Cannabidiol Usage as an Adjunct Therapy for Crohn's Disease

Phase 2

Withdrawn

• Conditions: Crohn Disease; Inflammatory Bowel Diseases; Cannabis
• Interventions: Drug: Placebo oral capsule; Drug: Cannabidiol

• Registration Number: NCT03467620
• Lead Sponsor: University of Illinois at Chicago

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.

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 Timeline

• Study First Submitted: 2018-03-05
• Study First Submitted QC: 2018-03-09
• Study First Posted: 2018-03-16
• Study Start: 2018-07
• Primary Completion: 2019-07
• Study Completion: 2019-07
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-23
• Last Update Posted: 2020-03-25

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo oral capsule	Placebo oral capsule	One placebo capsule per day for a duration of 12 weeks
Cannabidiol oral capsule	Cannabidiol	25-mg capsule of Cannabidiol (CBD) per day taken daily for a duration of 12 weeks.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Morbidity	12 weeks	Rates of hospitalization and adverse events