Combined THC and CBD Drops for Treatment of Crohn's Disease
1 other identifier
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Mar 2013
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2013
CompletedFirst Submitted
Initial submission to the registry
March 28, 2013
CompletedFirst Posted
Study publicly available on registry
April 8, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2018
CompletedMarch 8, 2019
March 1, 2019
5.3 years
March 28, 2013
March 7, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (5)
Remission of disease
8 weeks
endoscopic improvment
8 week
Improvment of CRP and calprotectine
8 week
Improvment of blood cytokine levls
8 weeks
Improvment of at least 30 points in quality of life as measured by the SF 36.
8 weeks
Other Outcomes (1)
Safety and side effects
8 weeks
Study Arms (2)
THC 5 mg/ml and CBD 50 mg/ml.
ACTIVE COMPARATORolive oil containing THC 5 mg/ml and CBD 50 mg/ml. which will be taken twice daily.
Placebo
PLACEBO COMPARATORolive oil but without any active ingredients.
Interventions
Eligibility Criteria
You may qualify if:
- Patients with a diagnosis of Crohn's disease of at least 3 months duration, which was proved by either endoscopy or appropriate imaging study.
- 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.
- Age 20 or older.
- Able to sign informed concent
- Active Crohn's disease with a CDAI 200 or more.
You may not qualify if:
- Patients with a diagnosis of a mental disorder
- Patients who by the judgment of their physician are likely to develop drug addiction.
- Pregnant women or women who are intending to become pregnant
- Patients with a known cannabis allergy
- Patients who are not capable of giving an informed consent
- Patients with an impending operation due to Crohn's disease.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Meir Hospital
Kfar Saba, Israel
Related Publications (1)
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.
PMID: 21910367BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 28, 2013
First Posted
April 8, 2013
Study Start
March 1, 2013
Primary Completion
June 1, 2018
Study Completion
June 1, 2018
Last Updated
March 8, 2019
Record last verified: 2019-03