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Cannabis for Inflammatory Bowel Disease

This study is currently recruiting participants.
Verified December 2011 by Meir Medical Center
Sponsor:
Information provided by (Responsible Party):
NAFTALI TIMNA, Meir Medical Center
ClinicalTrials.gov Identifier:
NCT01040910
First received: December 29, 2009
Last updated: December 15, 2011
Last verified: December 2011
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Double Blind Placebo Controlled Study of Cannabis Smoking in Inflammatory Bowel Disease

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Meir Medical Center:

Primary Outcome Measures:
  • reduction of CDAI by 70 points [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • adverse events due to cannabis smoking [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
  • change in quality of life before and at the end of study [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • change in IL-10. IL-2. TGF beta [ Time Frame: week 0 and week 8 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   20 Years to 70 Years
Genders Eligible for Study:   Both
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 smoking cannabis at a dose of two cigarettes a day which will contain either regular cannabis or pre treated cannabis 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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: NAFTALI TIMNA, MD, Meir Medical Center
ClinicalTrials.gov Identifier: NCT01040910     History of Changes
Other Study ID Numbers: cannabis1
Study First Received: December 29, 2009
Last Updated: December 15, 2011
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration
United States: Food and Drug Administration

Keywords provided by Meir Medical Center:
cannabis
Crohn's disease
Ulcerative colitis
IBD

Additional relevant MeSH terms:
Colitis
Colitis, Ulcerative
Crohn Disease
Inflammatory Bowel Diseases
Intestinal Diseases
Ulcer
 Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 19, 2013