Effectiveness and Safety of Oil Extracts Medical Cannabis Treatment for Patients With Chronic Pain
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Background: The current study will prospectively follow-up on chronic pain patients treated with oil extracts of medical cannabis (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 relief 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. We hypothesize that following the treatment with oil extracts of MC for chronic pain, associations will be found between its effectiveness and the types of clinical pain, personality traits and demographic characteristics. We also do not expect serious (life threatening) adverse events to be reported. Methods: This study has been already approved by the ethics committee of Haifa University (approval number 216/19). The sample will include a prospective cohort of 600 patients with chronic non-cancer pain that will request license to use oil extracts MC. 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 asked to fill a variety of questionnaires that may indicate the outcome of the treatment. The follow-up will take place in four time points: at the time of approval of the license (before starting the treatment, baseline), as well as at one, three, and six months from the initiation of treatment. Data will be collected by a web based data collection technology (Qualtrics®). In cases which there are a need for it, the information will be gathered by phone or face to face meetings.
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Layout table for eligibility information
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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.
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.
Patients who lack the ability to understand the purpose and instructions of the study.