Cannabidiol for Inflammatory Bowel Disease

Ulcerative Colitis Clinical Trial

Official title:

Use of Cannabidiol for the Treatment of Inflammatory Bowel Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01037322
• Other study ID #: canabidiol1
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: December 20, 2009
• Last updated: April 13, 2013
• Start date: January 2010
• Est. completion date: September 2012

Study information

• Verified date: April 2013
• Source: Meir Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colitis, Ulcerative
• Crohn Disease
• Crohn's Disease
• Inflammatory Bowel Diseases
• Ulcerative Colitis

Intervention

Drug:
• cannabidiol
cannabidiol given in olive oil drops, 5 mg twice daily
• placebo in drops
olive oil containing no drug given in drops twice daily

Locations

Country	Name	City	State
Israel	Sapir Medical center Meir Hospital	Kefar Saba

Sponsors (1)

Lead Sponsor	Collaborator
Meir Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	reduction of 70 points in CDAI		8 weeks	No
Secondary	change in quality of life during the study		8 weeks	No
Secondary	any adverse events during study period		8 weeks	Yes