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

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ClinicalTrials.gov Identifier: NCT02388217
Recruitment Status : Active, not recruiting
First Posted : March 13, 2015
Last Update Posted : March 8, 2016
Sponsor:
Information provided by (Responsible Party):
Elad Davidson, 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.

Condition or disease
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.


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Study Type : Observational
Estimated Enrollment : 400 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Effect of Cannabis on Pain and Related Quality Of Life Outcomes In Chronic Pain: A Prospective Open-Label Study
Study Start Date : April 2013
Estimated Primary Completion Date : March 2017
Estimated Study Completion Date : November 2020

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02388217


Locations
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Israel
Hadassah Medical Center
Jerusalem, Israel
Sponsors and Collaborators
Hadassah Medical Organization

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Responsible Party: Elad Davidson, MD, Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT02388217     History of Changes
Other Study ID Numbers: 07419-10-HMO
First Posted: March 13, 2015    Key Record Dates
Last Update Posted: March 8, 2016
Last Verified: March 2016

Keywords provided by Elad Davidson, Hadassah Medical Organization:
chronic pain
cannabis
Approved for cannabis treatment by Israeli ministry of health
Unrelieved chronic pain

Additional relevant MeSH terms:
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Chronic Pain
Marijuana Abuse
Pain
Neurologic Manifestations
Signs and Symptoms
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders