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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by Meir Medical Center
Sponsor:
Information provided by (Responsible Party):
Meir Medical Center
ClinicalTrials.gov Identifier:
NCT01826188
First received: March 28, 2013
Last updated: May 20, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention Phase
Crohn's Disease
Drug: THC 5 mg/ml and CBD 50 mg/ml.
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Combined THC and CBD Drops for Treatment of Crohn's Disease, a Phase II Double Blind Placebo Controlled Trial

Resource links provided by NLM:


Further study details as provided by Meir Medical Center:

Primary Outcome Measures:
  • Treatment sucsess will be defind as a decrease of at least 100 points in CDAI after 8 weeks of treatment. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Remission of disease [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    1. Remission of disease i.e CDAI of less the 150 points.

  • endoscopic improvment [ Time Frame: 8 week ] [ Designated as safety issue: No ]
    2. Improvment of at least one point in Endoscopic disease activity index

  • Improvment of CRP and calprotectine [ Time Frame: 8 week ] [ Designated as safety issue: No ]
    CRP and calprotectine will be measured before and after 8 weeks of study treatment

  • Improvment of blood cytokine levls [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    patients will answer a short form of Health related quality of life quasionnair before and at the end of the study.


Other Outcome Measures:
  • Safety and side effects [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
    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)


Estimated Enrollment: 50
Study Start Date: March 2013
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.
  Eligibility

Ages Eligible for Study:   20 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

    -

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01826188

Contacts
Contact: Timna Naftali, MD 97297471054 ext 1054 timna.naftali@clalit.org.il
Contact: Talia Yaffe, Msc 972-9-7472580 ext 1017 talya.yafe@clalit.org.il

Locations
Israel
Meir Hospital Recruiting
Kfar Saba, Israel
Contact: Timna Naftali, MD    97297471054    Timna.naftali@clalait.org.il   
Contact: Talia Yage, Msc    97297471017    talya.yafe@clalit.org.il   
Principal Investigator: Timna Naftali, MD         
Sponsors and Collaborators
Meir Medical Center
  More Information

Publications:
Responsible Party: Meir Medical Center
ClinicalTrials.gov Identifier: NCT01826188     History of Changes
Other Study ID Numbers: 0196-12-MMC
Study First Received: March 28, 2013
Last Updated: May 20, 2013
Health Authority: United States: Food and Drug Administration
Israel: Ministry of Health

Keywords provided by Meir Medical Center:
Crohn's disease
IBD Cannabis
THC
CBD

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Dronabinol
Hallucinogens
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Cannabinoid Receptor Agonists
Cannabinoid Receptor Modulators
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on August 20, 2014