ANZCTR search results

This study is a Phase 1, randomised, dose escalation, double-blind, placebo-controlled study of cannabidiol (CBD) in healthy volunteers. The study is designed to evaluate the safety, tolerability and pharmacokinetics (PK) of a single dose of Cannabidiol in healthy volunteers. A total of 24 subjects will be enrolled in this study. Eight subjects in each cohort will be randomised to receive either CBD or placebo in a 3:1 ratio, so that 6 subjects receive CBD and 2 subjects receive placebo: Cohort 1: 5mg/kg Cohort 2: 10mg/kg Cohort 3: 20mg/kg. Sentinel dosing will be implemented in the first 2 subjects (1 CBD and 1 placebo) of Cohort 1; the rest of the subjects in the cohort will then be dosed if there are no significant safety concerns identified in the sentinel participants within at least the first 24 hours after administration of the oral dose (CBD or placebo). Sentinel dosing may be implemented for subsequent cohorts if deemed appropriate by the Safety Review Committee (SRC). The study will be conducted at a single study centre. Each participant will be involved in the study for a maximum of 15 days (screening period (up to 28 days); treatment period (3 days); follow-up visits (Days 4, 6 and 8) and telephone contact (Day 15). The SRC will undertake a dose-escalation review of all available safety data up to Day 8, approximately 2 weeks after the final subject in a cohort has been dosed and prior to subjects commencing the next dose. The primary objective of the study is to: • Assess the safety and tolerability of CBD following a single oral dose in healthy volunteers The secondary objective of the study is to: • Assess the PK of CBD following a single oral dose in healthy volunteers The primary endpoints to be evaluated in the study are: • Safety and tolerability of CBD, including review of: - adverse events - vital signs - 12-lead ECG - clinical laboratory assessments - concomitant medications. The secondary endpoints to be evaluated in the study are: • The PK of CBD, plasma concentration of CBD and PK parameters including: - AUClast – area under the plasma concentration versus time curve from time zero to the last quantifiable concentration - AUCinf – area under the plasma concentration versus time curve extrapolated to infinite time - Cmax – maximum observed plasma concentration - Tmax – time of maximum observed plasma concentration - Kel – apparent terminal elimination rate constant - T1/2 – apparent terminal elimination half-life The CBD to be manufactured for this study will be prepared as an oil for oral administration. Dosing will be based on subject body weight and the assigned dose cohort. The matching placebo will be composed of the same excipients as the study drug (without the CBD).

The aim of the study is to identify how women cope with pelvic girdle pain in pregnancy. Many women complain of pelvic girdle pain in pregnancy and seek information about this condition. Currently there is not much available information about this disorder, particularly in Australian women, and this study aims to address this lack of knowledge. Previous studies have so far found that women need to change their daily activities in order to try and cope. A qualitative design will be used to provide a rich description of the lived experience of women living with pelvic girdle pain in pregnancy via interviews, diary or focus groups.

The purpose of this study is determine whether exercise-based rehabilitation is effective in cancer survivors with Chemotherapy Induced Peripheral Neuropathy (CIPN). Who is it for? You may be eligible for this study if you are an adult with chemotherapy-induced peripheral neuropathy symptoms which persist after the completion of your chemotherapy treatment. Study details Participants in this study will be randomly sorted into two groups: - Group 1: participates in 3 weekly exercise sessions for 8 weeks. These sessions will be held face to face and either one-one-one or in small groups. Exercises will be individualized based on your balance abilities and strength and fitness levels and include cardiovascular, resistance, balance and stretching exercises. - Group 2: will receive an at-home exercise intervention after an 8 week delayed start. The home-exercises will also be completed 3 times a week for 8 weeks, be individualized, and include the same types of exercises as Group 1. Participants will also be required to complete fitness, nerve, functional and questionnaire assessments before and after their 8-week exercise program. It is hoped that this study will provide evidence regarding the effectiveness of exercise-based rehabilitation for people with chemotherapy induced peripheral neuropathy and establish the merits of home-based v clinic-based treatment.

Radiotherapy treats cancer using high energy x-rays in order to destroy cancer cells including prostate cancer via a linear accelerator machine. A new technology, known as the SUPER-I is a prospective study that will assess the safety and efficacy of using the ‘SeedTracker’ system in prostate radiotherapy in South Western Sydney Local Health District. Who is it for? You may be eligible for this study if you are an adult male receiving radiotherapy treatment for prostate cancer within the Liverpool or Macarthur cancer therapy centres. Study details All participants in this study will undergo their usual radiotherapy treatment schedule. As part of this study, during the radiotherapy treatment, participants will have radiotherapy markers implanted in the prostate in order to detect the position of the prostate in real-time. All blood tests will be performed as standard care by your specialist. It is hoped that this study will improve radiotherapy treatment delivery accuracy for those with prostate cancer.

