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

Completed

• Conditions: Chronic Pain

• Registration Number: NCT02388217
• Lead Sponsor: Hadassah Medical Organization

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.

Study Timeline

• Study Start: 2013-04
• Study First Submitted: 2014-04-06
• Study First Submitted QC: 2015-03-12
• Study First Posted: 2015-03-13
• Primary Completion: 2017-03-01
• Study Completion: 2020-11-01
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-20
• Last Update Posted: 2022-03-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 400

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Change from baseline on SLP9 sleep disability scale	6 and 12 months
Change from baseline on BPI severity/interference scales	6 and 12 months
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

Trial Locations

Locations (1)

Hadassah Medical Center; 🇮🇱 Jerusalem, Israel