Cannabidiol Usage as an Adjunct Therapy for Crohn's Disease
Primary Purpose
Crohn Disease, Inflammatory Bowel Diseases, Cannabis
Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Cannabidiol
Placebo oral capsule
Sponsored by
About this trial
This is an interventional treatment trial for Crohn Disease
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Cannabidiol oral capsule
Placebo oral capsule
Arm Description
25-mg capsule of Cannabidiol (CBD) per day taken daily for a duration of 12 weeks.
One placebo capsule per day for a duration of 12 weeks
Outcomes
Primary Outcome Measures
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.
Fecal calprotectin
A statistically significant decrease in fecal calprotectin
Secondary Outcome Measures
Morbidity
Rates of hospitalization and adverse events
Full Information
NCT ID
NCT03467620
First Posted
March 5, 2018
Last Updated
March 23, 2020
Sponsor
University of Illinois at Chicago
1. Study Identification
Unique Protocol Identification Number
NCT03467620
Brief Title
Cannabidiol Usage as an Adjunct Therapy for Crohn's Disease
Official Title
Oral Cannabidiol Capsule Usage as an Adjunct Therapy for Crohn's Disease: a Randomized, Placebo-controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Withdrawn
Why Stopped
Inadequate funding
Study Start Date
July 2018 (Anticipated)
Primary Completion Date
July 2019 (Anticipated)
Study Completion Date
July 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Illinois at Chicago
4. Oversight
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
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn Disease, Inflammatory Bowel Diseases, Cannabis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cannabidiol oral capsule
Arm Type
Experimental
Arm Description
25-mg capsule of Cannabidiol (CBD) per day taken daily for a duration of 12 weeks.
Arm Title
Placebo oral capsule
Arm Type
Placebo Comparator
Arm Description
One placebo capsule per day for a duration of 12 weeks
Intervention Type
Drug
Intervention Name(s)
Cannabidiol
Other Intervention Name(s)
Cannabinoid
Intervention Description
Administration of one oral 25-mg capsule of Cannabidiol daily for a duration of 12 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo oral capsule
Other Intervention Name(s)
Placebo
Intervention Description
Administration of one oral placebo capsule daily for a duration of 12 weeks
Primary Outcome Measure Information:
Title
CDAI (Clinical Disease Activity Index) score
Description
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.
Time Frame
12 weeks
Title
Fecal calprotectin
Description
A statistically significant decrease in fecal calprotectin
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Morbidity
Description
Rates of hospitalization and adverse events
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Cannabidiol Usage as an Adjunct Therapy for Crohn's Disease
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