Clinical trial NCT01037322: Cannabidiol for Inflammatory Bowel Disease
Official title: Use of Cannabidiol for the Treatment of Inflammatory Bowel Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Crohn's Disease
Ulcerative Colitis
Keywords: crohn's disease
ulcerative colitis
cannabis
cannabidiol
Lead sponsor: Meir Medical Center
Sponsor class: OTHER
First posted: 2009-12-23
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: 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:
measure: reduction of 70 points in CDAI
timeFrame: 8 weeks
Secondary outcomes:
measure: change in quality of life during the study
timeFrame: 8 weeks
measure: any adverse events during study period
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Kefar Saba
country: Israel
facility: Sapir Medical center Meir Hospital
Study officials:
affiliation: Meir Hospital
name: Fred Konikoff, professor
role: STUDY_CHAIR
References:
citation: 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.