For the first time, researchers have conducted a 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, which was conducted by Israeli med-tech company Syqe Medical and published in the European Journal of Pain earlier this month, is the first scientific confirmation that microdosing—the process of using extremely low doses of active drug compounds to treat various conditions—actually works with cannabis.
Although widely championed, there has been scarce scientific evidence to support or even fully explore claims of microdosing benefits and safety until now. 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. Syqe patients consume 3-4 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 that patients can benefit from dramatically lower doses.
The Syqe Selective-Dose Inhaler, the company’s specialized drug delivery platform marketed in Israel by pharmaceutical giant Teva, allows physicians and patients to select microgram-level doses with precision. These results are presumed to be due to the bioavailability-enhancing technologies of the Syqe platform in conjunction with its selective-dosing capabilities.
In addition to CE approval now pending in Europe, Syqe believes that the published study and the actual patient use data in Israel will be an important part of its planned FDA submission in the U.S.
“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 Syqe Medical CEO Perry Davidson. “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.”
These findings may allow the establishment of a long-awaited industry milestone: a standardized therapeutic window for cannabis inhalation. By provably administering precise doses measured in micrograms and quantifying diminishing therapeutic returns versus increased psychoactivity, the study was able to document successful pain relief while minimizing potentially debilitating psychoactive side effects.
“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 Professor Elon Eisenberg, lead researcher and Dean of the Faculty of Medicine at the Technion-Israel Institute of Technology. “The doses given in this study, being so low, mandate very high precision in the treatment modality.”