Israeli med-tech company Syqe Medical has conducted the first clinical trial to demonstrate that extremely low and precise doses of inhaled THC – the principal psychoactive constituent of cannabis – can effectively relieve pain, while avoiding the common side effects associated with cannabis use.
The study, published in the European Journal of Pain, is the first scientific confirmation that microdosing – using extremely low doses of active drug compounds to treat various conditions – works with cannabis.
Until now there has been scarce scientific evidence to support claims of microdosing benefits and safety. The placebo-controlled, double-blind, multi-dose study was conducted at Rambam Medical Center in Israel and examined blood THC levels, pain relief, cognitive functions and psychoactivity.
The study shows that an optimally effective dose to relieve pain is just 500 micrograms of THC.
Patients using the Syqe Selective-Dose Inhaler, the company’s novel drug delivery platform marketed in Israel by pharmaceutical giant Teva, consume three to four inhalations per day, each up to 500 micrograms.
A typical medical cannabis patient consumes 1 gram of 15% THC cannabis per day, which contains 150,000 micrograms of THC. This illustrates a key finding from the study — patients can benefit from dramatically lower doses.
“This study is the first to show that human sensitivity to THC is significantly greater than previously assumed, indicating that if we can treat patients with much higher precision, lower quantities of drug will be needed, resulting in fewer side effects and an overall more effective treatment,” said Perry Davidson, Syqe Medical CEO.
“The Syqe drug delivery technology is also applicable to opioids and other compounds that, while potentially effective, are notoriously associated with dangerous side effects. The introduction of a tool to prescribe medications at such low doses with such high resolution may allow us to achieve treatment outcomes that previously were not possible.”
Syqe believes that the published study and patient use data in Israel will be an important part of its planned FDA submission in the United States. CE approval of its device in Europe is pending.
“We can conclude from the study results that low doses of cannabis may provide desirable effects while avoiding cognitive debilitations, significantly contributing to daily functioning, quality of life, and safety of the patient,” said Prof. Elon Eisenberg, lead researcher and dean of the Faculty of Medicine at the Technion-Israel Institute of Technology.
Syqe was founded in 2011 and is headquartered in Tel Aviv with offices in New York and Canada.