Overview

This trial is active, not recruiting.

Condition chronic pain
Sponsor Hadassah Medical Organization
Start date April 2013
End date March 2017
Trial size 400 participants
Trial identifier NCT02388217, 07419-10-HMO

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective

Primary Outcomes

Measure
Change from baseline on the S-TOPS pain symptom scale
time frame: 1 year

Secondary Outcomes

Measure
Change from baseline on S-TOPS physical disability scales
time frame: 6 and 12 months
Change from baseline on S-TOPS emotional/social disability scales
time frame: 6 and 12 months
Change from baseline on S-TOPS satisfaction scales
time frame: 6 and 12 months
Change from baseline on SLP9 sleep disability scale
time frame: 6 and 12 months
Change from baseline on BPI severity/interference scales
time frame: 6 and 12 months

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title The Effect of Cannabis on Pain and Related Quality Of Life Outcomes In Chronic Pain: A Prospective Open-Label Study
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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by Hadassah Medical Organization.