Clinical trial NCT02388217: The Effect of Cannabis on Pain and Related Quality Of Life Outcomes In Chronic Pain: A Prospective Open-Label Study
Official title: The Effect of Cannabis on Pain and Related Quality Of Life Outcomes In Chronic Pain: A Prospective Open-Label Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Pain
Keywords: chronic pain
cannabis
Approved for cannabis treatment by Israeli ministry of health
Unrelieved chronic pain
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2015-03-13
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Chronic pain patients with lack of satisfactory analgesic response or intolerable adverse effects with at least two analgesics from 2 different drug classes at full dose. Eligible for cannabis treatment following Israeli Ministry of Health approval.

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline on the S-TOPS pain symptom scale
timeFrame: 1 year
Secondary outcomes:
measure: Change from baseline on S-TOPS physical disability scales
timeFrame: 6 and 12 months
measure: Change from baseline on S-TOPS emotional/social disability scales
timeFrame: 6 and 12 months
measure: Change from baseline on S-TOPS satisfaction scales
timeFrame: 6 and 12 months
measure: Change from baseline on SLP9 sleep disability scale
timeFrame: 6 and 12 months
measure: Change from baseline on BPI severity/interference scales
timeFrame: 6 and 12 months
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Center
Study officials:
References: