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NCT Number: NCT02388217

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

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.

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Key information

Conditions

Chronic Pain Chemically-Induced Disorders Marijuana Abuse Mental Disorders Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Substance-Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hadassah Medical Center

Jerusalem, Israel

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Change from baseline on the S-TOPS pain symptom scale

    Time frame: 1 year

    The primary outcome is pain reduction (change from baseline) assessed by the Pain Symptom scale of the S-TOPS instrument

Secondary outcomes

  1. Change from baseline on S-TOPS physical disability scales

    Time frame: 6 and 12 months

  2. Change from baseline on S-TOPS emotional/social disability scales

    Time frame: 6 and 12 months

  3. Change from baseline on S-TOPS satisfaction scales

    Time frame: 6 and 12 months

  4. Change from baseline on SLP9 sleep disability scale

    Time frame: 6 and 12 months

  5. Change from baseline on BPI severity/interference scales

    Time frame: 6 and 12 months

Sponsors and collaborators

Lead sponsor

Hadassah Medical Organization

Other

Registry information

Important dates

Study start
2013
Primary completion
2017
Study completion
2020
First posted
Mar 13, 2015
Registry last updated
Mar 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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