A Phase 1/2 interventional study of THC 5mg/ml and CBS 50mg/ml and Placebo in Crohn's Disease, sponsored by Meir Medical Center. Completed at 1 site in Israel. Open to participants aged 20 Years to 85 Years. Per ClinicalTrials.gov, last updated 2019-03-08.
Sponsored by Meir Medical Center · Phase 1/2, Interventional, and Treatment
There are many reports about efficacy of Cannabis in Crohn's disease but no controlled trials. The aim of the proposed trial is to investigate the efficacy of oil containing the cannabinoids THC and CBD given by mouth for induction of remission in Crohn's disease.
The investigators have recently published a retrospective observational study about the beneficial effect of cannabis in Crohn's disease. The investigators have also concluded a double blind placebo controlled study of Inhaled cannabis in the treatment of Crohn's disease. Both studies have shown significant symptomatic improvement of disease. However, objective parameters of inflammation were not measured. The question arises as to whether the observed improvement is merely symptomatic or due to a real change in inflammation. In addition, administration per os is a healthier option than smoking but the efficacy of oral cannabis was not investigated.
The aim of the proposed study in to evaluate the efficacy of drops of cannabis oil in crohn's disease patients compared to placebo. Treatment success will be defined as a decrease of at least 100 points in CDAI after 8 weeks of treatment.
Secondary aims:
1,880 studies on the registry are indexed under Crohn Disease; 461 are open to participants now.
This study's enrollment of 50 is below the median of 66 across 1,188 interventional studies indexed under Crohn Disease.
Browse Crohn Disease studies →Meir Medical Center is the lead sponsor of 389 studies on the registry; 34 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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Exclusion Criteria:
Patients with an impending operation due to Crohn's disease.
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olive oil containing THC 5 mg/ml and CBD 50 mg/ml. which will be taken twice daily.
Drug: THC 5mg/ml and CBS 50mg/ml
olive oil but without any active ingredients.
Drug: Placebo
olive oil containing THC and CBD
olive oil without cannabis
Treatment sucsess will be defind as a decrease of at least 100 points in CDAI after 8 weeks of treatment.
The aim of the proposed study in to evaluate the efficacy of drops of cannabis oil in crohn's diseas patients compared to placebo. Treatment sucsess will be defind as a decrease of at least 100 points in CDAI after 8 weeks of treatment.
Time frame: 8 weeks
Remission of disease
1. Remission of disease i.e CDAI of less the 150 points.
Time frame: 8 weeks
endoscopic improvment
2. Improvment of at least one point in Endoscopic disease activity index
Time frame: 8 week
Improvment of CRP and calprotectine
CRP and calprotectine will be measured before and after 8 weeks of study treatment
Time frame: 8 week
Improvment of blood cytokine levls
blood cytokine levls including IL-10, TNF, and IL 23 will be measured before and at the end of the study
Time frame: 8 weeks
Improvment of at least 30 points in quality of life as measured by the SF 36.
patients will answer a short form of Health related quality of life quasionnair before and at the end of the study.
Time frame: 8 weeks
Safety and side effects
we will monitor side effects by questionnairs adressed to the patients and to a significant relative of the patients.both patient and a significant realitive (parent, spouse) living in the same residence with the patient will recive a quationnair monitiring cannabis use, with aminimus score of 0 (not dependant, no side effects) to a maximum score of 15 (very dependant, sever side effects)
Time frame: 8 weeks
This study is completed, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.
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Meir Medical Center