Cannabidiol Usage as an Adjunct Therapy for Crohn's Disease

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Inflammatory Bowel Diseases; Crohn Disease; Cannabis
• Intervention / Treatment: Drug: Cannabidiol; Drug: Placebo oral capsule

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.

• Study Type: Interventional
• Phase: Phase 2; Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Illinois at Chicago

Study record dates

Study Major Dates

• Study Start (Anticipated): July 1, 2018
• Primary Completion (Anticipated): July 1, 2019
• Study Completion (Anticipated): July 1, 2019

Study Registration Dates

• First Submitted: March 5, 2018
• First Submitted That Met QC Criteria: March 9, 2018
• First Posted (Actual): March 16, 2018

Study Record Updates

• Last Update Posted (Actual): March 25, 2020
• Last Update Submitted That Met QC Criteria: March 23, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Inflammatory Bowel Diseases; Crohn Disease; Anticonvulsants; Cannabidiol
• Other Study ID Numbers: 2018-0529 Adm Withdrawn

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No