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Cannabidiol for Inflammatory Bowel Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01037322
Recruitment Status : Completed
First Posted : December 23, 2009
Last Update Posted : April 16, 2013
Sponsor:
Information provided by (Responsible Party):
NAFTALI TIMNA, Meir Medical Center

Study Description
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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.


Condition or disease Intervention/treatment Phase
Crohn's Disease Ulcerative Colitis Drug: cannabidiol Drug: placebo in drops Phase 1 Phase 2

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
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Use of Cannabidiol for the Treatment of Inflammatory Bowel Disease
Study Start Date : January 2010
Actual Primary Completion Date : September 2012
Actual Study Completion Date : September 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Cannabidiol

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: cannabidiol in drops
cannabidiol given in drops of olive oil sub lingual 5 mg twice daily
 Drug: cannabidiol
cannabidiol given in olive oil drops, 5 mg twice daily
Placebo Comparator: placebo in drops
olive oil given in drops sub lingual
 Drug: placebo in drops
olive oil containing no drug given in drops twice daily


Outcome Measures
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Primary Outcome Measures :
  1. reduction of 70 points in CDAI [ Time Frame: 8 weeks ]

Secondary Outcome Measures :
  1. change in quality of life during the study [ Time Frame: 8 weeks ]
  2. any adverse events during study period [ Time Frame: 8 weeks ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01037322


Locations
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Israel
Sapir Medical center Meir Hospital
Kefar Saba, Israel, 44281
Sponsors and Collaborators
Meir Medical Center
Investigators
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Study Chair: Fred Konikoff, professor Meir Hospital
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: NAFTALI TIMNA, MD, Meir Medical Center
ClinicalTrials.gov Identifier: NCT01037322    
Other Study ID Numbers: canabidiol1
First Posted: December 23, 2009    Key Record Dates
Last Update Posted: April 16, 2013
Last Verified: April 2013
Keywords provided by NAFTALI TIMNA, Meir Medical Center:
crohn's disease
ulcerative colitis
cannabis
cannabidiol
Additional relevant MeSH terms:
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Crohn Disease
Colitis
Colitis, Ulcerative
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
 Digestive System Diseases
Intestinal Diseases
Colonic Diseases
Cannabidiol
Anticonvulsants