Combined THC and CBD Drops for Treatment of Crohn's Disease
|ClinicalTrials.gov Identifier: NCT01826188|
Recruitment Status : Unknown
Verified April 2013 by Meir Medical Center.
Recruitment status was: Recruiting
First Posted : April 8, 2013
Last Update Posted : February 24, 2015
|Condition or disease||Intervention/treatment||Phase|
|Crohn's Disease||Drug: THC 5 mg/ml and CBD 50 mg/ml.||Phase 1 Phase 2|
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.
- Remission of disease i.e CDAI of less the 150 points.
- Improvement of at least one point in Endoscopic disease activity index
- Improvement of CRP and calprotectine
- Improvement of blood cytokine levels
- 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 (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Combined THC and CBD Drops for Treatment of Crohn's Disease, a Phase II Double Blind Placebo Controlled Trial|
|Study Start Date :||March 2013|
|Estimated Primary Completion Date :||March 2015|
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 5 mg/ml and CBD 50 mg/ml.
Placebo Comparator: Placebo
olive oil but without any active ingredients.
- Treatment sucsess will be defind as a decrease of at least 100 points in CDAI after 8 weeks of treatment. [ Time Frame: 8 weeks ]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.
- Remission of disease [ Time Frame: 8 weeks ]1. Remission of disease i.e CDAI of less the 150 points.
- endoscopic improvment [ Time Frame: 8 week ]2. Improvment of at least one point in Endoscopic disease activity index
- Improvment of CRP and calprotectine [ Time Frame: 8 week ]CRP and calprotectine will be measured before and after 8 weeks of study treatment
- Improvment of blood cytokine levls [ Time Frame: 8 weeks ]blood cytokine levls including IL-10, TNF, and IL 23 will be measured before and at the end of the study
- Improvment of at least 30 points in quality of life as measured by the SF 36. [ Time Frame: 8 weeks ]patients will answer a short form of Health related quality of life quasionnair before and at the end of the study.
- Safety and side effects [ Time Frame: 8 weeks ]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)
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01826188
|Contact: Timna Naftali, MD||97297471054 ext firstname.lastname@example.org|
|Contact: Talia Yaffe, Msc||972-9-7472580 ext email@example.com|
|Kfar Saba, Israel|
|Contact: Timna Naftali, MD 97297471054 Timna.firstname.lastname@example.org|
|Contact: Aya Oren, DVM 97297471017 email@example.com|
|Principal Investigator: Timna Naftali, MD|