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

NCT01786109 | Completed Phase 2 Results

• 3 other identifiers: 08-008314 Part BR01DK079866UL1RR024150
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Irritable Bowel Syndrome

Keywords

anandamide; cannabinoid; fatty acid amide hydrolase; gastric; motility; small bowel; sensory; motor

Outcome Measures

Primary Outcomes (1)

• Colonic Compliance at Pressure at Half-Maximum Volume (Pr 1/2)

  Colonic compliance is a measure of the "stiffness" of the colon, that is, what pressure was needed to reach half the maximum volume of the colon. After the barostat catheter was inserted in the colon, the catheter was connected to a barostat machine. After an initial conditioning distension to 20 mm Hg, colonic compliance was measured by step-wise inflation with increments of 4 mm Hg up to 64 mm Hg. Colonic compliance was analyzed by a validated linear interpolation method. The pressure at half maximum volume serves as a summary of colonic compliance.

  1 hour after drug was ingested

Secondary Outcomes (7)

• Postprandial Change in Colonic Tone

  1 hour after ingestion of standard meal

• Post-treatment Sensory Threshold for First Perception of Pain

  1 hour after drug was ingested

• Post-Treatment Overall Sensory Rating in Response to 16, 24, 32, and 40 mm Hg Distensions

  1 hour after drug was ingested

• Fasting Colonic Tone

  After 12 hour fast, before drug administered

• Postprandial Colonic Motility Index

  1 hour after ingestion of standard meal

Study Arms (3)

Dronabinol 2.5 mg

EXPERIMENTAL

One dose of dronabinol 2.5 mg was taken orally with water.

Drug: Dronabinol

Dronabinol 5 mg

EXPERIMENTAL

One dose of dronabinol 5 mg was taken orally with water.

Drug: Dronabinol

Placebo

PLACEBO COMPARATOR

One dose of placebo was taken orally with water.

Drug: Placebo

Interventions

Dronabinol DRUG

Dronabinol is a synthetic delta-9-tetrahydrocannabinol, a nonselective cannabinoid agonist. Subjects received one dose of either 2.5 mg or 5 mg orally with water.

Also known as: Marimol

Dronabinol 2.5 mg; Dronabinol 5 mg

Placebo DRUG

Placebo will match study drug; taken as one dose orally with water.

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Michael Camilleri: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator
• National Center for Research Resources (NCRR): collaborator

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Publications (2)

• Wong BS, Camilleri M, Eckert D, Carlson P, Ryks M, Burton D, Zinsmeister AR. Randomized pharmacodynamic and pharmacogenetic trial of dronabinol effects on colon transit in irritable bowel syndrome-diarrhea. Neurogastroenterol Motil. 2012 Apr;24(4):358-e169. doi: 10.1111/j.1365-2982.2011.01874.x. Epub 2012 Jan 30.

  PMID: 22288893 BACKGROUND

• Wong BS, Camilleri M, Busciglio I, Carlson P, Szarka LA, Burton D, Zinsmeister AR. Pharmacogenetic trial of a cannabinoid agonist shows reduced fasting colonic motility in patients with nonconstipated irritable bowel syndrome. Gastroenterology. 2011 Nov;141(5):1638-47.e1-7. doi: 10.1053/j.gastro.2011.07.036. Epub 2011 Jul 29.

  PMID: 21803011 RESULT

Related Links

• Link to Part A of this study, results for GI and colonic motor functions, n=36

MeSH Terms

Conditions

Irritable Bowel Syndrome

Interventions

Dronabinol

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals

Results Point of Contact

• Title: Dr. Michael Camilleri
• Organization: Mayo Clinic

camilleri.michael@mayo.edu

507-266-2306

Study Officials

• Michael Camilleri, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: February 5, 2013
• First Posted: February 7, 2013
• Study Start: September 1, 2009
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: March 14, 2013
• Results First Posted: March 13, 2013

Record last verified: 2013-03

Locations

US (1)