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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| cannabis smoking for IBD | Active Comparator | patients with active disease receiving active cannabis for smoking |
|
| patients smoking non active cannabis | Placebo Comparator | patients with active disease receiving cannabis from which active ingredients have been chemically removed |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| smoking of cannabis | Drug | smoking of cannabis, 2 cigarettes a day, equivalent to about 50 mg THC |
|
| Measure | Description | Time Frame |
|---|---|---|
| reduction of CDAI by 70 points | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| adverse events due to cannabis smoking | 8 weeks | |
| change in quality of life before and at the end of study | 8 weeks | |
| change in IL-10. IL-2. TGF beta |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Timna Naftali, MD | Contact | 972-9-7472580 | 1054 | naftalit@clalit.org.il |
| Fred Konikoff, Professor | Contact | 972-9-7472580 | 2525 | fred.konikoff@clalit.org.il |
| Name | Affiliation | Role |
|---|---|---|
| Fred Konikoff, professor | Sackler school of medicine Tel Aviv university | Study Chair |
| Timna Naftali | Meir Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Meir hospital | Recruiting | Kfar Saba | 44281 | Israel |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33571293 | Derived | 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. | |
| 23648372 | Derived |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Apr 14, 2013 | |
| Reset | May 30, 2013 | |
| Release | Jun 7, 2020 | |
| Unrelease | Jun 7, 2020 | |
| Release | Jun 15, 2020 | |
| Reset | Jul 1, 2020 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Apr 14, 2013 | May 30, 2013 | |||
| Jun 7, 2020 | Jun 7, 2020 |
| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| D003093 | Colitis, Ulcerative |
| D002189 | Marijuana Abuse |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| smoking cigarettes with placebo | Drug | smoking cigarettes with cannabis that was chemically treated so that most active ingredients were removed |
|
| week 0 and week 8 |
| Meir Medical center | Recruiting | Kfar Saba | Israel |
|
| 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. |
| Jun 15, 2020 | Jul 1, 2020 |
| D007410 | Intestinal Diseases |
| D003092 | Colitis |
| D003108 | Colonic Diseases |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |