Australian Medicinal Cannabis Clinical Trials for Chronic Pain: Evidence, Outcomes & Current Research

Last updated: January 2026. This article is intended for educational purposes. Always consult a qualified healthcare professional before considering any medicinal cannabis treatment.

Why Clinical Trial Data Matters for Medicinal Cannabis in Australia

Australia's medicinal cannabis framework, overseen by the Therapeutic Goods Administration (TGA), places significant weight on clinical evidence when evaluating products for safety and efficacy. Since the landmark 2016 amendments to the Narcotic Drugs Act 1967 and the subsequent growth of the Special Access Scheme (SAS) and Authorised Prescriber pathways, demand for robust Australian trial data has grown considerably alongside prescribing volumes.

Chronic pain represents the single largest condition category for which medicinal cannabis is prescribed in Australia. According to TGA approval data, musculoskeletal pain, neuropathic pain, and cancer-related pain collectively account for a substantial share of SAS-B approvals. Understanding what the clinical trial evidence actually shows — and how observational studies fit into that evidence base — is essential for patients, prescribers, and researchers alike.

The Medcare Study: Medlab Clinical's NanaBis™ Observational Trial (2019–2024)

One of the most referenced Australian clinical research programmes in this space was the Medcare Study, conducted by Sydney-based biopharmaceutical company Medlab Clinical between approximately 2019 and 2024. The study investigated NanaBis™, a cannabis-based medicine utilising Medlab's proprietary NanoCelle® drug delivery technology, which uses nanoparticle encapsulation designed to enhance the oral bioavailability of cannabinoids including THC and CBD.

What Was the Medcare Study?

The Medcare Study was an observational, open-label clinical trial — meaning it tracked real-world patient outcomes without a placebo control arm. This design reflects a pragmatic approach commonly used when ethically randomising patients away from a potential treatment is difficult, particularly for chronic pain populations already experiencing significant suffering.

Key features of the study design included:

• Target population: Australian adults with chronic, treatment-resistant pain conditions including neuropathic pain, cancer pain, and musculoskeletal pain
• Intervention: Sublingual administration of NanaBis™, a combined THC/CBD formulation delivered via NanoCelle® nanoparticle technology
• Primary outcomes: Changes in pain intensity scores, quality of life measures, sleep quality, and opioid-sparing potential
• Duration: Participants were monitored over an extended period to capture long-term safety and tolerability data
• Setting: Multi-site, conducted through participating Australian clinicians

What Did Medlab's Research Find?

Medlab published interim and associated findings across several peer-reviewed outputs during the study period. Key themes emerging from their published research included:

• Pain reduction: Participants reported statistically meaningful reductions in pain scores on validated instruments such as the Brief Pain Inventory (BPI) and numeric rating scales (NRS)
• Sleep improvement: A consistent secondary finding across Medlab's research was improvement in sleep quality, which is clinically relevant given the well-documented relationship between chronic pain and sleep disruption
• Opioid reduction: A subset of participants were able to reduce concurrent opioid use, a finding of particular policy relevance given Australia's ongoing opioid harm reduction priorities
• Tolerability: Adverse events were predominantly mild to moderate, consistent with the known cannabinoid side effect profile (dizziness, dry mouth, mild cognitive effects), and serious adverse events were uncommon
• Bioavailability hypothesis: Medlab's NanoCelle® platform was designed to address the notoriously variable oral bioavailability of cannabinoids; their published work provided preliminary evidence supporting improved absorption profiles compared to conventional oral preparations

It is important to note that observational data of this kind informs, but does not definitively establish, clinical efficacy in the way a randomised controlled trial (RCT) would. Readers seeking the primary publications should search PubMed and the Australian New Zealand Clinical Trials Registry (ANZCTR) using the terms "NanaBis," "NanoCelle," and "Medlab Clinical."

How Observational Studies Contribute to the Evidence Base

A persistent critique of medicinal cannabis research globally is the relative scarcity of large, double-blind, placebo-controlled RCTs. This gap exists for several reasons unique to cannabis research: scheduling barriers historically impeded funding and supply, placebo blinding is difficult given the psychoactive properties of THC, and patient populations with severe chronic conditions may be reluctant to risk randomisation to a control arm.

Observational and registry-based studies fill a critical role in this context by:

• Generating real-world effectiveness data across heterogeneous patient populations that RCT selection criteria would typically exclude
• Capturing long-term safety signals over months or years, rather than the shorter windows typical of RCT designs
• Identifying subgroups of patients most likely to respond, informing better-designed future trials
• Supporting regulatory and prescriber decision-making in the absence of full Phase III evidence
• Contributing to systematic reviews and meta-analyses that pool findings across studies

Australia's own Lambert Initiative for Cannabinoid Therapeutics at the University of Sydney has articulated the value of pragmatic, real-world data collection as a complement to controlled trial designs, particularly for pain indications.

