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

Chronic Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02388217
• Other study ID #: 07419-10-HMO
• Status: Completed
• Start date: April 2013
• Est. completion date: November 1, 2020

Study information

• Verified date: March 2022
• Source: Hadassah Medical Organization
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: November 1, 2020
• Est. primary completion date: March 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Pain
• Marijuana Abuse

Locations

Country	Name	City	State
Israel	Hadassah Medical Center	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Hadassah Medical Organization

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change from baseline on S-TOPS physical disability scales		6 and 12 months
Secondary	Change from baseline on S-TOPS emotional/social disability scales		6 and 12 months
Secondary	Change from baseline on S-TOPS satisfaction scales		6 and 12 months
Secondary	Change from baseline on SLP9 sleep disability scale		6 and 12 months
Secondary	Change from baseline on BPI severity/interference scales		6 and 12 months