INTERVENTIONALCOMPLETEDNCT01037322

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.

Locally preserved from ClinicalTrials.govOpen ClinicalTrials.govlast source update 2013-04-16

What this record can show

Protocol only - no registry results posted

This locally preserved record separates the registered protocol from source-reported registry results. Neither is a treatment recommendation.

Registry facts

Study at a glance

Phase: PHASE1, PHASE2
Enrollment: 20 (ACTUAL)
Start date: 2010-01
Sponsor: Meir Medical Center
Design: RANDOMIZED · PARALLEL · TREATMENT
Locations: 1
Results record: Not present in registry snapshot

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.

Linked local records

Related local records

Local links use governed condition terms or exact source-reported intervention names. They are navigation candidates, not efficacy claims.

Conditions

Inflammatory Bowel Diseases

Cannabinoids and active compounds

cannabidiol

Medicines

No exact medicine-name link was found.

Interventions

What was registered

DRUG

cannabidiol

cannabidiol given in olive oil drops, 5 mg twice daily

DRUG

placebo in drops

olive oil containing no drug given in drops twice daily

Eligibility

Population and criteria

Sex: ALL
Minimum age: 20 Years
Maximum age: 80 Years
Healthy volunteers: Not accepted

Inclusion criteria

1. Patients with a diagnosis IBD at least 3 months before recruitment will be eligible to the study. 2. 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. 3. Disease activity index of either CDAI of more then 200 in Crohn's disease or Mayo score above 3 in UC. 4. Age above 20.

Exclusion criteria

1. Patients with a known mental disorder 2. Patients who are deemed to be at a high risk of abuse or addiction to the study drug. 3. Pregnant women 4. Patients who are sensitive to any of the ingredients of the study medication. 5. Patients who are unable to give informed consent. 6. Patients who may need surgery in the near future.

primary outcomes

primary measures

reduction of 70 points in CDAI

Time frame: 8 weeks

secondary outcomes

secondary measures

change in quality of life during the study

Time frame: 8 weeks

any adverse events during study period

Time frame: 8 weeks

Publications

Locally readable linked articles

No exact PMID-linked public article is currently readable locally.

Snapshot provenance

Snapshot: 3f7545a6-0c9a-44aa-8b72-98a677a89947
Retrieved: 24/09/2026, 14:25:29
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