Other Major Australian Medicinal Cannabis Chronic Pain Studies

The QUEST Initiative

The QUEST Initiative (Quality of Life, Utilisation, Effectiveness, Safety and Tolerability) was a large Australian observational registry study examining medicinal cannabis across multiple conditions including chronic non-cancer pain. Conducted with support from cannabis producer Cannatrek and academic collaborators, QUEST published data indicating patient-reported improvements in pain, anxiety, and sleep, while also capturing adverse event profiles in a real-world Australian cohort.

University of Sydney Lambert Initiative Research

The Lambert Initiative, Australia's largest dedicated cannabinoid research programme, has conducted and supported multiple trials relevant to chronic pain, including work on cannabidiol (CBD) for neuropathic pain and studies examining the pharmacokinetics of different cannabis delivery routes. Their published research is freely accessible and represents some of the highest-quality Australian academic work in this field.

ANZCTR-Registered Ongoing Trials

The Australian New Zealand Clinical Trials Registry (ANZCTR) lists several currently active or recently completed trials examining cannabis-based medicines for pain indications. As of early 2026, registered studies have included investigations of:

• CBD-dominant formulations for chemotherapy-induced peripheral neuropathy
• Cannabis-based medicines as opioid adjuncts in palliative care pain management
• Topical cannabinoid preparations for localised musculoskeletal pain
• THC:CBD ratio comparisons for central sensitisation pain conditions

Patients and clinicians seeking current recruitment opportunities should search the ANZCTR directly at anzctr.org.au using the term "cannabis" filtered to "Recruiting" status.

Summary of Key Australian Chronic Pain Cannabis Trials

Study / Programme	Sponsor / Lead	Design	Status (as of 2026)	Key Focus
Medcare Study (NanaBis™)	Medlab Clinical	Observational, open-label	Completed (~2024)	Chronic pain, NanoCelle® delivery, opioid sparing
QUEST Initiative	Cannatrek / academic partners	Patient registry, observational	Published data available	Multi-condition including chronic pain, QoL, safety
Lambert Initiative studies	University of Sydney	Multiple (RCT and observational)	Ongoing programme	Neuropathic pain, CBD pharmacology, delivery routes
ANZCTR-registered trials	Various sponsors	Mixed designs	Various — check ANZCTR	Neuropathic, cancer, palliative, musculoskeletal pain

Accessing Medicinal Cannabis for Pain in Australia: What Patients Should Know

Participating in or referencing clinical research is valuable, but most Australian patients access medicinal cannabis through the TGA's regulatory pathways rather than through trials. The two primary routes are:

• Special Access Scheme Category B (SAS-B): A treating medical practitioner applies to the TGA on a patient-by-patient basis. Approval is typically granted within a short timeframe for most cannabis products, and chronic pain is a commonly approved indication.
• Authorised Prescriber (AP) scheme: Clinicians with AP status can prescribe specified cannabis medicines to eligible patients without individual TGA approval for each prescription.

State and territory regulations add an additional layer. For example, in Queensland and New South Wales, patients prescribed Schedule 8 cannabis medicines (those containing THC above threshold levels) are subject to state controlled drugs legislation, which may require additional permits or impose monitoring requirements. Requirements vary and can change; patients should confirm current rules with their prescribing clinician or state health authority.

Medicinal cannabis products available in Australia are not interchangeable. Formulation (oil, flower, capsule, sublingual spray), cannabinoid ratio (THC:CBD), dose, and delivery technology — such as the NanoCelle® platform used in NanaBis™ — all influence pharmacokinetics and clinical effects. Treatment selection should always be guided by a qualified healthcare professional with experience in medicinal cannabis prescribing.

There are no guarantees of treatment outcomes. Clinical trial results, including those described in this article, represent population-level findings and cannot predict individual responses.

Sources

• Australian New Zealand Clinical Trials Registry (ANZCTR): anzctr.org.au
• Therapeutic Goods Administration — Medicinal Cannabis: tga.gov.au/products/unapproved-therapeutic-goods/medicinal-cannabis-products
• Lambert Initiative for Cannabinoid Therapeutics, University of Sydney: sydney.edu.au/lambert
• Grimison P et al. (2020). "Standardised oral cannabis solutions for chemotherapy-induced nausea and vomiting" — Lancet Oncology (accessible via PubMed PMID 33002426)
• Lintzeris N et al. (2020). "Medical cannabis use in Australia: consumer characteristics and patterns of use from the Cannabis as Medicine Survey (CAMS-18)" — Harm Reduction Journal: harmreductionjournal.biomedcentral.com
• TGA Special Access Scheme guidance: tga.gov.au/products/unapproved-therapeutic-goods/special-access-scheme-sas
• PubMed search — NanoCelle / Medlab Clinical: pubmed.ncbi.nlm.nih.gov/?term=NanoCelle+cannabis