Cannabis for Inflammatory Bowel Disease
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| ClinicalTrials.gov Identifier: NCT01040910 |
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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
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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 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 |
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: cannabis smoking for IBD
patients with active disease receiving active cannabis for smoking
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Drug: smoking of cannabis
smoking of cannabis, 2 cigarettes a day, equivalent to about 50 mg THC |
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Placebo Comparator: patients smoking non active cannabis
patients with active disease receiving cannabis from which active ingredients have been chemically removed
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Drug: smoking cigarettes with placebo
smoking cigarettes with cannabis that was chemically treated so that most active ingredients were removed |
- reduction of CDAI by 70 points [ Time Frame: 8 weeks ]
- 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 ]
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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 |
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.
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
| 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 | |
| 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 | |
| Study Chair: | Fred Konikoff, professor | Sackler school of medicine Tel Aviv university | |
| Principal Investigator: | Timna Naftali | Meir Medical Center |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | NAFTALI TIMNA, MD, Meir Medical Center |
| ClinicalTrials.gov Identifier: | NCT01040910 History of Changes |
| 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:
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cannabis Crohn's disease Ulcerative colitis IBD |
Additional relevant MeSH terms:
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Crohn Disease Colitis Ulcer Colitis, Ulcerative Intestinal Diseases Inflammatory Bowel Diseases Marijuana Abuse Gastroenteritis |
Gastrointestinal Diseases Digestive System Diseases Colonic Diseases Pathologic Processes Substance-Related Disorders Chemically-Induced Disorders Mental Disorders |