Clinical trial NCT01826188: Combined THC and CBD Drops for Treatment of Crohn's Disease
Official title: Combined THC and CBD Drops for Treatment of Crohn's Disease, a Phase II Double Blind Placebo Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Crohn's Disease
Keywords: Crohn's disease
IBD Cannabis
THC
CBD
Lead sponsor: Meir Medical Center
Sponsor class: OTHER
First posted: 2013-04-08
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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. Remission of disease i.e CDAI of less the 150 points.
2. Improvement of at least one point in Endoscopic disease activity index
3. Improvement of CRP and calprotectine
4. Improvement of blood cytokine levels
5. Improvement of at least 30 points in quality of life as measured by the SF 36. In addition the investigators will monitor side effects by questionnaires addressed to the patients and to a significant relative of the patients.

Eligibility criteria: Inclusion Criteria:

1. Patients with a diagnosis of Crohn's disease of at least 3 months duration, which was proved by either endoscopy or appropriate imaging study.
2. Patients who have failed treatment with either 5 ASA or corticosteroids or immunomodulators or biologic agents, or steroid dependant patients, or patients who were treated by the above mentioned drugs and could not tolerate them due to side effects.
3. Age 20 or older.
4. Able to sign informed concent
5. Active Crohn's disease with a CDAI 200 or more.

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Exclusion Criteria:

1. Patients with a diagnosis of a mental disorder
2. Patients who by the judgment of their physician are likely to develop drug addiction.
3. Pregnant women or women who are intending to become pregnant
4. Patients with a known cannabis allergy
5. Patients who are not capable of giving an informed consent
6. Patients with an impending operation due to Crohn's disease.

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Primary outcomes:
measure: Treatment sucsess will be defind as a decrease of at least 100 points in CDAI after 8 weeks of treatment.
timeFrame: 8 weeks
Secondary outcomes:
measure: Remission of disease
timeFrame: 8 weeks
measure: endoscopic improvment
timeFrame: 8 week
measure: Improvment of CRP and calprotectine
timeFrame: 8 week
measure: Improvment of blood cytokine levls
timeFrame: 8 weeks
measure: Improvment of at least 30 points in quality of life as measured by the SF 36.
timeFrame: 8 weeks
Other outcomes:
measure: Safety and side effects
timeFrame: 8 weeks
Locations:
city: Kfar Saba
country: Israel
facility: Meir Hospital
Study officials:
References:
citation: Naftali T, Lev LB, Yablecovitch D, Half E, Konikoff FM. Treatment of Crohn's disease with cannabis: an observational study. Isr Med Assoc J. 2011 Aug;13(8):455-8.