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Cannabidiol Usage as an Adjunct Therapy for Crohn's Disease

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ClinicalTrials.gov Identifier: NCT03467620
Recruitment Status : Not yet recruiting
First Posted : March 16, 2018
Last Update Posted : March 20, 2018
Sponsor:
Information provided by (Responsible Party):
Kyle M Geary, MD, 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.

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease

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




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



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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03467620


Contacts
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Contact: Kyle M Geary, MD 312-355-1700 kgeary3@uic.edu

Sponsors and Collaborators
University of Illinois at Chicago

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Responsible Party: Kyle M Geary, MD, Resident Physician, University of Illinois at Chicago
ClinicalTrials.gov Identifier: NCT03467620     History of Changes
Other Study ID Numbers: CBD2018
First Posted: March 16, 2018    Key Record Dates
Last Update Posted: March 20, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Epidiolex
Anticonvulsants