Cannabidiol Usage as an Adjunct Therapy for Crohn's Disease

Study Overview
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Brief Summary
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To date, few studies have assessed the efficacy and safety of Cannabinoids, compounds derived from the Cannabis plant, in patients with Crohn's disease. Our study seeks to pilot a randomized, placebo-controlled trial assessing the efficacy and safety of oral cannabinoids as an adjunct therapy in patients with Crohn's disease.

Detailed Description
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Crohn's disease is a type of inflammatory disease which can affect any portion of the gastrointestinal tract, from the mouth to the perianal area. Symptoms depend on location of the disease, however, many patients experience some aspect of recurrent abdominal pain, nausea, emesis, and unintentional weight loss. A common and challenging dilemma is how to manage patients who continue to have some degree of symptoms despite a common treatment regimen typically consisting of corticosteroids, thiopurines, methotrexate, or anti-TNF alpha therapies. With the recent wave of medicinal cannabis legalization in many states, many patients have begun using cannabis or commercially available cannabidiol-containing compounds as an adjunct therapy for their symptoms related to chronic inflammation and pain.

Official Title
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Oral Cannabidiol Capsule Usage as an Adjunct Therapy for Crohn's Disease: a Randomized, Placebo-controlled Study

Conditions
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Crohn Disease, Inflammatory Bowel Diseases, Cannabis

Intervention / Treatment
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* Drug: Cannabidiol
* Drug: Placebo oral capsule


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 or older English-speaking Ileal and/or ileocolonic involvement as demonstrated by most recent endoscopy Short CDAI score >150 Have not received oral or intravenous steroids for >1 month, or with stable dose for >1 month if currently taking Stable dose of AZA for >1 month, if currently taking Stable dose of anti-TNF inhibitor for >1 month, if currently taking Exclusion Criteria: Pregnant or intend to become pregnant in the next 6 months Major abdominal surgery within the past 3 months

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cannabidiol oral capsule<br>25-mg capsule of Cannabidiol (CBD) per day taken daily for a duration of 12 weeks. | Drug: Cannabidiol<br>* Administration of one oral 25-mg capsule of Cannabidiol daily for a duration of 12 weeks<br>* Other names: Cannabinoid;|
| Placebo Comparator: Placebo oral capsule<br>One placebo capsule per day for a duration of 12 weeks | Drug: Placebo oral capsule<br>* Administration of one oral placebo capsule daily for a duration of 12 weeks<br>* Other names: Placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CDAI (Clinical Disease Activity Index) score | A statistically significant decrease in CDAI score. The short CDAI score will be utilized for this study. This validated score consists of three subjective, patient-derived measures: (1) number of liquid or soft stools each day for 7 days (2) the sum of seven daily abdominal pain ratings (3) the sum of seven general well-being ratings. The calculation of CDAI score will be as follows: Short CDAI = 44 + (2 × the number of liquid or soft stools each day for 7 days) + [5 × the sum of seven daily abdominal pain ratings (0 = none, 1 = mild, 2 = moderate, 3 = severe)] + [7 × the sum of seven general well-being ratings (0 = generally well, 1 = slightly under par, 2 = poor, 3 = very poor, 4 = terrible). Outcome measures considered to be consistent with benefit from intervention includes either (1) disease remission (CDAI less than 150) or (2) CDAI score reduction of 60 points. | 12 weeks | 
| Fecal calprotectin | A statistically significant decrease in fecal calprotectin | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Morbidity | Rates of hospitalization and adverse events | 12 weeks |