Crohn's DiseasePhase 1/2NCT01037322
Cannabidiol for Inflammatory Bowel Disease
A Phase 1/2 study testing cannabidiol in people with Crohn's Disease and Ulcerative Colitis, run by Meir Medical Center at 1 site in Israel.
Trial summary
There are many anecdotal reports about improvement of Inflammatory bowel diseases (IBD) with cannabis smoking. The most effective anti inflammatory compound known today is cannabidiol. cannabidiol can be extracted from the cannabis plant, it has no central effect and is fat soluble so it can be given as drops in oil. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Crohn's Disease, Ulcerative Colitis
- What is being tested?
- cannabidiol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2010to Sep 2012
- Phase
- Phase 1/2
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with a diagnosis IBD at least 3 months before recruitment will be eligible to the study.
- Patients with active disease who are resistant to either 5 ASA, steroids or immunomodulators, or who can not receive those drugs due to adverse reactions will be offered the possibility of receiving cannabidiol at a dose of 10 mg in sub lingual drops or drops of olive oil as placebo.
- Disease activity index of either CDAI of more then 200 in Crohn's disease or Mayo score above 3 in UC.
- Age above 20.
Who cannot join
- Patients with a known mental disorder
- Patients who are deemed to be at a high risk of abuse or addiction to the study drug.
- Pregnant women
- Patients who are sensitive to any of the ingredients of the study medication.
- Patients who are unable to give informed consent.
- Patients who may need surgery in the near future.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Use of Cannabidiol for the Treatment of Inflammatory Bowel Disease
There are many anecdotal reports about improvement of Inflammatory bowel diseases (IBD) with cannabis smoking. The most effective anti inflammatory compound known today is cannabidiol. cannabidiol can be extracted from the cannabis plant, it has no central effect and is fat soluble so it can be given as drops in oil. Doses of up to 500mg did not cause any side effects.
The aim of the proposed study is to examine in a double blind placebo controlled fashion the effect of cannabidiol on disease activity in patients with IBD.
Read the detailed description
Background: Inflammatory bowel diseases (IBD) are relatively common disease with a rising incidence. Treatment includes various immunocompromising agents including corticosteroids, immunomodulators and biologic agents. Current treatment is not always effective and has many side effect.
Cannabinoids have been known to have anti inflammatory effect, probably via the CB2 receptor. There are many anecdotal reports of cannabinoids in inflammatory disease such as rheumatoid arthritis, and the impression is that cannabinoids do have an ameliorating effect on IBD and that side effects are negligible. However, there are no placebo controled trials in human subjects.
The cannabis plant contains about 600 ingredients, and it is not known which are the active ingredients affecting IBD. The most effective anti inflammatory compound known today is cannabidiol. Cannabidiol can be extracted from the cannabis plant, it has no central effect and is fat soluble so it can be given as drops in oil. Doses of up to 500mg did not cause any side effects.
The aim of the proposed study is to examine in a double blind placebo controlled fashion the effect of cannabidiol on disease activity in patients with IBD.
- Conditions
- Crohn's Disease, Ulcerative Colitis
- Being tested
- cannabidiol, placebo in drops
- Keywords
- crohn's disease, ulcerative colitis, cannabis, cannabidiol
- Medical subject headings
- Crohn Disease, Colitis, Ulcerative, Marijuana Abuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cannabidiolDrug
cannabidiol given in olive oil drops, 5 mg twice daily
placebo in dropsDrug
olive oil containing no drug given in drops twice daily
| Study group | Role | What they receive |
|---|---|---|
| cannabidiol in drops | Active comparator | cannabidiol given in drops of olive oil sub lingual 5 mg twice daily Receives: Drug: cannabidiol |
| placebo in drops | Placebo comparator | olive oil given in drops sub lingual Receives: Drug: placebo in drops |
What is being measured
The primary outcome is the main question the study is designed to answer.
reduction of 70 points in CDAI
Measured: 8 weeks
Secondary outcomes (2)
change in quality of life during the study
Measured: 8 weeks
any adverse events during study period
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2009 (estimated)
- Study startJan 2010
- Primary completionSep 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Crohn's DiseaseStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, NAFTALI TIMNA, Meir Medical Center
- Investigators
- Fred Konikoff, professor, Study chair, Meir Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01037322
- Sponsor's protocol ID
- canabidiol1
- Status last verified
- Apr 2013
- First submitted
- 20 Dec 2009
- Last updated
- 16 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Naftali T, Mechulam R, Marii A, Gabay G, Stein A, Bronshtain M, Laish I, Benjaminov F, Konikoff FM. Low-Dose Cannabidiol Is Safe but Not Effective in the Treatment for Crohn's Disease, a Randomized Controlled Trial. Dig Dis Sci. 2017 Jun;62(6):1615-1620. doi: 10.1007/s10620-017-4540-z. Epub 2017 Mar 27.