Anxiety affects 7% of young people & only 50% receive help. This project aims to test the feasibility of a new, stepped care, internet based Cognitive behavioural treatment (iCBT) model for youth anxiety utilising the BRAVE Program. Therapist supported iCBT demonstrates equivalent efficacy with face to face CBT, but cost and insufficient numbers of clinicians means therapist guided iCBT is often not available or unsuitable to reach large numbers of anxious youth. Self help iCBT (no therapist) offers one solution. A national trial of BRAVE Self Help (>16,000 registrations in 2 years) showed meaningful anxiety reductions for youth completing the program. Many children failed to complete the treatment without support and not all were successfully treated. There is a need to identify models of care that can reach large numbers and provide appropriate support; such as a Stepped Care Model (SCM). Within a SCM, all young people would first receive the less intensive treatment. Those who have not responded well to the first step then receive a more intensive intervention. In this project, all participants would first receive 5 sessions of self help iCBT (step 1; psychoeducation, skills acquisition). Those who respond will receive 5 more self help sessions (skill rehearsal & maintenance). Those who fail to respond after step 1 would `step up' to receive their remaining 5 iCBT sessions with therapist guidance (step 2). Pilot evidence supports the use of a SCM in high intensity face to face CBT for childhood anxiety. To date, no studies of SCMs for iCBT exist. If a SCM approach, using self help plus therapist guided iCBT is as effective as therapist guided iCBT alone, we will have identified a scalable, easily disseminated model that can produce clinical outcomes similar to standard clinical therapy. This particular project utilises small doses of 'high intensity' (e.g. face-to-face) contact to supplement an evidence based treatment. Thus it provides a potential model of care that can first capitalize on the benefits of online interventions, and subsequently provide high intensity care, only when needed. This may have the capacity to effectively personalize the treatment to the young person. The study will also provide insights into the acceptability of face-to-face contact via videoconferencing in such contexts.

Hereditary Angiodema (HAE) is a rare disease caused by low levels of C1 serine protease inhibitor in the body. Deficiencies in this protein leads to increased activation of inflammatory pathways which can cause swelling, severe abdominal pain and airway obstruction that can be life threatening. ATN-249 is a potential once a day oral treatment for HAE. The purpose of this research study is to test the safety and tolerability of extended release formulations of ATN-249 as well as the pharmacokinetics and pharmacodynamics of the study drug. The study is open to healthy male volunteers and the research goals are: - Does the drug have any side-effects and is it well tolerated when given as a multiple dose over several days? - How much of the drug gets into the blood stream, and how long does the body take to get rid of it? This study will also look at how the human body uses ATN-249 at different dose levels and under different dosing regimens (single day dosing or 14-day dosing).

The bond that develops between an infant and their caregiver shapes their developing brain and provides the framework through which they see themselves, others, and the world. Attachment theory provides a structure in which to understand this unique and important relationship. Research has shown that having a secure attachment provides resilience against adverse experiences while a poor attachment can lead to mental health problems and relational difficulties. Therapeutic interventions have been developed, which have been shown to be effective in helping caregiver­child dyads develop a secure attachment. However there is a need for these types of interventions to be less intensive and targeted at modifying the caregiver’s internal working models to increase sensitivity. This research proposes that modification can be done with psycho­education and increasing the caregivers reflective functioning. This research project proposes an attachment­based intervention using education and increasing the caregivers reflective functioning can be effective. Conducting the intervention using an internet based format will provide easily accessible and cost­effective means of helping parents and caregivers

Anxiety affects 7% of young people & only 50% receive help. This project aims to test the feasibility of a new, stepped care, internet based Cognitive behavioural treatment (iCBT) model for youth anxiety utilising the BRAVE Program. Therapist supported iCBT demonstrates equivalent efficacy with face to face CBT, but cost and insufficient numbers of clinicians means therapist guided iCBT is often not available or unsuitable to reach large numbers of anxious youth. Self help iCBT (no therapist) offers one solution. A national trial of BRAVE Self Help (>16,000 registrations in 2 years) showed meaningful anxiety reductions for youth completing the program. Many children failed to complete the treatment without support and not all were successfully treated. There is a need to identify models of care that can reach large numbers and provide appropriate support; such as a Stepped Care Model (SCM). Within a SCM, all young people would first receive the less intensive treatment. Those who have not responded well to the first step then receive a more intensive intervention. In this project, all participants would first receive 5 sessions of self help iCBT (step 1; psychoeducation, skills acquisition). Those who respond will receive 5 more self help sessions (skill rehearsal & maintenance). Those who fail to respond after step 1 would `step up' to receive their remaining 5 iCBT sessions with therapist guidance (step 2). Pilot evidence supports the use of a SCM in high intensity face to face CBT for childhood anxiety. To date, no studies of SCMs for iCBT exist. If a SCM approach, using self help plus therapist guided iCBT is as effective as therapist guided iCBT alone, we will have identified a scalable, easily disseminated model that can produce clinical outcomes similar to standard clinical therapy. This particular project utilises a very simple form of therapist support, primarily delivered via emails from the therapist, which can be conducted anywhere, anytime. Therefore, a stepped care model of intervention where people step up to email therapist support presents a model of care that can be easily distributed and is not intrusive to young people.

This study is an open-label clinical trial aiming to explore the effectiveness, feasibility and tolerability of oral ketamine on suicidality. The pathology and neurobiology of suicidality will be examined via MRI and EEG as neurological measures. The primary outcome of change in suicidality will be assessed using the Beck Scale for Suicide Ideation.

The primary aim of this study is to evaluate the effectiveness of an incremental goal-setting intervention (‘Small Steps’) on total sitting time, and blood glucose levels in older Australians living with T2DM. The secondary aim of this study is to explore the preliminary effectiveness of the intervention on self-reported types and context of sedentary behaviour, and quality of life (QOL). Associations between daily sitting time, and the time spent in prolonged bouts of sitting and changes in blood glucose levels in older adults with T2DM will also be explored.