Skip to main content
OpenTrials
Completed

NCT Number: NCT01037322

Cannabidiol for 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Crohn's Disease Chemically-Induced Disorders Colitis Colitis, Ulcerative Colonic Diseases Crohn Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases Marijuana Abuse Mental Disorders Substance-Related Disorders Ulcerative Colitis

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Sapir Medical center Meir Hospital

Kfar Saba, 44281, Israel

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cannabidiol

Drug

cannabidiol given in olive oil drops, 5 mg twice daily

placebo in drops

Drug

olive oil containing no drug given in drops twice daily

Primary outcomes

  1. reduction of 70 points in CDAI

    Time frame: 8 weeks

Secondary outcomes

  1. change in quality of life during the study

    Time frame: 8 weeks

  2. any adverse events during study period

    Time frame: 8 weeks

Sponsors and collaborators

Lead sponsor

Meir Medical Center

Other

Registry information

Official study title

Use of Cannabidiol for the Treatment of Inflammatory Bowel Disease

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Dec 23, 2009
Registry last updated
Apr 16, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.