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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Withdrawn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
University of Illinois at Chicago
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Crohn Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    March 5, 2018
    Last Updated
    March 23, 2020
    Sponsor
    University of Illinois at Chicago
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    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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