NCT01037322

Brief Summary

There are many anecdotal reports about improvement of Inflammatory bowel diseases (IBD) with cannabis smoking. The most effective anti inflammatory compound known today is cannabidiol. cannabidiol can be extracted from the cannabis plant, it has no central effect and is fat soluble so it can be given as drops in oil. Doses of up to 500mg did not cause any side effects. The aim of the proposed study is to examine in a double blind placebo controlled fashion the effect of cannabidiol on disease activity in patients with IBD.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jan 2010

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 20, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 23, 2009

Completed
9 days until next milestone

Study Start

First participant enrolled

January 1, 2010

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
Last Updated

April 16, 2013

Status Verified

April 1, 2013

Enrollment Period

2.7 years

First QC Date

December 20, 2009

Last Update Submit

April 13, 2013

Conditions

Crohn's DiseaseUlcerative Colitis

Keywords

crohn's diseaseulcerative colitiscannabiscannabidiol

Outcome Measures

Primary Outcomes (1)

  • reduction of 70 points in CDAI

    8 weeks

Secondary Outcomes (2)

  • change in quality of life during the study

    8 weeks

  • any adverse events during study period

    8 weeks

Study Arms (2)

cannabidiol in drops

ACTIVE COMPARATOR

cannabidiol given in drops of olive oil sub lingual 5 mg twice daily

Drug: cannabidiol

placebo in drops

PLACEBO COMPARATOR

olive oil given in drops sub lingual

Drug: placebo in drops

Interventions

cannabidiolDRUG

cannabidiol given in olive oil drops, 5 mg twice daily

cannabidiol in drops
placebo in dropsDRUG

olive oil containing no drug given in drops twice daily

placebo in drops

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with a diagnosis IBD at least 3 months before recruitment will be eligible to the study.
  • 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 receiving cannabidiol at a dose of 10 mg in sub lingual drops or drops of olive oil as placebo.
  • Disease activity index of either CDAI of more then 200 in Crohn's disease or Mayo score above 3 in UC.
  • Age above 20.

You may not qualify if:

  • Patients with a known mental disorder
  • Patients who are deemed to be at a high risk of abuse or addiction to the study drug.
  • Pregnant women
  • Patients who are sensitive to any of the ingredients of the study medication.
  • Patients who are unable to give informed consent.
  • Patients who may need surgery in the near future.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sapir Medical center Meir Hospital

Kfar Saba, 44281, Israel

Location

Related Publications (1)

  • Naftali T, Mechulam R, Marii A, Gabay G, Stein A, Bronshtain M, Laish I, Benjaminov F, Konikoff FM. Low-Dose Cannabidiol Is Safe but Not Effective in the Treatment for Crohn's Disease, a Randomized Controlled Trial. Dig Dis Sci. 2017 Jun;62(6):1615-1620. doi: 10.1007/s10620-017-4540-z. Epub 2017 Mar 27.

    PMID: 28349233DERIVED

MeSH Terms

Conditions

Crohn DiseaseColitis, UlcerativeMarijuana Abuse

Interventions

Cannabidiol

Condition Hierarchy (Ancestors)

Inflammatory Bowel DiseasesGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal DiseasesColitisColonic DiseasesSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

CannabinoidsTerpenesHydrocarbonsOrganic Chemicals

Study Officials

  • Fred Konikoff, professor

    Meir Hospital

    STUDY CHAIR

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
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

December 20, 2009

First Posted

December 23, 2009

Study Start

January 1, 2010

Primary Completion

September 1, 2012

Study Completion

September 1, 2012

Last Updated

April 16, 2013

Record last verified: 2013-04

Locations

IL(1)