Effectiveness and Safety of Oil Extracts Medical Cannabis Treatment for Patients With Chronic Pain: a Web Technology Based Prospective Study

The use of medical cannabis (MC) for the treatment of chronic pain has risen in the last decade. According to the Israel Medical Cannabis Unit (IMCU) of the Israeli Ministry of Health (IMOH), there are currently several tens of thousands licenses for the use of medical cannabis in Israel, mostly for the relief of chronic pain (mainly utilized by smoking and inhalation). It is estimated that 2,000 new licenses will be issued yearly. Recently, the IMOH approved the use of drops of whole extract of cannabis inflorescence formulated in oil, intended for sublingual administration, for the treatment of chronic pain. That far, there is a distinct lack of evidence about the efficacy and safety of MC treatment in the long-term with relatively few prospective randomized controlled trials (RCTs) examining this issue. This can be explained, at least partially, by the reluctance of physicians, researchers and pharmaceutical companies to engage in MC research for various reasons (mainly when utilized by smoking and inhalation). Such reasons include the following facts: MC is classified as a schedule I drug by the American Food and Drug Administration (FDA); MC is often smoked; that the level of cannabinoids and terpenes can vary between suppliers and even from the same supplier and therefore it is difficult to quantify the dose; there is abuse of MC; patentability of a natural compounds is problematic; and MC consumption is stigmatized. One of the accepted ways to narrow gaps of information in medical research where there is a dearth of RCTs is to develop cohorts that may allow for the prospective, structured data collection and data mining of a large number of "real life" patient conditions.

The current study will prospectively follow-up on chronic pain patients treated with oil extracts MC for a period of six months in "real life" conditions. This study will enable a deep investigation regarding the effects of the active extract of cannabis inflorescence formulated in oil, derived from the cannabis plant. The results may allow us to reduce the gap in understanding MC's effects on pain reduction and its safety, to identify predictors for treatment success/ failure, as well as to enable us tailoring a personalize MC treatment by choosing optimal concentration and dose according to the patient needs.

Methods: The sample will include a prospective cohort of patients with chronic non-cancer pain that will request license to use oil extracts medical cannabis. The estimated sample size is 600 patients. The patients who will be approved to receive a license will be followed-up longitudinally for a period of six months from the signing of the consent form. The patients will be recruited by their physicians in their clinics.

Inclusion criteria - Patients that will be recommended to use oil extracts medical cannabis for the treatment of all forms of chronic pain (despite cancer); Patients above the age of 18 years; Patients who will sign an informed consent after receiving explanation on the requirements, duration and nature of the study.

Exclusion criteria - Patients who lack the ability to understand the purpose and instructions of the study.