Cannabidiol Usage as an Adjunct Therapy for Crohn's Disease

NCT03467620 | Withdrawn Phase 2 DMC

• 1 other identifier: 2018-0529 Adm Withdrawn
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Crohn Disease; Inflammatory Bowel Diseases; Cannabis

Outcome Measures

Primary Outcomes (2)

• 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.

  12 weeks

• Fecal calprotectin

  A statistically significant decrease in fecal calprotectin

  12 weeks

Secondary Outcomes (1)

• Morbidity

  12 weeks

Study Arms (2)

Cannabidiol oral capsule

EXPERIMENTAL

25-mg capsule of Cannabidiol (CBD) per day taken daily for a duration of 12 weeks.

Drug: Cannabidiol

Placebo oral capsule

PLACEBO COMPARATOR

One placebo capsule per day for a duration of 12 weeks

Drug: Placebo oral capsule

Interventions

Cannabidiol DRUG

Administration of one oral 25-mg capsule of Cannabidiol daily for a duration of 12 weeks

Also known as: Cannabinoid

Cannabidiol oral capsule

Placebo oral capsule DRUG

Administration of one oral placebo capsule daily for a duration of 12 weeks

Also known as: Placebo

Placebo oral capsule

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Pregnant or intend to become pregnant in the next 6 months
• Major abdominal surgery within the past 3 months

Sponsors & Collaborators

• University of Illinois at Chicago: lead

MeSH Terms

Conditions

Crohn Disease; Inflammatory Bowel Diseases; Marijuana Abuse

Interventions

Cannabidiol; Cannabinoids

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Terpenes; Hydrocarbons; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Gastroenterology Fellow

Study Record Dates

• First Submitted: March 5, 2018
• First Posted: March 16, 2018
• Study Start: July 1, 2018
• Primary Completion: July 1, 2019
• Study Completion: July 1, 2019
• Last Updated: March 25, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share