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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01826188
• Date of registration: 28/03/2013
• Prospective Registration: No
• Primary sponsor: Meir Medical Center
• Public title: Combined THC and CBD Drops for Treatment of Crohn's Disease
• Scientific title: Combined THC and CBD Drops for Treatment of Crohn's Disease, a Phase II Double Blind Placebo Controlled Trial
• Date of first enrolment: March 2013
• Target sample size: 50
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01826188
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator).
• Phase: Phase 1/Phase 2

Countries of recruitment

Israel

Key inclusion & exclusion 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.

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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.

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Age minimum: 20 Years
Age maximum: 85 Years
Gender: All

Health Condition(s) or Problem(s) studied

Crohn's Disease

Intervention(s)

Drug: THC 5mg/ml and CBS 50mg/ml

Drug: Placebo

Primary Outcome(s)

Treatment sucsess will be defind as a decrease of at least 100 points in CDAI after 8 weeks of treatment. [Time Frame: 8 weeks]

Secondary Outcome(s)

Improvment of blood cytokine levls [Time Frame: 8 weeks]

Remission of disease [Time Frame: 8 weeks]

Improvment of at least 30 points in quality of life as measured by the SF 36. [Time Frame: 8 weeks]

endoscopic improvment [Time Frame: 8 week]

Improvment of CRP and calprotectine [Time Frame: 8 week]

Secondary ID(s)

0196-12-MMC

Source(s) of Monetary Support

Please refer to primary and secondary sponsors