Cannabidiol Usage as an Adjunct Therapy for Crohn's Disease

NCT03467620 — Phase 2 / Phase 3, Withdrawn, University of Illinois at Chicago

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

Registry	NCT03467620
Status	Withdrawn - Inadequate funding
Phase	Phase 2 / Phase 3
Study type	Interventional; randomized, parallel, masking: double, treatment
Sponsor	University of Illinois at Chicago (Other)
Conditions	Crohn Disease, Inflammatory Bowel Diseases, Cannabis
Interventions	Cannabidiol, Placebo oral capsule (Drug)
Dates	start 2018-07-01 (estimated), primary completion 2019-07-01 (estimated), completion 2019-07-01 (estimated), first posted 2018-03-16, last updated 2020-03-25

-Summary

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.

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+Detailed description

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.

+Arms and interventions

Arm	Type	Interventions	Description
Cannabidiol oral capsule	Experimental	Drug: Cannabidiol	25-mg capsule of Cannabidiol (CBD) per day taken daily for a duration of 12 weeks.
Placebo oral capsule	Placebo comparator	Drug: Placebo oral capsule	One placebo capsule per day for a duration of 12 weeks

Cannabidiol (Drug), also known as Cannabinoid: Administration of one oral 25-mg capsule of Cannabidiol daily for a duration of 12 weeks
Placebo oral capsule (Drug), also known as Placebo: Administration of one oral placebo capsule daily for a duration of 12 weeks

+Outcome measures

Primary outcomes

CDAI (Clinical Disease Activity Index) score [12 weeks]: 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.
Fecal calprotectin [12 weeks]: A statistically significant decrease in fecal calprotectin

Secondary outcomes

Morbidity [12 weeks]: Rates of hospitalization and adverse events

+Eligibility

Sex: All, ages: 18 Years to any

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

My Notes

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