participants lost to follow-up. Number of past-month drinking days, standard drinks and heavy drinking days (five or more standard drinks for women or non-binary; six or more standard drinks for men) were calculated for non-abstinent participants at each follow-up. FINDINGS: ApBM significantly delayed time to first lapse [ApBM median: 53 days, 95% confidence interval (CI) = 21-61; controls = 12 days, 95% CI = 9-21, P = 0.045]. Past-month abstinence rates at 3-, 6- and 12-month follow-ups were 33/153 (21.6%), 30/153 (19.6%), and 24/153 (15.7%) in controls; and 51/147 (34.7%), 30/147 (20.4%) and 29/147 (19.7%) in the ApBM group, respectively. Past-month abstinence was significantly more likely in ApBM participants than controls at the 3-month follow-up [odds ratio (OR) = 1.93, 95% CI = 1.16-3.23, P = 0.012], but not at 6- or 12-month follow-ups (6-month OR = 1.05, 95% CI = 0.60-1.95, P = 0.862; 12-month OR = 1.32, 95% CI = 0.73-2.40, P = 0.360). No significant group differences were found for indices of alcohol consumption in non-abstinent participants. CONCLUSIONS: Approach bias modification for alcohol delivered during inpatient withdrawal treatment helps to prevent relapse, increasing rates of abstinence from alcohol for at least 3 months post-discharge.

Reducing opioid prescribing on discharge after orthopedic surgery: Does a guideline improve opioid prescribing practice?

AIM: To investigate adherence to discharge advice in a prescription opioid prescribing guideline (GL) post-orthopedic surgery. METHODS: The guideline in draft form was introduced in February 2018. To assess longer-term adherence to discharge advice and to understand which components of that advice were adhered to, regular audits of discharge prescribing were performed after formal GL launch in February 2019, a year after the draft of the GL had been available. The post-GL audit was conducted for three months (March to May 2019) and results reviewed. When these audit results showed a need for improvement in prescribing practice, a 1-month education "booster" named prescription opioid practice improvement safe opioid supply (POPI SOS) took place. Audits for a further 3 months (July to Sept 2019) were then carried out to ascertain whether the additional effort improved adherence to the guideline. RESULTS: On average, adherence to all elements of the guideline was low at only 23.1 percent at 12 months post-draft GL and 1 month after its formal launch. After POPI SOS, a statistically significant improvement was achieved with an average increase in adherence to 52.5 percent (ρ < 0.001). Greatest improvement was seen in the percentage of patients discharged with an opioid plan included in the discharge summary, increasing from 35.8 to 77.7 percent (ρ < 0.001). The second significant improvement observed was in the supply of opioids being limited to four days or less, an increase from 38.1 to 61.9 percent (ρ < 0.001). CONCLUSION: Introduction of the guideline was not sufficient to promote sustained change in practice. Ongoing monitoring and education were required for its implementation. These findings highlight that comprehensive, locally adapted, evidence-based opioid stewardship is needed to increase the safety of patients and the community in relation to opioid therapy.

Pharmacists' perceptions and experiences of medicinal cannabis dispensing: A narrative review with a systematic approach.

OBJECTIVES: Medicinal cannabis was introduced with limited understanding of effect, and minimal rigorous evidence supporting efficacy, yet the global demand for medicinal cannabis continues to increase. In Australia, pharmacists remain a key conduit between the prescriber and patient, as most medicinal cannabis products are available only through approved prescriptions. This places pharmacists in a strong position to inform the evolving policy and practice of medicinal cannabis. This review aims to explore pharmacists' experiences and perceptions on medicinal cannabis in the global context by conducting a narrative review with a systematic approach. METHOD: MEDLINE (Ovid), EMBASE, and PubMed were searched on July 2021 using keywords and MeSH terms, with studies independently screened for eligibility. Of 278 identified studies, five met inclusion criteria, and were subjected to thematic synthesis for emergent themes. KEY FINDINGS: Whilst pharmacists valued being central to medicinal cannabis access, a repeating theme was that pharmacists perceived they were underprepared when engaging with patients about medicinal cannabis. These perceptions were congruent with their dispensing experiences, as most pharmacists reported patients seeking guidance on medicinal cannabis from them, yet only a small proportion felt comfortable in providing this guidance. Underpinning this was a lack of knowledge and low uptake of educational resources. CONCLUSIONS: Pharmacists are key in providing access to medicinal cannabis, yet they are expected to provide guidance with limited education. These limitations necessitate further investment in ongoing education to pharmacists in countries wishing to involve them in dispensing medicinal cannabis.

Reducing opioid prescribing on discharge after orthopaedic surgery: does a guideline and education improve prescribing practice 1 year later?