PubMed 28349233
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Cannabidiol for the Treatment of Inflammatory Bowel Disease
- ClinicalTrials.gov ID
- NCT01037322
- Acronym / sponsor ID
- canabidiol1
- Conditions
- Crohn's Disease, Ulcerative Colitis
- Keywords
- crohn's disease, ulcerative colitis, cannabis, cannabidiol
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 23 Dec 2009 (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.
There are many anecdotal reports about improvement of Inflammatory bowel diseases (IBD) with cannabis smoking. The most effective anti inflammatory compound known today is cannabidiol. cannabidiol can be extracted from the cannabis plant, it has no central effect and is fat soluble so it can be given as drops in oil. Doses of up to 500mg did not cause any side effects.
The aim of the proposed study is to examine in a double blind placebo controlled fashion the effect of cannabidiol on disease activity in patients with IBD.
Detailed description
Background: Inflammatory bowel diseases (IBD) are relatively common disease with a rising incidence. Treatment includes various immunocompromising agents including corticosteroids, immunomodulators and biologic agents. Current treatment is not always effective and has many side effect.
Cannabinoids have been known to have anti inflammatory effect, probably via the CB2 receptor. There are many anecdotal reports of cannabinoids in inflammatory disease such as rheumatoid arthritis, and the impression is that cannabinoids do have an ameliorating effect on IBD and that side effects are negligible. However, there are no placebo controled trials in human subjects.
The cannabis plant contains about 600 ingredients, and it is not known which are the active ingredients affecting IBD. The most effective anti inflammatory compound known today is cannabidiol. Cannabidiol can be extracted from the cannabis plant, it has no central effect and is fat soluble so it can be given as drops in oil. Doses of up to 500mg did not cause any side effects.
The aim of the proposed study is to examine in a double blind placebo controlled fashion the effect of cannabidiol on disease activity in patients with IBD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cannabidiol in drops | Active comparator | Drug: cannabidiolcannabidiol given in drops of olive oil sub lingual 5 mg twice daily |
| placebo in drops | Placebo comparator | Drug: placebo in dropsolive oil given in drops sub lingual |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with a diagnosis IBD at least 3 months before recruitment will be eligible to the study.
- Patients with active disease who are resistant to either 5 ASA, steroids or immunomodulators, or who can not receive those drugs due to adverse reactions will be offered the possibility of receiving cannabidiol at a dose of 10 mg in sub lingual drops or drops of olive oil as placebo.
- Disease activity index of either CDAI of more then 200 in Crohn's disease or Mayo score above 3 in UC.
- Age above 20.
Key exclusion criteria (6 listed)
- Patients with a known mental disorder
- Patients who are deemed to be at a high risk of abuse or addiction to the study drug.
- Pregnant women
- Patients who are sensitive to any of the ingredients of the study medication.
- Patients who are unable to give informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cannabidiolcannabidiol given in olive oil drops, 5 mg twice daily | Drug | cannabidiol in drops |
| placebo in dropsolive oil containing no drug given in drops twice daily | Drug | placebo in drops |
Primary outcome
reduction of 70 points in CDAI
Time frame: 8 weeks
2 secondary outcomes
change in quality of life during the study
Time frame: 8 weeks
any adverse events during study period
Time frame: 8 weeks
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 16 Apr 2013.
- Derived from this study: PubMed 28349233Naftali T, Mechulam R, Marii A, Gabay G, Stein A, Bronshtain M, Laish I, Benjaminov F, Konikoff FM. Low-Dose Cannabidiol Is Safe but Not Effective in the Treatment for Crohn's Disease, a Randomized Controlled Trial. Dig Dis Sci. 2017 Jun;62(6):1615-1620. doi: 10.1007/s10620-017-4540-z. Epub 2017 Mar 27.
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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.
Fred Konikoff, professor study chair
Meir Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing cannabidiol in people with Crohn's Disease and Ulcerative Colitis, run by Meir Medical Center 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 4 inclusion and 6 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 16 Apr 2013. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
reduction of 70 points in CDAI (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01037322, which also lists 1 linked publication.
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 16 Apr 2013; AzTrials last refreshed its copy on 29 Oct 2026.