ANZCTR search results

Sublocade (buprenorphine) is currently approved only for intra-abdominal subcutaneous injection for the treatment of opioid treatment disorder. However, intra-abdominal subcutaneous injection is sometimes poorly tolerated by patients because of certain discomfort. Using the same product in different sites may actually have a similar rate and extent of buprenorphine release. However, the rate and release profile of alternative injection sites (e.g., deltoid (shoulder) or thigh or buttock) compared to abdominal (stomach) injection is unknown. This study aims to evaluate the rate and extent of buprenorphine release and its tolerability from different injection sites in 50 patients who are on treatment for opioid use disorder. Eligible participants will be randomized to receive first injection sites and baseline samples will collected. Subsequent doses will be given in order abdomen, thigh, buttock, and deltoid. Serial blood samples will be collected after the injection for each subsequent injection.

The current evidence suggests that the optimal length of a sequence of night shifts may depend on the intensity of light that shiftworkers are exposed to during the night. If so, then OHS guidelines that recommend a blanket limit on night shifts of a maximum of 2-4 in a row may inadvertently expose shiftworkers to a higher level of fatigue-related risk than is necessary in some workplaces. In this project, we will test the proposition that shorter sequences of night shifts may be suited to workplaces where shiftworkers operate in dim light and are less likely to adapt to a nocturnal schedule, whereas longer sequences of night shift may be suited to workplaces where shiftworkers operate in normal indoor light and may be more likely to adapt to a nocturnal schedule. The project will include a multiple-day night work simulation study with three conditions. The only difference between conditions will be in the light intensity during night shifts – dim (10 lux), moderate (100 lux), and normal (350 lux) – as experienced by truck drivers, hospital-based healthcare practitioners, and control room operators, respectively. The data will be used to test three hypotheses: 1. Body clock time will get progressively later, i.e., delay, with each successive night shift, and the daily rate of delay will be smallest (or absent) in the dim light condition and greatest in the normal light condition. 2. The quantity/quality of daytime sleep will progressively increase with each successive night shift, and the daily increases will be smallest (or absent) in the dim light condition and greatest in the normal light condition. 3. Night-time alertness will decline with each successive night shift in the dim light condition, remain stable in the moderate light condition, and increase with each successive night shift in the normal light condition.

This study is investigating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single ascending dose of BW-20805 in healthy volunteers in 4 dose level cohorts. Approximately 32 men and women aged (more than equal to) 18 to (less than equal to) 60 years who fulfill the inclusion and exclusion criteria will be enrolled at one site in Australia. Eligible subjects will be admitted to the clinical research unit on Day -1, dosed on Day 1, discharged on Day 2 (24 hours post-dose), and return for outpatient visits through Week 24. Within each cohort, 8 subjects will be randomized in a 3:1 ratio to receive a single dose of BW-20805 (n=6) or placebo (n=2) on Day 1 in a double-blind fashion. Cohorts 1 to 4 and the control group will receive BW-20805 doses of 50mg, 150mg, 300mg, and 600mg, or placebo respectively.

Generalised joint hypermobility (GJH), defined as Beighton 6/9 or more, is prevalent in approximately 34 % of children and adolescents globally and associated with symptoms in about one in five of these children. Generalised Hypermobility Spectrum Disorder is the combination of Beighton 5/9 or greater for post-pubertal and 6/9 or greater for pre-pubertal children and adolescents together with musculoskeletal manifestations including joint pain, pes planus, hindfoot valgus, poor proprioception, joint laxity and instability. Children with symptomatic GJH can experience joint laxity or joint instability and reduced strength and endurance during walking and other physical activities. Children also frequently report soft tissue injuries and pain following exercise, particularly in the lower limbs. Longitudinal studies have shown that children with GJH are more likely than their non-hypermobile peers to experience persistent chronic pain 3 to 5 years later. In addition, children with symptomatic GJH can experience functional impairments such as difficulties with motor development, and impaired proprioception. Overall symptomatic GJH may negatively impact a child’s participation, including school attendance, poor academic performance, reduced quality of life and psychosocial function. To date no study has investigated the impact of custom-made orthotics on pain, functioning, fatigue and quality of life in children with GJH and lower limb pain. This study therefore investigated the safety of and outcomes following custom-made orthotic use with podiatric recommended footwear in children with GJH and lower limb pain through before and after assessment of pain, functioning, fatigue and quality of life over a three-month period.

Age-related increases in reactive oxygen species (ROS) production by skeletal muscle mitochondria have been linked to the failure of exercise responses in aged muscle. These changes limit the efficacy for exercise to maintain or improve muscle health in old age. Interventions that decrease mitochondrial ROS levels may improve the capacity of aged skeletal muscle to respond to exercise. The mitochondria-targeted antioxidant MitoQ is designed to accumulate in mitochondria and decrease ROS. The purpose of this study is to determine the effect of MitoQ supplementation on mitochondrial ROS levels and function and acute exercise responses in skeletal muscle from older individuals. Study hypotheses MitoQ supplementation will increase mitochondrial respiration and decrease mitochondrial ROS levels in skeletal muscle from older individuals. MitoQ supplementation will augment exercise responses in skeletal muscle from older individuals.

This study is investigating the effect of intrathecal morphine compared to standard care with oral and intravenous opioids on the quality of recovery after robotic-assisted radical prostatectomy. Who is it for? You may be eligible for this study if you are aged 18 years or older, have been diagnosed with prostate cancer, and are scheduled for robotic-assisted radical prostatectomy, and have no allergy to morphine. Participants undergoing robotic-assisted radical prostatectomy will be randomly allocated (by chance) to one of two groups: one group will be prepared for spinal anaesthesia and receive morphine administered through spinal injection and the other group will be prepared for spinal anaesthesia but will not receive a morphine injection. Both groups will receive standard care of oral and intravenous pain medications (opioids) from admission to discharge, as appropriate. Participants recovery, pain levels and oral morphine medications will be monitored in the first 24 hours post-surgery. Side effects will be monitored for the duration of the hospital stay. It is hoped that this research will help improve postoperative recovery after robotic-assisted radical prostatectomy.

This randomised clinical trial aims to determine the effectiveness of a pre-operative pharmacist-partnered opioid tapering program compared with standard care for patients awaiting elective Total Hip or Knee Arthroplasty (THA or TKA) on post-operative outcomes including persistent opioid use. Eligible participants must be aged greater than or equal to 18 years; awaiting elective unilateral or bilateral THA or TKA; speak and read English; use prescription opioid analgesics at least 4 days a week; and have access to internet or telephone. The participants will be excluded if they are undergoing a repeat surgery (same procedure within 6 months), are using opioids for cancer, palliative care or substance use disorder; have previously or are currently undergoing an opioid tapering program or active medication review; or have cognitive impairment. Enrolled participants will be randomised in a 1:1 ratio in permuted blocks of 2 and 4 to: (1) intervention, or; (2) standard care. A total of 314 participants will be recruited into the study. The intervention will include a pharmacist-partnered opioid tapering program, in which a pharmacist will work with participants to reduce their opioid dose over a 3-month period before surgery. Standard care will involve review by the hospital preadmission clinic multidisciplinary team to assess medical, physical and psychological health prior to surgery, and education sessions for preoperative and postoperative care. The primary outcome assessed is persistent opioid use 3-months post-surgery. The key secondary outcome is total Western Ontario and McMaster Universities Arthritis Index [WOMAC] score. Data analysis will be performed using an estimand framework, with a generalised estimating equation model for the primary outcome from 1-3 days pre-surgery to 3 months post-surgery and a multilevel model for the main secondary outcome from baseline to 3 months after surgery.

The broad aim of this effectiveness study is to conduct a pragmatic randomized controlled two-arm trial (RCT) to determine whether Family Life Skills Triple P plus Group Teen Triple P compared to Group Teen Triple P alone optimizes the parenting and self-regulatory skills, self-efficacy and well-being of parents and carers of young people (12 to 17 years) with severe and complex mental health problems. Recruitment will be statewide, and participants may include the parents/carers of young people (12 to 17 years) on the waitlist for or being discharged from Jacaranda Place Adolescent Unit and Day Program, Day Program South as well as parents/carers of young people referred from referring community CYMHS clinics, E-CYMHS, and CHQ HHS Emergency Departments (ED) (where presenting for serious and complex mental health difficulties). Data will be collected at baseline, post-intervention, and 6 months post intervention. Data will include parental self-report measures of family functioning, parenting, self- and emotional regulation, parental self-efficacy, parental assessment of parent-adolescent relationship and adolescent wellbeing, as well as young person self-report of adolescent functioning, family functioning and parent-adolescent relationship. Routine outcome measure (ROM) data recorded in the young persons’ electronic medical record will be utilised when available. This is a pragmatic study to assess feasibility and effectiveness of the program in ‘real life’ conditions.

Motherhood can give rise to significant physical and psychological difficulties. It is worthwhile to explore interventions that may improve mothers’ psychological functioning and support the development of the mother-infant bond. This study will test a novel flexible perspective taking intervention, comprising of: (1) ACT metaphors for enhancing a transcendent sense of self and applying them to perinatal context, (2) a guided experiential exercise on flexible perspective taking for pregnant and new mothers. Previous research has supported the effectiveness of brief online interventions for mothers of infants in Australia. The current study takes a similar approach by assessing the efficacy of a flexible perspective taking intervention.

Vulvar lichen planus (VLP) is a chronic inflammatory dermatosis characterized by erythema, erosions and hyperkeratosis on the vulva with possible vaginal involvement. The condition is particularly difficult to treat and runs a chronic and progressive course, requiring long-term management and follow-up. The first-line treatment for VLP is potent topical corticosteroids. However, approximately 20-40% of patients require second-line treatment with systemic immunosuppression to control their disease. Some of the systemic medications that have been used to treat VLP include prednisolone, methotrexate, mycophenolate mofetil, azathioprine, hydroxychloroquine and cyclosporine, with varying results. The best documented agent appears to be methotrexate, with authors reporting moderate efficacy and safety profile. However, these studies were either retrospective or small case series. Overall, there is a lack of high-quality evidence, such as randomized controlled trials (RCTs), to compare and guide second-line systemic treatments in VLP. The pathogenesis of VLP is not completely understood, but there is evidence of involvement of tyrosine kinase 2 (TYK2) mediated pathway. One drug known to modulate the TYK-2 pathway is Deucravacitinib (BMS-986165), a novel, oral, selective TYK-2 inhibitor. It is being studied in patients with psoriasis, psoriatic arthritis, and systemic lupus erythematosus with promising results. Given the lack of high-quality evidence to guide the use of second-line systemic treatments in VLP, the evidence of involvement of TYK2-mediated pathway, and that the best documented systemic agent in VLP to date is methotrexate, the aim of this study is to conduct a double-blinded RCT comparing the efficacy and safety of Deucravacitinib to that of Methotrexate, in patients with VLP who have failed first-line treatment with potent topical corticosteroids. Hypothesis: Deucravacitinib will be superior to methotrexate in treating VLP patients who have failed topical therapy with potent corticosteroids.