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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

Tracking Information
First Submitted Date  ICMJE March 5, 2018
First Posted Date  ICMJE March 16, 2018
Last Update Posted Date March 20, 2018
Estimated Study Start Date  ICMJE July 2018
Estimated Primary Completion Date July 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 15, 2018)
  • 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.
  • Fecal calprotectin [ Time Frame: 12 weeks ]
    A statistically significant decrease in fecal calprotectin
Original Primary Outcome Measures  ICMJE
 (submitted: March 9, 2018)
  • CDAI (Clinical Disease Activity Index) score [ Time Frame: 12 weeks ]
    A statistically significant decrease in CDAI score
  • Fecal calprotectin [ Time Frame: 12 weeks ]
    A statistically significant decrease in fecal calprotectin
Change History Complete list of historical versions of study NCT03467620 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 9, 2018)
Morbidity [ Time Frame: 12 weeks ]
Rates of hospitalization and adverse events
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Cannabidiol Usage as an Adjunct Therapy for Crohn's Disease
Official Title  ICMJE Oral Cannabidiol Capsule Usage as an Adjunct Therapy for Crohn's Disease: a Randomized, Placebo-controlled Study
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Crohn Disease
  • Inflammatory Bowel Diseases
  • Cannabis
Intervention  ICMJE
  • Drug: Cannabidiol
    Administration of one oral 25-mg capsule of Cannabidiol daily for a duration of 12 weeks
    Other Name: Cannabinoid
  • Drug: Placebo oral capsule
    Administration of one oral placebo capsule daily for a duration of 12 weeks
    Other Name: Placebo
Study Arms  ICMJE
  • Experimental: Cannabidiol oral capsule
    25-mg capsule of Cannabidiol (CBD) per day taken daily for a duration of 12 weeks.
    Intervention: Drug: Cannabidiol
  • Placebo Comparator: Placebo oral capsule
    One placebo capsule per day for a duration of 12 weeks
    Intervention: Drug: Placebo oral capsule
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: March 9, 2018)
36
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2019
Estimated Primary Completion Date July 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Kyle M Geary, MD 312-355-1700 kgeary3@uic.edu
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03467620
Other Study ID Numbers  ICMJE CBD2018
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Kyle M Geary, MD, University of Illinois at Chicago
Study Sponsor  ICMJE University of Illinois at Chicago
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of Illinois at Chicago
Verification Date March 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP