Cannabidiol for Inflammatory Bowel Disease

• ClinicalTrials.gov Identifier: NCT01037322
• Recruitment Status: Completed
• First Posted: December 23, 2009
• Last Update Posted: April 16, 2013
• Sponsor: Meir Medical Center
• Information provided by (Responsible Party): NAFTALI TIMNA, Meir Medical Center

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.

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

• 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

Arms and Interventions

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

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

• 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

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: NAFTALI TIMNA, MD, Meir Medical Center
• ClinicalTrials.gov Identifier: NCT01037322
• Other Study ID Numbers: canabidiol1
• First Posted: December 23, 2009
• 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:

Crohn Disease; Colitis; Colitis, Ulcerative; Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colonic Diseases; Cannabidiol; Anticonvulsants