Cannabis for Inflammatory Bowel Disease
Primary Purpose
Crohn's Disease, Ulcerative Colitis
Status
Unknown status
Phase
Phase 1
Locations
Israel
Study Type
Interventional
Intervention
smoking of cannabis
smoking cigarettes with placebo
Sponsored by
About this trial
This is an interventional treatment trial for Crohn's Disease focused on measuring cannabis, Crohn's disease, Ulcerative colitis, IBD
Eligibility Criteria
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.
Sites / Locations
- Meir hospitalRecruiting
- Meir Medical centerRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
cannabis smoking for IBD
patients smoking non active cannabis
Arm Description
patients with active disease receiving active cannabis for smoking
patients with active disease receiving cannabis from which active ingredients have been chemically removed
Outcomes
Primary Outcome Measures
reduction of CDAI by 70 points
Secondary Outcome Measures
adverse events due to cannabis smoking
change in quality of life before and at the end of study
change in IL-10. IL-2. TGF beta
Full Information
NCT ID
NCT01040910
First Posted
December 29, 2009
Last Updated
December 15, 2011
Sponsor
Meir Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT01040910
Brief Title
Cannabis for Inflammatory Bowel Disease
Official Title
A Double Blind Placebo Controlled Study of Cannabis Smoking in Inflammatory Bowel Disease
Study Type
Interventional
2. Study Status
Record Verification Date
December 2011
Overall Recruitment Status
Unknown status
Study Start Date
January 2010 (undefined)
Primary Completion Date
June 2012 (Anticipated)
Study Completion Date
July 2012 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Meir Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn's Disease, Ulcerative Colitis
Keywords
cannabis, Crohn's disease, Ulcerative colitis, IBD
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
cannabis smoking for IBD
Arm Type
Active Comparator
Arm Description
patients with active disease receiving active cannabis for smoking
Arm Title
patients smoking non active cannabis
Arm Type
Placebo Comparator
Arm Description
patients with active disease receiving cannabis from which active ingredients have been chemically removed
Intervention Type
Drug
Intervention Name(s)
smoking of cannabis
Intervention Description
smoking of cannabis, 2 cigarettes a day, equivalent to about 50 mg THC
Intervention Type
Drug
Intervention Name(s)
smoking cigarettes with placebo
Intervention Description
smoking cigarettes with cannabis that was chemically treated so that most active ingredients were removed
Primary Outcome Measure Information:
Title
reduction of CDAI by 70 points
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
adverse events due to cannabis smoking
Time Frame
8 weeks
Title
change in quality of life before and at the end of study
Time Frame
8 weeks
Title
change in IL-10. IL-2. TGF beta
Time Frame
week 0 and week 8
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Timna Naftali, MD
Phone
972-9-7472580
Ext
1054
Email
naftalit@clalit.org.il
First Name & Middle Initial & Last Name or Official Title & Degree
Fred Konikoff, Professor
Phone
972-9-7472580
Ext
2525
Email
fred.konikoff@clalit.org.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fred Konikoff, professor
Organizational Affiliation
Sackler school of medicine Tel Aviv university
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Timna Naftali
Organizational Affiliation
Meir Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Meir hospital
City
Kefar Saba
ZIP/Postal Code
44281
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Timna Naftali, MD
Phone
972-9-7472580
Ext
1054
Email
timna.naftali@clalit.org.il
First Name & Middle Initial & Last Name & Degree
Fred Konikoff, professor
Phone
972-9-7472580
Ext
2525
Email
fred.konikoff@clalit.org.il
Facility Name
Meir Medical center
City
Kfar Saba
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Timna Naftali, MD
Phone
+97297471054
Email
timna.naftali@clalit.org.il
First Name & Middle Initial & Last Name & Degree
Orly Mor
Phone
+97297471017
Email
orly.mor@clalit.org.il
First Name & Middle Initial & Last Name & Degree
Timna Naftali, MD
12. IPD Sharing Statement
Citations:
PubMed Identifier
33571293
Citation
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.
Results Reference
derived
PubMed Identifier
23648372
Citation
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.
Results Reference
derived
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Cannabis for Inflammatory Bowel Disease
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