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History of Changes for Study: NCT01037322
Cannabidiol for Inflammatory Bowel Disease
Latest version (submitted April 13, 2013) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 December 22, 2009 None (earliest Version on record)
2 May 2, 2010 Recruitment Status, Study Status and Contacts/Locations
3 July 25, 2010 Study Status
4 July 28, 2010 Study Status
5 May 2, 2011 Study Status
6 December 15, 2011 Sponsor/Collaborators and Study Status
7 April 13, 2013 Recruitment Status, Study Status, Contacts/Locations and Study Design
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Study NCT01037322
Submitted Date:  December 22, 2009 (v1)

Open or close this module Study Identification
Unique Protocol ID: canabidiol1
Brief Title: Cannabidiol for Inflammatory Bowel Disease
Official Title: Use of Cannabidiol for the Treatment of Inflammatory Bowel Disease
Secondary IDs:
Open or close this module Study Status
Record Verification: December 2009
Overall Status: Not yet recruiting
Study Start: January 2010
Primary Completion: June 2010 [Anticipated]
Study Completion: January 2011 [Anticipated]
First Submitted: December 20, 2009
First Submitted that
Met QC Criteria:
December 22, 2009
First Posted: December 23, 2009 [Estimate]
Last Update Submitted that
Met QC Criteria:
December 22, 2009
Last Update Posted: December 23, 2009 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Meir Medical Center
Responsible Party:
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: No
Open or close this module Study Description
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.

Open or close this module Conditions
Conditions: Crohn's Disease
Ulcerative Colitis
Keywords: crohn's disease
ulcerative colitis
cannabis
cannabidiol
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 1/Phase 2
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: Triple (Participant, Care Provider, Investigator)
Allocation: Randomized
Enrollment: 20 [Anticipated]
Open or close this module Arms and Interventions
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
Open or close this module Outcome Measures
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 ]

Open or close this module Eligibility
Minimum Age: 20 Years
Maximum Age: 80 Years
Sex: All
Gender Based:
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.
Open or close this module Contacts/Locations
Central Contact Person: Timna Naftali, MD
Telephone: 972-9-7472580 Ext. 1054
Email: naftalit@clalit.org.il
Central Contact Backup: Fred Konikoff, Professor
Telephone: 972-9-7472580 Ext. 2459
Email: fred.konikoff@clalit.org.il
Study Officials: Fred Konikoff, professor
Study Chair
Meir Hospital
Locations: Israel
Sapir Medical center Meir Hospital
Kefar Saba, Israel, 44281
Contact:Contact: Timna Naftali, MD 972-9-7472580 Ext. 1054 naftalit@clalit.org.il
Contact:Principal Investigator: Timna Naftali, MD
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links:
Available IPD/Information:

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