A phase III multisite randomised controlled trial to compare the efficacy of cannabidiol to placebo in the treatment of cannabis use disorder: the CBD-CUD study protocol.

BACKGROUND: Cannabis use disorder (CUD) is increasingly common and contributes to a range of health and social problems. Cannabidiol (CBD) is a non-intoxicating cannabinoid recognised for its anticonvulsant, anxiolytic and antipsychotic effects with no habit-forming qualities. Results from a Phase IIa randomised clinical trial suggest that treatment with CBD for four weeks reduced non-prescribed cannabis use in people with CUD. This study examines the efficacy, safety and quality of life of longer-term CBD treatment for patients with moderate-to-severe CUD. METHODS/DESIGN: A phase III multi-site, randomised, double-blinded, placebo controlled parallel design of a 12-week course of CBD to placebo, with follow-up at 24 weeks after enrolment. Two hundred and fifty adults with moderate-to-severe CUD (target 20% Aboriginal), with no significant medical, psychiatric or other substance use disorders from seven drug and alcohol clinics across NSW and VIC, Australia will be enrolled. Participants will be administered a daily dose of either 4 mL (100 mg/mL) of CBD or a placebo dispensed every 3-weeks. All participants will receive four-sessions of Cognitive Behavioural Therapy (CBT) based counselling. Primary endpoints are self-reported cannabis use days and analysis of cannabis metabolites in urine. Secondary endpoints include severity of CUD, withdrawal severity, cravings, quantity of use, motivation to stop and abstinence, medication safety, quality of life, physical/mental health, cognitive functioning, and patient treatment satisfaction. Qualitative research interviews will be conducted with Aboriginal participants to explore their perspectives on treatment. DISCUSSION: Current psychosocial and behavioural treatments for CUD indicate that over 80% of patients relapse within 1-6 months of treatment. Pharmacological treatments are highly effective with other substance use disorders but there are no approved pharmacological treatments for CUD. CBD is a promising candidate for CUD treatment due to its potential efficacy for this indication and excellent safety profile. The anxiolytic, antipsychotic and neuroprotective effects of CBD may have added benefits by reducing many of the mental health and cognitive impairments reported in people with regular cannabis use. TRIAL REGISTRATION: Australian and New Zealand Clinical Trial Registry: ACTRN12623000526673 (Registered 19 May 2023).

Designing, implementing and evaluating the overdose response with take-home naloxone model of care: An evaluation of client outcomes and perspectives.

INTRODUCTION AND DESIGNS: Take-home naloxone (THN) interventions are an effective response to preventing overdose deaths, however uptake across Australia remains limited. This project designed, implemented and evaluated a model of care targeting opioid users attending alcohol and other drug (AOD) treatment, needle and syringe programs (NSP) and related health services targeting people who inject drugs. DESIGN AND METHODS: Service providers, consumers and regulators collaboratively designed a THN brief intervention (ORTHN, Overdose Response with Take-Home Naloxone) involving client education and supply of naloxone in pre-filled syringes, delivered by nursing, allied health and NSP workers. ORTHN interventions were implemented in over 15 services across New South Wales, Australia. The evaluation included client knowledge, attitudes, substance use and overdose experiences immediately before and 3 months after ORTHN intervention in a subsample of participants. RESULTS: Six hundred and sixteen interventions were delivered, with 145 participants recruited to the research subsample, of whom 95 completed the three-month follow up. Overdose-related attitudes amongst participants improved following ORTHN, with no evidence of increased substance use or failure to implement other 'first responses' (e.g. calling an ambulance). Nine participants (10%) reversed an overdose using THN in the follow-up period. Participants identified a willingness to access THN from a range of services. While a minority (16%) indicated they were unwilling to pay for THN, the median price that participants were willing to pay was $AUD20 (IQR $10.40). DISCUSSION AND CONCLUSIONS: The ORTHN model of care for THN appears an effective way to disseminate THN to people who use opioids attending AOD, NSP and related health-care settings.

Markers of hepatitis B infection and immunity in patients attending Aboriginal community controlled health services.

OBJECTIVE: Hepatitis B virus (HBV) infection remains an important cause of morbidity and mortality in Aboriginal and Torres Strait Islander people, who have high rates of infection compared with non-Indigenous Australians. We aimed to increase the evidence base around HBV in Aboriginal and Torres Strait Islander people through an analysis of routine clinical encounter data. DESIGN: A cross-sectional study of de-identified records from electronic patient systems over 5 years (8 January 2009 to 11 July 2013). SETTING: Four Aboriginal community controlled health services. PARTICIPANTS: All patients attending for a clinical visit were included in the study. Hepatitis B testing records were included if at least one serological test for HBV was done. MAIN OUTCOME MEASURES: Percentage of clinical patients tested for hepatitis B, compliance with guidelines and serological status. RESULTS: A total of 2959 people aged 15-54 years were screened for HBV, representing 17.2% of all people with a clinical visit in the study period. A total of 865 Aboriginal patients were tested concurrently for hepatitis B surface antigen (HBsAg), hepatitis B core antibody and hepatitis B surface antibody. Of those, 352 (40.7%) were susceptible to HBV infection (95% CI, 37.4%-43.9%) and 34 (3.9%) had either an acute or chronic infection indicated by a positive HBsAg result (95% CI, 2.6%-5.2%). In 329 women with antenatal screening, six (1.8%) returned a positive HBsAg result (95% CI, 0.37%-3.28%). CONCLUSION: A substantial proportion of patients tested were susceptible to HBV, with a high percentage potentially infectious compared with the general population. High levels of active infection and susceptibility to infection suggest many opportunities for transmission and indicate the potential benefit of routine HBV testing and vaccination in this population.