Effect of a Cannabinoid Agonist on Colonic Sensory Functions in Patients With Irritable Bowel Syndrome

• Status: Completed
• Trial end date: 2011-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Irritable bowel syndrome (IBS) affects about 15% of the U.S. population. There are still no effective and safe medications approved for the treatment of abdominal pain associated with bowel symptoms in IBS. This study will investigate the effects of an approved medication, Dronabinol, on the movement of food through the stomach and colon in subjects with a history of diarrhea-predominant Irritable Bowel Syndrome (D-IBS).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Michael Camilleri
• Collaborators: National Center for Research Resources (NCRR); National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Treatments: Cannabinoid Receptor Agonists; Dronabinol

Criteria

Inclusion Criteria:

• Age 18-75 years

• Positive for IBS symptoms by Rome III criteria

• No prior abdominal surgery (except appendectomy or cholecystectomy

• Score of 10 or less on either Anxiety or Depression on the Hospital Anxiety/Depression Inventory

Exclusion Criteria:

• Patients with significant depression (score of greater than 10 on Hospital Depression Inventory

• Patients with anxiety (score of greater than 10 on Hospital Anxiety Inventory. However, patients on stable doses of selective serotonin inhibitors (SSRIs) or low dose of tricyclic antidepressants will be eligible.