Medicinal Cannabis Findings From Clinical Research

Are you interested in trialling medicinal cannabis?

Conducted by researchers at the University of Sydney, the QUality of life Evaluation STudy (QUEST Initiative) will be investigating the quality of life and health economic impact of prescribed medicinal cannabis on Australians with chronic disease over 12 months. The study is open to Australians with a range of conditions including chronic pain, cancer pain, neuropathic pain, insomnia, anxiety, multiple sclerosis and epilepsy.

You cannot participate if you are currently receiving medicinal cannabis treatment.

To learn more about the study, go to: https://www.thequestinitiative.com/wp-content/uploads/2020/12/201202_QUEST_ParticpantInfoStatement.pdf

To find out if you are eligible, Click Here

You must enrol before 31 March 2021.

Cannabinoid Medicine Observational Study (CMOS)

Applied Cannabis Research (ACR), is commencing Australia’s largest observational study ever undertaken for medical cannabis.

The Cannabinoid Medicine Observational Study (CMOS)  will collect data from 20,000 patients nationwide to assess the safety and efficacy of medicinal cannabis products for a range of difficult to manage conditions including fibromyalgia, chronic pain syndromes, epilepsy and other neurological conditions, PTSD and other mental illness.

CMOS provides a first-of-its-kind opportunity to capture data from a broader range of Australian prescribers and patients than in existing studies. Australia’s Therapeutic Goods Administration (TGA) has now approved over 67,000 applications for medical cannabis. With a lack of randomised clinical trials within the space, there is an urgent need for large-scale evidence-based studies of prescribing medicinal cannabis. Feedback on treatment-related progress, dosing and side-effects is becoming increasingly relevant.

Key Highlights:

• CMOS aims to recruit 20,000 patients nationwide over 5 years
• Some subsidised medicinal cannabis products may be available for study participants
• Data is collected through progress-related questionnaires over a 12-month period, capturing data on efficacy, side effects, dosage, adherence to medication, changes to other concomitant medications and progressing health status
• Patients may be asked to complete separate surveys according to relevant indications to monitor conditions such as pain, anxiety, depression, fatigue, sleep disorders, and physical function
• Data is collected from both treating doctors and their patients to provide a complete view of their medical cannabis treatment journey
• Patients are only identified by a unique study ID number

The CMOS study is open to both doctors and patients to get involved and can register their interest through either Patient or Doctor tab on the bottom of the page found here

People with epilepsy can register themselves into this study and do not need their treating doctor to register them.

This study will monitor several safety and health-related measures of patients engaged in medicinal cannabis treatment at Cannabis Access Clinics. This will help us gain a better understanding of the role of medicinal cannabis in treating various health conditions including epilepsy and help shape future clinical trials.

Recruitment: Open

Study: CANSLEEP Research Study

Research Collaborators: The Lambert Initiative for Cannabinoid Therapeutics, University of Sydney

About the Study: To assess the effects of a single dose of an oral cannabinoid medicine on sleep and next-day function relative to placebo in patients with chronic insomnia disorder. If eligible, participants need to attend the Woodcock Institute of Medical Research in Glebe, Sydney.

Publication: Pending

Recruitment: Closed

Study: Dravet Syndrome – Clinical Trial (International)

Research Collaborators: GW Pharmaceuticals

About the Study: International trial evaluating the use of Epidiolex® in treating Dravet Syndrome

Recruitment: Closed

Study: Tuberous Sclerosis Complex (International)

Research Collaborators: GW Pharmaceuticals

About the Study: International clinical trial evaluating the use of Epidiolex® in treating their seizures.

This Phase III global study, allows 210 patients access to Epidiolex®, in which 12 children in NSW are participating, through the SCHN, Clinical Research Centre

Publication: Pending

Recruitment: Expected April 2020

Study: A Double-blind, Placebo-controlled Study Investigating the Safety, Tolerability, Efficacy and Pharmacokinetics of EP1, an Enriched Cannabidiol Oil, in Children and Adolescents with Medication Resistant, Refractory Epilepsy

Research Collaborators: Melbourne Brain Centre (contact Mr Paul Lightfoot), Cann Pharmaceutical Aust Ltd Ltd

About the Study: The study will aim to determine if EP1 is an effective treatment for refractory epilepsy in children, adolescents and young adults by comparing different doses of EP1 against a placebo by measuring seizure frequency and character.

Publication: Pending

Recruitment: Open for Health Care Professionals and Patient Survey

Study: Australia Medicinal Cannabis Study

Research Collaborators:

• Victorian Office of Medicinal Cannabis, Department of Health and Human Services
• University of Melbourne, Department of Medicine
• University of Sydney, Lambert Initiative for Cannabinoid Therapeutics, University of Sydney,

About the Study: The surveys collect information focusing on the patterns of use, effectiveness and safety of medicinal cannabis products prescribed in Australia. The results of this study will be made available to researchers for further analysis and provide much needed information to guide policy decisions relating to medicinal cannabis in Australia.