BACKGROUND: An intervention Prescription Opioid Practice Improvement (POPI), addressing opioid prescribing on discharge following orthopaedic surgery, demonstrated improved practice. Here we report the sustainability of improved practice at 12 months, and the impact of a booster education intervention, POPI SOS (Safe Opioid Supply). METHODS: Audits were performed using methodology described in previously published studies. RESULTS: High proportion of patients were discharged on opioids, 89.9% 12 months post-POPI (n = 149) and 82.2% post-POPI SOS (n = 169). Twelve months post-POPI there was a significant reduction in combination immediate (IR) and slow release (SR) opioids, 45.7% at the end of POPI program to 34.3% at 12 months (χ2 (1, N = 364) = 4.47, ρ = 0.034); a significant decrease in opioid-weaning plans, 87.4% at the end of POPI program to 35.8% at 12 months (χ2 (1, N = 365) = 104.19, ρ = <0.001); and a significant increase in provision of full quantities of SR-opioids, 6.1% after the POPI program to 15.7% (χ2 (1, N = 364) = 8.95, ρ = 0.003). The POPI SOS booster program significantly improved measures including reduction in combination IR and SR, 34.3-22.3% (χ2 (1, N = 273) = 4.87, ρ = 0.028) and an increase in opioid plans in discharge summaries, from 35.8% to 77.7% (χ2 (1, N = 273) = 48.87, ρ < 0.001). CONCLUSION: Better practice in relation to opioid prescribing is achievable but, for sustained improvement, opioid stewardship activities are needed to reduce the potential harms associated with prescription opioids.

Over the counter low-dose cannabidiol: A viewpoint from the ACRE Capacity Building Group.

Amidst growing global acceptance of medicinal cannabinoids as a potential therapeutic interest in cannabidiol (CBD) is increasing. In Australia in 2020, a government inquiry examined the barriers that the public are experiencing in accessing medicinal cannabis. A number of recommendations to improve access were made. In response to these recommendations, the Australian therapeutics regulatory authority down-scheduled CBD from Prescription Only (Schedule 4) to Pharmacist Only (Schedule 3). As a group of early to mid-career researchers of the Australian Centre for Cannabinoid Clinical and Research Excellence (ACRE), we propose some considerations in relation to over-the-counter availability of CBD and opportunities to improve knowledge about its potential therapeutic benefits alongside its increased uptake.

Pharmacokinetics, Safety, and Tolerability of a Medicinal Cannabis Formulation in Patients with Chronic Non-cancer Pain on Long-Term High Dose Opioid Analgesia: A Pilot Study.

INTRODUCTION: This phase I open-label study examined pharmacokinetics, safety, and tolerability of escalating doses of a novel combination cannabinoid medication (1:1 tetrahydrocannabinol [THC]/cannabidiol [CBD]) in patients with chronic non-cancer pain (CNCP) on high dose opioid analgesia. METHODS: Nine people with CNCP and oral morphine equivalent daily dose of 60 mg or higher were recruited. Blood concentrations of THC, 11-hydroxytetrahydrocannabinol (OH-THC), 11-nor-9-carboxy-tetrahydrocannabinol (COOH-THC), and CBD were assayed weekly. Concentrations were measured after a single dose of 2.5 mg THC/2.5 mg CBD on day 1, and daily escalating doses up to a single dose of 12.5 mg THC/12.5 mg CBD on day 29. Follow-up was on day 36 after a 7-day washout. Secondary outcome data encompassed pain, mood, and sleep parameters. RESULTS: The parent compounds THC, and CBD, and metabolites OH-THC and COOH-THC were detected at most time points. In general, the concentration of all analytes increased until 2 h post-administration, decreasing to approximately pre-dose concentrations by 8 h. There was considerable inter- and intra-individual variability. The study medication was well tolerated. Eight participants reported at least one adverse event (AE), with a total of 62 AEs; most common were euphoric mood, headache, and agitation, none classified as severe. There was no significant change to pain severity self-ratings, nor use of pain medications. Improvements in pain interference scores, mood, and some sleep parameters were observed. CONCLUSION: The THC/CBD formulation was tolerated well in a group of patients with CNCP. Between-participant variability supports personalized dosing and "start low-go slow" titration. To validate and quantify improvements in secondary efficacy outcomes a randomized placebo-controlled study is needed. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Register (CT-2019-CTN-01224-1).

Many studies use healthy volunteers when they look at the way medicines are absorbed in the body and their clinical effects. The aim of this project was to examine a new formulation of medicinal cannabis in people who have chronic pain and other health conditions to help us to plan a larger study. We wanted information on how quickly it was absorbed and whether there were any negative effects of the medicine. We wondered whether the fact that participants were on a number of other medications might mean that we see different results to those seen with healthy volunteers. We found that the results of our group were very similar to those seen in other studies. Although we only tested a small number of participants we did not observe serious negative effects of the medication, and saw some positive effects on mood and sleep. We now have the data to assist us in planning a larger study which should provide important guidance to prescribers of medicinal cannabis in the future.