Medical cannabis: time for clear thinking

Penington, D. G.

doi:10.5694/mja14.01573

Cited by 6 publications

(5 citation statements)

References 16 publications

(15 reference statements)

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“…Legislative frameworks for medicinal cannabis provision are the focus of much current debate among Australian healthcare professionals and the general public, with the Federal government announcing changes to the Narcotic Drugs Act (1967) in February 2016 . More than two‐thirds of Australians support the use of medicinal cannabis, despite limited evidence for many indications .…”

Section: Introductionmentioning

confidence: 99%

Clinical trials of medicinal cannabis for appetite‐related symptoms from advanced cancer: a survey of preferences, attitudes and beliefs among patients willing to consider participation

Luckett

Phillips

Lintzeris

et al. 2016

Internal Medicine Journal

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Section: Introductionmentioning

confidence: 99%

Clinical trials of medicinal cannabis for appetite‐related symptoms from advanced cancer: a survey of preferences, attitudes and beliefs among patients willing to consider participation

Luckett

Phillips

Lintzeris

et al. 2016

Internal Medicine Journal

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“…In line with the Australian National Guidelines, participation in cannabis medicines trials, as with any clinical trial, must be voluntary and based upon enough information, and with the ability to withdraw consent and involvement in research at any time without prejudice [2,27]. An individual's capacity to consent must be assessed, and it is important to note that a participant's capacity may fluctuate with time and situation during trials using cannabis medicines due to sedative effects [28].…”

Section: Consentmentioning

confidence: 99%

Clinical trials with cannabis medicines—guidance for ethics committees, governance officers and researchers to streamline ethics applications and ensuring patient safety: considerations from the Australian experience

Martin

Hill

Walsh

et al. 2020

Trials

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With cannabis medicines now obtaining legal status in many international jurisdictions (generally on the authorisation of a medical professional), a rapid increase in consumer demand for access to cannabis as a therapeutic option in the treatment and management of a range of indications is being noted. Despite this accessibility, knowledge on optimal use is lacking. Further drug development and clinical trials at regulatory standards are necessary both if a better understanding of the efficacy of cannabis medicines, optimal product formulation and indication-specific dosing is needed and to ensure the broader quality and safety of cannabis medicines in the clinical setting.To enable this, clinical, academic and public calls for the undertaking of rigorous clinical trials to establish an evidence base for the therapeutic use of cannabis medicines have been made internationally. While this commitment to undertake human studies with cannabis medicines is welcomed, it has highlighted unique challenges, notably in the review stages of ethics and governance. This often results in lengthy delays to approval by Human Research Ethics Committees (herein ‘HREC’, Australia’s nomenclature for Institutional Review Boards) and trial commencement. A principal concern in these cases is that in contrast to clinical trials using other more conventional pharmaceutical products, trials of cannabis medicines in humans often involve the use of an investigational product prior to some (or any) of the preclinical and pharmaceutical safety issues being established. This paucity of data around product safety, potential drug interactions, continuity of supply, shelf life and product storage results in apprehension by HRECs and governance bodies to endorse trials using cannabis medicines.This manuscript draws from the experiences of Australian researchers and staff involved in clinical trials of cannabis medicines to describe some of the common difficulties that may be faced in the HREC approval process. It also presents practical advice aimed to assist researchers, HRECs and governance officers navigate this complex terrain. While the authors’ experiences are situated within the Australian setting, many of the barriers described are applicable within the international context and thus, the solutions that have been proposed are typically adaptive for use within other jurisdictions.

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“…7 There is limited evidence of the efficacy of cannabis products for the prevention and treatment of CINV. 8 While several studies have been carried out using smoked marijuana or synthetic oral tetrahydrocannabinol medicines (THC: dronabinol, nabilone) for treating CINV, most showed limited efficacy, were inadequately powered and used outdated control antiemetic arms. 9 …”

Section: Introductionmentioning

confidence: 99%

Oral cannabinoid-rich THC/CBD cannabis extract for secondary prevention of chemotherapy-induced nausea and vomiting: a study protocol for a pilot and definitive randomised double-blind placebo-controlled trial (CannabisCINV)

et al. 2018

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IntroductionChemotherapy-induced nausea and vomiting (CINV) remains an important issue for patients receiving chemotherapy despite guideline-consistent antiemetic therapy. Trials using delta-9-tetrahydrocannabinol-rich (THC) products demonstrate limited antiemetic effect, significant adverse events and flawed study design. Trials using cannabidiol-rich (CBD) products demonstrate improved efficacy and psychological adverse event profile. No definitive trials have been conducted to support the use of cannabinoids for this indication, nor has the potential economic impact of incorporating such regimens into the Australian healthcare system been established. CannabisCINV aims to assess the efficacy, safety and cost-effectiveness of adding TN-TC11M, an oral THC/CBD extract to guideline-consistent antiemetics in the secondary prevention of CINV.Methods and analysisThe current multicentre, 1:1 randomised cross-over, placebo-controlled pilot study will recruit 80 adult patients with any malignancy, experiencing CINV during moderate to highly emetogenic chemotherapy despite guideline-consistent antiemetics. Patients receive oral TN-TC11M (THC 2.5mg/CBD 2.5 mg) capsules or placebo capsules three times a day on day −1 to day 5 of cycle A of chemotherapy, followed by the alternative drug regimen during cycle B of chemotherapy and the preferred drug regimen during cycle C. The primary endpoint is the proportion of subjects attaining a complete response to CINV. Secondary and tertiary endpoints include regimen tolerability, impact on quality of life and health system resource use. The primary assessment tool is patient diaries, which are filled from day −1 to day 5. A subsequent randomised placebo-controlled parallel phase III trial will recruit a further 250 patients.Ethics and disseminationThe protocol was approved by ethics review committees for all participating sites. Results will be disseminated in peer-reviewed journals and at scientific conferences.Drug supplyTilray.Protocol version2.0, 9 June 2017.Trial registration numberANZCTR12616001036404; Pre-results.

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Medical cannabis: time for clear thinking

Cited by 6 publications

References 16 publications

Clinical trials of medicinal cannabis for appetite‐related symptoms from advanced cancer: a survey of preferences, attitudes and beliefs among patients willing to consider participation

Clinical trials of medicinal cannabis for appetite‐related symptoms from advanced cancer: a survey of preferences, attitudes and beliefs among patients willing to consider participation

Clinical trials with cannabis medicines—guidance for ethics committees, governance officers and researchers to streamline ethics applications and ensuring patient safety: considerations from the Australian experience

Oral cannabinoid-rich THC/CBD cannabis extract for secondary prevention of chemotherapy-induced nausea and vomiting: a study protocol for a pilot and definitive randomised double-blind placebo-controlled trial (CannabisCINV)

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