Chronic PainNCT02388217
The Effect of Cannabis on Pain and Related Quality Of Life Outcomes In Chronic Pain: A Prospective Open-Label Study
An observational study of Chronic Pain, run by Hadassah Medical Organization at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain
- How many people
- 400 participants
- Where
- 1 siteIsrael
- Study dates
- Apr 2013to 1 Nov 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this 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.
Read the 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.
- Conditions
- Chronic Pain
- Keywords
- chronic pain, cannabis, Approved for cannabis treatment by Israeli ministry of health, Unrelieved chronic pain
- Medical subject headings
- Chronic Pain, Marijuana Abuse
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 year
Secondary outcomes (5)
Change from baseline on S-TOPS physical disability scales
Measured: 6 and 12 months
Change from baseline on S-TOPS emotional/social disability scales
Measured: 6 and 12 months
Change from baseline on S-TOPS satisfaction scales
Measured: 6 and 12 months
Change from baseline on SLP9 sleep disability scale
Measured: 6 and 12 months
Change from baseline on BPI severity/interference scales
Measured: 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2015 (estimated)
- Study startApr 2013
- Primary completion1 Mar 2017
- Study completion1 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elyad Davidson, Hadassah Medical Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02388217
- Sponsor's protocol ID
- 07419-10-HMO
- Status last verified
- Mar 2022
- First submitted
- 6 Apr 2014
- Last updated
- 22 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Cannabis on Pain and Related Quality Of Life Outcomes In Chronic Pain: A Prospective Open-Label Study
- ClinicalTrials.gov ID
- NCT02388217
- Acronym / sponsor ID
- 07419-10-HMO
- Conditions
- Chronic Pain
- Keywords
- chronic pain, cannabis, Approved for cannabis treatment by Israeli ministry of health, Unrelieved chronic pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- 1 Mar 2017 (actual)
- Study completion
- 1 Nov 2020 (actual)
- First posted
- 13 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
5 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Pain, run by Hadassah Medical Organization at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline on the S-TOPS pain symptom scale (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2022.