NCT03467620

Cannabidiol Usage as an Adjunct Therapy for Crohn's Disease

Oral Cannabidiol Capsule Usage as an Adjunct Therapy for Crohn's Disease: a Randomized, Placebo-controlled Study

• Status: Withdrawn
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Illinois at Chicago · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Crohn Disease
• Inflammatory Bowel Diseases
• Cannabis

Interventions

Type	Name	Description
DRUG	Cannabidiol	Administration of one oral 25-mg capsule of Cannabidiol daily for a duration of 12 weeks
DRUG	Placebo oral capsule	Administration of one oral placebo capsule daily for a duration of 12 weeks

Timeline

• Start date: 2018-07-01
• Primary completion: 2019-07-01
• Completion: 2019-07-01
• First posted: 2018-03-16
• Last updated: 2020-03-25