Israeli med-tech company Syqe Medical is recruiting Australian participants for a phase II clinical trial examining its metered-dose medical cannabis inhaler as a treatment for diabetic peripheral neuropathic pain (DPNP).
The company aims to enrol 192 patients across up to 55 clinics in six countries — Australia, Israel, Canada, Poland, the Czech Republic and Germany — with recruitment to close by the end of June 2025.
The double-blind, randomised, placebo-controlled study will consider adults aged 18 to 75 who have a confirmed diabetes diagnosis and neuropathic pain in their feet. In Australia, the trial will be led by the NICM Health Research Institute at Western Sydney University.
Dr Orit Holtzman, co-founder and president of the Australia and New Zealand College of Cannabinoid Practitioners (ANZCCP), will serve as principal investigator.
The study will assess the efficacy, safety, tolerability and pharmacokinetics of inhaled THC at doses of 0.25mg, 0.5mg and 1mg, delivered through the SyqeAir inhaler three times per day across 15 weeks, compared against a placebo.
The TGA-approved device delivers a precise THC dose with predictable and consistent effects, allowing prescribers to offer an inhalation-based, full-spectrum flower treatment in a standardised way.
Researchers will monitor changes in pain characteristics, severity and intensity, as well as impacts on sleep, quality of life and general well-being.
Participants must agree to refrain from driving or operating heavy machinery throughout the treatment period, and those of reproductive age are required to use highly effective contraception.
Patients with a history of alcohol or substance abuse, chronic opioid use, or those who are pregnant or breastfeeding are not eligible to participate.
Data collection, titration and testing will occur across 14 on-site visits and six telephone consultations over a total duration of five and a half months.
Although the THC component means participants cannot drive during the 15-week treatment phase, Syqe will cover all transport costs to and from appointments.
Associate Professor Mike Armour from NICM acknowledged this as a common challenge in medicinal cannabis trials involving THC, describing Syqe's approach as the best available option within the existing drug-driving regulatory framework.
Dr Holtzman added: "In the current Australian landscape, where the distinction between non-medical and medical cannabis use is increasingly blurred — often favouring higher-THC concentrations — Syqe's commitment to pursuing evidence-based, accurate dosing and establishing a therapeutic window with optimal effect, minimal side effects and unparalleled safety is noteworthy."
DPNP affects between 6% and 34% of people living with diabetes. The condition produces symptoms such as burning, shooting, lancinating pain and tingling that typically begin in the feet and tend to worsen overnight.
The condition frequently disrupts daily functioning and sleep, often contributing to anxiety and depression, and is associated with a reduced quality of life.
Syqe has noted that side effects associated with existing pain management options can limit their use, meaning DPNP continues to be an area of unmet medical need.
Syqe and NICM are encouraging healthcare practitioners to refer eligible patients until December 2025. For further information, email DP*******@***************du.au.
