CLINICAL TRIALS

Australian-based clinical trials in cannabinoids currently managed by ACRE Investigators and our Affiliated Researchers.

 

CARE NSW [Advanced Cancer]

The CARE NSW Trial is a multi-site, state-wide clinical trial which will enrol up to 600 patients in metropolitan and regional centres across NSW. It is open to both men and women with advanced cancer who experience uncontrolled symptoms of pain and/or nausea and/or anorexia. The information collected in CARE NSW will guide the future use of cannabis medicines to control symptoms in people with advanced cancer.

SCIENTIFIC TITLE 

Cannabinoids for Symptom Control in Advanced Cancer, an Open Label Prospective Clinical Trial in NSW.

DISEASE TYPE 

Advanced Cancer

SUMMARY

The CARE NSW Trial is an open-label, prospective, Phase IV trial (which includes a Phase II pharmacokinetic component) to assess the safety and efficacy of a range of cannabis medicines on key symptoms experienced by patients with advanced cancer. This study also aims to identify the best dose and frequency of the cannabis medicine for symptom control. Gathering this evidence will guide the future prescribing of cannabis medicines for patients with advanced cancer.

Patients with advanced cancer who experience uncontrolled symptoms of pain and/or nausea and/or anorexia as well as meet the inclusion criteria are invited to participate.

All participants will be prescribed a cannabis medicine from a range of oral oils registered for human use in Australia. The cannabis medicines will be either predominantly Delta-9-Tetrahydrocannabinol (THC) or a combination of THC and Cannabidiol (CBD) in near equal amounts.

Participants will be prescribed these oils at no cost until they withdraw from the study or are no longer able to take them. Treatment will be given in addition to the participant’s usual medical treatments for advanced cancer and symptom control. Prior or current use of medicinal cannabis is not an exclusion to participate.

Participants will need to attend their local site every few weeks for clinical assessments, have several blood tests, and to complete surveys on how they feel. They will also complete a patient diary via a mobile phone application.

The CARE NSW Trial is sponsored and funded by the Health Administration Corporation, acting through the NSW Ministry of Health. It is coordinated by the Australian Centre for Cannabinoid Clinical and Research Excellence (ACRE) which is responsible for the day-to-day management and oversight of the study. The study is led by Professor Jennifer Martin alongside a research team of specialists in cancer, palliative care, public health, addiction medicine, pharmacology and toxicology.

CARE NSW will recruit up to 600 participants over three years and is expected to involve at least 10 hospitals from across the state.

FOR HEALTH PROFESSIONALS

If you are interested in referring participants to the CARE NSW Trial, please see the trial registration for Cannabinoids for Symptom Control in Advanced Cancer, an Open-Label Prospective Clinical Trial in New South Wales (NSW) or the CARE NSW Trial Information for Health Professionals Fact Sheet for further information.

FOR CONSUMERS 

If you think this trial is relevant to your situation, please contact your cancer specialist to discuss further.

CURRENT PARTICIPATING CENTRES (NSW only)

• Orange Health Service
• Chris O’Brien Lifehouse
• Liverpool Hospital
• Tamworth Hospital
• Prince of Wales Hospital
• Westmead Hospital
• Gosford and Wyong Hospitals
• Macquarie University
• Wollongong and Shoalhaven Hospitals
• St Vincent’s Hospital Sydney Ltd

CBD for Early-Stage Dementia [Dementia]

This study is a single site clinical trial which will enrol up to 60 participants in the Illawarra region of NSW. It is open to both men and women between 55 and 80 years of age who have received a diagnosis of dementia since January 2021, and who currently live at home with someone to support them. The information obtained by this clinical trial will be used to guide the potential future use of cannabidiol (CBD) to address neurobiological, behavioural, and psychological symptoms in individuals with early-stage dementia.

SCIENTIFIC TITLE 

Cannabidiol: Treatment for brain changes and depression in early-stage dementia.

DISEASE TYPE 

Early-stage Dementia

SUMMARY

This study is a randomised, double-blind, placebo-controlled clinical trial designed to assess whether daily treatment with CBD over a 12-week period is associated with improved neurobiological, behavioural, and psychological symptoms in individuals diagnosed with early-stage dementia. Investigating the potential efficacy of isolate CBD has the potential to inform a novel treatment that has the capacity to improve quality of life.

Participants meeting inclusion criteria will be randomised into either 99.9% pure CBD or placebo treatment conditions, and will take two capsules per day for twelve weeks. Participants and their supporting person will need to attend the University of Wollongong three times over the trial period for clinical assessments, to have blood tests, and complete surveys about how they feel. Participants will also need to have an MRI scan at the start and at the end of the study. Participants and their supporting person will also be visited once a week at their home by the trial registered nurse for monitoring of health and side effects.

Participants will be provided with the study medication at no cost until they withdraw from the study or are no longer able to take them. Treatment will be given in addition to the participant’s usual medical treatments for early-stage dementia.

FUNDING

This study is sponsored and funded by Australian Centre for Cannabinoid Clinical and Research Excellence (ACRE), the University of Wollongong (UOW) and the Illawarra Health and Medical Research Institute (IHMRI). The study is being coordinated by Dr Jessica Bartschi, alongside a research team of specialists in CBD, dementia and geriatrics, neuroimaging, neuroendocrinology, addiction medicine, psychiatry, and pharmacology.

FOR CONSUMERS AND HEALTH PROFESSIONALS

If you think this trial is relevant to your situation or someone close to you, or if you are interested in referring participants to the study, please contact Dr Jessica Bartschi on 02 4221 3732 or [email protected].