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A Double Blind Placebo Controlled Study of Cannabis Smoking in Inflammatory Bowel Disease


Phase 1/Phase 2
20 Years
70 Years
Open (Enrolling)
Both
Crohn's Disease, Ulcerative Colitis

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Trial Information

A Double Blind Placebo Controlled Study of Cannabis Smoking in Inflammatory Bowel Disease


Inclusion Criteria:



1. Patients with a diagnosis IBD at least 3 months before recruitment will be eligible
to the study.

2. Patients with active disease who are resistant to either 5 ASA, steroids or
immunomodulators, or who can not receive those drugs due to adverse reactions will
be offered the possibility of smoking cannabis at a dose of two cigarettes a day
which will contain either regular cannabis or pre treated cannabis as placebo.

3. Disease activity index of either CDAI of more then 200 in Crohn's disease or Mayo
score above 3 in UC.

4. Age above 20.

Exclusion Criteria:

1. Patients with a known mental disorder

2. Patients who are deemed to be at a high risk of abuse or addiction to the study drug.

3. Pregnant women

4. Patients who are sensitive to any of the ingredients of the study medication.

5. Patients who are unable to give informed consent.

6. Patients who may need surgery in the near future.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Outcome Measure:

reduction of CDAI by 70 points

Outcome Time Frame:

8 weeks

Safety Issue:

No

Principal Investigator

Fred Konikoff, professor

Investigator Role:

Study Chair

Investigator Affiliation:

Sackler school of medicine Tel Aviv university

Authority:

Israel: Israeli Health Ministry Pharmaceutical Administration

Study ID:

cannabis1

NCT ID:

NCT01040910

Start Date:

January 2010

Completion Date:

July 2012

Related Keywords:

  • Crohn's Disease
  • Ulcerative Colitis
  • cannabis
  • Crohn's disease
  • Ulcerative colitis
  • IBD
  • Colitis
  • Colitis, Ulcerative
  • Crohn Disease
  • Inflammatory Bowel Diseases
  • Intestinal Diseases
  • Marijuana Abuse
  • Ulcer

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