ClinicalTrials.gov
ClinicalTrials.gov Menu

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

December 20, 2009
December 23, 2009
April 16, 2013
January 2010
September 2012   (Final data collection date for primary outcome measure)
reduction of 70 points in CDAI [ Time Frame: 8 weeks ]
Same as current
Complete list of historical versions of study NCT01037322 on ClinicalTrials.gov Archive Site
  • change in quality of life during the study [ Time Frame: 8 weeks ]
  • any adverse events during study period [ Time Frame: 8 weeks ]
Same as current
Not Provided
Not Provided
 
Cannabidiol for Inflammatory Bowel Disease
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.

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.

Interventional
Phase 1
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
  • Crohn's Disease
  • Ulcerative Colitis
  • 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
  • Active Comparator: cannabidiol in drops
    cannabidiol given in drops of olive oil sub lingual 5 mg twice daily
    Intervention: Drug: cannabidiol
  • Placebo Comparator: placebo in drops
    olive oil given in drops sub lingual
    Intervention: Drug: placebo in drops
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
Same as current
September 2012
September 2012   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
20 Years to 80 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Israel
 
 
NCT01037322
canabidiol1
No
Not Provided
Not Provided
NAFTALI TIMNA, Meir Medical Center
Meir Medical Center
Not Provided
Study Chair: Fred Konikoff, professor Meir Hospital
Meir Medical Center
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP