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

Combined THC and CBD Drops for Treatment of Crohn's Disease, a Phase II Double Blind Placebo Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Crohn's Disease
• Intervention / Treatment: Drug: THC 5mg/ml and CBS 50mg/ml; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Israel
  • Kfar Saba, Israel
    • Meir Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Drug: THC 5mg/ml and CBS 50mg/ml; olive oil containing THC and CBD
Placebo Comparator: Placebo; olive oil but without any active ingredients.	Drug: Placebo; olive oil without cannabis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Remission of disease	1. Remission of disease i.e CDAI of less the 150 points.	8 weeks
endoscopic improvment	2. Improvment of at least one point in Endoscopic disease activity index	8 week
Improvment of CRP and calprotectine	CRP and calprotectine will be measured before and after 8 weeks of study treatment	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	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.	8 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	8 weeks

Collaborators and Investigators

• Sponsor: Meir Medical Center

Publications and helpful links

General Publications

• 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. Erratum In: Isr Med Assoc J. 2011 Sep;13(9):582. Yablekovitz, Doron [corrected to Yablecovitch, Doron].

Study record dates

Study Major Dates

• Study Start: March 1, 2013
• Primary Completion (Actual): June 1, 2018
• Study Completion (Actual): June 1, 2018

Study Registration Dates

• First Submitted: March 28, 2013
• First Submitted That Met QC Criteria: April 5, 2013
• First Posted (Estimate): April 8, 2013

Study Record Updates

• Last Update Posted (Actual): March 8, 2019
• Last Update Submitted That Met QC Criteria: March 7, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: CBD; Crohn's disease; THC; IBD Cannabis
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Inflammatory Bowel Diseases; Crohn Disease
• Other Study ID Numbers: 0196-12-MMC