Cannabidiol Usage as an Adjunct Therapy for Crohn's Disease

• ClinicalTrials.gov Identifier: NCT03467620
• Recruitment Status: Withdrawn
• First Posted: March 16, 2018
• Last Update Posted: March 25, 2020
• Sponsor: University of Illinois at Chicago
• Information provided by (Responsible Party): Kyle M Geary, MD, University of Illinois at Chicago

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Crohn Disease; Inflammatory Bowel Diseases; Cannabis	Drug: Cannabidiol; Drug: Placebo oral capsule	Phase 2; Phase 3

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 0 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Oral Cannabidiol Capsule Usage as an Adjunct Therapy for Crohn's Disease: a Randomized, Placebo-controlled Study
• Estimated Study Start Date: July 2018
• Estimated Primary Completion Date: July 2019
• Estimated Study Completion Date: July 2019

Arms and Interventions

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 Name: 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 Name: Placebo

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

1. Morbidity [ Time Frame: 12 weeks ]
   Rates of hospitalization and adverse events

Eligibility Criteria

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

Criteria

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

Contacts and Locations

No Contacts or Locations Provided

More Information

• Responsible Party: Kyle M Geary, MD, Gastroenterology Fellow, University of Illinois at Chicago
• ClinicalTrials.gov Identifier: NCT03467620
• Other Study ID Numbers: 2018-0529 Adm Withdrawn
• First Posted: March 16, 2018
• Last Update Posted: March 25, 2020
• Last Verified: March 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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

Additional relevant MeSH terms:

Crohn Disease; Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Cannabidiol; Anticonvulsants