The Effect of Cannabis on Pain and Related Quality Of Life Outcomes In Chronic Pain: A Prospective Open-Label Study

Study Overview
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Brief Summary
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The objective of the current study is to prospectively assess the effect of cannabis on pain and functional outcomes in a large group of patients with chronic pain.

Detailed Description
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This is a prospective, observational, open-label study carried out at the ambulatory pain clinic of Hadassah-Hebrew University Medical Center Pain Relief Unit. Study population: Patients suffering from chronic pain that has not been relieved with other analgesic medications, who are eligible for treatment with medical cannabis (cigarettes, oil or cookies) following approval of Israeli Ministry of health.The patients will receive a prescription to be dispensed at pre-approved cannabis distribution points by a certified provider. In this study, the efficacy of the cannabis treatment on pain and related quality of life (QoL) outcomes will be assessed by administering the S-TOPS questionnaire (Haroutiunian, Pain 2012), and the Brief Pain Inventory (BPI) before the treatment (baseline), and on expected follow-up visits at approximately 6 and 12 months.

Official Title
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The Effect of Cannabis on Pain and Related Quality Of Life Outcomes In Chronic Pain: A Prospective Open-Label Study

Conditions
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Chronic Pain

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age >18 years old Chronic pain, with duration of 3 months or longer Lack of satisfactory analgesic response or intolerable adverse effects with at least two analgesics from 2 different drug classes at full dose. Exclusion Criteria: Inability to read and understand the informed consent form. History of drug abuse/dependence Psychiatric co morbidity (or history) of schizophrenia or acute psychosis. Family history of schizophrenia. Psychologist evaluation of high abuse risk.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline on the S-TOPS pain symptom scale | The primary outcome is pain reduction (change from baseline) assessed by the Pain Symptom scale of the S-TOPS instrument | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline on S-TOPS physical disability scales |  | 6 and 12 months | 
| Change from baseline on S-TOPS emotional/social disability scales |  | 6 and 12 months | 
| Change from baseline on S-TOPS satisfaction scales |  | 6 and 12 months | 
| Change from baseline on SLP9 sleep disability scale |  | 6 and 12 months | 
| Change from baseline on BPI severity/interference scales |  | 6 and 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chronic pain, cannabis, Approved for cannabis treatment by Israeli ministry of health, Unrelieved chronic pain