Combined THC and CBD Drops for Treatment of Crohn's Disease

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-31

Study Completion Date

2018-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Crohn's Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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THC 5 mg/ml and CBD 50 mg/ml.

olive oil containing THC 5 mg/ml and CBD 50 mg/ml. which will be taken twice daily.

Group Type ACTIVE_COMPARATOR

THC 5mg/ml and CBS 50mg/ml

Intervention Type DRUG

olive oil containing THC and CBD

Placebo

olive oil but without any active ingredients.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

olive oil without cannabis

Interventions

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THC 5mg/ml and CBS 50mg/ml

olive oil containing THC and CBD

Intervention Type DRUG

Placebo

olive oil without cannabis

Intervention Type DRUG

Eligibility Criteria

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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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Minimum Eligible Age

20 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No