Cannabis for Inflammatory Bowel Disease

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2011 by Meir Medical Center.
Recruitment status was  Recruiting
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

December 29, 2009
December 15, 2011
January 2010
June 2012   (final data collection date for primary outcome measure)
reduction of CDAI by 70 points [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01040910 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Cannabis for Inflammatory Bowel Disease
A Double Blind Placebo Controlled Study of Cannabis Smoking in Inflammatory Bowel Disease

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.

Not Provided
Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
  • Crohn's Disease
  • Ulcerative Colitis
  • Drug: smoking of cannabis
    smoking of cannabis, 2 cigarettes a day, equivalent to about 50 mg THC
  • Drug: smoking cigarettes with placebo
    smoking cigarettes with cannabis that was chemically treated so that most active ingredients were removed
  • Active Comparator: cannabis smoking for IBD
    patients with active disease receiving active cannabis for smoking
    Intervention: Drug: smoking of cannabis
  • Placebo Comparator: patients smoking non active cannabis
    patients with active disease receiving cannabis from which active ingredients have been chemically removed
    Intervention: Drug: smoking cigarettes with placebo
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. PubMed PMID: 23648372.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
20
July 2012
June 2012   (final data collection date for primary outcome measure)

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.
Both
20 Years to 70 Years
No
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
Israel
 
NCT01040910
cannabis1
No
NAFTALI TIMNA, Meir Medical Center
Meir Medical Center
Not Provided
Study Chair: Fred Konikoff, professor Sackler school of medicine Tel Aviv university
Principal Investigator: Timna Naftali Meir Medical Center
Meir Medical Center
December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP