Clinical Research Study: Inflammatory Bowel Disease (IBD)

Inflammatory Bowel Disease (also called IBD) refers to a group of life-long conditions that cause inflammation and irritation of the gastrointestinal tract. The two most common types of IBD are ulcerative colitis, which affects the colon and rectum, and Crohn’s disease, which can affect any part of the digestive tract.    
 

IBD usually comes and goes in “flares” and “remission.” Common symptoms can be mild to very serious, and can include ongoing diarrhea, abdominal pain, cramping, and sometimes blood in the stool. People with IBD may also feel very tired, lose their appetite, lose weight without trying, and feel generally unwell. New approaches to managing these symptoms are being studied as they can greatly affect daily life. The NYS Office of Cannabis Management is conducting a six-month study to evaluate the effects of CBD and THC in improving symptoms of IBD. 
 

THC and CBD work with a natural system in the body, called the endocannabinoid system, that helps control pain, swelling, and how the gut works. This may help some with IBD to have less abdominal pain, a better appetite, and better sleep. This may also help make IBD symptoms easier to manage and improve quality of life. The purpose of this study is to evaluate changes in quality of life and IBD symptoms among participants who are using medical cannabis, based on questionnaires commonly used in clinical practice and research. The results from this study will provide helpful insight into the therapeutic effects of cannabidiol (CBD) and tetrahydrocannabinol (THC) including if they help IBD symptoms, overall health, and patient-reported quality of life.

If you believe you may be eligible, please complete the pre-screening questionnaire 
and submit your contact information. 
 

TAKE ELIGIBILITY SURVEY

• If you’re eligible, a member of the study team will contact you to talk about enrollment and review an Informed Consent Form (ICF), which provides information about the purpose of the study and what to expect if you participate.

• If you choose to participate, you will be registered on the study website, electronically sign the ICF and complete screening questions. These questions will collect information about your medical history, IBD diagnosis, and medical cannabis use.

• You will be required to provide documentation confirming your IBD diagnosis.

• Participants will receive a welcome package by mail containing a daily dosing diary and instructions for completing your monthly study activities, which helps ensure the study data is accurate and reliable.

• All questionnaires and study data will be entered into our secure study website called MyREDCapCloud.  

Compensation will be provided as a voucher, or a similar type of compensation, that can be used at participating medical cannabis dispensaries.

Your participation contributes valuable information that may help clinicians improve care for patients with IBD and better understand the role of cannabis in its management.