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Cannabidiol for Inflammatory Bowel Disease

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
NAFTALI TIMNA, Meir Medical Center
ClinicalTrials.gov Identifier:
NCT01037322
First received: December 20, 2009
Last updated: April 13, 2013
Last verified: April 2013
History of Changes
  Purpose

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 Intervention Phase
Crohn's Disease
Ulcerative Colitis
 Drug: cannabidiol
Drug: placebo in drops
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Use of Cannabidiol for the Treatment of Inflammatory Bowel Disease

Resource links provided by NLM:

Drug Information available for: Olive oil
U.S. FDA Resources

Further study details as provided by Meir Medical Center:

Primary Outcome Measures:
  • reduction of 70 points in CDAI [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • change in quality of life during the study [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • any adverse events during study period [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 20
Study Start Date: January 2010
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01037322

Locations
Israel
Sapir Medical center Meir Hospital
Kefar Saba, Israel, 44281
Sponsors and Collaborators
Meir Medical Center
Investigators
Study Chair: Fred Konikoff, professor Meir Hospital
  More Information

No publications provided

Responsible Party: NAFTALI TIMNA, MD, Meir Medical Center
ClinicalTrials.gov Identifier: NCT01037322     History of Changes
Other Study ID Numbers: canabidiol1
Study First Received: December 20, 2009
Last Updated: April 13, 2013
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Meir Medical Center:
crohn's disease
ulcerative colitis
cannabis
cannabidiol

Additional relevant MeSH terms:
Colitis
Colitis, Ulcerative
Crohn Disease
Inflammatory Bowel Diseases
Intestinal Diseases
Ulcer
 Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 23, 2013