Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1/PHASE2
20 participants
INTERVENTIONAL
2010-01-31
2012-07-31
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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cannabis smoking for IBD
patients with active disease receiving active cannabis for smoking
smoking of cannabis
smoking of cannabis, 2 cigarettes a day, equivalent to about 50 mg THC
patients smoking non active cannabis
patients with active disease receiving cannabis from which active ingredients have been chemically removed
smoking cigarettes with placebo
smoking cigarettes with cannabis that was chemically treated so that most active ingredients were removed
Interventions
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smoking of cannabis
smoking of cannabis, 2 cigarettes a day, equivalent to about 50 mg THC
smoking cigarettes with placebo
smoking cigarettes with cannabis that was chemically treated so that most active ingredients were removed
Eligibility Criteria
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Inclusion Criteria
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
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.
20 Years
70 Years
ALL
No
Sponsors
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Meir Medical Center
OTHER
Responsible Party
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NAFTALI TIMNA
MD
Principal Investigators
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Fred Konikoff, professor
Role: STUDY_CHAIR
Sackler school of medicine Tel Aviv university
Timna Naftali
Role: PRINCIPAL_INVESTIGATOR
Meir Medical Center
Locations
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Meir hospital
Kfar Saba, , Israel
Meir Medical center
Kfar Saba, , Israel
Countries
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Central Contacts
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Facility Contacts
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Timna Naftali, MD
Role: primary
Fred Konikoff, professor
Role: backup
Timna Naftali, MD
Role: primary
Orly Mor
Role: backup
References
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Naftali T, Bar-Lev Schleider L, Scklerovsky Benjaminov F, Konikoff FM, Matalon ST, Ringel Y. Cannabis is associated with clinical but not endoscopic remission in ulcerative colitis: A randomized controlled trial. PLoS One. 2021 Feb 11;16(2):e0246871. doi: 10.1371/journal.pone.0246871. eCollection 2021.
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.
Other Identifiers
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cannabis1
Identifier Type: -
Identifier Source: org_study_id