AIMS:This study tested the efficacy and safety of a 12-week course of lisdexamfetamine in reducing methamphetamine use, an outcome which is associated with improvements in health and wellbeing, in people dependent on methamphetamine. DESIGN, SETTING AND PARTICIPANTS:This study was a randomised double-blind placebo-controlled trial conducted in six specialist outpatient clinics in Adelaide, Melbourne, Newcastle and Sydney, Australia (2018-2021). Participants were164 adults with methamphetamine dependence, reporting at least 14 use days out of the previous 28 days (62% male, 38% female, < 1% other; mean age 39 years). INTERVENTIONS:Participants were randomly allocated 1:1 to a 15-week regimen of lisdexamfetamine (1-week induction to 250 mg, 12-week maintenance regimen, 2-week reduction; n = 80) or matched placebo (n = 84), followed-up to Week 19. MEASUREMENTS:The primary efficacy measure was past 28-day methamphetamine use at Week 13. Safety was assessed by adverse event rates. Secondary measures included methamphetamine use during the 12-week treatment period and treatment satisfaction. FINDINGS:Nine randomized participants did not start treatment (five were allocated to lisdexamfetamine and four allocated to placebo) and were excluded from the analyses. Fifty-seven per cent of participants were retained on study medication to primary end-point. There was only weak evidence of a lisdexamfetamine benefit at 13 weeks [adjusted difference in days of methamphetamine use = 2.2, 95% confidence interval (CI) = -0.5 to 5.0; P = 0.49]. However, throughout the whole 12-week treatment maintenance phase, the lisdexamfetamine group had fewer days of methamphetamine use in total (difference = 8.8, 95% CI = 2.7-15.0; P = 0.005). The lisdexamfetamine group reported greater self-reported treatment effectiveness [odds ratio (OR) = 2.89, 95% CI = 1.67-5.02; P < 0.001] and treatment satisfaction (OR = 3.80, 95% CI = 1.93-7.47; P < 0.001). Adverse events with lisdexamfetamine included nausea. Serious adverse events occurred in four (5%) of participants who received lisdexamfetamine. CONCLUSIONS:Lisdexamfetamine appears to reduce methamphetamine use over a 12-week treatment period, although there is only weak evidence that reduced use is maintained during the last 4 weeks.

Background The COVID-19 pandemic impacted patients with substance use disorder (SUD) more than the general population and resulted in substantially increased emergency department admissions. Routine care of patients attending drug health services during the pandemic transitioned, with telehealth being important in delivering appropriate care. However, telehealth introduces unique risks such as privacy, confidentiality, and data safety. Providing health care through telehealth may fail if the legal impacts are not fully identified and acted on by health professionals. It also poses unintended risks for patients and can result in ineffectiveness, damages, medical negligence, and detracts from the best intentions of governments and health professionals. Understanding the legal framework ensures that medical professionals operate health care through telehealth within the law. Providing health care successfully through telehealth depends on the balance between innovation and legal compliance. By considering these aspects, clinicians and practitioners can provide effective and safe telehealth services during pandemics or any other natural disaster. Objective We aimed to explore the legal impact of autonomy consent, confidentiality, privacy, data security, professional indemnity, and liability when delivering telehealth to patients with SUD. The scoping review also aimed to provide legal, ethical, and clinical considerations to minimize legal risks with using telehealth in drug health service outpatient settings. Methods We performed a scoping review to provide an overview of existing research, statutes, and case laws for the incorporation of clinical, ethical, and legal considerations into telehealth use. Six databases for medical and 6 databases for legal publications were searched, as well as Australian national and selected international regulatory standards. Medical articles published up to June 2022 were included in this review. Our search yielded 1436 publications, 614 abstracts were reviewed, and 80 published studies met the inclusion criteria from 614 legal and medical search results. Current regulations related to technology use in drug health services, relevant cases, and international regulatory standards are discussed. Results In total, 43 legal documents including 15 statutes, 4 case laws, and 37 medical publications were reviewed. The themes arising from the literature were consent and autonomy (20/80, 25%), confidentiality (8/80, 10%), privacy (8/80, 10%), data security (7/80, 9%), and professional indemnity issues (3/80, 4%) in telehealth use. Further, 24 studies identified legal issues associated with telehealth use in patients with SUD. Conclusions Our review identified potential legal issues associated with telehealth use in patients with SUD. Several legal and medical research articles provide frameworks, codes of conduct, or suggestions for clinicians to consider, but there was little discussion or evidence of how legal considerations are being applied when providing telehealth consultations at drug health services. Clinicians should be aware of the medicolegal implications when providing health care via telehealth at drug health services.

Background: In this study, we determined the impact of the COVID-19 pandemic on Western Sydney patients with substance use disorders (SUD) by comparing emergency department (ED) admission rates before and after the onset of the COVID-19 pandemic and before the rollout of COVID-19 vaccination. Methods: ED admission data for patients with SUD were retrieved from the local electronic medical record (eMR) on the hospital central database. ED data collected from 25 January to 25 July 2019 (before the COVID-19 pandemic) were compared with data from 25 January to 25 July 2020 (early pandemic). ED admission reasons were categorised based on the presenting complaints and ED diagnoses. Results: Despite an overall reduction in ED admissions during the early pandemic, compared to the pre-pandemic period, admissions for patients with SUD increased significantly (1.7% to 3.4%, p < 0.01). ED admission rates related to infection (0.05% to 0.12%, p < 0.01), local infection (0.02% to 0.05%, p < 0.01), trauma (0.06% to 0.12%, p < 0.01), alcohol (0.01% to 0.03%, p < 0.05), and other issues (0.06% to 0.10%, p < 0.05) increased significantly among Indigenous patients with SUD. ED admission rates related to drugs (0.12% to 0.39%, p < 0.01), infection (0.21% to 0.34%, p < 0.01), local infection (0.07% to 0.18%, p < 0.01), gastrointestinal (0.15% to 0.23%, p < 0.05), trauma (0.14% to 0.25%, p < 0.01), alcohol (0.36% to 0.74%, p < 0.01), and ‘other’ issues (0.47% to 0.91%, p < 0.01) increased significantly among non-Indigenous patients with SUD. Four cases of COVID-19 were reported among these patients. Conclusions: There was an increase in ED admissions for patients with SUD in the initial six months of the COVID-19 pandemic (before vaccine rollout), mainly for drugs, systemic infection, local infection, trauma, and alcohol-related reasons. Now that most people in New South Wales have been vaccinated against COVID-19, a further study is needed to quantify the effect of the pandemic on patients with SUD in the post-vaccine era.

BACKGROUND:Long-acting injectable depot buprenorphine is an important new treatment option for the management of opioid dependence, delivering therapeutic doses in weekly or monthly formulations. Depot buprenorphine aims to overcome challenges associated with traditional opioid agonist therapy (OAT), including: poor patient adherence; inconvenience of regular attendance for dosing; and, risk of non-medical use of takeaway doses. However, little is known about patients' experiences of depot buprenorphine. This qualitative study aimed to explore patients' experiences of the practical and social affordances of depot buprenorphine.METHODS:Participants were recruited from sites in Sydney, regional New South Wales, and Melbourne, Victoria, Australia. Thirty participants (16 men, 14 women; mean age 47.3 years) participated in semi-structured interviews. Participants had histories of both heroin and prescription opioid use, and previous OAT including daily dosing of buprenorphine and methadone.FINDINGS:Depot buprenorphine afforded positive benefits for many participants, including: opportunities to avoid stigma experienced at pharmacies/clinics; time to engage in activities (e.g., travel, work) by releasing participants from previous OAT treatment regimens; and, cost savings by not having to pay pharmacy fees associated with daily dosing. However, for some participants, moving to depot buprenorphine: disrupted engagements with important social/practical supports available at pharmacies/clinics; constrained their control over dosing; and, constrained their ability to generate income via the sale of takeaway doses.CONCLUSIONS:While generally experienced as affording benefits, depot buprenorphine can have differing social and practical impacts. Clinicians should monitor patients receiving depot buprenorphine to reduce the risk of unintended consequences including disruption to clinical supports.

