Cannabidiol Usage as an Adjunct Therapy for Crohn's Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2/PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-31

Study Completion Date

2019-07-31

Brief Summary

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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.

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Detailed Description

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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

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Crohn Disease Inflammatory Bowel Diseases Cannabis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Cannabidiol oral capsule

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

Group Type EXPERIMENTAL

Cannabidiol

Intervention Type DRUG

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

Placebo oral capsule

One placebo capsule per day for a duration of 12 weeks

Group Type PLACEBO_COMPARATOR

Placebo oral capsule

Intervention Type DRUG

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

Interventions

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Cannabidiol

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

Intervention Type DRUG

Placebo oral capsule

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

Intervention Type DRUG

Other Intervention Names

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Cannabinoid Placebo

Eligibility Criteria

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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