search
Back to results

Cannabidiol for Inflammatory Bowel Disease

Primary Purpose

Crohn's Disease, Ulcerative Colitis

Status
Completed
Phase
Phase 1
Locations
Israel
Study Type
Interventional
Intervention
cannabidiol
placebo in drops
Sponsored by
Meir Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Crohn's Disease focused on measuring crohn's disease, ulcerative colitis, cannabis, cannabidiol

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Sapir Medical center Meir Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

cannabidiol in drops

placebo in drops

Arm Description

cannabidiol given in drops of olive oil sub lingual 5 mg twice daily

olive oil given in drops sub lingual

Outcomes

Primary Outcome Measures

reduction of 70 points in CDAI

Secondary Outcome Measures

change in quality of life during the study
any adverse events during study period

Full Information

First Posted
December 20, 2009
Last Updated
April 13, 2013
Sponsor
Meir Medical Center
search

1. Study Identification

Unique Protocol Identification Number
NCT01037322
Brief Title
Cannabidiol for Inflammatory Bowel Disease
Official Title
Use of Cannabidiol for the Treatment of Inflammatory Bowel Disease
Study Type
Interventional

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
September 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Meir Medical Center

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn's Disease, Ulcerative Colitis
Keywords
crohn's disease, ulcerative colitis, cannabis, cannabidiol

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
cannabidiol in drops
Arm Type
Active Comparator
Arm Description
cannabidiol given in drops of olive oil sub lingual 5 mg twice daily
Arm Title
placebo in drops
Arm Type
Placebo Comparator
Arm Description
olive oil given in drops sub lingual
Intervention Type
Drug
Intervention Name(s)
cannabidiol
Intervention Description
cannabidiol given in olive oil drops, 5 mg twice daily
Intervention Type
Drug
Intervention Name(s)
placebo in drops
Intervention Description
olive oil containing no drug given in drops twice daily
Primary Outcome Measure Information:
Title
reduction of 70 points in CDAI
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
change in quality of life during the study
Time Frame
8 weeks
Title
any adverse events during study period
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with a diagnosis IBD at least 3 months before recruitment will be eligible to the study. 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. Disease activity index of either CDAI of more then 200 in Crohn's disease or Mayo score above 3 in UC. Age above 20. Exclusion Criteria: Patients with a known mental disorder Patients who are deemed to be at a high risk of abuse or addiction to the study drug. Pregnant women Patients who are sensitive to any of the ingredients of the study medication. Patients who are unable to give informed consent. Patients who may need surgery in the near future.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fred Konikoff, professor
Organizational Affiliation
Meir Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Sapir Medical center Meir Hospital
City
Kefar Saba
ZIP/Postal Code
44281
Country
Israel

12. IPD Sharing Statement

Citations:
PubMed Identifier
28349233
Citation
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.
Results Reference
derived

Learn more about this trial

Cannabidiol for Inflammatory Bowel Disease

We'll reach out to this number within 24 hrs