Cannabidiol Usage as an Adjunct Therapy for Crohn's Disease

University of Illinois

Status and phase: Withdrawn; Phase 3; Phase 2

Conditions: Cannabis; Inflammatory Bowel Diseases; Crohn Disease

Treatments: Drug: Placebo oral capsule; Drug: Cannabidiol

Study type: Interventional

Funder types: Other

Identifiers

NCT03467620

2018-0529 Adm Withdrawn

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 2 patient groups, including a placebo group

Cannabidiol oral capsule

Experimental group

Description:

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

Treatment:

Drug: Cannabidiol

Placebo oral capsule

Placebo Comparator group

Description:

One placebo capsule per day for a duration of 12 weeks

Treatment:

Drug: Placebo oral capsule