Cannabis for Inflammatory Bowel Disease

Sponsor

Meir Medical Center (Other)

Overall Status

Unknown status

CT.gov ID

NCT01040910

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Background: The marijuana plant Cannabis has been used for centuries in the medicinal treatment of many disorders and is still the subject of medical research and public debate. Cannabinoids have been purported to alleviate a variety of neurological conditions such as MS-related symptoms including spasticity, pain, tremor and bladder dysfunction. Other neurological conditions like chronic intractable pain, dystonic movement disorders and Tourette's Syndrome were all reported to be alleviated by cannabis use. Cannabis has been used to treat anorexia in AIDS and cancer patients. In gastroenterology cannabis has been used to treat symptoms and diseases including anorexia, emesis, abdominal pain, gastroenteritis, diarrhoea, intestinal inflammation and diabetic gastroparesis.

Cannabinoids have also a profound anti inflammatory effect, mainly through the CB2 receptor. Cell mediated immunity may be impaired in chronic marijuana users. And a potent anti-inflammatory effect of cannabis was observed in rats . Studying the functional roles of the endocannabinoid system in immune modulation reveals that there are no major immune events which do not involve the endocannabinoid system. Cannabinoids shift the balance of pro-inflammatory cytokines and anti-inflammatory cytokines towards the T-helper cell type 2 profiles (Th2 phenotype), and suppress cell-mediated immunity whereas humoral immunity may be enhanced. They are therefore used for various inflammatory conditions including rheumatoid arthritis and asthma. In a mouse model of colitis cannabinoids were found to ameliorate inflammation and there are many anecdotal reports about the effect of cannabis in inflammatory bowel disease. However, there are no methodical reports of the effect of cannabis on inflammatory bowel disease. The aim of the proposed study is to examine in a double blind placebo controlled fashion the effect of smoking cannabis on disease activity in patients with IBD.

Condition or Disease	Intervention/Treatment	Phase
Crohn's Disease Ulcerative Colitis	Drug: smoking of cannabis Drug: smoking cigarettes with placebo	Phase 1/Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

Official Title:

A Double Blind Placebo Controlled Study of Cannabis Smoking in Inflammatory Bowel Disease

Study Start Date :

Jan 1, 2010

Anticipated Primary Completion Date :

Jun 1, 2012

Anticipated Study Completion Date :

Jul 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: cannabis smoking for IBD patients with active disease receiving active cannabis for smoking	Drug: smoking of cannabis smoking of cannabis, 2 cigarettes a day, equivalent to about 50 mg THC
Placebo Comparator: patients smoking non active cannabis patients with active disease receiving cannabis from which active ingredients have been chemically removed	Drug: smoking cigarettes with placebo smoking cigarettes with cannabis that was chemically treated so that most active ingredients were removed

Arm

Intervention/Treatment

Active Comparator: cannabis smoking for IBD

patients with active disease receiving active cannabis for smoking

Drug: smoking of cannabis

smoking of cannabis, 2 cigarettes a day, equivalent to about 50 mg THC

Placebo Comparator: patients smoking non active cannabis

patients with active disease receiving cannabis from which active ingredients have been chemically removed

Drug: smoking cigarettes with placebo

smoking cigarettes with cannabis that was chemically treated so that most active ingredients were removed

Outcome Measures

Primary Outcome Measures

reduction of CDAI by 70 points [8 weeks]

Secondary Outcome Measures

adverse events due to cannabis smoking [8 weeks]
change in quality of life before and at the end of study [8 weeks]
change in IL-10. IL-2. TGF beta [week 0 and week 8]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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 smoking cannabis at a dose of two cigarettes a day which will contain either regular cannabis or pre treated cannabis 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.