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Cannabis for Inflammatory Bowel Disease

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ClinicalTrials.gov Identifier: NCT01040910
Recruitment Status : Unknown
Verified December 2011 by NAFTALI TIMNA, Meir Medical Center.
Recruitment status was:  Recruiting
First Posted : December 30, 2009
Last Update Posted : December 16, 2011
Sponsor:
Information provided by (Responsible Party):
NAFTALI TIMNA, Meir Medical Center

Study Description
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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
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Study Type : Interventional  (Clinical Trial)
Estimated 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 : January 2010
Estimated Primary Completion Date : June 2012
Estimated Study Completion Date : July 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Marijuana Smoking

Arms and Interventions
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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
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Primary Outcome Measures :
  1. reduction of CDAI by 70 points [ Time Frame: 8 weeks ]

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

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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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
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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
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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
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Study Chair: Fred Konikoff, professor Sackler school of medicine Tel Aviv university
Principal Investigator: Timna Naftali Meir Medical Center
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: NAFTALI TIMNA, MD, Meir Medical Center
ClinicalTrials.gov Identifier: NCT01040910    
Other Study ID Numbers: cannabis1
First Posted: December 30, 2009    Key Record Dates
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:
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Crohn Disease
Colitis
Colitis, Ulcerative
Inflammatory Bowel Diseases
Ulcer
Marijuana Abuse
Gastroenteritis
Gastrointestinal Diseases
 Digestive System Diseases
Intestinal Diseases
Colonic Diseases
Pathologic Processes
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders