NCT01826188

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Meir Medical Center · Academic / Other
• Sex: All
• Age: 20 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Crohn's Disease

Interventions

Type	Name	Description
DRUG	THC 5mg/ml and CBS 50mg/ml	olive oil containing THC and CBD
DRUG	Placebo	olive oil without cannabis

Timeline

• Start date: 2013-03-01
• Primary completion: 2018-06-01
• Completion: 2018-06-01
• First posted: 2013-04-08
• Last updated: 2019-03-08

Locations

1 site across 1 country: Israel