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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01826188
Recruitment Status : Completed
First Posted : April 8, 2013
Last Update Posted : March 8, 2019
Sponsor:
Information provided by (Responsible Party):
Meir Medical Center

Tracking Information
First Submitted Date  ICMJE March 28, 2013
First Posted Date  ICMJE April 8, 2013
Last Update Posted Date March 8, 2019
Study Start Date  ICMJE March 2013
Actual Primary Completion Date June 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 5, 2013)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 5, 2013)
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: April 5, 2013)
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)
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Combined THC and CBD Drops for Treatment of Crohn's Disease
Official Title  ICMJE Combined THC and CBD Drops for Treatment of Crohn's Disease, a Phase II Double Blind Placebo Controlled Trial
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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Crohn's Disease
Intervention  ICMJE
  • Drug: THC 5mg/ml and CBS 50mg/ml
    olive oil containing THC and CBD
  • Drug: Placebo
    olive oil without cannabis
Study Arms  ICMJE
  • 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.
    Intervention: Drug: THC 5mg/ml and CBS 50mg/ml
  • Placebo Comparator: Placebo
    olive oil but without any active ingredients.
    Intervention: Drug: Placebo
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].

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 5, 2013)
50
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2018
Actual Primary Completion Date June 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

    -

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.

    -

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01826188
Other Study ID Numbers  ICMJE 0196-12-MMC
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Meir Medical Center
Study Sponsor  ICMJE Meir Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Meir Medical Center
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP