ANZCTR search results

Clinically significant obstructive sleep apnoea (OSA) affects approximately 30% of the middle-aged population and contributes to long term poor health. Four main physiological mechanisms cause OSA, but current treatments typically only address one of these mechanisms and they are not well tolerated. A pharmaceutical therapy for OSA is desired by patients and has the potential to treat more than one of the mechanisms causing it. This study will examine the effect of a commonly prescribed medicinal cannabis product (delta-9-tetrahydrocannabinol, THC) on the mechanisms that contribute to OSA, its impact on OSA severity and effects on psychomotor and cognitive function. We hypothesise that compared to placebo, 10mg of medicinal THC will decrease the severity of OSA and beneficially alter some of the mechanisms which cause OSA without having a detrimental effect on next-day psychomotor and cognitive function.

Substance use significantly contributes to disease burden among Australians, with harms exacerbated among Aboriginal and Torres Strait Islander peoples by colonisation-related factors like stigma and trauma. Addressing this gap requires culturally acceptable, valid and reliable screening tools, available in a familiar language to the participant, to identify and provide support for those at-risk. This study aims to assess the validity, reliability and clinical utility of a culturally-adapted digital screening tool — the Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) — translated into Pitjantjatjara, to detect risk of substance-related harm among Aboriginal Australians.

The purpose of this study is to investigate the preliminary effectiveness and safety of a topical cannabidiol salve for rheumatoid arthritis. We hypothesise that using the salve for 4 weeks will have a clinically significant effect on functional status. This is an open label trial with all participants receiving the intervention for 4 weeks. Participants will apply the salve to affected joints twice daily for 28 days. The primary outcome is change in functional status. Secondary outcomes include health-related quality of life, pain, swollen and tender joint count, side effects, and change in inflammation.

This study involves healthy participants who will be assessed for driving performance under the influence of alcohol (0.05% BAC) versus placebo. As a sub-arm (Arm 2) of a larger study (CAN-TRACK, ACTRN12624001118594) examining the effects of medical cannabis on real-world driving performance, the primary hypothesis is that THC and alcohol will impair driving performance, with specific focus on lane positioning, speed maintenance, and other critical driving tasks. The findings are expected to provide valuable insights into the influence of alcohol on driving safety, providing as a comparator for a parallel study including medical cannabis patients.

This study is assessing the efficacy and safety of PEX010 in psilocybin-assisted psychotherapy for the treatment of adjustment disorder due to incurable cancer diagnosis Who is it for? You may be eligible to join this study if you are aged between 18 and 80 years old, and you suffer from anxiety after adjusting to an acutely stressful event of your cancer diagnosis. We call that an adjustment disorder. Study details Participants in this study will be randomly allocated by chance (similar to flipping a coin) to one of three groups: a 25mg PEX010 dose group, a 10 mg PEX010 dose group or a 1mg PEX010 dose group. Participants will be allocated a dose that will be administered during their psilocybin-assisted psychotherapy (PAP) dosing session. The PAP dosing session will run approximately 8 hours, with PEX010 administered at Day 14 (dosing day). At Week 12, non-responders that continue to meet the study eligibility criteria may commence an additional PAP cycle (at 25 mg PEX010). A maximum of 2 PAP cycles may be administered. Long term follow up will comprise of a study visit at 3- and 6-months post Week 12 (of the final cycle) to assess safety and tolerability of PEX010. It is hoped that this research will develop important scientific knowledge that could contribute to the development of a potential new treatment for anxiety and depression after adjusting to an acutely stressful event such as a cancer diagnosis.

Endometriosis is an oestrogen-dependent, chronic inflammatory condition characterised by the presence of endometrial-like tissue outside of the uterus in the form of lesions, affecting around 1 in 7 women and those assigned female at birth in Australia. Endometriosis has a significant impact on one's physical, psychological, and social wellbeing. Unfortunately many of the pharmaceutical medications for endometriosis have bothersome side effects or should only be used for a short period of time due to concerns related to dependence and addiction. Medicinal cannabis has well described analgesic, anti-inflammatory, anxiolytic, anti-depressant, and anti-emetic actions. Cannabis use in other chronic pain conditions has resulted in “substitution” of pharmaceuticals, commonly opioid analgesics, for cannabis. Our previous research has shown that women with endometriosis in Australia are using mostly illicit sources of cannabis to manage their pain and other symptoms. We hypothesise that either a balanced THC:CBD oil or CBD alone will reduce pelvic pain and other symptoms in women with endometriosis. The primary aim of this study is to determine the efficacy and safety of two medicinal cannabis products compared to placebo in women with endometriosis.

This study will determine if there are any changes in period pain, and other symptoms of primary dysmenorrhea as well as looking at the rate of adverse events after using medicinal cannabis. Changes in inflammatory markers in menstrual blood will also be tracked. This study will provide data for future clinical trials if potential benefits are found.

Anxiety disorders are one of the most common mental health conditions in young people, affecting around 7% of adolescents in Australia. Yet, the rate of inadequate treatment response and corresponding functional impairment in anxiety is high. Cannabidiol (CBD), a main component of Cannabis, can effectively reduce anxiety in adults with social anxiety disorder and has found to be safe and well tolerated in children and adolescents with epilepsy. The current study team have previously tested CBD (up to 800 mg/day for 12 weeks) in a pilot study involving in 31 individuals (mean 21 yrs) with treatment resistant anxiety disorders (ACTRN12617000825358). Two-thirds of participants had a >33% reduction in anxiety severity and 40% of participants had >50% reduction at 12 weeks. CBD was well tolerated with no severe, or unexpected adverse events; 94% of participants completed the intervention, indicating high acceptability. Thus, CBD may be a suitable candidate intervention for youth with inadequate response to anxiety treatments. This is a two-armed randomised control trial in 180 young people with a treatment-resistant anxiety disorder aged 12-25 years, randomised to receive CBD (600mg -800mg/d) or placebo equivalent at a 1:1 ratio, for 12 weeks. Ethics approval was received on 24/10/2023.

Melatonin is considered safe, cost-effective, and scalable, thus, a justifiable intervention for circadian mood disorders. To counter the previous clinical trials design flaws, the present study will employ a larger sample size allowing for high statistical power of analyses. Additionally, in the proposed target treatment approach, patients will be stratified based on SCRDs (Sleep and Circadian Rhythm Disturbance) to enhance the potential effectiveness of the intervention. In a recent proof-of-concept study utilizing agomelatine, a melatonin agonist and serotonin antagonist, for the treatment of major depressive disorder, adults with depression had significantly reduced symptoms after the intervention (Robillard et al., 2018). Moreover, sleep disturbances were significantly reduced, and a strong correlation between relative improvements in depression severity and some components of circadian rhythm disturbances was reported (Robillard et al., 2018). The overall aim of the study is to examine whether melatonin is a more effective early intervention for youth with depression and SCRDs compared to dCBT-I alone. Additionally, the study aims to investigate whether improvements in SCRDs causally mediate changes in depressive symptoms. The outcomes of this clinical trial will hold significant implications for early intervention in mood disorders. The findings have the potential to validate and strengthen the hypothesis that individuals with circadian depression may respond more favourably to sleep and circadian-based interventions, such as melatonin. This, in turn, could have transformative implications for personalised interventions in the treatment of mood disorders.

This project investigates how low and moderate doses of alcohol affects eye movement patterns during driving. It will also examine how these doses of alcohol affects cognition, visual information processing, and subjective intoxication. It is hypothesised that eye tracking methods will show good sensitivity and reliability for detecting impairment due to alcohol usage during actual driving.