BACKGROUND AND AIMS The Australian Treatment Outcomes Profile (ATOP) is a brief instrument measuring recent substance use, risk profile, and general health and wellbeing among clients attending Alcohol and other Drug (AoD) treatment services. This study evaluates the ATOP for concurrent validity, inter-rater and test-retest reliability among alcohol and opioid treatment groups. DESIGN For concurrent validity and inter-rater reliability, participants completed an ATOP with a clinician, and an ATOP plus standardised questionnaires (Time Line-Follow Back, Opiate Treatment Index, Kessler-10, 12 item Short Form Survey, WHO Quality of Life-BREF, Personal Wellbeing Index) with a researcher within 3 days. For test-retest reliability, participants completed two ATOPs with a researcher within a 3-day interval. SETTING Outpatient AoD treatment centres in Australia. PARTICIPANTS For testing concurrent validity and inter-rater reliability, 278 participants were recruited by advertisements in waiting rooms or clinician invitation over 2016-2018. A further 94 participants were recruited to examine test-retest reliability MEASUREMENTS: Statistical tests used for concurrent validity and test-retest reliability were Pearson's and Spearman rank order correlations for continuous variables, and Cohen's κ for nominal variables. Inter-rater reliability was assessed using Krippendorf's α. FINDINGS Most Australian Treatment Outcomes Profile items returned excellent or moderate validity and reliability. For the main substances used - alcohol, cannabis, and benzodiazepines - concurrent validity, interrater reliability and test retest reliability all reached excellent or good agreement (0.72-0.98). Psychological health, physical health and quality of life showed fair to strong agreement with their comparator scales (0.47-0.85). CONCLUSIONS The Australian Treatment Outcomes Profile is a validated and reliable instrument for assessing recent substance use and clinical risk, health and welfare among alcohol and opioid clients in Alcohol and other Drug treatment settings. Its ability to reliably measure complex constructs, such as psychological and physical health, against longer scales makes it suitable for integration into routine clinical care, enabling regular monitoring of patient outcomes and safety parameters.

Key Points Question Are patient-reported outcomes, such as treatment satisfaction with medication, higher among patients treated with weekly and monthly subcutaneous buprenorphine depot formulations vs daily sublingual buprenorphine? Findings In this open-label randomized clinical trial of 119 participants, the mean Treatment Satisfaction Questionnaire for Medication global score was significantly higher in the group receiving depot buprenorphine than in the group receiving sublingual buprenorphine at week 24. Meaning These findings suggest that treatment satisfaction and other patient-reported outcomes may serve as alternative end points to traditional markers of substance use when comparing different medications in addiction outcome studies.

INTRODUCTION AND AIMS:The Australian Treatment Outcomes Profile (ATOP) is a brief clinical tool measuring recent substance use, health and wellbeing among clients attending alcohol and other drug (AOD) treatment services. It has previously been assessed for concurrent validity and inter-rater reliability. In this study we examine whether it is suitable for administration over the telephone.DESIGN AND METHODS:We recruited a sample of 107 AOD clients across public sector specialist AOD treatment services in New South Wales, Australia between 2016 and 2018. Participants had a mean age of 47 years and 46% were female. Participants completed a face-to-face ATOP and a phone ATOP with a researcher within 5 days. Comparisons between the two administration modes were undertaken using Spearman's rank correlation coefficient for continuous or ordinal variables, and Cohen's Kappa for nominal variables.RESULTS:Among 107 participants, 59% were attending for alcohol treatment and 41% for opioid treatment. Most ATOP items (76%) reached above 0.7 (good) or 0.9 (excellent) agreement between face-to-face and telephone use.DISCUSSION AND CONCLUSIONS:Our findings suggest that the ATOP is a suitable instrument for telephone monitoring of recent substance use, health and social functioning among AOD clients. Its validation for remote use over the telephone will support staff to monitor clients' risks and outcomes-of particular relevance in response to the COVID-19 pandemic in which services are increasingly relying on telework approaches to client monitoring.