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| ID | Type | Description | Link |
|---|---|---|---|
| R01DK079866 | U.S. NIH Grant/Contract | View source | |
| UL1RR024150 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
| National Center for Research Resources (NCRR) | NIH |
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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).
Irritable bowel syndrome (IBS) affects about 15% of the U.S. population. Despite increasing understanding of the pathophysiology of IBS, there is no effective medication approved for the treatment of abdominal pain associated with IBS. Cannabinoid receptors (CBR) are on cholinergic neurons in the brain stem, stomach and colon. A cannabinoid receptor 1 (CB1) antagonist, rimonabant, is effective in induction of weight loss; however, the mechanism of this benefit is unclear. Human studies from this lab show that a CBR agonist, dronabinol, inhibits gastric and colonic motility, which may alter appetite or satiation in obesity, and may have potential in the treatment of IBS. The overall focus of the study is on the mechanisms involved in the modulation of gastric and colonic motor and sensory functions by cannabinoid receptors (CBR) in health and in IBS. CB1 receptors are also involved in nociception and in mediating inflammation which are increasingly recognized as being potential pathophysiological mechanisms in IBS.
All participants underwent the following procedures:
Note: This study is related to NCT01253408, part A of the same protocol. Part A explored the effect of dronabinol on gastric and colonic motor functions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dronabinol 2.5 mg | Experimental | One dose of dronabinol 2.5 mg was taken orally with water. |
|
| Dronabinol 5 mg | Experimental | One dose of dronabinol 5 mg was taken orally with water. |
|
| Placebo | Placebo Comparator | One dose of placebo was taken orally with water. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Postprandial Change in Colonic Tone | Colonic tone is a measurement of the volume of the colon. Colonic tone was assessed by noting the changes in the balloon volume in the presence of a constant operating pressure in the balloon (in the barostat-manometric assembly placed in the colon.) | 1 hour after ingestion of standard meal |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Camilleri, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22288893 | Background | 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. | |
| 21803011 | Result | 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. |
| Label | URL |
|---|---|
| Link to Part A of this study, results for GI and colonic motor functions, n=36 | View source |
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All participants were recruited from a database of patients with irritable bowel syndrome (IBS) who reside within 120 miles of Rochester, Minnesota
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| ID | Title | Description |
|---|---|---|
| FG000 | Dronabinol 2.5 mg | One dose of dronabinol 2.5 mg will be taken orally with water. |
| FG001 | Dronabinol 5 mg | One dose of dronabinol 5 mg will be taken orally with water. |
| FG002 | Placebo | One dose of placebo will be taken orally with water. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Dronabinol 2.5 mg | One dose of dronabinol 2.5 mg will be taken orally with water. |
| BG001 | Dronabinol 5 mg | One dose of dronabinol 5 mg will be taken orally with water. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Intention-to-treat analysis | Posted | Mean | Standard Error | mL/mm Hg | 1 hour after drug was ingested |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Dronabinol 2.5 mg | One dose of dronabinol 2.5 mg will be taken orally with water. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Drowsy/tired | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Michael Camilleri | Mayo Clinic | 507-266-2306 | camilleri.michael@mayo.edu |
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| ID | Term |
|---|---|
| D043183 | Irritable Bowel Syndrome |
| ID | Term |
|---|---|
| D003109 | Colonic Diseases, Functional |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
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| ID | Term |
|---|---|
| D013759 | Dronabinol |
| ID | Term |
|---|---|
| D002186 | Cannabinoids |
| D013729 | Terpenes |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
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|
| Placebo | Drug | Placebo will match study drug; taken as one dose orally with water. |
|
| Post-treatment Sensory Threshold for First Perception of Pain |
The sensory threshold for first perception of pain was measured by stepwise inflation in increments of 4 mm Hg at 60 second intervals up to a maximum pressure of 64 mm Hg. During this assessment participants were asked to report when they had the first sensation. The investigator recorded the threshold pressure at which the participants reported this sensation. |
| 1 hour after drug was ingested |
| Post-Treatment Overall Sensory Rating in Response to 16, 24, 32, and 40 mm Hg Distensions | The sensory rating was measured by a 100 mm long Visual Analog Scale (VAS). The VAS does not have any pre-set marks between the extremes of 0 for no pain and 100 mm for extreme pain. The investigator measures the mark made by the participant in mm and records this for the value of pain. | 1 hour after drug was ingested |
| Fasting Colonic Tone | Colonic tone is a measurement of the volume of the colon. Colonic tone was assessed by noting the changes in the balloon volume in the presence of a constant operating pressure in the balloon (in the barostat-manometric assembly placed in the colon.) | After 12 hour fast, before drug administered |
