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NCT Number: NCT01826188

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

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.

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Key information

Conditions

Crohn's Disease Crohn Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

20 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Meir Hospital

Kfar Saba, Israel

About this study

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:

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

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Exclusion criteria

  • 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.

-

Treatment and study plan

THC 5mg/ml and CBS 50mg/ml

Drug

olive oil containing THC and CBD

Placebo

Drug

olive oil without cannabis

Primary outcomes

  1. 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.

Secondary outcomes

  1. Remission of disease

    Time frame: 8 weeks

    • Remission of disease i.e CDAI of less the 150 points.

  2. endoscopic improvment

    Time frame: 8 week

    • Improvment of at least one point in Endoscopic disease activity index

  3. Improvment of CRP and calprotectine

    Time frame: 8 week

    CRP and calprotectine will be measured before and after 8 weeks of study treatment

  4. 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

  5. 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.

Other outcomes

  1. 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)

Sponsors and collaborators

Lead sponsor

Meir Medical Center

Other

Registry information

Official study title

Combined THC and CBD Drops for Treatment of Crohn's Disease, a Phase II Double Blind Placebo Controlled Trial

Important dates

Study start
2013
Primary completion
2018
Study completion
2018
First posted
Apr 8, 2013
Registry last updated
Mar 8, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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