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Cannabis for Inflammatory Bowel Disease

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.

Verified December 2011 by NAFTALI TIMNA, Meir Medical Center.
Recruitment status was: Recruiting

Sponsor:

ClinicalTrials.gov Identifier:

NCT01040910

First Posted: December 30, 2009

Last Update Posted: December 16, 2011

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Information provided by (Responsible Party):

NAFTALI TIMNA, Meir Medical Center

Purpose

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


Study Type:	Interventional
Study Design:	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

Resource links provided by NLM:

Genetics Home Reference related topics: Crohn disease ulcerative colitis

MedlinePlus related topics: Marijuana Smoking

U.S. FDA Resources

Further study details as provided by NAFTALI TIMNA, Meir Medical Center:

Primary Outcome Measures:

reduction of CDAI by 70 points [ Time Frame: 8 weeks ]

Secondary Outcome Measures:

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


Estimated Enrollment:	20
Study Start Date:	January 2010
Estimated Study Completion Date:	July 2012
Estimated Primary Completion Date:	June 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:	20 Years to 70 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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 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.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01040910

Contacts


Contact: Timna Naftali, MD	972-9-7472580 ext 1054	naftalit@clalit.org.il
Contact: Fred Konikoff, Professor	972-9-7472580 ext 2525	fred.konikoff@clalit.org.il

Locations


Israel
Meir hospital	Recruiting
Kefar Saba, Israel, 44281
Contact: Timna Naftali, MD 972-9-7472580 ext 1054 timna.naftali@clalit.org.il
Contact: Fred Konikoff, professor 972-9-7472580 ext 2525 fred.konikoff@clalit.org.il
Meir Medical center	Recruiting
Kfar Saba, Israel
Contact: Timna Naftali, MD +97297471054 timna.naftali@clalit.org.il
Contact: Orly Mor +97297471017 orly.mor@clalit.org.il
Principal Investigator: Timna Naftali, MD

Sponsors and Collaborators

Meir Medical Center

Investigators


Study Chair:	Fred Konikoff, professor	Sackler school of medicine Tel Aviv university
Principal Investigator:	Timna Naftali	Meir Medical Center

More Information

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

Naftali T, Bar-Lev Schleider L, Dotan I, Lansky EP, Sklerovsky Benjaminov F, Konikoff FM. Cannabis induces a clinical response in patients with Crohn's disease: a prospective placebo-controlled study. Clin Gastroenterol Hepatol. 2013 Oct;11(10):1276-1280.e1. doi: 10.1016/j.cgh.2013.04.034. Epub 2013 May 4.


Responsible Party:	NAFTALI TIMNA, MD, Meir Medical Center
ClinicalTrials.gov Identifier:	NCT01040910 History of Changes
Other Study ID Numbers:	cannabis1
First Submitted:	December 29, 2009
First Posted:	December 30, 2009
Last Update Posted:	December 16, 2011
Last Verified:	December 2011

Keywords provided by NAFTALI TIMNA, Meir Medical Center:


cannabis Crohn's disease Ulcerative colitis IBD

Additional relevant MeSH terms:


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

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