| Postprandial Colonic Motility Index | Colonic phasic pressure activity is summarized as a motility index (MI)=log_e[number of contractions * sum of amplitudes) + 1]. A normal fasting average motility index (MI) would be about 12. An increase in MI means an increase in the phasic contractions (in contrast to tone) which is measured as a change in volume of the barostat balloon. (Therefore, an increase in MI means that the meal is moving more quickly through the colon.) | 1 hour after ingestion of standard meal |
| Post-treatment Sensory Threshold for First Sensation | The sensory threshold for first sensation was measured by stepwise inflation in increments of 4 mm Hg at 60 second intervals up to a maximum pressure of 64 mm Hg. During this assessment participants were asked to report when they had the first sensation. The investigator recorded the threshold pressure at which the participants reported this sensation. | 1 hour after drug was ingested |
| Post-Treatment Sensory Threshold for First Perception of Gas | The sensory threshold for first perception of gas was measured by stepwise inflation in increments of 4 mm Hg at 60 second intervals up to a maximum pressure of 64 mm Hg. During this assessment participants were asked to report when they had the first sensation. The investigator recorded the threshold pressure at which the participants reported this sensation. | 1 hour after drug was ingested |
| adverse effects colon preparation |
|
| BG002 | Placebo | One dose of placebo will be taken orally with water. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body Mass Index | Mean | Standard Deviation | kg/m^2 |
|
| OG001 |
| Dronabinol 5 mg |
One dose of dronabinol 5 mg will be taken orally with water. |
| OG002 | Placebo | One dose of placebo will be taken orally with water. |
|
|
| Secondary | Postprandial Change in Colonic Tone | Colonic tone is a measurement of the volume of the colon. Colonic tone was assessed by noting the changes in the balloon volume in the presence of a constant operating pressure in the balloon (in the barostat-manometric assembly placed in the colon.) | Intention-to-treat analysis | Posted | Mean | Standard Error | mL | 1 hour after ingestion of standard meal |
|
|
|
| Secondary | Post-treatment Sensory Threshold for First Perception of Pain | The sensory threshold for first perception of pain was measured by stepwise inflation in increments of 4 mm Hg at 60 second intervals up to a maximum pressure of 64 mm Hg. During this assessment participants were asked to report when they had the first sensation. The investigator recorded the threshold pressure at which the participants reported this sensation. | Intention-to-treat analysis | Posted | Mean | Standard Deviation | mm Hg | 1 hour after drug was ingested |
|
|
|
| Secondary | Post-Treatment Overall Sensory Rating in Response to 16, 24, 32, and 40 mm Hg Distensions | The sensory rating was measured by a 100 mm long Visual Analog Scale (VAS). The VAS does not have any pre-set marks between the extremes of 0 for no pain and 100 mm for extreme pain. The investigator measures the mark made by the participant in mm and records this for the value of pain. | Intention-to-treat analysis | Posted | Mean | Standard Error | mm | 1 hour after drug was ingested |
|
|
|
| Secondary | Fasting Colonic Tone | Colonic tone is a measurement of the volume of the colon. Colonic tone was assessed by noting the changes in the balloon volume in the presence of a constant operating pressure in the balloon (in the barostat-manometric assembly placed in the colon.) | Intention-to-treat analysis | Posted | Mean | Standard Error | mL | After 12 hour fast, before drug administered |
|
|
|
| Secondary | Postprandial Colonic Motility Index | Colonic phasic pressure activity is summarized as a motility index (MI)=log_e[number of contractions * sum of amplitudes) + 1]. A normal fasting average motility index (MI) would be about 12. An increase in MI means an increase in the phasic contractions (in contrast to tone) which is measured as a change in volume of the barostat balloon. (Therefore, an increase in MI means that the meal is moving more quickly through the colon.) | Intention-to-treat analysis | Posted | Mean | Standard Deviation | log mm Hg | 1 hour after ingestion of standard meal |
|
|
|
| Secondary | Post-treatment Sensory Threshold for First Sensation | The sensory threshold for first sensation was measured by stepwise inflation in increments of 4 mm Hg at 60 second intervals up to a maximum pressure of 64 mm Hg. During this assessment participants were asked to report when they had the first sensation. The investigator recorded the threshold pressure at which the participants reported this sensation. | Intention-to-treat analysis | Posted | Mean | Standard Deviation | mm Hg | 1 hour after drug was ingested |
|
|
|
| Secondary | Post-Treatment Sensory Threshold for First Perception of Gas | The sensory threshold for first perception of gas was measured by stepwise inflation in increments of 4 mm Hg at 60 second intervals up to a maximum pressure of 64 mm Hg. During this assessment participants were asked to report when they had the first sensation. The investigator recorded the threshold pressure at which the participants reported this sensation. | Intention-to-treat analysis | Posted | Mean | Standard Deviation | mm Hg | 1 hour after drug was ingested |
|
|
|
| 0 |
| 24 |
| 10 |
| 24 |
| EG001 | Dronabinol 5 mg | One dose of dronabinol 5 mg will be taken orally with water. | 0 | 24 | 13 | 24 |
| EG002 | Placebo | One dose of placebo will be taken orally with water. | 0 | 27 | 10 | 27 |
| Flushing/hot | General disorders | Systematic Assessment |
|
| Headache | General disorders | Systematic Assessment |
|
| Dizzy/light-headed | General disorders | Systematic Assessment |
|
| Loopy/foggy thinking | General disorders | Systematic Assessment |
|
| Elevated heart rate | Cardiac disorders | Systematic Assessment |
|
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| D004066 | Digestive System Diseases |
|
| 32 mm Hg Distension |
|
| 40 mm Hg Distension |
|
|