The Australian Medicinal Cannabis Study began in late 2018 and will recruit participants over a 3 year period, with final surveys completed 15 months later.

Publication: Pending

Recruitment: Closed

Study: GWPCARE2 A Study to Investigate the Efficacy and Safety of Cannabidiol (GWP42003-P) in Children and Young Adults with Dravet Syndrome

Research Collaborators: GW Research Ltd

About the Study: International study to investigate the potential antiepileptic effects of cannabidiol (GWP42003-P) in children and young adults with Dravet syndrome.

Publication: Pending

The NSW Government has committed $3.5 million towards research into the use of cannabis medicines for children with severe, treatment-resistant refractory epilepsy. A Compassionate Access Scheme and clinical trials are underway.

Recruitment: Enrolments commenced early 2019 and are ongoing (speak with your neurologist)

Study: Rett Syndrome Clinical Trial

Research Collaborators: Sydney Children’s Hospital Network

About the Study: Aims to evaluate the long-term safety and efficacy of a new cannabis medicine called Cannabidivarin (CBDV).

Publication: Pending

Newly available evidence supports earlier findings that cannabidiol probably reduces the frequency of seizures among children with drug-resistant epilepsy.

Findings:
CBD treatments were effective compared with placebo, regardless of the dose administered.

The safety analysis is related to tolerable side effects found in studies with both CBD and medicinal cannabis.

There was a greater tendency for side effects in short-term treatment compared with long-term treatment.

Recruitment: Closed

Study: Exploring the effects of THC and CBD on simulated driving.

Research Collaborators: The Lambert Initiative at the University of Sydney, Royal Prince Alfred Hospital and Tilray.

Chief Investigators: Professor Iain McGregor (Lambert Initiative, University of Sydney)

Completed: 2018

About the Study: This study explores the idea that CBD content in cannabis plant material will modify the effects of THC on driving, and investigates the link between concentrations of cannabinoids in blood and saliva, and driving ability. Drug testing of saliva and blood followed current Australian police procedures. A secondary aim of the study was to examine the relationship between positive results on these tests and actual driving impairment, currently a very controversial topic in the community and in legal circles.

Publication: Pending

Recruitment: Closed

Study: Knowledge and attitudes of Australian general practitioners towards medicinal cannabis.

Research Collaborators: The Lambert Initiative at the University of Sydney and HealthEd.

Chief Investigators: Professor Iain McGregor (Lambert Initiative, University of Sydney)

Completed: 2018

About the Study: A cross-sectional survey completed by 640 Australian General Practioners attending multiple-topic educational seminars in five major Australian cities between August and November 2017 was undertaken to assess the knowledge and attitudes of these clinicians toward medicinal cannabis.

Results: The majority of GPs (61.5%) reported one or more patient enquiries about medicinal cannabis in the past three months. Most felt that their own knowledge was inadequate and only 28.8% felt comfortable discussing medicinal cannabis with patients. Over half (56.5%) supported availability on prescription, with the preferred access model involving trained GPs prescribing independently of specialists. Support for use of medical cannabis was condition-specific, with strong support for use in cancer pain, palliative care and epilepsy, and much lower support for use in depression and anxiety.

Publication: https://bmjopen.bmj.com/content/8/7/e022101

Recruitment: Closed

Study: Cannabis as Medicine Survey (CAMS16)

Research Collaborators: The Lambert Initiative at the University of Sydney and South East Sydney Local Health District.

Chief Investigators: Professor Nick Lintzeris (South East Sydney Local Health District)

Completed: 2018

About the Study: The CAMS (Cannabis As Medicine Survey) is the first large scale survey of medicinal cannabis users in Australia for more than a decade. The objective of this survey is to create a national snapshot of the demographics of medical cannabis consumers, the conditions being treated, patterns of cannabis use, perceived efficacy, and the physical and mental health of consumers. In 2016, the CAMS study surveyed 1,749 Australians who reported using cannabis for medicinal purposes.

Results: Results indicated that the primary conditions being treated included anxiety (50.2%), back pain (49.4%), depression (48.8%), and sleep conditions (43%). Inhaled route was the most common routes of administration. A third of patients spent $0-$50 on cannabis, suggesting a sizeable proportion of home grown supply. Respondents self-reported overwhelmingly positive changes in the primary health condition being treated as a result of cannabis use, with more than 90 percent of respondents reporting an improvement.

Publication: https://onlinelibrary.wiley.com/doi/full/10.5694/mja17.01247